Bovine pericardium vs dacron for patch angioplasty after carotid endarterectomy : a prospective randomized study . HYPOTHESIS Bovine pericardium ( BP ) demonstrates improved intraoperative hemostasis and equivalent perioperative morbidity compared with Dacron when used as patch material for angioplasty following carotid endarterectomy . OBJECTIVE To prospectively compare BP and Dacron patch angioplasty after carotid endarterectomy in a randomized fashion . METHODS Ninety-five consecutive primary carotid endarterectomies were performed in a prospective randomized fashion in 92 patients . Fifty-one procedures were performed using BP and 44 using Dacron . Intraoperative suture line bleeding was subjectively evaluated by observing bleeding at 3 and 4 minutes following carotid cross-clamp removal and then objectively weighing the sponge used to tamponade bleeding during these time intervals . Perioperative morbidity , including cervical wound hematoma , transient ischemic attack , and stroke , and perioperative mortality were recorded . Statistical analysis was performed using paired t tests , chi ( 2 ) analysis , Fisher exact test , or multiple linear regression as appropriate . RESULTS Suture line bleeding at 3 minutes was present in 7 ( 14 % ) of 51 patients in the BP group and 24 ( 55 % ) of 44 patients in the Dacron group ( P < .001 ) . Suture line bleeding evaluated at 4 minutes was present in 2 ( 4 % ) of 51 patients in the BP group and 13 ( 30 % ) of 44 patients in the Dacron group ( P =.001 ) . Net +/- SEM sponge weight ( total intraoperative suture line bleeding ) was 6.25 +/- 0.55 g in the BP group and 16.34 +/- 1.85 g in the Dacron group ( P < .001 ) . Total suture line bleeding was significantly affected by activated clotting time ; however , multivariate analysis demonstrated that bleeding was significantly less with BP ( P < .001 ) even after adjusting for differences in activated clotting time . CONCLUSIONS Bovine pericardium demonstrated a statistically significant decrease in intraoperative suture line bleeding compared with Dacron . Handling characteristics were judged by the surgeons to be superior for BP . Therefore , we believe BP may be an alternative to Dacron when performing patch angioplasty of the carotid artery after endarterectomy .

Bovine pericardium

dacron

Bovine pericardium ( BP )

Dacron

carotid endarterectomy

BP

Dacron patch angioplasty

BP

Dacron

carotid cross-clamp removal

BP

Dacron

BP

Dacron

BP

Dacron

BP

Bovine pericardium

Dacron

BP

BP

Dacron

Perioperative morbidity

cervical wound hematoma

transient ischemic attack

stroke

perioperative mortality

Suture line bleeding at 3 minutes

Total suture line bleeding

bleeding

after carotid endarterectomy

carotid endarterectomies


A pilot study of the safety and efficacy of supplemental arginine to enhance immune function in persons with HIV/AIDS . OBJECTIVE We collected preliminary data on the safety and efficacy of supplemental arginine to improve natural killer cell cytotoxicity in a sample of persons with human immunodeficiency virus ( HIV ) and acquired immunodeficiency syndrome ( AIDS ) . METHODS In a randomized , double-blind , placebo-controlled pilot study in an academic medical center-based infectious disease clinic , 11 clinically stable , HIV-infected adults had been treated with highly active , antiretroviral therapy and had HIV plasma RNA levels of less than 10 000 copies/mL . Participants were randomly assigned to receive 19.6 g of arginine/d ( n = 6 ) or placebo ( n = 5 ) for 14 d. Plasma HIV RNA levels , neuropsychologic functioning , and self-reported adverse events were analyzed for safety of treatment . Efficacy was measured by natural killer cell cytotoxicity . RESULTS None of the participants experienced any adverse clinical , virologic , or neuropsychologic events that necessitated withdrawal from the study . The arginine-supplemented group showed a mean natural killer cell cytotoxicity increase of 18.9 lytic units , whereas the placebo group showed an increase of 0.3 lytic units . This difference was not statistically significant ( P = 0.79 ) . CONCLUSIONS Short-term arginine supplementation is safe for persons with HIV/AIDS . Additional studies with larger samples and longer periods are warranted to determine the effects of arginine supplementation on other indices of immune function and on clinical outcomes such as intercurrent illnesses .

arginine

arginine

antiretroviral therapy

19.6 g of arginine/d

placebo

arginine-supplemented

arginine

Plasma HIV RNA levels

neuropsychologic functioning

self-reported adverse events

Efficacy

mean natural killer cell cytotoxicity

adults


Overexpression of vascular endothelial growth factor ( VEGF ) and its cellular receptor KDR ( VEGFR-2 ) in the bone marrow of patients with acute myeloid leukemia . Vascular endothelial growth factor ( VEGF ) and its cellular receptor VEGFR-2 have been implicated as the main endothelial pathway required for tumor neovascularization . However , the importance of the VEGF/VEGFR-2 system for angiogenesis in hematologic malignancies such as AML remains to be elucidated . In 32 patients with newly diagnosed untreated AML , we observed by immunohistochemical analysis of bone marrow biopsies significantly higher levels of VEGF and VEGFR-2 expression than in 10 control patients ( P < 0.001 ) . In contrast , VEGFR-1 staining levels in AML patients were in the same range as in the controls . Expression of VEGF and VEGFR-2 was significantly higher in patients with a high degree of microvessel density compared to those with a low degree ( VEGF : P =0.024 ; VEGFR-2 : P =0.040 ) and correlated well with bone marrow microvessel density ( r ( s ) =0.566 and 0.609 , respectively ; P < 0.001 ) . Furthermore , in patients who achieved a complete remission following induction chemotherapy VEGFR-2 staining levels decreased into the normal range . In conclusion , our results provide evidence for increased expression of VEGF/VEGFR-2 of leukemic blasts and correlation with angiogenesis in the bone marrow of AML patients . Thus , VEGF/VEGFR-2 might constitute promising targets for antiangiogenic and antileukemic treatment strategies in AML .

induction chemotherapy

antiangiogenic

Expression of VEGF and VEGFR-2

remission

VEGFR-2 staining levels

VEGF/VEGFR-2 of leukemic blasts


Pain and fatigue management : results of a nursing randomized clinical trial . PURPOSE/OBJECTIVES Through a randomized clinical trial , to compare patients undergoing an initial course of chemotherapy who report pain and fatigue at baseline and who are receiving conventional care alone with those receiving conventional care plus a nursing intervention on outcomes reported at 20 weeks . SETTING Chemotherapy clinics of two comprehensive and two community cancer centers . METHODS Interviews were conducted at baseline and 10 and 20 weeks . An 18-week , 10-contact nursing intervention utilizing problem-solving approaches to symptom management and improving physical functioning and emotional health was implemented . SAMPLE The sample consisted of 53 patients in the experimental arm and 60 in the control arm who reported pain and fatigue at baseline . VARIABLES Pain and fatigue , numbers of other symptoms , and physical role impact and social-functioning subscales from the Medical Outcomes Study 36 Short Form . FINDINGS Patients who received the intervention reported a significant reduction in the number of symptoms experienced and improved physical and social functioning . Fewer patients in the experimental arm reported both pain and fatigue at 20 weeks . CONCLUSIONS Behavioral interventions targeted to patients with pain and fatigue can reduce symptom burden , improve the quality of the daily life of patients , and demonstrate the " value-added " role of nursing care for patients undergoing chemotherapy . IMPLICATIONS FOR NURSING These data support the " value-added " role of nursing interventions for symptom management and improved quality of life during the course of cancer treatment .

chemotherapy

conventional care alone

intervention

Behavioral interventions

nursing care

nursing interventions

Pain

pain

physical functioning

emotional health

pain

fatigue

Pain

fatigue

numbers of other symptoms

physical role impact

number of symptoms experienced

physical

social functioning

pain

fatigue

pain

fatigue

symptom burden

quality of the daily life

improved quality of life

cancer


Combining weight-loss counseling with the weight watchers plan for obese breast cancer survivors . OBJECTIVE The objective was to develop effective weight-loss methods for women who have had breast cancer , because obesity may result in an adverse prognosis . RESEARCH METHODS AND PROCEDURES This randomized pilot study tested an individualized approach toward weight loss in obese women who have had a diagnosis of breast cancer . An individualized approach was applied either alone or combined with the commercial Weight Watchers program . Forty-eight women ( body mass index of 30 to 44 kg/m ( 2 ) ) were enrolled . RESULTS Weight change after 12 months of intervention was as follows ( mean +/- SD ) : 0.85 +/- 6.0 kg in the control group , -2.6 +/- 5.9 kg in the Weight Watchers group , -8.0 +/- 5.5 kg in the individualized group , and -9.4 +/- 8.6 kg in the comprehensive group that used both individualized counseling and Weight Watchers . Weight loss relative to control was statistically significant in the comprehensive group 3 , 6 , and 12 months after randomization , whereas weight loss in the individualized group was significant only at 12 months . Weight loss of 10 % or more of initial body weight was observed in 6 of 10 women in the comprehensive group at 12 months . In the comprehensive and Weight Watchers-only groups , weight loss was significantly related to frequency of attendance at Weight Watchers meetings , and attendance was more frequent in the comprehensive group . DISCUSSION These data indicate that the most weight loss was achieved when the counseling approach combined both Weight Watchers and individualized contacts . This was effective even though most of the individualized contacts were by telephone .

control group

Weight Watchers group

weight loss

Weight change

Weight loss

weight loss

Weight loss

weight loss

weight loss

obese breast cancer survivors .


Efficacy of porcine secretin in children with autism and pervasive developmental disorder . Secretin , a gastrointestinal ( GI ) hormone , was reported in a preliminary study to improve language and behavior in children with autism/pervasive developmental disorder ( PDD ) and chronic diarrhea . To determine the efficacy of secretin , we completed a double-blind , placebo-controlled , crossover ( 3 weeks ) study in children with autism/PDD and various GI conditions using a single dose of intravenous porcine secretin . Children with chronic , active diarrhea showed a reduction in aberrant behaviors when treated with the secretin but not when treated with the placebo . Children with no GI problems are unaffected by either secretin or placebo . The improvement seen with secretin in children with autism/PDD and chronic diarrhea suggests that there may be a subtype of children with autism/PDD who respond to secretin .

porcine secretin

Secretin

secretin

placebo-controlled

intravenous porcine secretin .

secretin

placebo .

secretin

placebo

secretin

secretin .

Efficacy

language and behavior

aberrant behaviors


Double-blind placebo-controlled trial of secretin : effects on aberrant behavior in children with autism . Secretin has been proposed as a treatment alternative for autistic spectrum disorders , but empirical support is lacking . A double-blind placebo-controlled study examined the effect of a single dose of synthetic human secretin on aberrant behavior . Parent and teacher data from the Aberrant Behavior Checklist for eight male children were analyzed for reliable change in a clinical replication series . By parent and teacher report , the majority of change occurred either on the placebo trial or reflected deterioration subsequent to secretin infusion . Repeated-measures multivariate analysis of variance results were similar . Results are consistent with other studies , suggesting that secretin may not be an effective treatment option .

secretin :

Secretin

synthetic human secretin

placebo

secretin

secretin

autistic spectrum disorders

aberrant behavior .

Aberrant Behavior Checklist

children with autism .


Use of high-dose cytarabine to enhance cisplatin cytotoxicity-effects on the response and overall survival rates of advanced head and neck cancer patients . UNLABELLED It has been reported that cytarabine , acting by at least two different mechanisms , enhances the cytotoxic effect of cisplatin in in vitro systems . The aim of this open , prospective , randomised study was to estimate the eventual benefits from the inclusion of high-dose cytarabine in the cisplatin-5-fluorouracil ( 5-FU ) regimen as first-line treatment of patients with advanced head and neck cancer . The study recruited successive patients with unresectable grade I/II head and neck cancer who were not suitable for irradiation treatment ( T any N3 or T4 N2C ) , metastatic or previously irradiated . All patients gave their informed consent . A joint ear , nose and throat ( ENT ) oncological committee performed the selection . A total of 170 patients were included in the study . Patients randomised to arm A were given 1000 mg/m ( 2 ) cytarabine on day 1 preceding for 6 h cisplatin infusion , 30 mg/m ( 2 ) /24 h cisplatin intravenous ( i.v . ) bolus days 1-4 and 1000 mg/m ( 2 ) /24 h 5-FU in a 4-h infusion on days 1-4 . Patients in arm B were given cisplatin and 5-FU in the same dosage and schedule as in arm A . Additional irradiation+/-surgery was performed if and when feasible . Patients in both arms were well balanced with regard to clinical variables . The following results were obtained : Arm A : 84 patients were included , 74 were evaluable for activity ; RESPONSE complete response ( CR ) 8 ( 11 % ) , partial response ( PR ) 40 ( 54 % ) , stable disease ( SD ) 11 ( 15 % ) , progressive disease ( PD ) 15 ( 20 % ) . The overall response rate ( RR ) based on the evaluable patients was 48/74 ( 65 % , 95 % confidence interval ( CI ) 54-75 % ) ; The RR based on an intent-to-treat analysis was 57 % , 95 % CI 47-67 % ; Median survival was 13 months ; There were 50 episodes of granulocytopenia grade IV and 15 of febrile neutropenia per 316 cycles . Arm B : 86 patients were included , 80 were evaluable for activity ; RESPONSE CR 7 ( 9 % ) , PR 29 ( 36 % ) , SD 10 ( 12.5 % ) , PD 34 ( 42.5 % ) ; The overall RR based on the evaluable patients was 36/80 ( 45 % , 95 % CI 35-56 % ) ; The RR based on an intent-to-treat analysis was 42 % , 95 % CI 32-52 % ; Median survival was 8 months ; There were 14 episodes of granulocytopenia grade IV and 7 febrile neutropenias per 324 cycles . The RR was significantly higher in arm A ( P=0.013 ) , power ( one-sided ) 80 % . The proportion of patients from the appropriate subset who achieved a clinical response making additional treatment feasible was higher in arm A ( P=0.00015 ) , as well as the proportion of patients with a performance status 2+3 achieving a response ( P < 0.0001 ) . Using the Log-rank test , patients from arm A achieved a significantly longer survival ( P=0.009 ) , with the probability of survival at 12 months of 0.58 for patients in arm A and 0.28 for patients in arm B. Grade IV granulocytopenia and thrombocytopenia were more frequent in arm A . Due to its haematological side-effects , cytarabine might not be the ideal drug to modulate the cytotoxicity of cisplatin . However , other modulators of its activity could be of interest for further studies in head and neck cancer patients .

cytarabine

cisplatin

cytarabine

cisplatin

cytarabine

cisplatin-5-fluorouracil ( 5-FU )

irradiation treatment

1000 mg/m ( 2 ) cytarabine

cisplatin infusion

cisplatin

cisplatin and 5-FU

irradiation+/-surgery

cytarabine

cisplatin

cytotoxicity-effects

survival rates

complete response ( CR )

partial response ( PR )

stable disease ( SD )

progressive disease

overall response rate ( RR )

RR based on an intent-to-treat analysis

Median survival

granulocytopenia grade IV

febrile neutropenia

CR

PR

SD

PD

overall RR

RR was significantly higher

survival

survival at 12 months

haematological side-effects

cytotoxicity


Multiple doses of secretin in the treatment of autism : a controlled study . UNLABELLED Dramatic effects on autistic behaviour after repeated injections of the gastrointestinal hormone secretin have been referred in a number of case reports . In the absence of curative and effective treatments for this disabling condition , this information has created new hope among parents . Although controlled studies on the effect of mainly one single dose have not documented any effect , many children still continue to receive secretin . Six children enrolled in a double-blind , placebo-controlled crossover study in which each child was its own control . Human synthetic secretin , mean dose 3.4 clinical units , and placebo were administered intravenously in randomized order every 4th wk , on three occasions each . The measurement instruments were the visual analogue scale ( VAS ) and the aberrant behaviour checklist ( ABC ) . Statistically significant differences were found for placebo in 3 out of 6 children and for secretin in one child , using parental ratings only ( VAS scores ) . Differences were small and lacked clinical significance , which was in accordance with the overall impression of the parents and teachers and visual inspection of graphs . CONCLUSION In this placebo-controlled study , multiple doses of secretin did not produce any symptomatic improvement .

secretin

secretin

secretin

Human synthetic secretin

placebo

secretin

parental ratings only ( VAS scores )

autism

children

Six

children


Monitoring tumour cells in the peripheral blood of small cell lung cancer patients . BACKGROUND Flow cytometry was used to enumerate tumour cells in longitudinal studies of peripheral blood from small cell lung cancer ( SCLC ) patients , together with magnetic bead selection to isolate and identify these cells . As part of a trial , 11 patients received either standard ( four weekly ) chemotherapy with ifosfamide , carboplatin , and etoposide ( ICE ) or accelerated ( two weekly ) ICE with filgrastim ( granulocyte colony-stimulating factor [ G-CSF ] ) and autologous stem cell support . METHODS Fresh venous blood was taken throughout treatment and follow-up . Aliquots were stained with a " tumour-specific " antibody against epithelial tissue ( Ber EP4 ) , verified as a good marker of SCLC cells by immunohistochemistry . Matched samples labelled with Ber EP4 were separated magnetically by adding a secondary bead-antibody conjugate for confirmation of tumour cell identity . RESULTS Circulating tumour cells were detected and monitored throughout treatment periods . An initial rise in circulating cells after the first cycle was followed by a fall in both treatment arms to baseline levels set by normal controls . This was achieved by week 12 in the accelerated treatment arm and by week 24 in the standard arm . CONCLUSIONS Flow cytometry and magnetic bead isolation can be used to identify changes in numbers of circulating tumour cells in patients undergoing chemotherapy for SCLC and thereafter during follow-up periods . Absence of tumour cells may indicate a more favourable patient group who would benefit from a more intense course of treatment .

Flow cytometry

chemotherapy

ifosfamide

carboplatin

etoposide ( ICE )

autologous stem cell support

chemotherapy

Circulating tumour cells


Relation between early mitral regurgitation and left ventricular thrombus formation after acute myocardial infarction : results of the GISSI-3 echo substudy . OBJECTIVE To evaluate the prevalence and correlates of left ventricular thrombosis in patients with acute myocardial infarction , and whether the occurrence of early mitral regurgitation has a protective effect against the formation of left ventricular thrombus . DESIGN AND SETTING Multicentre clinical trial carried out in 47 Italian coronary care units . PATIENTS AND METHODS 757 patients from the GISSI-3 echo substudy population with their first acute myocardial infarct were studied by echocardiography at 24-48 hours from symptom onset ( S1 ) , at discharge ( S2 ) , at six weeks ( S3 ) , and at six months ( S4 ) . The diagnosis of left ventricular thrombosis was based on the detection of an echo dense mass with defined margins visible throughout the cardiac cycle in at least two orthogonal views . RESULTS In 64 patients ( 8 % ) , left ventricular thrombosis was detected in one or more examinations . Compared with the remaining 693 patients , subjects with left ventricular thrombosis were older ( mean ( SD ) age : 64.6 ( 13.0 ) v 59.8 ( 11.7 ) years , p < 0.005 ) , and had larger infarcts ( extent of wall motion asynergy : 40.9 ( 11.5 ) % v 24.9 ( 14 ) % , p < 0.001 ) , greater depression of left ventricular ejection fraction at S1 ( 43.3 ( 6.9 ) % v 48.1 ( 6.8 ) % , p < 0.001 ) , and greater left ventricular volumes at S1 ( end diastolic volume : 87 ( 22 ) v 78 ( 18 ) ml/m ( 2 ) , p < 0.001 ; end systolic volume : 50 ( 17 ) v 41 ( 14 ) ml/m ( 2 ) , p < 0.001 ) . The prevalence of moderate to severe mitral regurgitation on colour Doppler at S1 was greater in patients who had left ventricular thrombosis at any time ( 10.2 % v 4.2 % , p < 0.05 ) . On stepwise multiple logistic regression analysis the only independent variables related to the presence of left ventricular thrombosis were the extent of wall motion asynergy and anterior site of infarction . CONCLUSIONS Left ventricular thrombosis is not reduced , and may even be increased , by early moderate to severe mitral regurgitation after acute myocardial infarction . The only independent determinant of left ventricular thrombosis is the extent of the akinetic-dyskinetic area detected on echocardiography between 24-48 hours from symptom onset .

left ventricular thrombosis

left ventricular thrombosis

larger infarcts

left ventricular volumes at S1

left ventricular thrombosis

left ventricular thrombosis

Left ventricular thrombosis


A scanning electron microscopic study of different caries removal techniques on human dentin . Scanning electron microscopy ( SEM ) evaluated the effect of different caries removal techniques on human dentin topography . Thirty-six extracted human carious mandibular molars were randomly assigned to six groups according to caries removal technique . Carious tissue was removed by hand excavation , bur excavation , air-abrasion , laser ablation , chemomechanical methods and sono-abrasion . The remaining dentin surfaces were replicated and gold-coated . The surfaces were examined using SEM and distinct differences in appearance were observed among specimens treated with different caries removal techniques . While hand-excavated , bur-excavated and air-abraded carious dentin surfaces were covered with a residual smear layer , sono-abrasion with patent dentinal tubules completely removed the smear layer . A few patent orifices of dentinal tubules were observed in dentin subjected to laser ablation and chemo-mechanical caries removal .

hand excavation

bur excavation

air-abrasion

laser ablation

chemomechanical methods

sono-abrasion

replicated and gold-coated

removal techniques

hand excavation

bur excavation

air-abrasion

laser ablation

chemomechanical methods

sono-abrasion

residual smear layer

patent orifices of dentinal tubules


Walking trials in postmenopausal women : effect of one vs two daily bouts on aerobic fitness . We compared the effects of one vs two daily bouts of walking on aerobic fitness and body composition in postmenopausal women . One hundred and thirty-four subjects were randomized into exercise groups or a control group and 130 completed the study . The subjects walked 5 d/week for 15 weeks at 65 % of their maximal aerobic power expending 300 kcal ( 1255 kJ ) in exercise in one ( Group S1 ) or two daily sessions ( Group S2 ) . VO ( 2max ) was measured in a direct maximal treadmill test . Body mass index ( BMI ) was calculated and the percentage of body fat ( fat % ) estimated using skinfold measurements . The net change in the VO ( 2max ) was 2.5 mL min/kg ( 95 % CI 1.5 , 3.5 ) ( 8.7 % ) in Group S1 and 2.5 mL min/kg ( 95 % CI 1.5 , 3.5 ) ( 8.8 % ) in Group S2 . The net change in body mass was -1.2 kg ( 95 % CI-1.9 , -0.5 ) in Group S1 and -1.1 kg ( 95 % CI -1.8 , -0.4 ) in Group S2 . The net fat % change was -2.1 % ( 95 % CI-2.7 , -1.4 ) in Group S1 and -1.7 % ( 95 % CI-2.3 , -1.0 ) in Group S2 . Exercise improved the maximal aerobic power and body composition equally when walking was performed in one or two daily bouts .

one vs two daily bouts of walking

walked

exercise

direct maximal treadmill test

walking

aerobic fitness .

aerobic fitness

body composition

VO ( 2max )

Body mass index ( BMI )

VO ( 2max )

net change in body mass

net fat % change

postmenopausal

women

postmenopausal

women

One hundred and thirty-four


Intramuscular depot medroxyprogesterone versus oral megestrol for the control of postmenopausal hot flashes in breast cancer patients : a randomized study . BACKGROUND Hot flashes are frequent in postmenopausal breast cancer patients , especially when treated with tamoxifen . Estrogen replacement therapy is the most effective treatment for hot flashes , but its use is controversial in breast cancer survivors . Progestins may offer a good alternative for the control of hot flashes in this setting ; in particular , oral megestrol acetate has been proven effective in a randomized , placebo-controlled clinical trial . With the aim of further improving these results , we have designed a randomized study comparing oral megestrol acetate with depot intramuscular ( i.m . ) medroxyprogesterone acetate ( MPA ) for the control of hot flashes in postmenopausal patients with a history of breast cancer . PATIENTS AND METHODS Seventy-one postmenopausal patients were randomized to receive an i.m . injection of depot MPA 500 mg on days 1 , 14 and 28 , or oral megestrol acetate 40 mg daily for 6 weeks . Patients recorded daily the number and severity of their hot flashes ; response was defined as a > or =50 % decrease in the number and severity of hot flashes . RESULTS At week 6 , hot flashes were reduced by 86 % on average in the whole group of patients , without significant differences between the two progestins . Response was obtained by 75 and 67 % of patients receiving MPA or megestrol , respectively ( P = 0.5 ) . Responders were followed to assess maintenance of response ( without further treatment ) , which was significantly better with i.m . MPA : in this group , 89 % of responders still showed a benefit at week 24 , compared with 45 % in the megestrol group ( P = 0.03 ) . CONCLUSIONS Our study shows that a short cycle of i.m . depot MPA injections provides significant and long-lasting relief from postmenopausal hot flashes in patients with a history of breast cancer , offering an alternative to estrogen replacement therapy or prolonged administration of oral megestrol .

medroxyprogesterone

megestrol

Estrogen replacement therapy

megestrol acetate

medroxyprogesterone acetate ( MPA )

depot MPA

oral megestrol acetate

MPA

megestrol

MPA

megestrol

hot flashes

Hot flashes

hot flashes

hot flashes

hot flashes

hot flashes

hot flashes

relief

postmenopausal hot flashes

breast cancer patients :

postmenopausal breast cancer patients


Is periprostatic local anesthesia for transrectal ultrasound guided prostate biopsy associated with increased infectious or hemorrhagic complications ? A prospective randomized trial . PURPOSE Periprostatic local anesthesia for prostate biopsy requires 2 or more extra needle punctures and injection of the local anesthetic through the highly colonized rectum . To our knowledge we report the first prospective randomized trial to assess the infectious or hemorrhagic complications associated with this method . MATERIALS AND METHODS A total of 100 consecutive patients with sterile urine cultures underwent transrectal ultrasound guided prostate biopsy . They were randomized to receive a periprostatic nerve block or no anesthesia . Patients were evaluated for the amount of rectal and urethral bleeding , and symptoms and signs of infection after biopsy . RESULTS The amount of urethral bleeding was slight and similar in the 2 groups . Rectal bleeding was significantly less in the patients who received anesthesia . High fever ( greater than 37.8C ) was more frequent in the nerve block group and 2 patients in this group required rehospitalization . Bacteriuria in post-biopsy urine cultures was significantly more common in the anesthesia group . CONCLUSIONS Our results suggest that periprostatic local anesthesia for prostate biopsy does not increase the risk of urethral bleeding . It is associated with a decreased incidence of rectal bleeding , presumably due to decreased patient discomfort . The incidence of bacteriuria was significantly higher in the anesthesia group . High fever and hospitalization due to infectious complications were also more common in the local anesthesia group , although not statistically significant . Prospective randomized trials seem warranted to determine the optimum antibiotic prophylaxis regimen in patients undergoing biopsy with a periprostatic nerve block .

anesthesia

periprostatic nerve block

anesthesia

rectal and urethral bleeding

symptoms and signs of infection after

biopsy

anesthesia

infectious or hemorrhagic complications

infectious or hemorrhagic complications

amount of rectal and urethral bleeding

infection after biopsy

amount of urethral bleeding

Rectal bleeding

High fever

urethral bleeding

rectal bleeding

bacteriuria

High fever and hospitalization

sterile urine cultures


Limited effects of micronutrient supplementation on strength and physical function after abdominal aortic aneurysmectomy . BACKGROUND Tissue injury following ischemia-reperfusion is mediated in part by free oxygen radicals . We hypothesized that perioperative micronutrient supplementation would augment antioxidant defenses , minimize muscle injury , and minimize postoperative decreases in muscle strength and physical function following abdominal aortic aneurysmectomy . SETTING A university-affiliated hospital and regional referral center . DESIGN A randomized , double-blind , placebo-controlled trial of supplementation with beta-carotene , vitamins C and E , zinc , and selenium for a period of 2-3 weeks prior to surgery and 1 week thereafter . STUDY POPULATION Patients undergoing elective abdominal aortic aneurysmectomy ( n=18 per group ) . PRINCIPAL MEASUREMENTS Handgrip and other measures of strength and physical function . RESULTS Handgrip and quadriceps strength decreased following surgery , but not to a significantly different extent in the placebo and supplemented groups . Self-rated physical function decreased following surgery in the placebo group and was preserved in the supplemented group . CONCLUSIONS Perioperative supplementation with micronutrients with antioxidant properties has limited effects on strength and physical function following major elective surgery .

micronutrient supplementation

micronutrient supplementation

placebo-controlled

abdominal aortic aneurysmectomy

surgery

strength and physical function

abdominal

augment antioxidant defenses ,

minimize muscle injury

Handgrip and quadriceps strength

Self-rated physical function

strength and physical function

abdominal aortic aneurysmectomy .

abdominal aortic aneurysmectomy


Oral desensitization in papular urticaria in children . Papular urticaria ( PU ) is among the commonest skin ailments in children . Induced specific desensitization to insect bites is theoretically an effective means of prevention of PU . In this double blind placebo controlled study , an oral vaccine prepared from insect saliva was compared with placebo ( stable vaccine solvent ) . Vaccine and placebo effectiveness were tested by counting active PU lesions , serum eosinophils , and IgE , before and after 4 months of treatment . Statistically significant differences between oral vaccine and placebo were not found in the clinical or the immunological variables tested . We conclude that , although a lack of oral vaccine efficacy was suspected , larger study samples are needed to strengthen our conclusion .

placebo

placebo ( stable vaccine solvent ) .

Vaccine

placebo

counting active PU lesions

serum eosinophils

IgE

papular urticaria in

children

. Papular urticaria


Fusion surgery is slightly better than non-surgical treatment in patients with severe chronic non-specific low back pain .

Fusion surgery

non-surgical treatment


Effect of clinical pharmacy services on the blood pressure of African-American renal transplant patients . OBJECTIVE The objective of this study was to determine if African-American renal transplant patients who received direct patient care from a clinical pharmacist had better blood pressure control compared to African-American renal transplant patients who did not have clinical pharmacy services . METHODS Renal transplant patients were prospectively randomized into an intervention group or a control group . Patients in the intervention group received clinical pharmacy services that included a clinical pharmacist performing patient medication reviews , with emphasis on preventing or resolving medication-related problems and providing medication recommendations . Patients in the control group received routine clinic services , but had no clinical pharmacist interaction . Analysis was performed to detect differences between the intervention and control groups in baseline and quarterly systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) for one year post-study enrollment . RESULTS There were no differences between the intervention ( N = 13 ) and control ( N = 10 ) groups in baseline blood pressures or in the percentage of hypertensive patients . Significant differences in the change in SBP and DBP from baseline between the intervention and control groups were observed at the second , third , and fourth quarters of the study , favoring the intervention group ( P < .01 ) . Mean SBP was significantly lower in the intervention group at the second ( 137.8 +/- 15.0 vs 168.9 +/- 15.3 ) , third ( 135.9 +/- 11.7 vs 164.6 +/- 20.1 ) , and fourth ( 145.3 +/- 16.8 vs 175.8 +/- 33.9 ) quarters of the study ( P < .05 ) . Mean DBP was significantly lower in the intervention group at the second ( 76.0 +/- 11.8 vs 84.9 +/- 6.1 ) and fourth ( 77.0 +/- 10.2 vs 91.8 +/- 12.0 ) quarters ( P < .05 ) . CONCLUSION Direct patient care services provided by a clinical pharmacist , in addition to routine clinical services , have a positive effect on the blood pressure of African-American renal transplant patients . A multidisciplinary team that includes a clinical pharmacist is beneficial to patient care .

clinical pharmacy services

clinical pharmacist

received

routine clinic services

, but had

no clinical pharmacist interaction

blood pressure

blood pressure control

diastolic blood pressure ( DBP )

blood pressures

SBP

DBP

Mean SBP

Mean DBP

blood pressure

renal transplant

Renal transplant patients


Risperidone in children with autism and serious behavioral problems . BACKGROUND Atypical antipsychotic agents , which block postsynaptic dopamine and serotonin receptors , have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances . However , data on the safety and efficacy of atypical antipsychotic agents in children are limited . METHODS We conducted a multisite , randomized , double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums , aggression , or self-injurious behavior in children 5 to 17 years old . The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement ( CGI-I ) scale at eight weeks . RESULTS A total of 101 children ( 82 boys and 19 girls ; mean [ +/-SD ] age , 8.8+/-2.7 years ) were randomly assigned to receive risperidone ( 49 children ) or placebo ( 52 ) . Treatment with risperidone for eight weeks ( dose range , 0.5 to 3.5 mg per day ) resulted in a 56.9 percent reduction in the Irritability score , as compared with a 14.1 percent decrease in the placebo group ( P < 0.001 ) . The rate of a positive response , defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale , was 69 percent in the risperidone group ( 34 of 49 children had a positive response ) and 12 percent in the placebo group ( 6 of 52 , P < 0.001 ) . Risperidone therapy was associated with an average weight gain of 2.7+/-2.9 kg , as compared with 0.8+/-2.2 kg with placebo ( P < 0.001 ) . Increased appetite , fatigue , drowsiness , dizziness , and drooling were more common in the risperidone group than in the placebo group ( P < 0.05 for each comparison ) . In two thirds of the children with a positive response to risperidone at eight weeks ( 23 of 34 ) , the benefit was maintained at six months . CONCLUSIONS Risperidone was effective and well tolerated for the treatment of tantrums , aggression , or self-injurious behavior in children with autistic disorder . The short period of this trial limits inferences about adverse effects such as tardive dyskinesia .

Risperidone

atypical antipsychotic

risperidone

placebo

risperidone

placebo

risperidone

placebo

risperidone

placebo

Risperidone

placebo

risperidone

Risperidone

Irritability score

Irritability score

CGI-I scale

average weight gain

appetite ,

fatigue

drowsiness

dizziness

, and

drooling

children

autism

behavioral problems .

autistic disorder

children

children

autistic disorder


Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo : a final update . PURPOSE Different outcome results have been published in trials comparing maximal androgen blockade ( MAB ) with chemical or surgical castration alone . The conflicting results could be explained by the fact that patients were included with different prognostic factors . In this new analysis of the Anandron European Study , independent prognostic factors have been evaluated in order to identify those which could influence the study outcome and the impact of the treatment . MATERIAL AND METHODS 399 out of 457 patients recruited in this study were divided in a good or poor prognostic group depending on the presence of two or more poor prognostic factors , these were pain requiring treatment , > 5 bone metastases , hydronephrosis , and alkaline phosphatase > 2 ULN . RESULTS When expressed as a percentage , the improvement in time to progression , overall and cancer specific survival in the Anandron treated patients was identical in both groups . In absolute terms this improvement , however , was greater in the good prognostic group . CONCLUSION In comparison with surgical castration MAB using Anandron , in patients with metastatic prostate cancer improves the time to objective progression , overall and cancer specific survival , irrespective of certain poor prognostic factors .

castration

anandron

placebo

chemical or surgical castration alone

Anandron

surgical castration

MAB using Anandron

improvement in

time to progression

overall and cancer specific survival

objective progression

overall and cancer specific survival

advanced prostate cancer

metastatic prostate cancer


A randomised , controlled study of dietary intervention in autistic syndromes . Impaired social interaction , communication and imaginative skills characterize autistic syndromes . In these syndromes urinary peptide abnormalities , derived from gluten , gliadin , and casein , are reported . They reflect processes with opioid effect . The aim of this single blind study was to evaluate effect of gluten and casein-free diet for children with autistic syndromes and urinary peptide abnormalities . A randomly selected diet and control group with 10 children in each group participated . Observations and tests were done before and after a period of 1 year . The development for the group of children on diet was significantly better than for the controls .

dietary intervention

gluten and casein-free diet

controls .

Observations and tests

development

autistic syndromes .

children

autistic syndromes

urinary peptide abnormalities .

children


Primary deep sclerectomy versus primary deep sclerectomy with the use of mitomycin C in primary open-angle glaucoma . PURPOSE To prospectively study and compare the effectiveness and the safety of primary deep sclerectomy with and without the use of mitomycin C in eyes with open-angle glaucoma . PATIENTS AND METHODS A total of 90 eyes of 90 patients with primary open-angle glaucoma or pseudoexfoliative glaucoma underwent deep sclerectomy . Patients were enrolled consecutively and assigned randomly to undergo deep sclerectomy without the use of mitomycin C ( DS group ) and deep sclerectomy with the application of mitomycin C ( DSMMC group ) in a concentration of 0.2 mg/mL for 2.5 minutes , before the superficial scleral flap formation . RESULTS The intraocular pressure was significantly decreased by 7.13 mm Hg or 27.59 % in the DS group and by 11.68 mm Hg or 42.25 % in the DSMMC group at the end of the follow-up period . The intraocular pressure reduction in the DSMMC group was statistically significant when compared with that in the DS group ( P < 0.05 ) . The complete ( IOP < 22 mm Hg without medication ) and qualified ( IOP < 22 mm Hg with or without medication ) success rates at the end of the follow-up period were 42.5 % and 72.5 % in the DS group and 50 % and 95 % in the DSMMC group . The qualified success rate in the DSMMC group was statistically significant when compared with that in the DS group . Differences in complications ( choroidal detachment , hyphema , leakage ) seen between the two groups were statistically nonsignificant . A hemorrhagic detachment of the Descemet membrane was observed in one eye in the DSMMC group . CONCLUSIONS The use of intraoperative mitomycin C during deep sclerectomy significantly reduced the postoperative IOP and increased the success rate of the procedure .

Primary deep sclerectomy

mitomycin C

effectiveness

safety

intraocular pressure

success rates

qualified success rate

primary open-angle glaucoma

eyes with open-angle glaucoma

90 eyes of 90 patients


Cyclosporine inhibition of P-glycoprotein in chronic myeloid leukemia blast phase . Chronic myeloid leukemia blast phase ( CML-BP ) cells commonly express the multidrug transporter , P-glycoprotein ( Pgp ) . To determine whether Pgp inhibition improves treatment outcome in CML-BP , the Southwest Oncology Group performed a randomized , controlled trial testing the benefit of the Pgp modulator , cyclosporin A ( CsA ) . Seventy-three eligible patients were assigned to treatment with cytarabine and infusional daunorubicin with or without intravenous CsA . Treatment with CsA yielded no improvement in treatment outcome as measured by the frequency of induction resistance ( 68 % vs 53 % ) , rate of complete remission or restored chronic phase ( CR/CP , 8 % vs 30 % ) , and survival ( 3 vs 5 months ) . Blast expression of Pgp ( 63 % ) and LRP ( 71 % ) was common , whereas only Pgp adversely impacted the rate of CR/CP ( P =.025 ) . We conclude that Pgp has prognostic relevance in CML-BP but that the modulation of Pgp function with CsA as applied in this trial is ineffective .

Cyclosporine

Pgp modulator

cyclosporin A ( CsA )

no improvement

frequency of induction resistance

rate of complete remission

restored chronic phase

survival

Blast expression of Pgp

LRP

rate of CR/CP

chronic myeloid leukemia blast phase

Seventy-three


A randomized , double-blind , placebo-controlled comparison of the analgesic efficacy , onset of action , and tolerability of ibuprofen arginate and ibuprofen in postoperative dental pain . BACKGROUND Because of its enhanced pharmacokinetic characteristics , ibuprofen arginate might be expected to provide faster pain relief than standard ibuprofen formulations in patients experiencing acute pain . OBJECTIVE This study assessed the analgesic efficacy , speed of onset , and tolerability of ibuprofen arginate compared with a commercially available form of ibuprofen in patients with postoperative dental pain . METHODS Patients were randomized to receive ibuprofen arginate 200 or 400 mg , ibuprofen 200 or 400 mg , or placebo in this multicenter , double-blind , double-dummy , parallel-group trial . Patients were observed for 6 hours after administration of a single dose of study medication . A repeated-dose , open-label phase followed . Pain intensity and pain relief were measured using traditional verbal descriptor scales ; onset of analgesia was assessed using 2 stopwatches to measure the time to achievement of specific pain relief criteria . RESULTS A total of 498 patients ( 219 men , 279 women ; mean age , 21.5 years ) participated in this study . Baseline pain was moderate in 388 patients ( 78 % ) and severe in 110 patients ( 22 % ) . Meaningful pain relief was reached after a median of 29 and 28 minutes with ibuprofen arginate 200 and 400 mg , respectively , and after 52 and 44 minutes with ibuprofen 200 and 400 mg , respectively ( all , P < 0.05 ) . The percentages of patients who achieved meaningful pain relief within the first hour after treatment were 77.6 % and 83.7 % for ibuprofen arginate 200 and 400 mg , respectively , 61.0 % and 63.0 % for ibuprofen 200 and 400 mg , respectively , and 39.8 % for placebo . The differences between ibuprofen arginate and ibuprofen were statistically significant ( both doses , P < 0.05 ) . Significantly greater numbers of patients achieved meaningful pain relief with ibuprofen arginate 400 mg compared with placebo from 20 minutes through 6 hours and with ibuprofen arginate 200 mg from 30 minutes through 6 hours ( P < 0.05 ) . Compared with placebo , a greater number of patients achieved meaningful pain relief with ibuprofen 400 mg from 45 minutes through 6 hours ; with ibuprofen 200 mg. the corresponding interval was from I through 6 hours . After the first hour , pain reduction was similar for the similar doses of the 2 ibuprofen preparations . Median remedication times with both doses of ibuprofen arginate were similar to those with both doses of ibuprofen , ranging from 4.0 to 5.2 hours . Adverse-event profiles were similar between the 2 active medications . CONCLUSIONS Ibuprofen arginate was effective in this population of patients experiencing moderate to severe pain after surgical extraction of > or = 1 impacted third molar , with 16 to 24 minutes ' faster time to meaningful pain relief than with ibuprofen . The 2 formulations had similar tolerability profiles .

ibuprofen arginate

ibuprofen

ibuprofen arginate

standard ibuprofen

placebo

ibuprofen arginate

ibuprofen

ibuprofen arginate

ibuprofen

ibuprofen arginate

placebo

ibuprofen

ibuprofen

ibuprofen arginate

Ibuprofen arginate

analgesic efficacy

, onset of action

tolerability

pharmacokinetic characteristics

pain relief

analgesic efficacy

, speed of onset , and tolerability

Pain intensity and pain relief

Baseline pain

pain relief

pain relief

pain relief

pain relief

pain reduction

Median remedication times

Adverse-event profiles

pain relief

tolerability

postoperative dental pain .

acute pain .

postoperative dental pain

men

women


[ Local treatment of periarthropathies with the 5-HT3-receptor-antagonist tropisetron ] . All substances used in the local treatment for periarthropathies , such as local anesthetics , corticosteroids or botulinum toxin A , possess certain disadvantages . Finding alternatives to these agents in the local treatment of the disease therefore seems desirable . Comparative studies proved a local injection of the 5-HT3 receptor antagonist , tropisetron ( Navoban ( R ) ) , to be more effective than an injection of the local anesthetic prilocaine in treating periarthropathies of different localizations . A comparison between the local injection of 10 mg of depot dexamethasone combined with 60 mg of lidocaine and 5 mg of tropisetron showed that the two regimens had the same effect . These findings demonstrate that a local injection of 5 mg tropisetron does represent an alternative to the local treatment with corticosteriods plus local anesthetics . However , these results should be corroborated by additional studies .

5-HT3-receptor-antagonist tropisetron ]

local anesthetics

corticosteroids

botulinum toxin A

local anesthetic prilocaine

depot dexamethasone

lidocaine

tropisetron

tropisetron

corticosteriods

local anesthetics

effective

local injection of 5 mg tropisetron

periarthropathies

periarthropathies

periarthropathies


Home based management in multiple sclerosis : results of a randomised controlled trial . BACKGROUND Home based medical care is a popular alternative to standard hospital care but there is uncertainty about its cost-effectiveness . OBJECTIVES To compare the effectiveness and the costs of multidisciplinary home based care in multiple sclerosis with hospital care in a prospective randomised controlled trial with a one year follow up . METHODS 201 patients with clinically definite multiple sclerosis were studied . They were randomised in a ratio 2:1 to an intervention group ( 133 ) or a control group ( 68 ) . They were assessed at baseline and one year after randomisation with validated measures of physical and psychological impairment and quality of life ( SF-36 health survey ) . The costs to the National Health Service over the one year follow up were calculated by a cost minimisation analysis . RESULTS There were no differences in functional status between the home based care group and the hospital group . There was a significant difference between the two groups favouring home based management in four SF-36 health dimensions-general health , bodily pain , role-emotional , and social functioning ( all p < or = 0.001 ) . The cost of home based care was slightly less ( 822 euros/patient/year ) than hospital care , mainly as a result of a reduction in hospital admissions . CONCLUSIONS Comprehensive planning of home based intervention implemented by an interdisciplinary team and designed specifically for people with multiple sclerosis may provide a cost-effective approach to management and improve the quality of life .

Home based management

Home based medical care

multidisciplinary home based care

cost-effectiveness .

effectiveness and the costs

functional status

cost

cost-effective

quality of life

multiple sclerosis


Combined therapy in the treatment of primary mediastinal B-cell lymphoma : conventional versus escalated chemotherapy . Treatment of patients with primary mediastinal B-cell lymphoma ( PMBCL ) remains controversial . We started a controlled clinical trial to evaluate the efficacy and toxicity of a conventional versus more intensive regimen of combined chemotherapy followed by radiotherapy to the mediastinum with the mantle technique . From 1989 to 1997 , 68 patients diagnosed with previously untreated PMBCL , aged 18-65 years and negative for immunodeficiency virus test , were considered candidates to receive either conventional chemotherapy with CEOP-Bleo ( cyclophosphamide 750 mg/m ( 2 ) , vincristine 1.4 mg/m ( 2 ) , prednisone 40 mg/m ( 2 ) , epirubicin 70 mg/m ( 2 ) , and bleomycin 10 mg/m ( 2 ) ) or mega CEOP-Bleo ( cyclophosphamide 1000 mg/m ( 2 ) , epirubicin 120 mg/m ( 2 ) , vincristine , prednisone , and bleomycin at the same doses ) every 21 days for six cycles , followed by radiotherapy to the mediastinum with the mantle technique ( 35-45 Gy , mean 38 Gy ) . Complete response ( CR ) rates were not statistically different : 64 % [ 95 percent confidence interval ( CI ) : 58 percent to 70 percent ] for conventional arm vs 81 percent ( 95 CI : 77-86 percent ) in the intensive group ( p=0.2 ) . However , failure-free survival ( FFS ) and overall survival ( OS ) had statistical differences . At 5 years , actuarial FFS for patients treated with conventional chemotherapy was 51 percent ( 95 percent CI : 44-59 percent ) compared to 70 percent ( 95 percent CI : 65-76 percent ) in the intensive arm ( p > 0.01 ) . OS rates were also different : 54 percent ( 95 percent CI : 48-57 percent ) vs 70 percent ( 95 percent CI : 65-76 percent ) , respectively ( p < 0.01 ) . Toxicity was mild and no therapy-related deaths were observed . At a median follow-up of 7.3 years , no second neoplasia or acute leukemia has been observed . The international prognostic index was not useful to define clinical risk in this selected group of patients . Multivariate analysis identified pleural and pericardial effusion and chemotherapy regimen as prognostic factors influencing FFS and OS . We feel that patients with PMBCL should be treated with more intensive , but not myeloablative chemotherapy , followed by adjuvant radiotherapy to achieve an improvement in outcome in this setting of patients . Patients with pleural or pericardial effusion are considered at high risk for failure with the actual programs of treatment and probably will be considered for experimental therapeutic approaches .

efficacy and toxicity

Complete response ( CR ) rates

confidence interval ( CI ) :

actuarial FFS

OS rates

Toxicity

therapy-related deaths

neoplasia or acute leukemia

The international prognostic index

FFS and OS .

primary mediastinal B-cell lymphoma


Local warming and insertion of peripheral venous cannulas : single blinded prospective randomised controlled trial and single blinded randomised crossover trial . OBJECTIVE To determine whether local warming of the lower arm and hand facilitates peripheral venous cannulation . DESIGN Single blinded prospective randomised controlled trial and single blinded randomised crossover trial . SETTING Neurosurgical unit and haematology ward of university hospital . PARTICIPANTS 100 neurosurgical patients and 40 patients with leukaemia who required chemotherapy . INTERVENTIONS Neurosurgical patients ' hands and forearms were covered for 15 minutes with a carbon fibre heating mitt . Patients were assigned randomly to active warming at 52 degrees C or passive insulation ( heater not activated ) . The same warming system was used for 10 minutes in patients with leukaemia . They were assigned randomly to active warming or passive insulation on day 1 and given alternative treatment during the subsequent visit . MAIN OUTCOME MEASURES PRIMARY : success rate for insertion of 18 gauge cannula into vein on back of hand . SECONDARY : time required for successful cannulation . RESULTS In neurosurgical patients , it took 36 seconds ( 95 % confidence interval 31 to 40 seconds ) to insert a cannula in the active warming group and 62 ( 50 to 74 ) seconds in the passive insulation group ( P=0.002 ) . Three ( 6 % ) first attempts failed in the active warming group compared with 14 ( 28 % ) in the passive insulation group ( P=0.008 ) . The crossover study in patients with leukaemia showed that insertion time was reduced by 20 seconds ( 8 to 32 , P=0.013 ) with active warming and that failure rates at first attempt were 6 % with warming and 30 % with passive insulation ( P < 0.001 ) . CONCLUSIONS Local warming facilitates the insertion of peripheral venous cannulas , reducing both time and number of attempts required . This may decrease the time staff spend inserting cannulas , reduce supply costs , and improve patient satisfaction .

active warming at 52 degrees C

passive insulation

peripheral venous cannulation .

insert a cannula

failed

insertion time

failure rates at first attempt

insertion of peripheral venous cannulas

time and number of attempts required .

time

inserting cannulas

supply costs

leukaemia


Should we debrief and counsel people who have had psychological shock ?


Endoscopic ligation compared with sclerotherapy for bleeding esophageal varices in children with extrahepatic portal venous obstruction . Endoscopic sclerotherapy is an effective treatment for bleeding esophageal varices , but it is associated with significant complications . Endoscopic ligation , a new form of endoscopic treatment for bleeding varices , has been shown to be superior to sclerotherapy in adult patients with cirrhosis . To determine the efficacy and safety of endoscopic sclerotherapy and ligation , the 2 methods were compared in a randomized control trial in 49 children with extrahepatic portal venous obstruction who had proven bleeding from esophageal varices . Twenty-four patients were treated with sclerotherapy and 25 with band ligation . No significant differences were found between the sclerotherapy and ligation groups in arresting active index bleeding ( 100 % each ) and achieving variceal eradication ( 91.7 % vs. 96 % , P =.61 ) . Band ligation eradicated varices in fewer endoscopic sessions than did sclerotherapy ( 3.9 +/- 1.1 vs. 6.1 +/- 1.7 , respectively , P < .0001 ) . The rebleeding rate was significantly higher in the sclerotherapy group ( 25 % vs. 4 % , P =.049 ) , as was the rate of major complications ( 25 % vs. 4 % , P =.049 ) . After eradication , esophageal variceal recurrence was not significantly different in patients treated by ligation than by sclerotherapy ( 17.4 % vs. 10 % , P =.67 ) . In conclusion , variceal band ligation in children is a safe and effective technique that achieves variceal eradication more quickly , with a lower rebleeding rate and fewer complications compared with sclerotherapy .

Endoscopic ligation

sclerotherapy

Endoscopic sclerotherapy

Endoscopic ligation

sclerotherapy

band ligation .

variceal band ligation

bleeding esophageal varices

significant complications

efficacy and safety

arresting active index bleeding

achieving variceal eradication

varices

endoscopic sessions

rebleeding rate

rate of major complications

esophageal variceal recurrence

safe and effective

variceal eradication

rebleeding rate

complications

children

extrahepatic portal venous obstruction

extrahepatic portal venous obstruction

bleeding from esophageal varices

Twenty-four

children


Mandibular advancement splint improves indices of obstructive sleep apnoea and snoring but side effects are common . AIM To assess the efficacy of a mandibular advancement splint ( MAS ) in the treatment of obstructive sleep apnoea syndrome ( OSAS ) . METHODS Nineteen patients using a MAS for symptomatic OSAS underwent polysomnography , with MAS use randomised to one half of the night . Indices of snoring and OSAS were compared . Side effects , compliance and treatment response were evaluated by questionnaire . RESULTS Use of the MAS improved total respiratory disturbance index ( RDI ) from 22.2 +/- 19.8 ( SD ) events per hour to 16.5 +/- 21.4/hr ( p = 0.03 ) , supine RDI ( 30.8 +/- 23.8/hr to 18.8 +/- 22.1/hr , p = 0.01 ) , arousal index ( 25.2 +/- 18.9/hr to 19.3 +/- 14.2/hr , p = 0.01 ) and snoring intensity ( 52.7 +/- 4.1 to 50.7 +/- 2.7 dB , p = 0.02 ) but not total snore frequency ( p > 0.05 ) . Using polysomnographic criteria , MAS treatment was completely successful in four ( 21 % ) patients , partially successful in ten ( 52.6 % ) and a failure in five ( 26.3 % ) . Treatment over a median of 6.5 weeks ( range 2-48 ) was perceived as beneficial by ten of eleven partners . Fifteen patients ( 79 % ) reported side effects , 9 ( 46 % ) did not use the device every night and four ( 21 % ) used the device less than three nights per week . CONCLUSION The use of the MAS resulted in significant reductions in indices of OSAS and snoring . However , a significant number of patients had difficulty tolerating and regularly using the device .

Mandibular advancement splint

mandibular advancement splint ( MAS )

MAS

MAS

MAS

MAS

MAS

Indices of snoring

OSAS

Side effects

compliance

treatment response

events per hour

supine RDI

arousal index

snoring intensity

total snore frequency

completely successful

partially successful

failure

side effects

OSAS

snoring

obstructive sleep apnoea and snoring

Nineteen


Effect of diuresis on extracorporeal shockwave lithotripsy treatment of ureteric calculi . OBJECTIVE To evaluate the effect of diuresis during extracorporeal shockwave lithotripsy ( ESWL ) treatment of ureteric calculi . The purpose is to improve stone fragmentation and clearance rates . MATERIALS AND METHODS One hundred and six consecutive patients with ureteric calculi at different levels were treated by ESWL using Siemens Lithostar 2 machine . Patients have been randomized into two treatment groups . The first group was treated by standard ESWL and included 54 patients . The second group was treated by ESWL with diuresis during the ESWL session . Shock waves were given at a rate of 90 shocks/minute with energy starting from 10 up to 18 KV . During the ESWL session the patient belonging to the second group received i.v . infusion of 500 ml normal saline containing 40 mg furosemide as a diuretic . The stone fragmentation and clearance rates were the two end points for evaluation . RESULTS The average number of sessions per stone was 1.92 and 1.5 and the average number of shocks per stone was 6295 and 5300 for the first and second treatment groups respectively . Stone fragmentation rate was 47/54 ( 87 % ) and 50/52 ( 96.2 % ) and the stone clearance ( success ) rate was 47/54 ( 87 % ) and 48/52 ( 92.3 % ) for the first and the second groups respectively . Analysis of the results in relation to stone location showed that the two treatment groups were comparable for upper and middle ureteric calculi . However for distal ureteric stones , the addition of diuresis during ESWL was associated with a lower mean number of ESWL sessions and shocks per stone compared with standard ESWL : 1.38 and 4950 for ESWL with diuresis compared with 2.9 and 8544 for standard ESWL respectively . The stone fragmentation and 3-month clearance ( success ) rates were clearly higher : 93.8 % and 87.5 % respectively for ESWL with diuresis compared with 70.6 % ( for both fragmentation and clearance ) with standard ESWL . CONCLUSIONS Diuresis is a useful , inexpensive and safe adjunct to ESWL of ureteric stones . It markedly improves the results of ESWL treatment of distal ureteric stones compared with standard ESWL .

diuresis

ESWL

standard ESWL

stone fragmentation

clearance rates

average number of sessions per stone

average number of shocks per stone

Stone fragmentation rate

stone clearance ( success ) rate

mean number of ESWL sessions

shocks per stone

stone fragmentation

3-month clearance ( success ) rates

ureteric calculi .


Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer . PURPOSE This phase III study compared the time to progression ( TTP ) of an oral regimen of dihydropyrimidine dehydrogenase inhibitory fluoropyrimidine composed of a fixed combination of tegafur and uracil in a 1:4 molar ratio ( UFT ) and leucovorin ( LV ) to intravenous ( IV ) fluorouracil ( 5-FU ) and LV in previously untreated metastatic colorectal carcinoma ( CRC ) patients . Secondary end points were survival , tumor response , safety , and quality of life . PATIENTS AND METHODS Between May 1996 and July 1997 , 380 patients were randomized to receive either UFT ( 300 mg/m ( 2 ) /d ) and LV ( 90 mg/d ) , administered for 28 days every 35 days , or 5-FU ( 425 mg/m ( 2 ) /d ) and LV ( 20 mg/m ( 2 ) /d ) , given IV for 5 days every 35 days . RESULTS No statistically significant difference in TTP was observed between treatments . With 320 events assessed , the median TTP was 3.4 months ( 95 % Confidence interval [ CI ] , 2.6 to 3.8 ) on UFT/LV and 3.3 months ( 95 % CI , 2.5 to 3.7 ) on 5-FU/LV ( P =.591 , stratified log-rank test ) . There were no statistically significant differences in survival , tumor response , duration of response , and time to response . Substantial safety benefits were observed in patients treated with UFT/LV . They experienced significantly less stomatitis/mucositis ( P < .001 ) and myelosuppression , resulting in fewer episodes of febrile neutropenia ( P < .001 ) and less documented infection ( P =.04 ) . Concomitant medication usage was significantly greater on 5-FU/LV ( P =.010 ) . With respect to quality of life , after correcting for baseline imbalances , there were no significant differences between treatments for any scale , except diarrhea . CONCLUSION The oral UFT/LV regimen failed to achieve improved TTP ; however , the study confirms significant safety improvements compared with bolus IV 5-FU/LV for the first-line treatment of metastatic CRC .

tegafur and uracil

leucovorin

intravenous ( IV ) fluorouracil

and LV

UFT

LV

LV

time to progression ( TTP )

survival

tumor response

safety

quality of life

TTP

TTP

survival

tumor response

duration of response

time to response

safety benefits

stomatitis/mucositis

myelosuppression

febrile neutropenia

documented infection

quality of life

diarrhea

TTP

metastatic colorectal cancer

380 patients


14 day endoscopy study comparing risedronate and alendronate in postmenopausal women stratified by Helicobacter pylori status . OBJECTIVE Bisphosphonates are effective treatment for osteoporosis but have been associated with gastrointestinal ( GI ) mucosal injury . This study compared the incidence of gastric ulcers after treatment with risedronate , a pyridinyl bisphosphonate , or alendronate , a primary amino bisphosphonate , in healthy postmenopausal women stratified by Helicobacter pylori status . METHODS Subjects were randomized to receive risedronate 5 mg ( n = 318 ) or alendronate 10 mg ( n = 317 ) daily for 14 days . Endoscopy and evaluator-blind assessments of the esophageal , gastric , and duodenal mucosa were performed at baseline and on Days 8 and 15 . RESULTS Overall , gastric ulcers > or = 3 mm were observed in 18 ( 6.0 % ) of 300 evaluable subjects in the risedronate group and 36 ( 12.1 % ) of 297 in the alendronate group during treatment ( p = 0.013 ) . On Day 8 , the incidences of gastric ulcers in the risedronate and alendronate groups were 3.6 % and 6.6 % , respectively ( p = 0.133 ) , and on Day 15 , they were 3.3 % and 8.7 % ( p = 0.008 ) . The incidence of gastric ulcers was not affected by H. pylori status . Mean gastric endoscopy scores at Days 8 and 15 were significantly lower in the risedronate group than in the alendronate group ( p < 0.001 ) . Mean esophageal and duodenal endoscopy scores were similar in the 2 groups at Days 8 and 15 . When the treatment groups were combined , gastric endoscopy scores were significantly higher among H. pylori negative than H. pylori positive subjects at Days 8 and 15 ( p < 0.05 ) . Upper GI adverse events were reported by 18 ( 5.7 % ) subjects in the risedronate group ( 19 events ) and 28 ( 8.8 % ) subjects in the alendronate group ( 32 events ) . Symptoms did not predict the presence of mucosal damage . CONCLUSION Risedronate was associated with a significantly lower incidence of gastric ulcers than alendronate . H. pylori infection did not increase the incidence of bisphosphonate related gastric ulcers . The findings from this 14 day study in healthy volunteers support the hypothesis that bisphosphonates may differ from one another in their potential to produce upper GI mucosal damage .

risedronate

alendronate

Bisphosphonates

risedronate

pyridinyl bisphosphonate

alendronate

primary amino bisphosphonate

risedronate

alendronate

Endoscopy

risedronate

risedronate

alendronate

risedronate

alendronate

risedronate

alendronate

Risedronate

alendronate

gastric ulcers

incidences of gastric ulcers

incidence of gastric ulcers

Mean gastric endoscopy scores

gastric endoscopy scores

Upper GI adverse events

postmenopausal

women

Helicobacter pylori

healthy postmenopausal

women

Helicobacter pylori


Multimodal evaluation of risperidone for destructive behavior : functional analysis , direct observations , rating scales , and psychiatric impressions . Risperidone , an atypical neuroleptic , has become a popular option for treating destructive behaviors of persons with developmental disabilities . A few studies have been conducted that evaluate the effects of risperidone on destructive behavior ; however , none of these studies have combined objective measures with rating scales to evaluate the effects of risperidone on destructive behavior across home and clinical settings . This study evaluated the wide range of effects of risperidone on destructive behavior of 2 persons with developmental disabilities using weekly functional analysis sessions , daily observations , hourly home data , weekly rating scales , and monthly psychiatric impressions . Results indicate that risperidone does decrease destructive behavior and that , for the most part , all of the various measures yielded similar results .

risperidone

Risperidone

risperidone

risperidone

risperidone

destructive behavior

developmental disabilities

developmental disabilities


Examining possible gender differences among cocaine-dependent outpatients . Potential differences in sociodemographics , drug use , and measures of treatment outcome were examined among 137 male and 51 female cocaine-dependent outpatients . More women than men were unemployed , received public assistance , and were living with their children . Women reported fewer years of regular cocaine use , spending less money per week on cocaine , less prior treatment for cocaine abuse , and were more likely than men to test positive for cocaine at intake . With respect to other drug use , fewer women than men reported using sedatives and tested positive for sedatives at intake . Women reported a lower frequency of alcohol use before intake , and fewer women than men met criteria for cannabis dependence . Men and women experienced comparable improvement during the course of treatment and follow-up .

using sedatives

sedatives at intake .

frequency of alcohol use before intake

cocaine-dependent

male

female

cocaine-dependent

women

men


Boosting uptake of influenza immunisation : a randomised controlled trial of telephone appointing in general practice . BACKGROUND Immunisation against influenza is an effective intervention that reduces serologically confirmed cases by between 60 % and 70 % . Almost all influenza immunisation in the UK is done within general practice . Current evidence on the effectiveness of patient reminders for all types of immunisation programmes is largely based on North American studies . AIM To determine whether telephone appointments offered bygeneral practice receptionists increase the uptake of irfluenza immunisation among the registered population aged over 65 years in east London practices . DESIGN OF STUDY Randomised controlled trial . SETTING Three research general practices within the East London and Essex network of researchers ( ELENoR ) . METHOD Participants were 1,820 low-risk patients aged 65 to 74 years who had not previously been in a recall system for influenza immunisation at their general practice . The intervention , during October 2000 , was a telephone call from the practice receptionist to intervention group households , offering an appointment for influenza immunisation at a nurse-run . clinic Main outcome measures were the numbers of individuals in each group receiving immunisation , and practice costs of a telephone-appointing programme . RESULTS intention to treat analysis showed an immunisation rate in the control group of 44 % , compared with 50 % in the intervention group ( odds ratio = 1.29 , 95 % confidence interval = 1.03 to 1.63 ) . Of the patients making a telephone appointment , 88 % recieved immunisation , while 22 % of those not wanting an appointment went on to be immunised . In the controlgroup , income generated was 11.35 pounds per immunisation , for each additional immunisation in the intervention group the income was 5.20 pounds . The 'number needed to telephone ' was 17 . CONCLUSION Uptake of influenza immunisation among the low-risk older population in inner-city areas can be boosted by around 6 % using a simple intervention by receptionists . Immunisation rates in this low-risk group fell well short of the 60 % government target . Improving immunisation rates will require a sustained public health campaign . Retaining the item-of-service payments to practices should support costs of practice-based interventions .

telephone appointments

control

telephone appointment

controlgroup

uptake of irfluenza immunisation

immunisation rate

immunisation

income generated

'number needed to telephone

Immunisation rates

immunisation rates

over 65 years

65 to 74

low-risk older


Hysteroscopic transcervical endometrial resection versus thermal destruction for menorrhagia : a prospective randomized trial on satisfaction rate . OBJECTIVE The purpose of this study was to compare the satisfaction rate and the effectiveness of transcervical hysteroscopic endometrial resection and thermal destruction of the endometrium in the treatment of menorrhagia . STUDY DESIGN A prospective randomized trial with 2 years of follow-up was carried out in the Department of Gynecology of the University of Naples . Eighty-two patients who were affected by menorrhagia that was unresponsive to medical treatment were respectively randomized to transcervical hysteroscopic endometrial resection or to thermal destruction of the endometrium . Satisfaction rate , operative time , discharge time , complication rate , reintervention rate , and resumption of normal activity were evaluated in each group . RESULTS The satisfaction rate was significantly higher in the thermal destruction group . Operative time was significantly shorter in the thermal destruction group ( 24 +/- 4 minutes vs 37 +/- 6 minutes ) . Intraoperative blood loss was significantly lower in the thermal destruction group ( 7.2 +/- 2.8 mL vs 89 +/- 38 mL ) . Reintervention rates were higher in the transcervical hysteroscopic endometrial resection group , although postoperative pain was not significantly different between the two groups . Discharge time , complication rate , and resumption of normal activity were not significantly different between the two groups . CONCLUSION Thermal destruction of the endometrium for the treatment of menorrhagia should be considered an effective therapeutic option because of its acceptability among patients , shorter operative time , and lower blood loss .

thermal destruction

thermal destruction

thermal destruction of the endometrium

thermal destruction

Thermal destruction of the endometrium

satisfaction rate

effectiveness

Satisfaction rate

operative time

discharge time

complication rate

reintervention rate

resumption of normal activity

satisfaction rate

Operative time

Intraoperative blood loss

Reintervention rates

Discharge time

complication rate

resumption of normal activity

acceptability

shorter operative time

lower blood loss

menorrhagia

unresponsive to medical treatment


Combination of sotalol and magnesium prevents atrial fibrillation after coronary artery bypass grafting . BACKGROUND Atrial fibrillation ( AF ) is a common complication reported in 20 % to 40 % of patients after coronary operations . Sotalol alone and magnesium alone have been shown to partially decrease the incidence of AF . The goal of this study was to evaluate the efficacy of these two pharmacological agents , used alone or in combination , to reduce postoperative AF . METHODS Two hundred seven consecutive coronary artery bypass patients ( mean age 62 +/- 11 years ) were randomized to receive sotalol alone ( 80 mg twice daily for 5 days starting from the morning of the first postoperative day ) ( group S ) , magnesium alone ( 1.5 g daily for 6 days starting in the operating room just before cardiopulmonary bypass ) ( group M ) , both pharmacologic agents at the same dosages ( group S+M ) , or no antiarrhythmic agents ( group CTR ) . All patients with an ejection fraction less than 0.40 were excluded . RESULTS The incidence of postoperative AF was 11.8 % ( 6/51 ) in the S group , 14.8 % ( 8/54 ) in the M group , 1.9 % ( 1/52 ) in the S+M group , and 38 % ( 19/50 ) in the CTR group . The following differences were significant : group CTR versus groups S , M , and S+M with values of p = 0.002 , p = 0.007 and p < 0.0001 , respectively ; and group S+M versus groups S and M with p = 0.04 and p = 0.01 , respectively . CONCLUSIONS Incidence of AF after coronary operation was significantly reduced by the administration of sotalol alone and magnesium alone ; more importantly , the incidence was further reduced by combining these agents .

sotalol

magnesium

Sotalol alone

magnesium alone

alone or in combination

sotalol alone

magnesium alone

or no antiarrhythmic agents

sotalol

magnesium

postoperative AF .

incidence of postoperative AF

Incidence of AF

after coronary operations

Two hundred seven


Stepwise hook extension technique for radiofrequency ablation therapy of hepatocellular carcinoma . OBJECTIVE Our study was designed to examine the efficacy of stepwise hook extension technique for radiofrequency ablation ( RFA ) therapy of hepatocellular carcinoma in a randomized controlled study . METHOD Twenty patients with hepatocellular carcinoma measuring < 25 mm were divided randomly into two equal groups . RFA was applied using our new stepwise hook extension technique in patients of group 1 , and the full extension method in group 2 . The 10-hook electrode of LeVeen needle was deployed in four steps to full extension during ablation in group 1 , and full extension at start of treatment in group 2 . RESULTS Roll-off was achieved in all 10 patients of group 1 , indicative of sufficient tumor coagulation , but only in 3 of 10 patients of group 2 . The median time to completion of treatment was 6 min and 55 s ( range 3 min to 14 min and 3 s ) and 15 min ( 6-15 min ) , respectively . The total power output used for RF was lower in group 1 than in group 2 ( median 271 vs. 1,045 W.m ) . The diameters of RFA-induced lesions were not significantly different between the groups ( group 1 : 27 , range 23-37 mm ; group 2 : 23 , 0-42 mm ) . CONCLUSIONS Application of RFA using stepwise hook extension technique is superior to the full extension method since it produces the same therapeutic effects within a short period using a lower energy .

Stepwise hook extension technique

RFA

stepwise hook extension technique

full extension method

10-hook electrode of LeVeen needle

Roll-off

median time to completion of treatment

total power output

diameters of RFA-induced lesions

same therapeutic effects

hepatocellular carcinoma

hepatocellular carcinoma

Twenty


Clinical evaluation of two adhesive composite cements for the suppression of dentinal cold sensitivity . STATEMENT OF PROBLEMS Postoperative cold sensitivity after the cementation of indirect restorations with composite cements has been reported frequently but not scientifically documented . PURPOSE This controlled clinical study was designed to simulate the dentin/composite cement interface immediately after cementation of a cast restoration . The desensitizing capabilities of a composite cement that contains a self-etching , dual-polymerizing resin adhesive system were compared with those of a composite cement that use phosphoric acid etching followed by a single-bottle , light-activated primer/resin-based adhesive . MATERIAL AND METHODS The hypersensitive root surfaces of selected teeth were randomized to receive 1 of 3 treatments : coating with a self-etching adhesive ( Linkmax ) and its respective cement , coating with a conventionally etched adhesive ( RelyX ARC ) and its cement , or no treatment ( negative control ) . The sample size was 22 . Dentin sensitivity was ascertained with an accurate cold testing device that slowly decreased in temperature . Tooth sensitivity was measured both immediately and at 7 days after placement . Two-way analysis of variance and Fisher 's least significant difference test ( P < .05 ) were used to determine whether significant differences existed as a function of treatment type or time . RESULTS Immediately after placement , the self-etching adhesive and its respective cement resulted in more suppression of cold sensitivity than no treatment ( control ) ; with Linkmax treatment , the temperature at which teeth responded was reduced by 8.4 degrees C. The conventionally etched adhesive and its cement reduced the temperature at which teeth responded by 9.4 degrees C. After 1 week , these temperature reductions were 7.0 degrees C and 4.3 degrees C , respectively . Untreated controls at the 2 intervals showed a mean decrease in sensitivity to cold of 3.6 degrees C and 4.1 degrees C. Statistical analysis showed type of composite cement to be a significant factor . CONCLUSION Within the limitations of this study and in comparison to untreated control teeth , Linkmax treatment resulted in a significant reduction in tooth root sensitivity over 1 week ( P=.02 ) , whereas RelyX ARC did not ( P=.066 ) .

composite cements

phosphoric acid

no treatment

etched adhesive and its cement

Linkmax

treatment

Dentin sensitivity

suppression of cold sensitivity

temperature at which teeth responded

temperature reductions

decrease in sensitivity to cold

tooth root sensitivity

dentinal cold sensitivity .

sample size was 22


Laser treatment of childhood haemangioma : progress or not ?


Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells : a pilot study and a randomised controlled trial . BACKGROUND Preclinical studies have established that implantation of bone marrow-mononuclear cells , including endothelial progenitor cells , into ischaemic limbs increases collateral vessel formation . We investigated efficacy and safety of autologous implantation of bone marrow-mononuclear cells in patients with ischaemic limbs because of peripheral arterial disease . METHODS We first did a pilot study , in which 25 patients ( group A ) with unilateral ischaemia of the leg were injected with bone marrow-mononuclear cells into the gastrocnemius of the ischaemic limb and with saline into the less ischaemic limb . We then recruited 22 patients ( group B ) with bilateral leg ischaemia , who were randomly injected with bone marrow-mononuclear cells in one leg and peripheral blood-mononuclear cells in the other as a control . Primary outcomes were safety and feasibility of treatment , based on ankle-brachial index ( ABI ) and rest pain , and analysis was per protocol . FINDINGS Two patients were excluded from group B after randomisation . At 4 weeks in group B patients , ABI was significantly improved in legs injected with bone marrow-mononuclear cells compared with those injected with peripheral blood-mononuclear cells ( difference 0.09 [ 95 % CI 0.06-0.11 ] ; p < 0.0001 ) . Similar improvements were seen for transcutaneous oxygen pressure ( 13 [ 9-17 ] ; p < 0.0001 ) , rest pain ( -0.85 [ -1.6 to -0.12 ] ; p=0.025 ) , and pain-free walking time ( 1.2 [ 0.7-1.7 ] ; p=0.0001 ) . These improvements were sustained at 24 weeks . Similar improvements were seen in group A patients . Two patients in group A died after myocardial infarction unrelated to treatment . INTERPRETATION Autologous implantation of bone marrow-mononuclear cells could be safe and effective for achievement of therapeutic angiogenesis , because of the natural ability of marrow cells to supply endothelial progenitor cells and to secrete various angiogenic factors or cytokines .

bone marrow-mononuclear cells

peripheral blood-mononuclear cells

Therapeutic angiogenesis

collateral vessel formation

efficacy and safety

safety and feasibility of treatment

ankle-brachial index ( ABI )

rest pain

ABI

transcutaneous oxygen pressure

rest pain

pain-free walking time

died after myocardial infarction

safe and effective

therapeutic angiogenesis


Treatment of canine parvoviral enteritis with interferon-omega in a placebo-controlled challenge trial . Canine parvoviral enteritis continues to cause significant morbidity and mortality in dogs worldwide , and efficacious antiviral therapies are lacking . The present trial was aimed at evaluating the therapeutic efficacy of a recombinant feline interferon ( type omega ) preparation in the treatment of parvoviral enteritis in dogs . A double-blind , placebo-controlled challenge trial was performed in beagle pups ( 8-9 weeks ) ; clinical signs , body weight , hematologic parameters , and mortality were monitored for a period of 14 days after challenge . Fourteen animals were inoculated with virulent canine parvovirus ; 10 animals that developed clinical signs thereby meeting the inclusion criteria were admitted to the treatment phase in two randomly selected groups ( placebo and IFN ) of equal size . The IFN group received daily intravenous injections of rFeIFN-omega ( 2.5 MU/kg ) for three consecutive days . The placebo group received daily injections of saline without IFN . Both groups of animals received individual supportive treatment consisting of adjusted diet and electrolyte solution . All five dogs in the placebo group developed fulminating enteritis with typical clinical signs and died within 10 days post-inoculation ( or 6 days post-treatment ) . In the IFN-treated group , one animal died on day 2 after the treatment was started , whereas the other four dogs survived the challenge and gradually recovered . Our data confirm that the rFeIFN-omega can exert a significant therapeutic effect on dogs with parvoviral enteritis by improving clinical signs and reducing mortality .

interferon-omega

antiviral therapies

placebo

IFN

rFeIFN-omega

placebo

saline

rFeIFN-omega

died

died

survived

recovered

canine

Canine parvoviral enteritis

dogs

parvoviral enteritis in dogs

pups

( 8-9

Fourteen

virulent canine parvovirus

dogs

parvoviral enteritis


Effect of mycophenolate mofetil on the prevention of acute renal allograft rejection .

mycophenolate mofetil

acute renal allograft rejection .


Efficacy of erbium : yttrium-aluminum-garnet laser-assisted delivery of topical anesthetic . BACKGROUND Penetration through the stratum corneum limits effectiveness of topical anesthetics . OBJECTIVE Our aim was to evaluate the effectiveness of 5 % lidocaine ( ELA-Max ) cream applied after erbium : yttrium-aluminum-garnet ( Er : YAG ) laser ablation of the stratum corneum . METHODS Randomized , controlled , split-face comparison of anesthesia was performed on 12 volunteers . The stratum corneum was painlessly ablated with a low-fluence Er : YAG laser on half of the face , then the whole face was covered with ELA-Max cream for 60 minutes . Full-face laser resurfacing was performed , and visual analog pain scores ( 0 to 10 ) were recorded during each of 2 passes . RESULTS Laser-assisted topical anesthesia demonstrated significantly lower mean pain scores than topical anesthesia alone . This was more pronounced during the more painful second pass . Resurfacing after laser-assisted topical anesthesia was well tolerated by 72 % of subjects in pass 1 and 58 % in pass 2 . CONCLUSION Laser-assisted topical anesthesia is fast , painless , and substantially more effective than conventional topical anesthesia but does not provide adequate anesthesia for full-face resurfacing in all subjects .

5 % lidocaine ( ELA-Max ) cream

Er : YAG

ELA-Max cream

Laser-assisted topical anesthesia

Efficacy

visual analog pain scores ( 0 to 10 )

mean pain scores

tolerated

12 volunteers .


Acute cardiac effects of nicotine in healthy young adults . BACKGROUND Nicotine is known to have many physiologic effects . The influence of nicotine delivered in chewing gum upon cardiac hemodynamics and conduction has not been well-characterized . METHODS We studied the effects of nicotine in nonsmoking adults ( 6 male , 5 female ; ages 23-36 years ) using a double-blind , randomized , cross-over study . Subjects chewed nicotine gum ( 4 mg ) or placebo . After 20 minutes ( approximate time to peak nicotine levels ) , echocardiograms and signal-averaged electrocardiograms ( SAECG ) were obtained . After 40 minutes , subjects were again given nicotine gum or placebo in cross-over fashion . Standard echocardiographic measurements were made from two-dimensional images . We then calculated end-systolic wall stress ( ESWS ) , shortening fraction ( SF ) , systemic vascular resistance ( SVR ) , velocity for circumferential fiber shortening corrected for heart rate ( Vcfc ) , stroke volume , and cardiac output . P wave and QRS duration were measured from SAECG . RESULTS Significant differences ( P < 0.05 ) from control or placebo were found for ESWS , mean blood pressure , cardiac output , SVR , heart rate , and P wave duration . No significant changes were seen in left ventricular ejection time ( LVET ) , LV dimensions , SF , contractility ( Vcfc ) , or QRS duration . CONCLUSIONS These results suggest that nicotine chewing gum increases afterload and cardiac output . Cardiac contractility does not change acutely in response to nicotine gum . Heart rate and P wave duration are increased by chewing nicotine gum .

nicotine

nicotine

nicotine

nicotine gum ( 4 mg )

placebo

nicotine gum

placebo

ESWS

blood pressure

cardiac output

SVR

heart rate

P wave duration

SF

contractility ( Vcfc )

QRS duration

Heart rate

P wave duration


7-hexanoyltaxol-eluting stent for prevention of neointimal growth : an intravascular ultrasound analysis from the Study to COmpare REstenosis rate between QueST and QuaDS-QP2 ( SCORE ) . BACKGROUND Inhibition of neointimal tissue growth has been demonstrated in preliminary human feasibility studies with a stent-based polymer sleeve delivering 7-hexanoyltaxol . The Study to COmpare REstenosis rate between QueST and QuaDS-QP2 ( SCORE ) trial is a human , randomized , multicenter trial comparing 7-hexanoyltaxol ( QP2 ) -eluting stents ( qDES ) with bare metal stents ( BMS ) in the treatment of de novo coronary lesions . The purpose of this substudy was to evaluate the acute expansion property and long-term neointimal responses of qDES compared with BMS as assessed by intravascular ultrasound ( IVUS ) . METHODS AND RESULTS A total of 122 ( qDES 66 , BMS 56 ) patients were enrolled into the IVUS substudy . All IVUS images ( immediately after the procedure and at 6-month follow-up ) were analyzed at an independent core laboratory in a blind manner . At baseline , qDES achieved stent expansion similar to BMS . At follow-up , qDES showed reduced neointimal growth by 70 % at the tightest cross section and by 68 % over the stented segment ( P < 0.0001 for both ) , resulting in a significantly larger lumen in qDES than in BMS . Unlike intracoronary brachytherapy , there was no evidence of negative edge effects , unhealed dissections , or late stent-vessel wall malapposition over the stented and adjacent references segments in either group . CONCLUSIONS Detailed IVUS analysis revealed that qDES had comparable acute mechanical and superior long-term biological effects to BMS . Although the long-term benefits and limitations of this technology require further investigation , the reduction in neointimal thickenings demonstrated that local delivery of 7-hexanoyltaxol through polymer sleeves augments conventional mechanical treatment of atherosclerotic disease .

7-hexanoyltaxol-eluting stent

stent-based polymer sleeve

qDES

BMS

qDES

qDES

qDES

BMS

acute expansion property

long-term neointimal responses

stent expansion

neointimal growth

negative edge effects

unhealed dissections

late stent-vessel wall malapposition

treatment of de novo coronary lesions

qDES 66

BMS 56

atherosclerotic disease


Tegaserod , a 5-hydroxytryptamine type 4 receptor partial agonist , is devoid of electrocardiographic effects . OBJECTIVES Certain GI prokinetic agents have been shown to affect cardiac repolarization , which may be associated with life-threatening arrhythmias . The selective 5-hydroxytryptamine type 4 receptor partial agonist tegaserod is a novel promotile agent developed for the treatment of functional motility disorders such as irritable bowel syndrome ( IBS ) . The aim of the study was to investigate the cardiac safety profile of tegaserod through analysis of electrocardiographic data from clinical studies conducted in patients with IBS and a study conducted in healthy male subjects . METHODS In three randomized , double blind , placebo-controlled , parallel group clinical studies , 2516 IBS patients with symptoms of abdominal pain and constipation received tegaserod 2 or 6 mg b.i.d . ( n = 1679 ) or placebo ( n = 837 ) for 12 wk . In an additional study , 36 healthy male subjects received iv . single doses of tegaserod ( 0.8 mg to 20 mg ) or placebo . Standard 12-lead electrocardiograms were recorded at baseline and during treatment . Baseline values were compared with data collected during the treatment period . RESULTS The proportion of patients with prolongation of the QTc interval was the same for placebo and tegaserod , as was the frequency of overall electrocardiographic abnormalities . No ventricular or supraventricular tachycardia was observed . Comparable electrocardiographic results were obtained during placebo and tegaserod treatment . In healthy volunteers , tegaserod at i.v . doses resulting in plasma concentrations up to 100 times those measured after therapeutic doses ( 6 mg b.i.d . ) did not influence electrocardiographic parameters . CONCLUSIONS Tegaserod is devoid of electrocardiographic effects and is not expected to adversely influence cardiac function . These data confirm preclinical findings .

GI prokinetic agents

tegaserod

tegaserod

placebo

tegaserod

placebo

electrocardiographic effects

cardiac safety profile

prolongation of the QTc interval

electrocardiographic results

plasma concentrations

electrocardiographic effects

cardiac function

IBS

healthy

male

IBS

abdominal pain

constipation

healthy

male

healthy volunteers


Multifaceted support to improve clinical decision making in diabetes care : a randomized controlled trial in general practice . AIMS To evaluate the effectiveness of a multifaceted intervention to improve the clinical decision making of general practitioners ( GPs ) for patients with diabetes . To identify practice characteristics which predict success . METHODS Cluster randomized controlled trial with 124 practices and 185 GPs in The Netherlands . The intervention group received feedback reports and support from a facilitator ; the control group received no special attention . Outcome measures were the compliance rates with evidence-based recommendations pertaining to discussion of body weight control , discussion of problems with medication , blood pressure measurement , foot examination , eye examination , initiating anti-diabetic medication or increasing the dosage in cases of uncontrolled blood glucose , and scheduling a follow-up appointment . RESULTS The GPs reported on their clinical decision making in 1410 consultations with Type 2 diabetic patients at baseline and 1449 consultations after the intervention period . The intervention resulted in statistically significant improvement for two of the seven outcome measures : foot examination ( odds ratio 1.68 ; 95 % confidence interval 1.19-2.39 ) and eye examination ( 1.52 ; 1.07-2.16 ) . Discussion of problems with medication showed a near significant trend towards increased benefit for the intervention group ( 1.52 ; 0.99-2.32 ) . Practice characteristics were not found to be related to the success of the intervention . CONCLUSIONS Feedback reports with support from facilitators appear to increase rates of foot examination and eye examination in general practice . Alternative interventions should be explored to improve the pursuit of metabolic control by GPs .

Multifaceted support

multifaceted intervention

no special attention

124 practices

Type 2 diabetic patients


Effect of macronutrient composition of the diet on the regulation of lipolysis in adipose tissue at rest and during exercise : microdialysis study . The aim of the present study was to elucidate , using a microdialysis technique , whether modifications in the proportion of fat in the diet influence lipid mobilization from adipose tissue in situ . Nine healthy volunteers ( age , 23.4 +/- 0.2 years ; body mas index [ BMI ] , 23.5 +/- 1.6 kg/m ( 2 ) ) were fed , in random order , with a high-fat diet ( HFD ) ( 65 % of energy content fat , 15 % protein , 20 % carbohydrate ) or a high-carbohydrate diet ( HCD ) ( 70 % carbohydrate , 15 % protein , 15 % fat ) for 5 days , with a washout period of 10 days between the diets . Subjects were studied in the fasting state on the morning following days 4 and 5 of each diet . We measured the concentration of extracellular glycerol ( EGC ) in adipose tissue in response to ( 1 ) pharmacologic stimulation with isoprenaline ( 1 and 10 micromol/L ) in situ , ( 2 ) stimulation with intravenous infusion of epinephrine ( 0.0375 microg/min/kg body weight ) , and ( 3 ) submaximal aerobic exercise ( 50 % V*O2max , 60-minute duration ) . No effect of the diet composition was found in the increases of EGC in response to isoprenaline ( area under the curve [ AUC ] : HFD , 1,534 +/- 370 micromol/90 min ; HCD , 1,108 +/- 465 micromol/90 min ; not significant [ NS ] ) or epinephrine stimulations ( AUC : HFD , 190 +/- 92 micromol/30 min ; HCD , 251 +/- 298 micromol/30 min ; NS ) . The exercise-induced increase in EGC was higher during the HFD ( AUC : HFD , 1,641 +/- 181 micromol/60 min ; HCD , 963 +/- 156 micromol/60 min ; P < .05 ) and was associated with a higher exercise-induced response of norepinephrine ( P < .05 ) and epinephrine ( P =.056 ) and lower insulinemia during exercise . The results suggest that macronutrient composition of diet does not affect the beta-adrenergic responsiveness of adipose tissue to catecholamine action at rest . During exercise , the HFD promotes higher lipolysis in adipose tissue and this is associated with a higher catecholamine response and lower insulinemia .

macronutrient

fat in the diet

isoprenaline

epinephrine

aerobic exercise

HFD

lipid mobilization

diet composition

increases of EGC

epinephrine stimulations

higher exercise-induced response

insulinemia

healthy volunteers (

age , 23.4 +/- 0.2 years