Two randomized studies demonstrate the efficacy and safety of dapsone gel , 5 % for the treatment of acne vulgaris . BACKGROUND A new aqueous gel formulation of dapsone has been developed that allows clinically-effective doses of dapsone to be administered topically with minimal systemic absorption . OBJECTIVES The goal of these studies was to evaluate the efficacy and safety of dapsone gel , 5 % in the treatment of acne . METHODS Patients 12 years of age and older with acne vulgaris ( N = 3010 ) participated in two identically-designed 12-week , randomized , double-blind studies of twice-daily monotherapy with dapsone gel , 5 % , versus a vehicle gel . RESULTS Dapsone gel-treated patients achieved superior results in terms of the investigator 's global acne assessment ( P < .001 ) and the mean percentage reduction in inflammatory , noninflammatory , and total lesion counts ( all , P < .001 ) at week 12 . Reductions in inflammatory lesion counts favoring dapsone gel over vehicle were apparent as early as 2 weeks and reached statistical significance by 4 weeks . No clinically significant changes in laboratory parameters , including hemoglobin , even among glucose-6-phosphate dehydrogenase-deficient patients , were observed . Adverse events were comparable between the treatment groups and rarely led to discontinuation . LIMITATIONS Adjunctive topical treatments and their impact on acne were not studied in this trial . CONCLUSIONS Dapsone gel , 5 % appears to be an effective , safe , and well-tolerated treatment for acne vulgaris , with a rapid onset of action .

dapsone gel

dapsone

dapsone

dapsone gel

monotherapy with dapsone gel , 5

vehicle gel

Dapsone gel-treated

dapsone gel

Dapsone gel

efficacy

safety

efficacy

safety

inflammatory lesion counts

hemoglobin

Adverse events

acne vulgaris

acne vulgaris

Patients 12 years of age and older

acne vulgaris

N = 3010


Bradykinin-induced cough reflex markedly increases in patients with cough associated with captopril and enalapril . We studied the effects of angiotensin converting enzyme ( ACE ) inhibitors on cough responses to bradykinin ( BK ) , substance P ( SP ) and citric acid in a double blind , random study on 10 hypertensive patients receiving ACE inhibitors . Of these patients , five had reported cough with ACE inhibitors . Cough responses to citric acid were similar between patients with and without cough , and SP up to 10 ( -5 ) M did not cause cough in any of the subjects . BK caused cough at 13.4 +/- 1.2 ( -log M ) in 5 patients with cough associated with ACE inhibitors , but it did not cause cough at concentrations up to 10 ( -5 ) M in other 5 patients . One month after the withdrawal of ACE inhibitors , 5 patients were free from cough symptoms , and BK did not cause cough up to 10 ( -5 ) M in these patients , except for one who coughed at 10 ( -9 ) M , without changes in responses to citric acid . BK caused cough at 14.3 +/- 0.7 ( -log M ) although BK1-7 , a major metabolite of BK by ACE , caused cough at 5.7 +/- 0.7 ( -log M ) in another 3 patients with cough associated with ACE inhibitor . These results suggest that impaired metabolism of BK induced by ACE inhibitors may relate to the manifestation of cough in hypertensive patients receiving ACE inhibitors .

cough responses to bradykinin ( BK )

substance P ( SP )

citric acid

ACE inhibitors

ACE inhibitors

BK

ACE inhibitors

cough responses

cough

cough

cough symptoms

cough

cough

cough

hypertensive

five

cough


5 alpha-metabolism in finasteride-treated subjects and male pseudohermaphrodites with inherited 5 alpha-reductase deficiency . A review . Male pseudohermaphrodites ( MPHs ) with inherited 5 alpha-reductase deficiency and decreased dihydrotestosterone production have a global defect in 5 alpha-metabolism affecting both C19 androgen metabolism and C21 steroid metabolism . However , the decreased 5 alpha-reduction of testosterone to dihydrotestosterone is the only impaired steroid conversion to have clinical consequences , e.g. , ambiguous genitalia , impaired prostate differentiation and development , and decreased facial and body hair . The 5 alpha-steroid metabolite profile in the MPHs was compared with that of men with benign prostatic hyperplasia who were administered varying doses of the 5 alpha-reductase inhibitor finasteride . Finasteride was found to be a potent inhibitor of both C19 androgen and C21 5 alpha-steroid metabolism affecting both hepatic and peripheral 5 alpha-metabolism . The 5 alpha-steroid metabolite profile was strikingly similar to that of MPHs with inherited 5 alpha-reductase deficiency . The data suggest that a 5 alpha-reductase gene codes for an enzyme with affinity for multiple steroid substrates .

finasteride-treated

5 alpha-reductase inhibitor finasteride

Finasteride

decreased facial and body hair

5 alpha-steroid metabolite profile

finasteride-treated subjects

pseudohermaphrodites

inherited 5 alpha-reductase deficiency

men with benign prostatic hyperplasia


Dynamic surface electromyographic responses in chronic low back pain treated by traditional bone setting and conventional physical therapy . OBJECTIVE This study compared the dynamic surface electromyographic ( EMG ) activities of back muscles and pain before and after traditional bone setting and physical therapy . METHODS This study was a prospective clinical trial that compared surface EMG dynamic activities after traditional bone setting and physical therapy . Sixty-one patients ( mean age , 41 years ) with nonspecific low back pain were randomized into two subgroups by treatment . The patients underwent a dynamic EMG evaluation for which they were asked to stand and then bend forward as far as possible , stay fully flexed , and return to standing . A flexion-relaxation ratio was calculated by comparing maximal EMG activity while flexing with the average EMG activity in full flexion . Concentric ( maximal EMG activity during extension ) and eccentric ( maximal EMG activity during flexion ) ratios were also used in the analyses . RESULTS Disability , depression , and visual analog scale scores decreased significantly after both treatments . The concentric ratio increased statistically in both groups after the treatments . The study failed to show a significant association between experienced back pain and EMG parameters . CONCLUSIONS Both treatments seem to have a positive influence on back muscle function by improving muscle symmetry ; however , the treatments had no effect on the flexion-relaxation phenomenon after 1 month . Active back exercise at home together with rehabilitation treatments might be effective and improve function for patients with chronic low back pain .

dynamic EMG evaluation

Active back exercise at home

treatments

surface electromyographic responses

surface EMG dynamic activities

dynamic EMG evaluation

flexion-relaxation ratio

maximal EMG activity

Disability

depression

visual analog scale scores

concentric ratio

EMG parameters

muscle symmetry ;

flexion-relaxation phenomenon

chronic low back pain


Effects of nifedipine and nitrendipine on insulin secretion in obese patients . Data on the influence of calcium antagonists on glucose tolerance and insulin release in humans are conflicting . The present double-blind , double-dummy , controlled trial was designed to investigate the effect of a short-term ( 7 days ) treatment with nitrendipine , 20 mg b.i.d . ; nitrendipine , 20 mg once daily ; or placebo on blood glucose and plasma insulin and C-peptide response to an intravenous glucose load in mildly or transiently hypertensive nondiabetic obese patients . No statistically significant differences were found in fasting glucose , insulin , and C-peptide , or in the glucose disappearance rate and in any of the parameters for insulin and C-peptide response after i.v . glucose , between the three groups of patients . However , a slight decrease in early insulin response to glucose was observed in the nifedipine and the nitrendipine groups . This study confirms that calcium antagonists have no clinically relevant effect on glucose homeostasis even if a slight alteration of insulin release after glucose load can not be ruled out .

nifedipine

nitrendipine

insulin secretion

glucose tolerance

insulin release

blood glucose

plasma insulin

C-peptide response

fasting glucose

insulin

C-peptide

early insulin response to glucose

clinically relevant effect

obese


Comparison of 7-day and 14-day proton pump inhibitor-containing triple therapy for Helicobacter pylori eradication : neither treatment duration provides acceptable eradication rate in Korea . BACKGROUND AND AIMS Although triple combination therapy containing a proton pump inhibitor ( PPI ) and two antibiotics is considered as a standard regimen for the first-line anti-Helicobacter pylori treatment , there are still debates on the ideal duration of treatment . The aim of this study was to compare the efficacies of 7-day and 14-day PPI-containing triple therapy . MATERIALS AND METHODS This study was performed in a randomized , multicenter , prospective manner . After upper gastrointestinal endoscopy , H. pylori-infected patients with a gastric ulcer and/or a duodenal ulcer were randomly assigned to a PAC7 group ( omeprazole 20 mg or equivalent dose of other PPIs , amoxicillin 1000 mg , and clarithromycin 500 mg twice daily for 7 days ) or to a PAC14 group ( the same regimen as the PAC7 group but for 14 days ) . H. pylori status was evaluated by ( 13 ) C urea breath test 5 weeks after anti-ulcer treatment completion . RESULTS A total of 598 patients were enrolled ; 337 were randomized to the PAC7 group and 261 to the PAC14 group . The two groups were comparable in terms of baseline characteristics . The eradication rates of the PAC7 group were not inferior to those of the PAC14 group in both intention-to-treat analysis ( 71.2 % vs. 75.5 % ) and per-protocol analysis ( 83.6 % vs. 86.6 % ) . Incidences of adverse events were comparable . CONCLUSIONS Although the 7-day PPI-containing triple anti-H. pylori therapy is not inferior to the 14-day therapy , neither treatment duration provides acceptable eradication rate reaching 90 % in per-protocol analysis . New combination regimen with higher efficacy should be developed as a first-line eradication therapy for H. pylori in Korea .

triple combination therapy

proton pump inhibitor ( PPI )

two antibiotics

upper gastrointestinal endoscopy

7-day PPI-containing triple anti-H.

pylori therapy

Helicobacter pylori eradication

efficacies

C urea breath

adverse events

eradication rate

Helicobacter pylori eradication

upper gastrointestinal endoscopy

H. pylori-infected

gastric ulcer and/or a duodenal ulcer

H. pylori


Can patient coaching reduce racial/ethnic disparities in cancer pain control ? Secondary analysis of a randomized controlled trial . PURPOSE Minority patients with cancer experience worse control of their pain than do their white counterparts . This disparity may , in part , reflect more miscommunication between minority patients and their physicians . Therefore , we examined whether patient coaching could reduce disparities in pain control in a secondary analysis of a randomized controlled trial . METHODS Sixty-seven English-speaking adult cancer outpatients , including 15 minorities , with moderate pain over the prior 2 weeks were randomly assigned to the experimental ( N = 34 ) or control group ( N = 33 ) . Experimental patients received a 20-minute individualized education and coaching session to increase knowledge of pain self-management , to redress personal misconceptions about pain treatment , and to rehearse an individually scripted patient-physician dialog about pain control . The control group received standardized information on controlling pain . Data on average pain ( 0-10 scale ) were collected at enrollment and 2-week follow-up . RESULTS At enrollment , minority patients had significantly more pain than their white counterparts ( 6.0 vs 5.0 , P = 0.05 ) . At follow-up , minorities in the control group continued to have more pain ( 6.4 vs 4.7 , P = 0.01 ) , whereas in the experimental group , disparities were eliminated ( 4.0 vs 4.3 , P = 0.71 ) . The effect of the intervention on reducing disparities was significant ( P = 0.04 ) . CONCLUSIONS Patient coaching offers promise as a means of reducing racial/ethnic disparities in pain control . Larger studies are needed to validate these findings and to explore possible mechanisms .

patient coaching

patient coaching

received

Patient coaching

disparities in pain control

pain control

average pain

pain

pain

Minority patients with cancer

minority patients

Sixty-seven

adult

cancer outpatients

minority patients


How does Cash and Counseling affect costs ? OBJECTIVE To test the effect of a consumer-directed model ( Cash and Counseling ) of Medicaid personal care services ( PCS ) or home- and community-based waiver services ( HCBS ) on the cost of Medicaid services . DATA SOURCES/STUDY SETTING Medicaid claims data were collected for all enrollees in the Cash and Counseling demonstration . Demonstration enrollees included those eligible for PCS ( in Arkansas ) , those assessed to receive such services ( in New Jersey ) , and recipients of Medicaid HCBS ( in Florida ) . Enrollment occurred from December 1998 through April 2001 . The follow-up period covered up to 24 months after enrollment . STUDY DESIGN Demonstration volunteers were randomly assigned to have the option to participate in Cash and Counseling ( the treatment group ) , or to receive Medicaid services as usual from an agency ( the control group ) . Ordinary least squares regressions were used to estimate the effect of the program on costs for Medicaid PCS/waiver services and other Medicaid services , while controlling for consumers ' preenrollment characteristics and preenrollment Medicaid spending . Models were estimated separately for nonelderly and elderly adults in each state and for children in Florida . DATA EXTRACTION METHODS Each state supplied claims data for demonstration enrollees . PRINCIPAL FINDINGS Largely because the program increased consumers ' ability to get the authorized amount of paid care , expenditures for personal care/waiver services were higher for the treatment group than for the control group in each state and age group , except among the elderly in Florida . Higher costs for personal care/waiver services were partially offset by savings in other Medicaid services , particularly those related to long-term care . During year 1 , total Medicaid costs were generally higher for the treatment group than for the control group , with treatment-control cost differences ranging from 1 percent ( and statistically insignificant ) for the elderly in Florida to 17 percent for the elderly in Arkansas . In year 2 , these cost differences were generally greater than in year 1 . Only in Arkansas did the treatment-control difference in total cost shrink over time-to less than 5 percent ( and statistically insignificant ) in year 2 . CONCLUSIONS Medicaid costs were generally higher under Cash and Counseling because those in the traditional system did not get the services they were entitled to . Compared with the treatment group , ( 1 ) control group members were less likely to receive any services at all ( despite being authorized for them ) , and ( 2 ) service recipients received a lower proportion of the amount of care that was authorized . In addition , a flaw in Florida 's reassessment procedures led to treatment group members receiving more generous benefit amounts than control group members . To keep total Medicaid costs per recipient at the level incurred under the traditional system , consumer-directed programs need to be carefully designed and closely monitored .

Cash and Counseling

Cash and Counseling

Cash and Counseling

Cash and Counseling

costs for Medicaid PCS/waiver services

Medicaid services

costs for personal care/waiver services

total Medicaid costs

cost differences

cost shrink over time-to

Medicaid costs

receive any services

lower proportion of the amount of care

personal care services ( PCS )

nonelderly

elderly adults

children


Does ambient light contribute to the therapeutic effects of topical photodynamic therapy ( PDT ) using aminolevulinic acid HCl ( ALA ) ?


Role of diltiazem in the treatment of silent myocardial ischemia . Silent myocardial ischemia is a frequent finding when Holter monitoring is done in patients with advanced coronary disease . Silent ischemia is associated with a worse prognosis in patients with stable or unstable angina , survivors of myocardial infarction , and populations at risk for coronary disease . Whether medical therapy for silent ischemia improves prognosis is not known . In a randomized , placebo-controlled , multicenter trial of 60 patients with documented coronary disease , positive exercise tests , and ischemic episodes on Holter monitoring , long-acting diltiazem reduced ischemic episodes by 50 % compared to placebo , from a mean of 5.6 to 2.8 ( p less than 0.0001 ) . Efficacy was maintained over 24 h and diltiazem also significantly improved exercise test parameters . Three smaller studies also demonstrated that diltiazem effectively reduces ambulatory ischemia ; however , results with nifedipine are conflicting , with several studies showing no benefit . In contrast , beta-blockers reliably reduce ischemic episodes . The role of medical therapy for silent ischemia will be clarified only when its effect upon morbidity and mortality are determined .

diltiazem

placebo-controlled

diltiazem

placebo

diltiazem

diltiazem

ischemic episodes

Efficacy

exercise test parameters

ambulatory ischemia

ischemic episodes

advanced coronary disease

coronary disease ,


[ Effect of ulinastatin on inflammatory responses induced by oesophagectomy ] . OBJECTIVE To examine the effect of ulinastatin ( UTI ) on the inflammatory responses induced by oesophagectomy . METHODS Forty patients with esophageal cancer ( without serious hypertension , heart disease , or respiratory function impairment , including 34 men and 6 women aged 46 to 70 years ) scheduled for oesophagectomy via left thoracotomy were randomly divided into control group ( n=20 ) and UTI group ( n=20 ) . Anesthesia induction and perioperative management followed the same protocols in the two groups , and in UTI group , patients received 5000 U/kg UTI while those in the control group were given the same volume of saline . Before operation ( T ( 1 ) ) , 10 min after recovery of two-lung ventilation ( T ( 2 ) ) , and 24 h ( T ( 3 ) ) and 48 h ( T ( 4 ) ) after operation , the venous blood sample was taken from the internal jugular vein and the plasma was separated and stored at -70 degrees C for later analysis of IL-6 and IL-8 with enzyme-linked immunosorbent assay ( ELISA ) . The bronchoalveoar lavage fluid ( BAFL ) was also collected at T ( 1 ) and T ( 2 ) for IL-6 and IL-8 detection . RESULTS IL-6 , IL-8 levels in the plasma and BALF collected at T ( 2 ) -T ( 4 ) increased significantly as compared with those in samples collected at T ( 1 ) , and their peak concentration inplasma and BALF samples were similar . IL-6 and IL-8 levels in the UTI group were significantly lower than those in the control group during the time points of T ( 2 ) -T ( 4 ) . CONCLUSION Inflammatory responses occur during and after oesophagectomy , which can be inhibited with UTI .

ulinastatin

ulinastatin

oesophagectomy via left thoracotomy

Anesthesia induction

received 5000 U/kg UTI

inflammatory responses

inflammatory responses

increased significantly

peak concentration inplasma and BALF

significantly lower

inflammatory responses

oesophagectomy

inflammatory responses

Forty

esophageal cancer

serious hypertension

heart disease

respiratory function impairment

34 men

6 women

46 to 70 years


Developmental disabilities modification of the Children 's Global Assessment Scale . BACKGROUND Interventions for pervasive developmental disorders ( PDD ) aim to alleviate symptoms and improve functioning . To measure global functioning in treatment studies , the Children 's Global Assessment Scale was modified and psychometric properties of the revised version ( DD-CGAS ) were assessed in children with PDD . METHODS Developmental disabilities-relevant descriptors were developed for the DD-CGAS , and administration procedures were established to enhance rater consistency . Ratings of clinical case vignettes were used to assess inter-rater reliability and temporal stability . Validity was assessed by correlating the DD-CGAS with measures of functioning and symptoms in 83 youngsters with PDD . Sensitivity to change was assessed by comparing change from baseline to post-treatment with change on the Aberrant Behavior Checklist-Irritability and Clinical Global Impressions-Improvement subscale scores in a subset of 14 children . RESULTS Inter-rater reliability ( intraclass correlation coefficient [ ICC ] = .79 ) and temporal stability ( average ICC = .86 ) were excellent . The DD-CGAS scores correlated with measures of functioning and symptoms with moderate to large effect sizes . Changes on the DD-CGAS correlated with changes on the Aberrant Behavior Checklist-I ( r = -.71 ) and Global Impressions Scale-I ( r = -.52 ) . The pre-post DD-CGAS change had an effect size of .72 . CONCLUSIONS The DD-CGAS is a reliable instrument with apparent convergent validity for measuring global functioning of children with PDD in treatment studies .

Interventions

temporal stability ( average ICC

DD-CGAS scores

functioning

symptoms

DD-CGAS

Aberrant Behavior Checklist-I

Global Impressions Scale-I

pre-post DD-CGAS change


Positive effects of methylphenidate on inattention and hyperactivity in pervasive developmental disorders : an analysis of secondary measures . BACKGROUND Methylphenidate has been shown elsewhere to improve hyperactivity in about half of treated children who have pervasive developmental disorders ( PDD ) and significant hyperactive-inattentive symptoms . We present secondary analyses to better define the scope of effects of methylphenidate on symptoms that define attention-deficit/hyperactivity disorder ( ADHD ) and oppositional defiant disorder ( ODD ) , as well as the core autistic symptom domain of repetitive behavior . METHODS Sixty-six children ( mean age 7.5 y ) with autistic disorder , Asperger 's disorder , and PDD not otherwise specified , were randomized to varying sequences of placebo and three different doses of methylphenidate during a 4-week blinded , crossover study . Methylphenidate doses used approximated .125 , .25 , and .5 mg/kg per dose , twice daily , with an additional half-dose in the late afternoon . Outcome measures included the Swanson , Nolan , and Pelham Questionnaire revised for DSM-IV ( ADHD and ODD scales ) and the Children 's Yale-Brown Obsessive Compulsive Scales for PDD . RESULTS Methylphenidate was associated with significant improvement that was most evident at the .25- and .5-mg/kg doses . Hyperactivity and impulsivity improved more than inattention . There were not significant effects on ODD or stereotyped and repetitive behavior . CONCLUSIONS Convergent evidence from different assessments and raters confirms methylphenidate 's efficacy in relieving ADHD symptoms in some children with PDD . Optimal dose analyses suggested significant interindividual variability in dose response .

methylphenidate

Methylphenidate

methylphenidate

placebo

methylphenidate

inattention

hyperactivity

hyperactivity

Hyperactivity and impulsivity

inattention

efficacy

ADHD symptoms

inattention and hyperactivity

pervasive developmental disorders

Sixty-six

children

mean age 7.5 y

children

PDD


Effects of sibutramine on thermogenesis in obese patients assessed via immersion calorimetry . Glucose utilization studies show that sibutramine-induced thermogenesis is mediated via selective sympathetic activation of brown adipose tissue . The goal of the present study was to use a new calorimetry method in which resting metabolic rate is enhanced to evaluate the effects of sibutramine treatment on thermogenesis . Sixty obese women were included in the study . Subjects were divided into 2 equal groups-the placebo and sibutramine treatment groups . The sibutramine group was given sibutramine 10 mg daily for 12 wk . At baseline and at the end of the 12-wk treatment period , thermogenic measurements were taken with the use of water immersion calorimetry . Subjects were examined at weeks 4 , 8 , and 12 of treatment to identify adverse effects . Body mass index , measured at 31.5+/-2.05 kg/m2 in the placebo group , decreased to 30.4+/-2.94 kg/m ( 2 ) after 12 wk ( P=.07 ) . In the sibutramine group , it decreased from 33.5+/-4.1 kg/m ( 2 ) to 30.9+/-4.8 kg/m ( 2 ) ( P < .05 ) . In the sibutramine group , mean thermogenic response changed from a baseline value of 1.27+/-0.29 kcal/kg/h to 1.44+/-0.13 kcal/kg/h after 12 wk of treatment . In the placebo group , the baseline value was 1.56+/-0.27 kcal/kg/h ; it changed to 1.33+/-0.36 kcal/kg/h at the end of 12 wk . The findings of this study suggest that sibutramine treatment promotes thermogenesis , thus facilitating weight loss . Calorimetry enhances resting metabolism through more efficient heat transfer from the body .

sibutramine

sibutramine-induced

sibutramine

placebo

sibutramine

sibutramine

sibutramine

sibutramine

sibutramine

water immersion calorimetry

Body mass index

mean thermogenic response

thermogenesis

weight loss

resting metabolism

heat transfer from the body

obese patients


Desmopressin in the treatment of nocturia : a double-blind , placebo-controlled study . OBJECTIVES To investigate efficacy , safety , and impact on quality of sleep of desmopressin in the treatment of nocturia . METHODS Adults aged > or =18 yr with nocturia ( > or =2 voids/night ) received desmopressin tablets ( 0.1 , 0.2 , or 0.4 mg ) during a 3-wk dose-titration period . Patients should show sufficient response during the dose-titration period ( > or =20 % reduction in nocturnal diuresis ) and a return of nocturnal diuresis to > or =80 % of baseline levels during washout . Eligible patients then entered a 3-wk double-blind treatment period and received either desmopressin or placebo . RESULTS 127 patients were randomised to either desmopressin ( n=61 ) or placebo ( n=66 ) . Twenty ( 33 % ) desmopressin-treated patients compared with seven ( 11 % ) placebo-treated patients showed a clinical response , defined as a > or =50 % reduction in the number of nocturnal voids compared with baseline ( p=0.0014 ) . Compared with placebo , desmopressin resulted in a significant reduction in the mean number of nocturnal voids ( 39 % reduction with desmopressin vs. 15 % with placebo ; absolute difference -0.84 , p < 0.0001 ) and duration of the first sleep period ( prolonged by 108 min with desmopressin vs. 41 min with placebo ; p < 0.0001 ) . Quality of sleep was also improved with desmopressin versus placebo ( statistically significant for one of the two parameters evaluated ) . Adverse events were mainly mild . CONCLUSIONS Oral desmopressin tablets provide an effective and well-tolerated treatment for nocturia . Compared with placebo , nocturnal voiding frequency is reduced , duration of the first sleep period is increased , and sleep quality may be improved .

Desmopressin

desmopressin

desmopressin

desmopressin

placebo

desmopressin

placebo

desmopressin-treated

placebo-treated

desmopressin

desmopressin

placebo

desmopressin

placebo

desmopressin

placebo

desmopressin

placebo

efficacy , safety

quality of sleep

number of nocturnal voids

mean number of nocturnal voids

duration of the first sleep period

Quality of sleep

Adverse events

nocturnal voiding frequency

sleep quality

nocturia :


Granulocyte-macrophage colony-stimulating factor ( GM-CSF ) as adjunct therapy in relapsed Hodgkin disease . OBJECTIVE To determine the clinical and economic effects of granulocyte macrophage colony-stimulating factor ( GM-CSF ) as adjunct therapy in relapsed or refractory Hodgkin disease . DESIGN A randomized , double-blind , phase III clinical trial . SETTING A tertiary referral center . PATIENTS Twenty-four patients ( twelve of whom were controls ) treated with high-dose chemotherapy and autologous bone marrow transplantation . MAIN RESULTS The 12 patients treated with GM-CSF , when compared with placebo recipients , had shorter periods of neutropenia ( median duration of an absolute neutrophil count of less than 1000 cells/mm3 , 16 days compared with 27 days ; P = 0.02 ) , shorter periods of platelet-transfusion dependency ( median duration , 13.5 days compared with 21 days ; P = 0.03 ) , and shorter hospitalizations ( median hospital stay , 32 days compared with 40.5 days ; P = 0.004 ) . Other clinical outcomes , such as frequency and severity of toxicities , development of pneumonia or infection , in-hospital death , and response rate were similar in the two groups . Actuarial long-term disease-free survival was 64 % for patients treated with GM-CSF and 58 % for patients who received placebo after 32 months of follow-up ( P = 0.15 ) . The group treated with GM-CSF had lower total charges after infusion of autologous marrow than the placebo group ( median in-hospital charges , $ 39,800 compared with $ 62,500 ; P = 0.005 ) because of lower post-infusion charges for room and board , antibiotic therapy , transfusions , laboratory tests , and physical therapy visits . CONCLUSIONS Administration of GM-CSF was associated with acceleration of myeloid and platelet recovery and was cost effective in the treatment of patients with relapsed Hodgkin disease who received intensive chemotherapy .

high-dose chemotherapy

GM-CSF

placebo

GM-CSF

placebo

GM-CSF

placebo

GM-CSF

periods of neutropenia

shorter hospitalizations

frequency and severity of toxicities

development of pneumonia or infection

in-hospital death

response rate

long-term disease-free survival

lower post-infusion charges

cost effective

relapsed Hodgkin disease .


The patient experience of community hospital -- the process of care as a determinant of satisfaction . AIMS AND OBJECTIVES We report findings from a qualitative study to identify patient views of community hospital care . We consider how far these were in accord with the hospital staffs ' views . This constituted part of a wider randomized controlled trial ( RCT ) . The methodological challenges in seeking to identify patient satisfaction and in linking qualitative findings with trial results are explored . DESIGN A sample of 13 patients randomized to the community hospital arm of the RCT joined the qualitative study . Official documentation from the hospital were accessed and six staff interviewed to identify assumptions underlying practice . RESULTS Analysis of interviews identified a complex picture concerning expectations These could be classified as ideal , realistic , normative and unformed . The hospital philosophy and staff views about service delivery were closely in harmony , they delivered rehabilitation in a home-based atmosphere . The formal , or 'hard ' , process of rehabilitation was not well understood by patients . They were primarily concerned with 'soft ' or process issues -- where and how care was delivered . CONCLUSIONS We identify a model of community hospital care that incorporates technical aspects of rehabilitation within a human approach that is welcomed by patients . If patients are to be able to participate in making informed decisions about care , the rationale for the activities of staff need to be more clearly explained . Recommendations are made about the appropriate scope of qualitative findings in the context of trials and about techniques to access patient views in areas where they have difficulty in expressing critical impressions .

community hospital care

qualitative study

interviews

satisfaction

qualitative findings

staff views

patient


Effectiveness of aromatherapy massage in the management of anxiety and depression in patients with cancer : a multicenter randomized controlled trial . PURPOSE To test the effectiveness of supplementing usual supportive care with aromatherapy massage in the management of anxiety and depression in cancer patients through a pragmatic two-arm randomized controlled trial in four United Kingdom cancer centers and a hospice . PATIENTS AND METHODS Two hundred eighty-eight cancer patients , referred to complementary therapy services with clinical anxiety and/or depression , were allocated randomly to a course of aromatherapy massage or usual supportive care alone . RESULTS Patients who received aromatherapy massage had no significant improvement in clinical anxiety and/or depression compared with those receiving usual care at 10 weeks postrandomization ( odds ratio [ OR ] , 1.3 ; 95 % CI , 0.9 to 1.7 ; P = .1 ) , but did at 6 weeks postrandomization ( OR , 1.4 ; 95 % CI , 1.1 to 1.9 ; P = .01 ) . Patients receiving aromatherapy massage also described greater improvement in self-reported anxiety at both 6 and 10 weeks postrandomization ( OR , 3.4 ; 95 % CI , 0.2 to 6.7 ; P = .04 and OR , 3.4 ; 95 % CI , 0.2 to 6.6 ; P = .04 ) , respectively . CONCLUSION Aromatherapy massage does not appear to confer benefit on cancer patients ' anxiety and/or depression in the long-term , but is associated with clinically important benefit up to 2 weeks after the intervention .

aromatherapy massage

aromatherapy massage

aromatherapy massage

usual supportive care alone

aromatherapy massage

aromatherapy massage

Aromatherapy massage

Effectiveness

anxiety and depression

effectiveness

clinical anxiety and/or depression

self-reported anxiety

anxiety

depression

benefit


Combination of arteriovenous extracorporeal lung assist and high-frequency oscillatory ventilation in a porcine model of lavage-induced acute lung injury : a randomized controlled trial . BACKGROUND To compare the combined effects of arteriovenous extracorporeal lung assist ( AV-ECLA ) and high-frequency oscillatory ventilation ( HFOV ) on pulmonary gas exchange , hemodynamics , and respiratory parameters in a lavage-induced porcine lung injury model . METHODS A prospective , randomized animal study . Saline lung lavage was performed in 33 healthy female pigs , weighing 52 +/- 4.1 kg ( mean +/- SD ) , until the Pao2 decreased to 53 +/- 8 mm Hg . After a stabilization period of 60 minutes , the animals were randomly assigned to four groups : group 1 , pressure-controlled ventilation ( PCV ) with a tidal volume of 6 mL/kg ; group 2 , PCV with a tidal volume of 6 mL/kg and AV-ECLA ; group 3 , HFOV ; group 4 , HFOV and AV-ECLA . In groups 2 and 4 , the femoral artery and vein were cannulated and a low-resistance membrane lung was interposed . After isolated evaluation of AV-ECLA , the mean airway pressure was increased by 3 cm H2O from 16 to 34 cm H2O every 20 minutes , accompanied by blood gas analyses and measurements of respiratory and hemodynamic variables . RESULTS Only in AV-ECLA-treated animals was normocapnia achieved . No significant increase of Pao2 attributable to AV-ECLA alone was detected . Mean airway pressure augmentation resulted in a significant increase in Pao2 in all groups . Peak inspiratory pressure was significantly lower in HFOV-treated animals . CONCLUSIONS The combination of AV-ECLA and HFOV resulted in normocapnia and comparable Pao2 , although a smaller ventilator pressure amplitude was applied . Long-term animal studies are needed to assess whether this approach results in further lung protection .

high-frequency oscillatory ventilation

Saline lung lavage

pressure-controlled ventilation ( PCV )

PCV

AV-ECLA

HFOV

HFOV and AV-ECLA

AV-ECLA

AV-ECLA-treated

AV-ECLA

AV-ECLA

HFOV

mean airway pressure

normocapnia

Pao2 attributable

Mean airway pressure augmentation

Peak inspiratory pressure

normocapnia

lavage-induced acute lung injury

female


Safety trial of the vaginal microbicide cellulose sulfate gel in HIV-positive men . OBJECTIVE Cellulose sulfate ( CS ) is a promising vaginal microbicide . Because men will be exposed to the microbicide when engaging in vaginal intercourse , safety and acceptability need to be assessed in men . DESIGN This randomized double-blind phase I study assessed the safety and acceptability of seven consecutive daily doses of CS versus KY Jelly in 36 HIV-positive men . RESULTS No new or worsening of existing genital findings were observed during the follow-up examination . Mild genital symptoms were reported in 42 % of CS users ( itching , burning , tingling , testicular pain , dysuria , and warm or cold feeling ) and 8 % of KY Jelly users . CONCLUSION CS gel applied to the penis was well tolerated in this HIV-positive male population . The itching and burning symptoms were not severe and can be explained by the preservative benzyl alcohol present in the CS gel .

Cellulose sulfate ( CS )

CS

KY Jelly

CS

KY

CS

CS

safety and acceptability

safety and acceptability

Mild genital symptoms

itching

burning

tingling

testicular pain

dysuria

warm or cold feeling

tolerated

itching and burning

HIV-positive

men

men

men

HIV-positive

men

HIV-positive

male


[ Occupational exposure to nitrous oxide and sevoflurane during pediatric anesthesia : evaluation of an anesthetic gas extractor ] . OBJECTIVES To determine the level of occupational exposure to anesthetic gases in the absence of an extractor during pediatric anesthesia and to assess the efficacy of a purpose-built extraction system . METHODS The patients were 24 children undergoing tonsillectomy and adenoidectomy . Gases were extracted from the room for 1 group and were not extracted for the other group ( n=12 in each group ) . Induction was with 8 % sevoflurane , 60 % nitrous oxide ( N2O ) , 40 % oxygen at a flow rate of 8 L x min ( -1 ) through a Mapleson C circuit . Maintenance was with 2 % sevoflurane at the same flow rate and gas mixture under spontaneous ventilation with an endotracheal tube and a Mapleson D circuit . The circuits were equipped with an airway pressure-limiting valve to allow connection to an anesthetic gas extractor . Ambient levels of sevoflurane and N2O were measured in the breathing area around the anesthesiologist . The surgeon and the nurse were asked about symptoms related to occupational exposure . RESULTS The mean ( SD ) exposure to N2O and sevoflurane in the group without an extractor was 423 ( 290 ) and 12 ( 10.9 ) parts per million ( ppm ) , respectively . In the group working with the extractor , exposure was 94 % and 91 % lower : 24.7 ( 26 ) and 1.1 ( 1 ) ppm ( P < .001 ) . A higher incidence of noticing a " smell of gas " was registered for the group without an extractor ( 87 % vs 11 % in the extractor group , P=.003 ) . Higher rates were also found for general discomfort ( 62 % vs 11 % , P=.05 ) , nausea ( 62 % vs 0 % , P=.009 ) , and headache ( 62 % vs 0 % , P=.009 ) in the absence of the extractor . CONCLUSIONS Gas extraction decreased the level of exposure by up to 94 % , achieving levels that were below the recommended limits and greatly reducing occupational risk .

nitrous oxide and sevoflurane

pediatric anesthesia

pediatric anesthesia

sevoflurane

nitrous oxide

oxygen

sevoflurane

spontaneous ventilation

endotracheal tube

sevoflurane

Ambient levels

of sevoflurane and N2O

The

mean ( SD ) exposure to N2O

and sevoflurane

exposure

" smell of gas "

general discomfort

nausea

headache

level of exposure

occupational risk .


Stage II carcinoma of the ovary : an analysis of survival after comprehensive surgical staging and adjuvant therapy . Ninety-three women with FIGO stage II epithelial ovarian carcinoma underwent comprehensive surgical staging and were randomized prospectively to therapy consisting of either intraperitoneal radioactive phosphorus or oral melphalan . No patient had gross residual disease at the time of randomization . Ten of the forty-five women treated with melphalan experienced severe bone marrow depression at some time during therapy and two women expired from leukemia . Four of the forty-eight women treated with intraperitoneal phosphorus required surgical reexploration for intestinal obstruction or bowel injury . Twenty-one women died of their disease . Survival was not statistically different between the two treatment arms . The 5-year actuarial survival was 78 % .

surgical staging

adjuvant therapy

intraperitoneal radioactive phosphorus

oral melphalan

melphalan

intraperitoneal phosphorus

survival

severe bone marrow depression

expired from leukemia

died

Survival

5-year actuarial survival

Stage II carcinoma of the ovary

Ninety-three

women

forty-five

women

forty-eight

women

treated with intraperitoneal phosphorus


Injection sclerotherapy versus electrocoagulation in the management outcome of early haemorrhoids . OBJECTIVE To study the symptomatology of early hemorrhoids and to compare injection sclerotherapy ( IS ) with electrocoagulation ( EC ) in the management outcome of early haemorrhoids with respect to pain during the procedure , reduction in bleeding per rectum , and overall patient satisfaction score . METHODS A total of 102 patients were included in this experimental study at the POF Hospital , Wah Cantt from October 2004 to June 2005 . A detailed history was taken and proctoscopic examination was performed . Patients were then randomly divided into two groups ( Lottery method ) . One group was subjected to EC and the other to IS . In the EC , using the EC machine ( Wieda , China ) , direct current of 10-20 mA was applied in the submucosal plane of each pile core for 5-7 minutes . In the IS 1-2 ml of 5 % phenol in almond oil was injected in the same plane in each pile core . Pain during the procedure , reduction in bleeding per rectum and overall patient satisfaction , were studied as outcome measures . RESULTS The mean age of the patients was 44 years , 86 were males and 16 were females . Two thirds of the patients were having symptoms for more than 6 months . A third of patients had associated local pain while another third had associated mucous discharge . Chronic constipation was present in 81 % patients . Only 24.5 % of the patients had a positive family history of haemorrhoids . Patients in the electrocoagulation ( EC ) group experienced more pain during the procedure than the injection sclerotherapy ( IS ) group ( P < 0.000 ) , but EC was significantly more effective than IS in terms of reducing the bleeding per rectum ( P = 0.039 ) , and also significantly higher number of patients were fully satisfied with EC than with IS ( P < 0.04 ) . CONCLUSION EC , although more painful , is a safe , more effective and a highly satisfying procedure for treating early hemorrhoids .

Injection sclerotherapy

versus electrocoagulation

injection sclerotherapy ( IS )

electrocoagulation ( EC )

phenol in almond oil

pain during the procedure

reduction in bleeding per rectum

overall patient satisfaction score

Pain during the procedure

reduction in bleeding per rectum

overall patient satisfaction

local pain

mucous discharge

Chronic constipation

pain during the procedure

bleeding per rectum

fully satisfied

painful

safe

effective

highly satisfying

early haemorrhoids

102 patients

males

positive family history of haemorrhoids


Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement . OBJECTIVE To evaluate ciprofloxacin 0.3 % /dexamethasone 0.1 % ( CIPRODEX , Alcon , Ft. Worth , TX ) for the prevention of early post-operative otorrhea following TT placement . METHODS This was a single-center , randomized , evaluator-blinded , parallel-group study . Two hundred children undergoing bilateral TT placement were categorized as having unilateral ( " wet/dry " ) , bilateral ( " wet/wet " ) , or no ( " dry/dry " ) effusion at the time of surgery . All patients received Ciprodex or no treatment for 5 days post-operatively and returned at 2 weeks . RESULTS Physician-observed otorrhea was reported in 5 ( 4.95 % ) patients receiving Ciprodex and 39 ( 39.39 % ) patients receiving no treatment ( p < 0.0001 ) . Treatment decreased otorrhea in all groups , while the greatest benefit was observed in patients with bilateral effusion ( 93 % reduction ) . Ciprodex treatment also decreased the rate of clinically diagnosed otitis media ( OM ) and effusion following TT placement ( p < or =0.0006 ) . CONCLUSION Ciprodex reduced early post-operative otorrhea , clinically diagnosed OM and effusion following TT insertion . The greatest reduction in otorrhea was observed in patients with bilateral effusion at the time of surgery .

Ciprofloxacin/dexamethasone

ciprofloxacin 0.3 % /dexamethasone

Ciprodex

otorrhea

Physician-observed otorrhea

otorrhea

effusion

early post-operative otorrhea

clinically diagnosed OM

effusion

otorrhea


Misoprostol versus oxytocin for the reduction of postpartum blood loss . OBJECTIVE To compare the effect of 400 mug of oral misoprostol with 5 U of intravenous oxytocin in the reduction of postpartum blood loss and prevention of postpartum hemorrhage . METHODS In a prospective , double-blind , randomized controlled trial conducted in a tertiary maternity hospital 622 women received either 400 mug of oral misoprostol or 5 U of intravenous oxytocin after delivery of the anterior shoulder or within 1 min of delivery . The primary outcome was a hematocrit drop of 10 % or greater 24 h postpartum . The secondary outcomes were a hemoglobin drop of 30 mg/L or greater , the use of additional oxytocin , an estimated blood loss greater than 1000 mL , manual removal of the placenta , a blood transfusion , and shivering and fever ( > or=38 degrees C ) as adverse effects of misoprostol . RESULTS There was no difference between the 2 groups regarding the primary outcome ( a > or=10 % hematocrit drop occurred in 3.4 % and 3.7 % of the participants in the oxytocin and misoprostol groups , P=0.98 ) . The rate of use of additional oxytocin was higher in the misoprostol group ( 51 % versus 40.5 % , P=0.01 ) . Shivering was confined to the misoprostol group ( 6.8 % ) , and fever occurred in 12.5 % of the women in the misoprostol group and 0.3 % of the women in the oxytocin group . CONCLUSION The routine use of 400 microg of oral misoprostol was no less effective than 5 U of intravenous oxytocin in reducing blood loss after delivery , as assessed by change in postpartum hematocrit . The adverse effects of misoprostol were mild and self-limiting .

Misoprostol

oxytocin

oral misoprostol

intravenous oxytocin

oral misoprostol

intravenous oxytocin

oxytocin

misoprostol

oxytocin

misoprostol

oxytocin

misoprostol

misoprostol

misoprostol

oxytocin

misoprostol

oxytocin

misoprostol

postpartum blood loss .

postpartum blood loss

hemoglobin drop of 30 mg/L or greater

use of additional oxytocin

manual removal of the placenta

blood transfusion

shivering

fever

use of additional oxytocin

Shivering

blood loss

postpartum

women


Dose-response effect of flecainide in patients with symptomatic paroxysmal atrial fibrillation and/or flutter monitored with trans-telephonic electrocardiography : a multicenter , placebo-controlled , double-blind trial . BACKGROUND A double-blind , randomized , parallel-group , placebo-controlled trial was conducted in patients with paroxysmal atrial fibrillation or flutter ( PAF/PAFL ) experiencing 2 or more episodes of symptomatic PAF/PAFL during a 28-day observation period to determine the dose-response effect and safety of flecainide . METHODS AND RESULTS A total of 143 patients at 30 centers were randomized to receive 25 , 50 , or 100 mg of flecainide or placebo twice daily ( BID ) . In 123 patients ( per protocol set ) , those remaining free from PAF/PAFL after the treatment were 3.1 % on placebo , 7.7 % on 25 mg/BID , 9.4 % on 50 mg/BID , and 39.4 % on 100 mg/BID of flecainide . As a whole group , a significant linear dose-response ( p < 0.001 ) was observed and a significant difference between placebo and 100 mg/BID was observed ( p < 0.001 ) . A similar dose-response between the present study and Caucasian study was demonstrated . Although there were 5 patients who needed cardioversion or ablation because of frequent episodes of PAF/PAFL ( 2 in 25 mg/BID , 1 in 50 mg/BID , and 2 in 100 mg/BID of flecainide ) , neither death nor ventricular proarrhythmic event was reported . CONCLUSIONS This study indicated that flecainide exerted a significant dose-dependent effect on the prevention of symptomatic PAF/PAFL recurrence and showed that there was no inter-ethnic difference in the clinical effect of flecainide in patients with PAF/PAFL .

flecainide

placebo-controlled

flecainide

flecainide

placebo

placebo

flecainide

flecainide

flecainide

flecainide

Dose-response effect

effect and safety

PAF/PAFL

significant linear dose-response

dose-response

cardioversion

ablation

death

ventricular proarrhythmic event

symptomatic PAF/PAFL

PAF/PAFL


Do cervical cancer screening rates increase in association with an intervention designed to increase mammography usage ? OBJECTIVES To assess cervical cancer screening behaviors among underserved women participating in an intervention designed to increase mammography use . METHODS This was a randomized trial of 897 women from three racial groups ( white , African American , Native American ) living in a rural county in North Carolina . Baseline and followup surveys were completed by 815 women ; 775 women provided data to be included in these analyses . The intervention group received an educational program focused on mammography delivered by a lay health advisor , and the control group received a physician letter/brochure focusing on Pap tests . RESULTS Women in both the intervention ( OR 1.70 ; 1.31 , 2.21 , p < 0.001 ) and control groups ( OR 1.38 ; 1.04 , 1.82 , p = 0.025 ) significantly increased cervical cancer screening rates within risk appropriate guidelines . No differences by racial group were documented . Women categorized in the high-risk group for developing cervical cancer ( > 2 sexual partners , age < 18 years at first sexual intercourse , smoker ; treated for sexually transmitted disease [ STD ] or partner with treated STD ) significantly ( OR 1.88 ; 1.54 , 2.28 , p < 0.001 ) increased Pap test completion . However , a nonsignificant increase ( OR 1.25 ; 0.87 , 1.79 , p = 0.221 ) in Pap test completion was demonstrated in women categorized as low risk for cervical cancer . CONCLUSIONS This study suggests that women in an intensive behavioral intervention designed to increase mammography use may also increase Pap test completion , similar to a minimal intervention focused only on increasing Pap test completion . These results have implications for the design and evaluation of behavioral intervention studies .

cervical cancer screening behaviors

cervical cancer screening rates

increased Pap test completion

Pap test completion

Pap test completion

Pap test completion

women

women

women

women


Cost-effectiveness of collaborative care including PST and an antidepressant treatment algorithm for the treatment of major depressive disorder in primary care ; a randomised clinical trial . BACKGROUND Depressive disorder is currently one of the most burdensome disorders worldwide . Evidence-based treatments for depressive disorder are already available , but these are used insufficiently , and with less positive results than possible . Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm , and research in the UK has also shown good results with Problem Solving Treatment . These treatment strategies may also work very well in the Netherlands too , even though health care systems differ between countries . METHODS/DESIGN This study is a two-armed randomised clinical trial , with randomization on patient-level . The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework , including contracting and adherence-improving strategies , combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm . Forty general practices will be randomised to either the intervention group or the control group . Included will be patients who are diagnosed with moderate to severe depression , based on DSM-IV criteria , and stratified according to comorbid chronic physical illness . Patients in the intervention group will receive treatment based on the collaborative care approach , and patients in the control group will receive care as usual . Baseline measurements and follow up measures ( 3 , 6 , 9 and 12 months ) are assessed using questionnaires and an interview . The primary outcome measure is severity of depressive symptoms , according to the PHQ9 . Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR , and cost-effectiveness measured with the TiC-P , the EQ-5D and the SF-36 . DISCUSSION In this study , an American model to enhance care for patients with a depressive disorder , the collaborative care model , will be evaluated for effectiveness in the primary care setting . If effective across the Atlantic and across different health care systems , it is also likely to be an effective strategy to implement in the treatment of major depressive disorder in the Netherlands .

collaborative care including PST

antidepressant treatment algorithm

antidepressant treatment algorithm

Problem Solving Treatment

questionnaires

interview

collaborative care model

Cost-effectiveness

Problem Solving Treatment

treatment

severity of depressive symptoms

cost-effectiveness

the TiC-P

the EQ-5D

the SF-36

major depressive disorder

Forty


The study of inhibiting systematic inflammatory response syndrome by applying xenogenic ( porcine ) acellular dermal matrix on second-degree burns . OBJECTIVE To investigate the influence of xenogenic ( porcine ) acellular dermal matrix on the systematic inflammatory reaction syndrome ( SIRS ) , and the reaction of burn patients to tissue damage upon application to second-degree burn wounds . METHOD Seventy-two cases of patients with acute second-degree burns were enrolled in the study . According to the total burn surface area ( TBSA ) and the treatment methods , we randomly divided the patients into four groups . Group A ( treatment group ) : patients with less than 30 % TBSA covered with xenogenic acellular dermal matrix . Group B ( control group ) : patients with less than 30 % TBSA covered with betadine ointment gauzes . Group C ( treatment group ) : patients with more than 30 % TBSA covered with porcine acellular dermal matrix . Group D ( control group ) : patients with more than 30 % TBSA covered with betadine ointment gauzes . Serum level of C-reactive protein ( CRP ) was measured by single radial immunodiffusion method on 1 , 4 , 7 and 14 days postburn . RESULTS The serum level of CRP in group A was significantly less than that of in group B ( P < 0.05 ) on days 4 , 7 and 14 . The serum level of CRP in group C increased slowly , descended quickly and was significantly less than that of in group D on days 4 , 7 and 14 . CONCLUSION The application of xenogenic ( porcine ) acellular dermal matrix on second-degree burn wound can decrease serum level of CRP of the patients , which may play an important role in reducing SIRS and sepsis incidence .

xenogenic acellular dermal matrix .

betadine ointment gauzes .

porcine acellular dermal matrix .

betadine ointment gauzes .

serum level of CRP

serum level of CRP

serum level of CRP

second-degree burns

burn patients

second-degree burn wounds

Seventy-two

acute second-degree burns

second-degree burn wound


Comparison of the effect of gonadotropin-releasing hormone analog ( Diphereline ) and Cabergoline ( Dostinex ) treatment on uterine myoma regression . OBJECTIVE To investigate the effect of cabergoline ( Dostinex , a dopamine agonist ) on the myoma growth compared to Diphereline ( a gonadotropin-releasing hormone agonist ) . METHODS This study took place in the Department of Obstetrics and Gynecology of Tabriz University of Medical Sciences , Tabriz , Iran from July 2004 to December 2005 . Fifty women with uterine myoma , who met the criteria of the study thoroughly , were randomly allocated into 2 equal groups to take either Diphereline or Cabergoline . The first Group took 3.75 mg of Diphereline 4 times every 28 days and the second group took 0.5 mg of Cabergoline once a week for 6 weeks . RESULTS The Cabergoline was well tolerated and fewer adverse effects were noted . The tumor regressed significantly and volume reduction rate of individual tumor nodule varied from 46-53 % . The gonadotropin releasing hormone agonist group all responded to the treatment , and volume reduction rate of the individual tumor nodule varied from 21-97 % . The extent of tumor shrinkage was positively correlated to the number of nodules ( p=0.881 , p < 0.005 and 0.701 , p < 0.005 ) . CONCLUSION In light of therapeutic efficacy and few adverse effects , the dopamine agonists may hold promise as novel treatment modalities for leiomyoma . Further studies are warranted to determine the optimal strategy for the treatment of leiomyoma through these agents .

Cabergoline ( Dostinex )

Diphereline

Cabergoline

Diphereline

Cabergoline

Cabergoline

gonadotropin releasing hormone agonist

dopamine agonists

well tolerated

fewer adverse effects

tumor regressed significantly

volume reduction rate

tumor shrinkage

number of nodules

uterine myoma regression

Fifty women

uterine myoma


Comparison of increasing doses of olmesartan medoxomil , losartan potassium , and valsartan in patients with essential hypertension . This 12-week , randomized , double-blind , forced-titration study compared the efficacy of 3 angiotensin receptor blockers . Patients received olmesartan medoxomil 20 mg , losartan potassium 50 mg , valsartan 80 mg , or placebo once daily . At week 4 , doses were titrated to 40 , 100 , and 160 mg once daily for olmesartan , losartan , and valsartan , respectively . At week 8 , losartan was increased to 50 mg twice daily and valsartan increased to 320 mg once daily ( olmesartan remained at 40 mg once daily ) . The primary end point was mean change from baseline in seated diastolic blood pressure ( SeDBP ) at week 8 . All 3 medications significantly reduced mean SeDBP from baseline compared with placebo at weeks 4 , 8 , and 12 ( P < .001 ) . At week 8 , olmesartan reduced mean SeDBP more than losartan ( P < .001 ) ; more patients in the olmesartan medoxomil group achieved a blood pressure goal of < 140/90 mm Hg ( P < .001 ) . Olmesartan did not reduce mean SeDBP significantly compared with valsartan , although more patients attained blood pressure goal with olmesartan ( P=.031 ) . At week 12 , all agents lowered blood pressure equivalently .

losartan

valsartan

olmesartan

placebo

mean SeDBP

SeDBP

blood pressure

mean SeDBP

blood pressure

blood pressure

patients with essential hypertension


Pathological features and inhaled corticosteroid response of eosinophilic and non-eosinophilic asthma . BACKGROUND Non-eosinophilic asthma is a potentially important clinicopathological phenotype since there is evidence that it responds poorly to inhaled corticosteroid therapy . However , little is known about the underlying airway immunopathology and there are no data from placebo-controlled studies examining the effect of inhaled corticosteroids . METHODS Airway immunopathology was investigated using induced sputum , bronchial biopsies , bronchial wash and bronchoalveolar lavage in 12 patients with symptomatic eosinophilic asthma , 11 patients with non-eosinophilic asthma and 10 healthy controls . The patients with non-eosinophilic asthma and 6 different patients with eosinophilic asthma entered a randomised , double-blind , placebo-controlled crossover study in which the effects of inhaled mometasone 400 microg once daily for 8 weeks on airway responsiveness and asthma quality of life were investigated . RESULTS Patients with non-eosinophilic asthma had absence of eosinophils in the mucosa ( median 4.4 cells/mm ( 2 ) vs 23 cells/mm ( 2 ) in eosinophilic asthma and 0 cells/mm ( 2 ) in normal controls ; p = 0.03 ) and normal subepithelial layer thickness ( 5.8 microm vs 10.3 microm in eosinophilic asthma and 5.1 microm in controls , p = 0.002 ) . Non-eosinophilic and eosinophilic asthma groups had increased mast cell numbers in the airway smooth muscle compared with normal controls ( 9 vs 8 vs 0 cells/mm ( 2 ) , p = 0.016 ) . Compared with placebo , 8 weeks of treatment with inhaled mometasone led to less improvement in methacholine PC ( 20 ) ( 0.5 vs 5.5 doubling concentrations , 95 % CI of difference 1.1 to 9.1 ; p = 0.018 ) and asthma quality of life ( 0.2 vs 1.0 points , 95 % CI of difference 0.27 to 1.43 ; p = 0.008 ) . CONCLUSIONS Non-eosinophilic asthma represents a pathologically distinct disease phenotype which is characterised by the absence of airway eosinophilia , normal subepithelial layer thickness and a poor short-term response to treatment with inhaled corticosteroids .

placebo-controlled

inhaled mometasone 400 microg

airway responsiveness

asthma quality of life

absence of eosinophils in the mucosa

subepithelial layer thickness

mast cell numbers

improvement

methacholine PC ( 20 )

asthma quality of life

airway eosinophilia

subepithelial layer thickness

short-term response to treatment

12 patients

symptomatic eosinophilic asthma

11 patients

non-eosinophilic asthma

healthy controls

6 different patients


Compliance with continuous passive movement is low after surgical treatment of idiopathic club foot in infants : a prospective , double-blinded clinical study . Treatment by continuous passive movement at home is an alternative to immobilisation in a cast after surgery for club foot . Compliance with the recommended treatment , of at least four hours daily , is unknown . The duration of treatment was measured in 24 of 27 consecutive children with a mean age of 24 months ( 5 to 75 ) following posteromedial release for idiopathic club foot . Only 21 % ( 5 ) of the children used the continuous passive movement machine as recommended . The mean duration of treatment at home each day was 126 minutes ( 11 to 496 ) . The mean range of movement for plantar flexion improved from 15.2 degrees ( 10.0 degrees to 20.6 degrees ) to 18.7 degrees ( 10.0 degrees to 33.0 degrees ) and for dorsiflexion from 12.3 degrees ( 7.4 degrees to 19.4 degrees ) to 18.9 degrees ( 10.0 degrees to 24.1 degrees ) ( both , p = 0.0001 ) when the first third of therapy was compared with the last third . A low level of patient compliance must be considered when the outcome after treatment at home is interpreted .

continuous passive movement

continuous passive movement at home

continuous passive movement

idiopathic club foot

infants

mean age of 24 months ( 5 to 75 )

following posteromedial release


[ Effect of alpha dihydroergocryptine in patients with fibrocystic breast disease ] . OBJECTIVE To evaluate the effectiveness of alpha dihidroergocriptine in patients with fibrocystic mastopathy . PATIENTS AND METHODS Patients with diagnosis of fibrocystic breast disease were included in a prospective longitudinal blind double , controlled with placebo study . Patients were randomly assigned to one of two treatment groups : of treatment group A : Alpha dihidroergocriptine tablets of 10 mg , group B : Placebo , during 6 months . After to basal evaluation , the patients were revised in a monthly way evaluating the following symptoms and signs : mastalgia , mammary tension , presence of nodules , nipple secretion , and the presence of adverse events . RESULTS 39 patients with alpha dihidroergocriptine and 38 with placebo . Mastodinia , a satisfactory response was observed in 100 % of alpha dihidroergocriptine group vs 61.11 % of placebo group ( p = 0.0002 ) . Mastalgia responded in 100 % of alpha dihidroergocriptine group vs 64.86 % of placebo group ( p = 0.0003 ) . Galactorrea responded 100 % of alpha dihidroergocriptine group vs 93.33 % of the placebo . The nodules in the group alpha dihidroergocriptine disappeared in 23.1 % and in 21.1 % of the placebo group . Ultrasound evaluation of the nodules did not show significant differences between both groups . Prolactin levels showed a decrease in the group treated with alpha dihidroergocriptine with an important difference between both groups at the end of the 6 months study period . There were not differences in the presence of adverse events between groups . CONCLUSIONS Alpha dihidroergocriptine is effective in the treatment of fribrocystic breast disease with minimum adverse events when compared with similar drugs .

alpha dihydroergocryptine

alpha dihidroergocriptine

placebo

Placebo

alpha dihidroergocriptine

placebo

alpha dihidroergocriptine

placebo

alpha dihidroergocriptine

alpha dihidroergocriptine

Alpha dihidroergocriptine

mastalgia

mammary tension

presence of nodules

nipple secretion

presence of adverse events

Mastodinia

Mastalgia

Galactorrea

nodules

Prolactin levels

presence of adverse events

patients with fibrocystic mastopathy

fibrocystic breast disease

alpha dihidroergocriptine

placebo

fribrocystic breast disease


Immediately restored , single-tapered implants in the anterior maxilla : prosthodontic and aesthetic outcomes after 1 year . BACKGROUND Conventional implant protocols advocate a two-stage technique with a load-free , submerged healing period . Recent studies suggest that immediate restoration of single implants may be a viable treatment option . PURPOSE The purpose of this study was to evaluate prosthodontic and aesthetic peri-implant mucosal outcomes of immediately restored , Southern single-tapered implants in the anterior maxilla after 1 year . MATERIALS AND METHODS Participants ( mean age : 43.25 years ; range : 23-71 years ) satisfying specified inclusion criteria were randomly allocated to conventional two-stage restoration ( control group ; n=14 ) and immediate restoration groups ( test group ; n =14 ) in a randomized controlled clinical trial . Tapered , roughened-surface Southern implants were placed using a standardized technique , and implant level bone impressions were made . Provisional screw-retained crowns , out of occlusion , were placed at second-stage surgery after 26 weeks for the conventional restoration group , and within 4 hours of implant placement for the immediate restoration group . Both groups had definitive screw-retained metal-ceramic crowns placed in occlusion 8 weeks later . Peri-implant mucosal response and papilla index were recorded 4 weeks after definitive crown placement to allow for mucosal maturation and at 1 year . Prosthodontic and aesthetic outcomes were assessed using established criteria . RESULTS There were no significant differences within , or between , the control and test groups for age , gender , bone quality or quantity , implant stability measurements at surgery , or implant length . There were no significant differences in the implant success rate as determined by radiographic bone loss and stability tests after 1 year . There were no significant differences in prosthodontic maintenance , peri-implant mucosal response , and papilla index between the two groups over 1 year . CONCLUSIONS Tapered , roughened-surface implants immediately restored with single provisional crowns at surgery and definitive crowns 8 weeks later were as prosthodontically and aesthetically successful as conventionally restored two-stage implants during the first year of service . Restoring single implants immediately with screw-retained crowns is an efficient procedure , but the short-term outcome is by no means superior to a conventional two-stage approach .

implants

implants

two-stage restoration

Restoring

Prosthodontic and aesthetic

implant length

implant success rate

bone loss

prosthodontic maintenance

implants in the anterior maxilla

prosthodontic

aesthetic peri-implant


The NORwegian study on DIstrict treatment of ST-elevation myocardial infarction ( NORDISTEMI ) . OBJECTIVES Thrombolysis is the treatment of choice for patients with ST-elevation myocardial infarction ( STEMI ) living in rural areas with long transfer delays to percutaneous coronary intervention ( PCI ) . This trial compares two different strategies following thrombolysis : to transfer all patients for immediate coronary angiography and intervention , or to manage the patients more conservatively . DESIGN The NORwegian study on DIstrict treatment of STEMI ( NORDISTEMI ) is an open , prospective , randomized controlled trial in patients with STEMI of less than 6 hours of duration and more than 90 minutes expected time delay to PCI . A total of 266 patients will receive full-dose thrombolysis , preferably pre-hospital , and then be randomized to either strategy . Our primary endpoint is the one year combined incidence of death , reinfarction , stroke or new myocardial ischaemia . The study is registered with ClinicalTrials.gov , number NCT00161005 . RESULTS By April 2006 , 109 patients have been randomized . Thrombolysis has been given pre-hospital to 52 % of patients . The median transport distance from first medical contact to catheterization laboratory was 155 km ( range 90-396 km ) . Results of the study are expected in 2008 .

PCI

receive

full-dose thrombolysis

combined incidence of death

reinfarction

stroke

new myocardial ischaemia


Providing live supervision via teleconferencing improves acquisition of motivational interviewing skills after workshop attendance . Teleconferencing Supervision is a method for training community-based substance abuse clinicians in Motivational Interviewing ( MI ) . Following a 2-day workshop , 13 clinicians received live supervision via telephone during 5 counseling sessions conducted at their community treatment facilities . Clinicians were assessed for skill level at post-workshop , at post-training , and 3 months later ; learning was assessed using the MI Treatment Integrity instrument . All summary scores and therapist behavior frequency counts improved by post-training or by the 3 month follow-up , although some gains were not statistically significant . Teleconferencing Supervision may help facilitate the proficient use of MI community clinicians following workshop instruction .

live supervision via teleconferencing

Teleconferencing Supervision

Motivational Interviewing ( MI )

live supervision via telephone

Teleconferencing Supervision

skill level at post-workshop

summary scores

therapist behavior frequency counts


p16 ( INK4a ) Expression does not predict the outcome of cervical intraepithelial neoplasia grade 2 . Spontaneous regression of cervical intraepithelial neoplasia grade 2 ( CIN2 ) lesions has been recognized since 1955 , but predictors of this are poorly understood . Among the predictive markers studied , p16 ( INK4a ) has been suggested to be of some value in monitoring the diagnosis of CIN2 . In this clinical trial , 90 Brazilian women , diagnosed to CIN2 and high-risk human papillomavirus infection , were randomized into two groups of equal size : 45 women whose lesions were excised and 45 women subjected to prospective follow-up at 3-month intervals at least for 1 year ( mean 6.8 months ) . p16 ( INK4a ) expression was analyzed in paraffin-embedded sections using immunohistochemical staining . Among the 45 women in the follow-up group , 42 % experienced spontaneous regression , 11 % showed persistence , 22 % progressed to CIN3 , and 20 % had partial regression to CIN1 or ASCUS ( atypical squamous cell undetermined signifiance ) . p16 ( INK4a ) expression was detected in 68.9 % of the patients . In univariate survival ( Cox ) analysis , no significant difference in regression was obtained between p16 ( INK4a ) -negative and -positive CIN2 lesions ( adjusted HR = 1.1 ; 95 % CI 0.6-2.0 ) . In conclusion , p16 ( INK4a ) expression could be useful in the diagnosis of CIN2 . However , it failed to predict the outcome of CIN2 . Because of its high spontaneous regression rate , follow-up could be considered as a management option of CIN2 in young and compliant women .

p16 ( INK4a ) Expression

p16 ( INK4a )

lesions were excised

prospective follow-up

p16 ( INK4a )

immunohistochemical staining

p16 ( INK4a )

p16 ( INK4a ) -negative

and -positive

p16 ( INK4a )

p16 ( INK4a ) Expression

p16 ( INK4a ) expression

p16 ( INK4a ) expression

univariate survival ( Cox ) analysis

p16 ( INK4a ) expression

diagnosis of CIN2

45 women


Safety , pharmacokinetics and pharmocodynamics of recombinant human porphobilinogen deaminase in healthy subjects and asymptomatic carriers of the acute intermittent porphyria gene who have increased porphyrin precursor excretion . BACKGROUND AND OBJECTIVE Acute intermittent porphyria is an autosomal dominant disorder caused by deficient activity of the third enzyme in the haem biosynthetic pathway , porphobilinogen deaminase . It is characterised by acute , potentially life-threatening neurological attacks that are precipitated by various drugs , reproductive hormones and other factors . During acute attacks , the porphyrin precursors 5-aminolevulinic acid and porphobilinogen accumulate and are excreted at high concentrations in the urine . Current treatment is based on glucose loading and parenteral haem replenishment , which reduce the accumulation of 5-aminolevulinic acid and porphobilinogen . Recently , a new form of treatment based on porphobilinogen deaminase enzyme replacement therapy has been shown to be effective in an acute intermittent porphyria mouse model which , during phenobarbital ( phenobarbitone ) induction of haem biosynthesis , mimics the biochemical pattern of acute porphyric attacks . The objective of the present study was to investigate the safety , pharmacokinetics and pharmacodynamics of recombinant human porphobilinogen deaminase ( P 9808 ) , administered to healthy subjects and asymptomatic porphobilinogen deaminase-deficient subjects with high concentrations of porphobilinogen , the substrate of porphobilinogen deaminase . STUDY DESIGN Forty individuals participated in this two-part study : 20 asymptomatic porphobilinogen deaminase-deficient subjects ( both male and female ) with > or =4 times the upper reference urinary porphobilinogen level , and 20 healthy male subjects . Four different doses of recombinant human porphobilinogen deaminase were studied ( 0.5 , 1 , 2 and 4 mg/kg bodyweight ) . Part A included 12 asymptomatic porphobilinogen deaminase-deficient subjects , and the enzyme was administered in an open-label , single-dose design . Part B included 20 asymptomatic porphobilinogen deaminase-deficient subjects and 20 healthy subjects . The same enzyme dosages were administered as divided doses every 12 hours for 4 consecutive days in a randomised , double-blinded , placebo-controlled design . The washout period between Parts A and B was 2 weeks . METHODS The concentrations of recombinant human porphobilinogen deaminase and titres of antibodies against recombinant human porphobilinogen deaminase were analysed by ELISA . Plasma porphobilinogen and 5-aminolevulinic acid concentrations were analysed using a novel liquid chromatography-tandem mass spectrometry method . Urinary porphobilinogen , 5-aminolevulinic acid and porphyrin concentrations , as well as plasma porphyrin concentrations , were analysed using standard methods . The pharmacodynamic effect of the enzyme was studied through changes in plasma porphobilinogen concentrations . RESULTS No serious adverse events were observed . Seven subjects ( four healthy men and three asymptomatic porphobilinogen deaminase-deficient subjects ) developed antibodies against recombinant human porphobilinogen deaminase but did not experience allergic manifestations . The mean elimination half-lives of the highest doses of recombinant human porphobilinogen deaminase ranged between 1.7 and 2.5 hours for both healthy men and asymptomatic porphobilinogen deaminase-deficient subjects . The area under the plasma concentration-time curve was proportional to the respective dose . In asymptomatic porphobilinogen deaminase-deficient subjects , plasma porphobilinogen concentrations decreased below measurable levels almost instantaneously after administration of any dose of the enzyme . The effect lasted for approximately 2 hours , after which the plasma porphobilinogen concentration slowly increased , reaching about 70 % of the initial values 12 hours after administration . There was no effect on plasma 5-aminolevulinic acid concentrations , and there was a transitory increment in porphyrin concentrations . The corresponding concentrations of metabolites in the urine reflected the pattern observed in the plasma . CONCLUSIONS The recombinant human porphobilinogen deaminase enzyme preparation was found to be safe to administer and effective for removal of the accumulated metabolite porphobilinogen from plasma and urine . The pharmacokinetic profile of recombinant human porphobilinogen deaminase showed dose proportionality , and the elimination half-life was about 2.0 hours for the two highest doses . Thus , clinical grounds were established for investigation of the therapeutic efficacy of the enzyme during periods of overt disease in patients with acute intermittent porphyria .

porphobilinogen deaminase

human porphobilinogen deaminase

human porphobilinogen deaminase

plasma porphyrin concentrations

serious adverse events

allergic manifestations .

plasma porphobilinogen concentrations

plasma porphobilinogen concentration

porphyrin concentrations .

therapeutic efficacy

porphyrin


A comparison of laser-assisted drug delivery at two output energies for enhancing the delivery of topically applied LMX-4 cream prior to venipuncture . BACKGROUND Laser-assisted drug delivery ( LAD ) has the potential for facilitating topical anesthesia with reduced onset time . METHODS In this randomized , double-blind , crossover study we compared the efficacy and adverse event profile of LAD for topical anesthesia before venipuncture using two output energies ( 2.0 and 3.5 J/cm2 ) . RESULTS Mean Visual Analog Scale pain scores were not statistically different ( P = 0.57 ) between the low-energy ( mean = 6.7 ) and high-energy ( mean = 8.1 ) lasers . CONCLUSIONS LAD at an energy of 2.0 J/cm2 ( 570 mJ ) is as effective , with similar adverse events , as an energy of 3.5 J/cm2 ( 1000 mJ ) in facilitating topical anesthesia .

laser-assisted drug delivery

topically applied LMX-4 cream

venipuncture .

Laser-assisted drug delivery ( LAD )

LAD for topical anesthesia

venipuncture

LAD

Mean Visual Analog Scale pain scores

adverse events

laser-assisted drug delivery

prior to venipuncture

before venipuncture


Exercise capacity in atrial fibrillation : a substudy of the Sotalol-Amiodarone Atrial Fibrillation Efficacy Trial ( SAFE-T ) . BACKGROUND Therapy for chronic atrial fibrillation ( AF ) focuses on rate versus rhythm control , but little is known about the effects of common therapeutic interventions on exercise tolerance in AF . METHODS Six hundred fifty-five patients with chronic AF underwent maximal exercise testing at baseline and 8 weeks , 6 months , and 1 year after randomization to sotalol , amiodarone , or placebo therapy and attempted direct current cardioversion . Analyses of baseline determinants of exercise capacity , predictors of change in exercise capacity at 6 months and 1 year , and the short- and long-term effects of cardioversion on exercise capacity were made . RESULTS Age , obesity , and presence of symptoms accompanying AF were inversely associated with baseline exercise capacity , but these factors accounted for only 10 % of the variance in exercise capacity . Patients most likely to benefit from cardioversion were those most limited initially , younger , not obese or hypertensive , and with an uncontrolled ventricular rate at baseline . Conversion to sinus rhythm ( SR ) resulted in significant reductions in resting ( approximately 25 beat/min ) and peak exercise ( approximately 40 beat/min ) heart rates at 6 months and 1 year ( P < .001 ) . Successful cardioversion improved exercise capacity by 15 % at 8 weeks , and these improvements were maintained throughout the year . This improvement was observed both among those who maintained SR and those with intermittent AF . CONCLUSION Cardioversion resulted in a sustained improvement in exercise capacity over the course of 1 year , and this improvement was similar between those in SR and those with SR and recurrent AF . Patients most likely to improve with treatment tended to be younger and nonobese and have the greatest limitations initially .

maximal exercise testing

sotalol

amiodarone

placebo

attempted direct current cardioversion

cardioversion

Cardioversion

Exercise capacity

resting

peak exercise

heart rates

exercise capacity


Middle cerebral arterial blood flow velocity and hemodynamics in heart surgery . The aim of this study was to evaluate the effects of propofol , isoflurane , and sevoflurane on middle cerebral arterial blood flow velocity during open heart surgery , and the relationship between these effects and hemodynamic parameters . Fifty-two patients undergoing coronary artery bypass on cardiopulmonary bypass were divided randomly into 3 groups : the first group received 100 microg x kg ( -1 ) x min ( -1 ) propofol , the other groups received one minimum alveolar concentration of sevoflurane or isoflurane for anesthesia maintenance . Middle cerebral arterial blood flow velocities were measured by transcranial Doppler , and hemodynamics were measured by the thermodilution technique . Middle cerebral arterial blood flow velocities decreased significantly after administration of isoflurane and propofol , but there was no significant difference between the groups . After weaning from cardiopulmonary bypass , cerebral blood flow increased and came close to the value after induction in all groups . The pulsatility index and resistivity index increased significantly only after the propofol infusion , but there was no significant difference between the groups .

propofol

isoflurane

sevoflurane

propofol

sevoflurane

isoflurane

anesthesia maintenance

hemodynamics

cerebral blood flow increased

pulsatility index and resistivity index

open heart surgery


Oral sildenafil to control pulmonary hypertension after congenital heart surgery . This study investigates the role of oral sildenafil in decreasing pulmonary pressure after congenital heart surgery . Between September 2002 and September 2004 , among a group of postoperative children with large septal defects , moderate to severe pulmonary hypertension [ pulmonary artery ( PA ) to aortic ( Ao ) pressure ratio of 0.76 +/- 0.17 ] and systemic desaturation ( Ao Sat = 0.89 +/- 0.11 ) , oral sildenafil ( 0.3 mg x kg ( -1 ) , every 3 hours ) was administered for a period of 24-48 hours ( sildenafil group ) . These patients were compared to a group of 22 children with similar pathologies who did not receive sildenafil ( control group ) . Postoperative PA pressure ( 28.61 +/- 7.80 vs 39.40 +/- 10.80 mm Hg ) and PA/Ao pressure ( 0.28 +/- 0.08 vs 0.41 +/- 0.11 ) were significantly lower in the sildenafil group ( p = 0.001 and 0.001 respectively ) . Pulmonary hypertensive crisis was detected in 4 patients in the control group , but none in the sildenafil group ( p = 0.02 ) . There was no significant rise in PA pressure following discontinuation of the drug ( 26.30 +/- 6.66 vs 28.49 +/- 10.93 mm Hg , p = 0.366 ) . No significant complications were noticed regarding sildenafil use . Low doses of oral sildenafil appear to be effective and safe to control postoperative PA pressure in children . Absence of rebound pulmonary hypertension , availability , and low cost of the drug are considered as its major advantages .

Oral sildenafil

sildenafil

congenital heart surgery .

oral sildenafil

sildenafil

sildenafil

sildenafil

sildenafil

sildenafil

sildenafil

pulmonary hypertension

pulmonary pressure

Postoperative PA pressure

PA/Ao pressure

Pulmonary hypertensive crisis

pulmonary hypertension

after congenital heart surgery .

patients


A prospective study of plasma vitamin D metabolites , vitamin D receptor polymorphisms , and prostate cancer . BACKGROUND Vitamin D insufficiency is a common public health problem nationwide . Circulating 25-hydroxyvitamin D3 ( 25 [ OH ] D ) , the most commonly used index of vitamin D status , is converted to the active hormone 1,25 dihydroxyvitamin D3 ( 1,25 [ OH ] 2D ) , which , operating through the vitamin D receptor ( VDR ) , inhibits in vitro cell proliferation , induces differentiation and apoptosis , and may protect against prostate cancer . Despite intriguing results from laboratory studies , previous epidemiological studies showed inconsistent associations of circulating levels of 25 ( OH ) D , 1,25 ( OH ) 2D , and several VDR polymorphisms with prostate cancer risk . Few studies have explored the joint association of circulating vitamin D levels with VDR polymorphisms . METHODS AND FINDINGS During 18 y of follow-up of 14,916 men initially free of diagnosed cancer , we identified 1,066 men with incident prostate cancer ( including 496 with aggressive disease , defined as stage C or D , Gleason 7-10 , metastatic , and fatal prostate cancer ) and 1,618 cancer-free , age- and smoking-matched control participants in the Physicians ' Health Study . We examined the associations of prediagnostic plasma levels of 25 ( OH ) D and 1,25 ( OH ) 2D , individually and jointly , with total and aggressive disease , and explored whether relations between vitamin D metabolites and prostate cancer were modified by the functional VDR FokI polymorphism , using conditional logistic regression . Among these US physicians , the median plasma 25 ( OH ) D levels were 25 ng/ml in the blood samples collected during the winter or spring and 32 ng/ml in samples collected during the summer or fall . Nearly 13 % ( summer/fall ) to 36 % ( winter/spring ) of the control participants were deficient in 25 ( OH ) D ( < 20 ng/ml ) and 51 % ( summer/fall ) and 77 % ( winter/spring ) had insufficient plasma 25 ( OH ) D levels ( < 32 ng/ml ) . Plasma levels of 1,25 ( OH ) 2D did not vary by season . Men whose levels for both 25 ( OH ) D and 1,25 ( OH ) 2D were below ( versus above ) the median had a significantly increased risk of aggressive prostate cancer ( odds ratio [ OR ] = 2.1 , 95 % confidence interval [ CI ] 1.2-3.4 ) , although the interaction between the two vitamin D metabolites was not statistically significant ( pinteraction = 0.23 ) . We observed a significant interaction between circulating 25 ( OH ) D levels and the VDR FokI genotype ( pinteraction < 0.05 ) . Compared with those with plasma 25 ( OH ) D levels above the median and with the FokI FF or Ff genotype , men who had low 25 ( OH ) D levels and the less functional FokI ff genotype had increased risks of total ( OR = 1.9 , 95 % CI 1.1-3.3 ) and aggressive prostate cancer ( OR = 2.5 , 95 % CI 1.1-5.8 ) . Among men with plasma 25 ( OH ) D levels above the median , the ff genotype was no longer associated with risk . Conversely , among men with the ff genotype , high plasma 25 ( OH ) D level ( above versus below the median ) was related to significant 60 % approximately 70 % lower risks of total and aggressive prostate cancer . CONCLUSIONS Our data suggest that a large proportion of the US men had suboptimal vitamin D status ( especially during the winter/spring season ) , and both 25 ( OH ) D and 1,25 ( OH ) 2D may play an important role in preventing prostate cancer progression . Moreover , vitamin D status , measured by 25 ( OH ) D in plasma , interacts with the VDR FokI polymorphism and modifies prostate cancer risk . Men with the less functional FokI ff genotype ( 14 % in the European-descent population of this cohort ) are more susceptible to this cancer in the presence of low 25 ( OH ) D status .

plasma vitamin D metabolites

vitamin D receptor polymorphisms

25-hydroxyvitamin D3 ( 25 [ OH ] D )

25 ( OH ) D

1,25 ( OH ) 2D

vitamin D status

VDR FokI polymorphism

median plasma 25 ( OH ) D levels

25 ( OH ) D

plasma 25 ( OH ) D levels

Plasma levels of 1,25 ( OH ) 2D

risk of aggressive prostate cancer

25 ( OH ) D levels

VDR FokI genotype

plasma 25 ( OH ) D levels

risks of total

aggressive prostate cancer

plasma 25 ( OH ) D levels

high plasma 25 ( OH ) D level

25 ( OH ) D in plasma


Information source affects peers ' initial attitudes toward autism . Authors examined the effects of information source on peers ' cognitive and behavioral attitudes toward an unfamiliar child with autism . Children ( N=296 ; M age=10.21 years ) received information about an unfamiliar child with autism from one of the following sources : ( a ) videotape , ( b ) teacher , ( c ) hypothetical mother , ( d ) hypothetical father , or ( e ) hypothetical " doctor . " Interactive effects between source , and sex and grade were found for cognitive and behavioral attitudes . Fifth-graders reported more favorable cognitive and behavioral attitudes when information was provided by extra-familial sources ( i.e. , " doctor " ) versus parent sources . Mother yielded more persuasive effects on behavioral attitudes for third-graders versus fifth-graders . Attitudes toward autism differ depending on who provides information about the disability . Persuasion theory appears useful to guide evaluation of educational interventions to improve attitudes towards autism . Implications of the findings , study limitations , and recommendations for future research are discussed .

Information source

videotape

teacher

hypothetical mother

hypothetical father

hypothetical " doctor . "

autism

cognitive and behavioral attitudes

cognitive and behavioral attitudes

attitudes towards autism .

teacher


Effects of electro-acupuncture on T cell subpopulations , NK activity , humoral immunity and leukocyte count in patients undergoing chemotherapy . OBJECTIVE To observe the effects of electro-acupuncture on T cell subpopulations , natural killer cell ( NK ) activity , humoral immunity and leukocyte count in patients undergoing chemotherapy . METHODS Electro-acupuncture was added for patients undergoing chemotherapy . Tests were done on T cell subpopulations , NK activity , humoral immunity and leukocyte count before treatment and after 4 courses of treatment . RESULTS After 4 courses of treatment with chemotherapy and electro-acupuncture , no obvious changes were found in T cell subpopulations , NK activity , humoral immunity and leukocyte count ( P > 0.05 ) as compared with those before treatment . Patients undergoing chemotherapy combined with electro-acupuncture showed obviously higher leukocyte count than that of the control group given no leukogenic drugs ( P < 0.01 ) . CONCLUSION Electro-acupuncture may reduce immunologic damage caused by chemotherapy , thus it can be used as the auxiliary therapy for patients undergoing chemotherapy .

electro-acupuncture

electro-acupuncture

chemotherapy

Electro-acupuncture

chemotherapy

chemotherapy

electro-acupuncture

chemotherapy

electro-acupuncture

Electro-acupuncture

chemotherapy

chemotherapy

T cell subpopulations

natural killer cell ( NK ) activity

humoral immunity

leukocyte count

T cell subpopulations

NK activity

humoral immunity

leukocyte count

changes

T cell subpopulations

NK activity

humoral immunity

leukocyte count

leukocyte count

immunologic damage

chemotherapy

chemotherapy

chemotherapy

chemotherapy


Enhanced inotropic state of the failing left ventricle by cardiac contractility modulation electrical signals is not associated with increased myocardial oxygen consumption . BACKGROUND Previous studies in patients and in dogs with experimentally induced heart failure ( HF ) showed that electrical signals applied to the failing myocardium during the absolute refractory period improved left ventricular ( LV ) function . We examined the effects these same cardiac contractility modulating ( CCM ) electrical signals on myocardial oxygen consumption ( MVO ( 2 ) ) in both patients and dogs with chronic HF . METHODS AND RESULTS Six dogs with microembolizations-induced HF and 9 HF patients underwent CCM leads and generator ( OPTIMIZER II ) implantation . After baseline measurements , CCM signals were delivered continuously for 2 hours in dogs and for 30 minutes in patients . MVO ( 2 ) was measured before and after CCM therapy . In dogs , CCM therapy increased LV ejection fraction at 2 hours ( 26 +/- 1 versus 31 +/- 2 % , P = .001 ) without increasing MVO ( 2 ) ( 257 +/- 41 versus 180 +/- 34 micromol/min ) . In patients , CCM therapy increased LV peak +dP/dt by 10.1 +/- 1.5 % . As with dogs , the increase in LV function after 30 minutes of CCM therapy was not associated with increased MVO ( 2 ) ( 13.6 +/- 9.7 versus 12.5 +/- 7.2 mL O ( 2 ) /min ) . CONCLUSIONS The study results suggest that unlike cAMP-dependent positive inotropic drugs , the increase in LV function during CCM therapy is elicited without increasing MVO ( 2 ) .

electrical signals

microembolizations-induced HF

CCM signals

CCM therapy

CCM therapy

CCM therapy

CCM therapy

CCM therapy

myocardial oxygen consumption

left ventricular ( LV ) function

MVO ( 2 )

LV ejection fraction

MVO ( 2 )

LV peak +dP/dt

LV function

MVO ( 2 )

LV function


[ Evaluation on the effect of intervention regarding breast self-examination for decreasing breast cancer mortality ] . OBJECTIVE A randomized trial of breast self-examination ( BSE ) Program was carried out to evaluate whether the intensive BSE could reduce the number of deaths among women from breast cancer . METHODS This study was a randomized controlled trial ( RCT ) . A total of 266 064 women ( age of 30 to 64 years ) associated with 519 textile factories in Shanghai had been randomly assigned to a BSE group ( 132 979 women ) or a control group ( 133 085 women ) since 1989 . Initial instruction in BSE group would include demonstration of proper palpation techniques and was followed by 2 reinforcement sessions during the subsequent 4 years including video shows , BSE instruction sessions and BSE practice under medical supervision . These activities were continued for 5 years . Attendance at all events was recorded . The cohort was followed through July 2000 for development of breast diseases , and the breast cancer cases were followed through 2001 for vital status . Data analysis methods used would include Kaplan-Meier plots , log-rank test and Cox modeling . RESULTS Among women under instruction , 864 breast cancers detected and 133 breast cancer deaths occurred while 896 breast cancers were detected and 130 deaths recorded in the control group . The tumor size ( P = 0.07 ) , TNM stage ( P = 0.39 ) and cumulative breast cancer mortality rate ( P = 0.72 ) were not significantly different between the 2 groups . However , more and smaller fibroadenomas were detected in the instruction group than in the control group ( P < 0.01 ) . CONCLUSION Intensive instruction in BSE did not seem to have reduced the mortality rate of breast cancer , but more and smaller benign breast lumps could be detected .

breast self-examination ( BSE ) Program

BSE

BSE

control

BSE

BSE

breast cancer mortality rate

mortality rate of breast cancer


Comparison of indicators for a primary care medical home between children with autism or asthma and other special health care needs : National Survey of Children 's Health . OBJECTIVE To assess the extent to which parents of children with autism compared with parents of children with asthma or other special health care needs report receiving primary care for their child consistent with the American Academy of Pediatrics medical home model . DESIGN Population-based cross-sectional study . SETTING National Survey for Children 's Health 2003-2004 telephone interview . PARTICIPANTS Parents of 495 children with autism , parents of 6716 children with asthma , and parents of 11,403 children with other special health care needs without asthma . Main Exposures Autism and other special health care needs including asthma . MAIN OUTCOME MEASURES Medical home score and components of care , as follows : personal provider and preventive ; family-centered , compassionate , and culturally appropriate ; accessible ; comprehensive ; and coordinated . RESULTS The odds of parents reporting care consistent with that in a medical home were less likely for children with autism ( odds ratio , 0.45 ; 95 % confidence interval , 0.30-0.66 ) and more likely for children with asthma ( odds ratio , 1.17 ; 95 % confidence interval , 1.06-1.30 ) compared with children with other special health care needs ( 1 [ reference ] ) . These differences persisted even after controlling for condition severity , personal characteristics , and insurance status . Specific components of a medical home less prevalent among children with autism than among children with other special health care needs included family-centered , comprehensive , and coordinated care . CONCLUSION Although we could not evaluate the reasons why , a large percentage of children with autism do not receive primary care consistent with that in a medical home .

less likely for children with autism

children

autism

asthma

special health care needs

children

autism

children

asthma

special health care needs

children

autism

children

asthma

special health care needs

asthma