Investigation of maxillary tooth sizes in patients with palatal canine displacement . AIM The aim of this retrospective trial was to investigate differences in mesiodistal and vestibulo-oral crown sizes of naturally , fully-erupted permanent maxillary teeth between patients with and without palatal canine displacement . PATIENTS AND METHOD 115 patients ( mean age : 14 years 10 months ; females : 77 males : 38 ) treated in the Department of Orthodontics , University of Munich were included in the study . 65 of the patients showed at least one palatally-displaced canine . Diagnosis and the location of the displacement were determined on the basis of standardized radiographs and confirmed by surgical documentation . Each maxillary tooth 's mesiodistal and vestibulo-oral width was measured using a dial caliper on each dental cast . Excluded were partially-erupted teeth and surfaces with caries or restorations that had to be measured . An analysis of available space was made by evaluating the pre-treatment dental casts of all patients included in the study . RESULTS Comparing the tooth widths of patients with unilateral canine displacement with the corresponding contralateral quadrants , we noted a statistically significant difference , namely that the central and lateral incisors and the canines of the affected side were narrower than those of the non-affected side in the same patient . Moreover , the displaced upper canines showed an increase in vestibulo-oral dimension . Overall tooth width ( including all tooth groups ) in patients with palatally-displaced canines was significantly less than that in the control group . However , when comparing the crown diameters of unilaterally- and bilaterally-affected patients , no differences in tooth-size were observed . The space-analysis showed excessive dental-arch space in patients with a palatally-displaced canine . CONCLUSION Patients affected by palatal canine displacement showed significantly smaller maxillary tooth size .

standardized radiographs

dial caliper

maxillary tooth sizes

tooth widths

vestibulo-oral dimension

Overall tooth width

crown diameters

tooth-size

dental-arch space


Autism-Spectrum Quotient-Japanese version and its short forms for screening normally intelligent persons with pervasive developmental disorders . A Japanese version of the Autism Spectrum Quotient ( AQ ) , AQ-J was administered to 25 normally intelligent high-functioning pervasive developmental disorder ( HPDD ) patients ( mean age , 24.2 years ; 24 male , one female ) and 215 controls ( mean age , 30.4 years ; 86 male , 129 female ) randomly selected from the general population . The AQ-J had satisfactory internal consistency reliability ( Cronbach 's alpha > 0.70 in the two groups ) , test-retest reliability , and discriminant validity [ i.e . the AQ-J score was significantly higher in the HPDD ( mean , 29.6 ) than controls ( mean , 22.2 ) ] . At a cut-off of 26 , the AQ-J had satisfactory sensitivity , specificity , and negative predictive value , but it had low positive predictive value ( 0.24 ) possibly due to the facts that the 25 mild HPDD patients scored lower and the controls scored higher on the AQ-J than British counterparts on the AQ . The AQ-J-21 ( consisting of 21 items significantly associated with HPDD diagnosis ) and the AQ-J-10 ( consisting of 10 of the 21 items with an effect size > 0.17 ) had higher , although not satisfactory , positive predictive values of 0.35 and 0.46 at cut-offs of 12 and 7 , respectively , than the AQ-J . The AQ-J and two short forms are useful not to predict but to rule out mild HPDD , the most difficult part of HPDD to be distinguished from non-PDD conditions , in persons scoring under the cut-offs and to consider professionals ' examination of HPDD in persons scoring over them , because their negative predictive values were satisfactory .

Autism-Spectrum Quotient-Japanese

AQ-J

AQ-J

AQ-J

AQ-J

AQ-J

low positive predictive value

associated with HPDD diagnosis

effect size > 0.17

mild HPDD

normally intelligent

pervasive developmental disorders

HPDD

24.2 years

male

one

female

30.4 years

male

female


Prospective randomized multicenter trial of sevelamer hydrochloride and calcium carbonate for the treatment of hyperphosphatemia in hemodialysis patients in Japan . A prospective , randomized open-label trial of sevelamer hydrochloride with or without calcium carbonate ( CC ) involved 86 hemodialysis patients in Japan . The dosage of CC was fixed at 3.0 g/day for the 12-week study . After the first 4 weeks all subjects were changed from CC to sevelamer 3.0 g/day for another 4 weeks , then allocated randomly to three groups for the final 4 weeks : group A , sevelamer 6.0 g/day ; group B , sevelamer 3.0 g/day and CC 3.0 g/day ; group C , CC 3.0 g/day . The target serum phosphorous concentration ( P ) =5.5 mg/dL and the corrected calcium concentration ( Ca ) was 9.0-10.0 mg/dL . Of the 86 patients , 62 finished the study without a change of dosage and their data were analyzed ( group A , N=16 ; group B , N=26 ; group C , N=20 ) . At week 8 compared with week 4 , the concentration of P increased from 5.7+/-1.4 to 6.4+/-1.7 mg/dL in group A , and decreased significantly in groups B and C , and in group B compared with groups A and C ; groups A and C had similar concentrations at week 8 . The Ca concentration decreased significantly from 9.7+/-1.0 to 9.1+/-0.7 mg/dL after the change to sevelamer . At week 8 Ca was not significantly changed in group A , whereas a significant increase occurred in groups B and C. Side-effects with sevelamer administration occurred in 34 of the 86 patients and 24 dropped out of the study , with a high frequency in group A ( 13/29 ; 44.8 % ) . In conclusion , there was an additive effect of sevelamer for the treatment of hyperphosphatemia with CC . The combination therapy was better tolerated and showed higher patient compliance than CC or sevelamer monotherapy .

CC to sevelamer

group A , sevelamer 6.0 g/day

CC 3.0 g/day ; group C

CC 3.0 g/day

sevelamer

sevelamer

hyperphosphatemia

target serum phosphorous concentration

corrected calcium concentration ( Ca )

concentration of P

Ca concentration

Ca

Side-effects

additive effect

tolerated

patient compliance

Japan

hemodialysis


Effect of mild endurance exercise training and pravastatin on peripheral vasodilatation of forearm resistance vessels in patients with coronary artery disease . BACKGROUND Improved endothelial function may contribute to the beneficial effects of cholesterol lowering therapy in patients with coronary artery disease ( CAD ) , but results of the effect of statin therapy on endothelial function are disparate in these patients . Exercise training has been reported to improve endothelial function of patients at risk of or with established CAD . The goal of the study was to compare the effect of mild exercise training or statin therapy on forearm endothelial function in CAD patients with average cholesterol levels . DESIGN AND METHODS Twenty-eight sedentary male patients with angiographically documented CAD and average pretreatment total plasma cholesterol levels ( 5.1+/-0.9 mmol/l ) aged 42-75 years were included . They were randomly assigned in a 2 : 1 order to either statin therapy ( pravastatin , 40 mg daily ) or exercise training therapy ( mild endurance exercise three or more times a week ) . The effects of 10 weeks of either treatment on endothelium-dependent and independent vasodilation of forearm resistance vessels was assessed by plethysmography . Cardiopulmonary exercise testing was performed at baseline and after 10 weeks . RESULTS Ten weeks of pravastatin therapy significantly reduced low-density lipoprotein cholesterol ( from 3.8+/-0.6 to 3.1+/-0.6 mmol/l at study end , P=0.04 ) and the ratio of total to high-density lipoprotein cholesterol ( from 4.9+/-0.8 to 3.7+/-0.7 mmol/l , P=0.002 ) . Exercise training did not significantly modify the lipid profile . Peak oxygen consumption , maximal achieved workload and exercise duration tended to improve in the exercise training group but remained unchanged in the pravastatin-treated group . Neither 10 weeks of pravastatin nor mild endurance exercise training improved endothelium-dependent or independent vasomotor function in forearm resistance vessels . CONCLUSIONS In patients with CAD and average cholesterol levels , 10 weeks of treatment with mild endurance exercise training or with pravastatin failed to improve endothelium-dependent or independent vasomotor function in forearm resistance vessels .

mild endurance exercise training

pravastatin

Exercise training

mild exercise training

statin therapy

statin therapy ( pravastatin

exercise training therapy

Cardiopulmonary exercise

pravastatin

Exercise training

pravastatin-treated

pravastatin

mild endurance exercise training

mild endurance exercise training

pravastatin

low-density lipoprotein cholesterol

lipid profile

Peak oxygen consumption

maximal achieved workload

exercise duration

patients with coronary artery disease .


[ Treatment of hyperhomocysteinemia and endothelial dysfunction in renal-transplant recipients with vitamin B ] . OBJECTIVE To study the effect of vitamin B on treatment of hyperhomocysteinemia and endothelial dysfunction in renal-transplant recipients . METHODS Thirty-six stable hyperhomocysteinemic renal-transplant recipients were randomly assigned to vitamin treatment ( group A , n = 18 , folic acid 5 mg/d , vitamin B ( 6 ) 50 mg/d , B ( 12 ) 1000 microg/d ) or controlled group ( group B , n = 18 ) for 6 months . All subjects underwent assessment of levels for creatinine , creatinine clearance , average pressure , total cholesterol , triglyceride and fasting homocysteine . Endothelial function was evaluated using high-resolution vascular ultrasound . RESULTS The levels of homocysteine markedly decreased in group A [ ( 13 +/- 4 ) micromol/L vs ( 20 +/- 5 ) micromol/L , t = 5.3 , P < 0.01 ] after treatment , whereas no significant changes were observed in group B . In group A , endothelium dependent [ ( 12 +/- 5 ) % vs ( 9 +/- 5 ) % , t = 2.9 , P < 0.01 ] and independent [ ( 18 +/- 4 ) % vs ( 12 +/- 5 ) % , t = 3.4 , P < 0.01 ] vasodilatation responses significantly increased after treatment , no significant changes were observed in group B. Endothelium dependent [ ( 9 +/- 6 ) % , t = 2.8 , P < 0.01 ] and independent [ ( 12 +/- 5 ) % , t = 3.5 , P < 0.01 ] vasodilatation responses of group A were significantly lower than that of group B after treatment . CONCLUSIONS Vitamin B supplementation can reduce the levels of homocysteine and improve the endothelial function in hyperhomocysteinemic renal-transplant recipients .

controlled group

effect

vasodilatation responses

vasodilatation responses

renal-transplant recipients

renal-transplant recipients .


Reactivation of unstable angina after the discontinuation of heparin . BACKGROUND Heparin is an effective , widely used treatment for unstable angina . Among patients enrolled in a double-blind , randomized , placebo-controlled trial comparing intravenous heparin , aspirin , both treatments , and neither during the acute phase of unstable angina , we encountered patients in whom unstable angina was reactivated after heparin was discontinued . METHODS The study population included 403 of the original 479 patients in the trial who had completed six days of blinded therapy without refractory angina or myocardial infarction . After the discontinuation of therapy , clinical events , including reactivation of unstable angina and myocardial infarction occurring within 96 hours after hospitalization , were closely monitored . RESULTS Early reactivation occurred in 14 of the 107 patients who received heparin alone , as compared with only 5 patients in each of the other three study groups ( P less than 0.01 ) . These reactivations required urgent intervention ( thrombolysis , angioplasty , or coronary-bypass surgery ) in 11 patients treated with heparin alone , but in only 2 patients in the other groups combined ( P less than 0.01 ) . Four of the six patients who had a myocardial infarction during a reactivation of their disease were in the heparin group . Reactivations in this group occurred in a cluster a mean ( +/- SD ) of 9.5 +/- 5 hours after the discontinuation of the study drug but were randomly distributed over the initial 96 hours in the other three groups . CONCLUSIONS Although heparin is beneficial in treating unstable angina , the disease process may be reactivated within hours of the discontinuation of this drug . Concomitant therapy with aspirin may prevent this withdrawal phenomenon .

heparin

Heparin

placebo-controlled trial

intravenous heparin

aspirin

both treatments

heparin

heparin

heparin

heparin

Reactivation of unstable angina

Early reactivation

reactivations

myocardial infarction

Reactivations

reactivated

unstable


A single dose of gabapentin reduces acute pain and allodynia in patients with herpes zoster . This randomized , double-blind , placebo-controlled crossover study measured the effect of a single dose of oral gabapentin ( 900 mg ) on pain and allodynia associated with herpes zoster . Pain severity decreased by 66 % with gabapentin compared to 33 % with placebo . Reductions in allodynia area and severity , and overall pain relief , were also greater with gabapentin .

gabapentin

placebo-controlled

oral gabapentin

gabapentin

placebo

gabapentin

acute pain

allodynia

pain

allodynia associated with herpes zoster

Pain severity

allodynia area and severity

overall pain relief

herpes zoster


Hydrogen peroxide mouth rinse : an analgesic post-tonsillectomy . OBJECTIVE To compare the analgesic efficacy of hydrogen peroxide ( H2O2 ) mouth rinse with control for post-tonsillectomy pain management . DESIGN Double-blinded , prospective , randomized , controlled clinical trial . PATIENTS AND METHODS Thirty-seven patients from 5 to 14 years old undergoing electrocautery tonsillectomy were randomized to either the H2O2 mouth rinse or the water rinse ( control ) group . For 14 days , patients recorded pain levels twice daily using a visual analogue scale . Analgesic uses , as well as any complications , were also noted by the patients . RESULTS Thirty-seven patients completed the study , 21 in the treatment group and 16 in the control group . Mean postoperative days of pain were 10.3 and 8.3 , respectively , and differed significantly ( p = .008 ) . Mean postoperative days of analgesic use were 9.0 and 6.7 , respectively , and differed significantly ( p = .005 ) . Only one incidence of postoperative hemorrhage occurred in the study group . CONCLUSION In our study , the H2O2 mouth rinse does not provide a better analgesic effect than the water rinse for post-tonsillectomy pain relief .

Hydrogen peroxide mouth rinse

hydrogen peroxide ( H2O2 ) mouth rinse

control

electrocautery tonsillectomy

H2O2 mouth rinse

the

water rinse

( control ) group

H2O2 mouth rinse

analgesic efficacy

post-tonsillectomy pain management .

pain levels

visual analogue scale .

Mean postoperative days of pain

Mean postoperative days of analgesic

postoperative hemorrhage

analgesic effect

post-tonsillectomy pain relief

post-tonsillectomy .


Effect of soy protein containing isoflavones on blood lipids in moderately hypercholesterolemic adults : a randomized controlled trial . BACKGROUND Dietary intake of soy protein with isoflavones may be associated with reductions in serum cholesterol . OBJECTIVES To compare the effects of a water-washed soy protein concentrate with a milk-protein based control on blood lipid levels in hyperlipidemic men and women . METHODS A randomized , double-blind , controlled clinical trial including 159 subjects . After a 3-week run-in period during which all subjects consumed a milk protein-based supplement , participants were randomized into one of two groups : a control group ( continued milk protein ) and an intervention group ( soy protein ) for a five-week period . Fasting venous blood draws for lipid measurement were obtained at baseline , towards the end of the run-in period and at the end of the intervention . Blood isoflavone concentrations were measured at the end of the study . RESULTS Blood lipid levels were not significantly different between groups at any point in time ; and there were no significant associations between blood isoflavones and lipid levels . Significant decreases in total cholesterol ( 19 mg/dL ) , and LDL-cholesterol ( 11 mg/dL ) , were observed during the run-in period , with no further decreases in lipids during the intervention period in either group . CONCLUSIONS These results do not support the hypothesis that water-washed soy protein has an effect on blood lipids . Several hypotheses are discussed , highlighting the selective nature of the effect of soy consumption in the population . The cholesterol-lowering effect during the run-in period may be explained by the " regression to the mean effect " and by other factors related to study participation , mainly nutrient displacement induced by the protein supplement .

soy protein containing isoflavones

Dietary intake

soy protein with isoflavones

water-washed soy protein concentrate

milk-protein based control

milk protein-based supplement

continued milk protein

soy protein

isoflavone

isoflavones

soy protein

protein supplement

blood lipids

Blood isoflavone concentrations

Blood lipid levels

blood isoflavones

lipid levels

decreases

total cholesterol

LDL-cholesterol

blood lipids

hypercholesterolemic

adults

hyperlipidemic

men

women .


Nitrous oxide diffusion into tracheal tube cuffs -- efficacy of a new prototype cuff pressure release valve . BACKGROUND The aim of this study was to evaluate the performance of a new cuff pressure release valve ( CPRV ) , in which the release pressure can be adjusted from 10 to 25 cmH2O , particularly intended to control pressure in paediatric cuffed tracheal tubes and to avoid cuff hyperinflation caused by N2O diffusion . METHODS In vitro : the PRV was set to 10 , 15 , 20 or 25 cmH2O release pressure and connected to a cuffed tube placed into a box flushed with 66 % N2O in O2 . The cuff pressure was monitored with and without CPRV for 60 min . Experiments were performed four times using two different CPRVs . In vivo : with Institutional Review Board approval , CPRV was studied in 50 children undergoing general anaesthesia with tracheal intubation and standardized anaesthesia technique ( including 66 % N2O in O2 ) and ventilator settings . Patients were randomized into two groups ( with and without CPRV ) . The cuff pressure baseline was 20 cmH2O and CPRV was set to 25 cmH2O . If the cuff pressure exceeded 25 cmH2O , it was manually released to 20 cmH2O . The numbers of deflations in both groups were noted and compared by Mann-Whitney U-test ( P < 0.05 ) . RESULTS In vitro : the cuff pressure exceeded 50 cmH2O after 60 min without CPRV , but did not exceed the settings with CPRV . In vivo : there was no need to manually deflate the cuff in the CPRV group but , in every patient in the control group , three ( two to seven ) deflating manoeuvres were required within the first hour of anaesthesia ( P < 0.0001 ) . CONCLUSION The CPRV allows reliable cuff pressure release at various pressure levels and reliably prevents cuff pressure increases caused by N2O .

cuff pressure release valve

cuff pressure release valve

with

and without

CPRV

cuffs --

efficacy

performance

cuff pressure

cuff pressure

cuff pressure

cuff pressure

cuff pressure

reliable cuff pressure release

cuff pressure

paediatric cuffed tracheal tubes

children


Safety and immunogenicity of an oral , inactivated , whole-cell vaccine for Shigella sonnei : preclinical studies and a Phase I trial . Orally delivered , inactivated whole-cell vaccines are safe methods of inducing local and systemic immunity . To increase surface proteins associated with adherence and invasion , Shigella sonnei were grown in BHI broth containing deoxycholate . A whole-cell vaccine ( SsWC ) was then produced by formalin inactivation . In pre-clinical studies , the SsWC vaccine was immunogenic and protected against S. sonnei-induced keratoconjunctivitis in the guinea pig model . In a randomized , double-blind , placebo-controlled , Phase I study , 10 evaluable subjects received either three doses of SsWC on Days 0 , 14 , and 28 ( N = 3 ) ; five doses of SsWC on Days 0 , 2 , 4 , 6 , and 28 ( N = 4 ) ; or placebo ( N = 3 ) . Each dose contained 2.0 x 10 ( 10 ) inactivated cells . Serum and fecal antibodies against SsWC , LPS , and IpaC were measured by ELISA . A > or = 4-fold increase in titer was considered significant . Both SsWC dosing regimens were well tolerated . No fever or severe gastrointestinal symptoms were noted by any of the vaccinated subjects . Antibody responses were similar in the two dosing groups . Serum IgG or IgA responses to SsWC were seen in six of seven vaccinees ( 86 % ) , to LPS in four of seven ( 57 % ) , and to IpaC in five of seven ( 61 % ) . Fecal IgA responses to these three antigens developed in five of five , three of five , and three of five subjects , respectively . Among the seven vaccinees , geometric mean rises in serum IgA levels to all three immunogens were significant ; IgG increases trended toward significance ( paired one-tailed t-test ) . We conclude that SsWC was immunogenic and protective in animal studies and well tolerated and immunogenic in a Phase I trial .

vaccines

whole-cell vaccine ( SsWC )

SsWC vaccine

placebo-controlled

SsWC

SsWC

placebo

SsWC

SsWC

SsWC

surface proteins

tolerated

Antibody responses

Serum IgG or IgA responses

Fecal IgA responses

serum IgA levels

IgG increases

protective

tolerated


Migration of the acetabular component : effect of cement pressurization and significance of early radiolucency : a randomized 5-year study using radiostereometry . BACKGROUND Cementing technique is a crucial factor in prosthesis fixation . No randomized studies have been published , however , comparing the outcome of conventional fingerpacking with the outcome of pressurization of the cement prior to cup insertion . PATIENTS AND METHODS We randomized 50 THAs to either fingerpacking or sequential pressurization ( including individual pressurization of each anchorage hole ) and followed the patients with RSA for 5 years . The penetration of cement into the anchorage holes was measured on digital radiographs . Postoperative radiolucent lines around the cup were correlated to later RSA results . For clinical evaluation , we used SF-36 and HHS . RESULTS The pressurized group of THAs was more stable regarding changes in inclination . We found no other difference in the migratory behavior . The cement penetration into the anchorage holes was deeper with the pressurization technique than with fingerpacking . For the whole group taken together , there was a strong relation between the presence of radiolucent lines as measured on the postoperative radiograph and later migration observed by RSA at 2 and 5 years . INTERPRETATION Pressurization of the cement produced better cement penetration and increased the cup stability in terms of changes in inclination . Early findings of radiolucent lines can predict later unfavorable cup migration .

cement pressurization

fingerpacking

sequential pressurization

effect of cement pressurization

significance of early radiolucency

Migration of the acetabular component

significance of early radiolucency

prosthesis fixation


Effect of exercise , training , and glycogen availability on IL-6 receptor expression in human skeletal muscle . The cytokine interleukin-6 ( IL-6 ) exerts it actions via the IL-6 receptor ( IL-6R ) in conjunction with the ubiquitously expressed gp130 receptor . IL-6 is tightly regulated in response to exercise , being affected by factors such as exercise intensity and duration , as well as energy availability . Although the IL-6 response to exercise has been extensively studied , little is known about the regulation of the IL-6R response . In the present study , we aimed to investigate the effect of exercise , training , and glycogen availability , factors known to affect IL-6 , on the regulation of gene expression of the IL-6R in human skeletal muscle . Human subjects performed either 10 wk of training with an acute exercise bout before and after the training period , or a low-glycogen vs. normal-glycogen acute exercise trial . The IL-6R mRNA response was evaluated in both trials . In response to acute exercise , an increase in IL-6R mRNA levels was observed . Neither training nor intramuscular glycogen levels had an effect on the IL-6R mRNA response to exercise . However , after 10 wk of training , the skeletal muscle expressed a higher mRNA level of IL-6R compared with before training . The present study demonstrated that the IL-6R gene expression levels in skeletal muscle are increased in response to acute exercise , a response that is very well conserved , being affected by neither training status nor intramuscular glycogen levels , as opposed to IL-6 . However , after the training period , IL-6R mRNA production was increased in skeletal muscle , suggesting a sensitization of skeletal muscle to IL-6 at rest .

exercise , training

glycogen availability

exercise

exercise , training

glycogen availability

normal-glycogen acute exercise trial

training

IL-6R mRNA response

IL-6R mRNA levels

IL-6R mRNA response

mRNA level of IL-6R

IL-6R gene expression levels

training status

intramuscular glycogen levels

IL-6R mRNA production

human skeletal muscle .


Open flap debridement with or without intentional cementum removal : a 4-month follow-up . OBJECTIVES The aim of this study was to investigate the influence of cementum removal on periodontal repair . MATERIAL AND METHODS Forty subjects with chronic periodontitis and presenting , at least , two proximal sites in anterior teeth ( upper or lower ) with probing depth > or =5 mm were selected . After oral hygiene instructions and ultrasonic supragingival instrumentation , the subjects were randomly assigned for one of the following groups : CIC , scaled with Gracey curettes ; CIUS , scaled with ultrasonic device ; CDC , calculus deattachment with Gracey curettes and brushing with saline solution ; and CDUS , calculus deattachment with ultrasonic device and brushing with saline solution . Full-thickness flaps were reflected and the instrumentation was performed with a clinical microscope . Probing depth ( PD ) , relative gingival margin level ( RGML ) and relative attachment level ( RAL ) were registered at five experimental periods : baseline and 30 , 60 , 90 and 120 days postoperative . RESULTS All the approaches were able to markedly reduce the PD values from the baseline to the other evaluation periods ( p < 0.0001 ) . The increase in RGML values was statistically significant only for the CDUS group . There were no statistically significant differences between the baseline and postoperative values in all groups for the RAL changes . The changes in RAL were statistically significant only among the groups CDC and CDUS ( p < 0.0001 ) . CONCLUSION The conventional scaling and root planing and the calculus deattachment were effective in reducing the probing depth values , regardless of the instrumentation method .

CDUS

CDC

CDUS

RGML values

RAL changes .

RAL

Open flap debridement

periodontal repair

Forty

chronic periodontitis


NHS Direct and older people .

NHS

older people


Analgesic efficacy of caudal block versus diclofenac suppository and local anesthetic infiltration following pediatric laparoscopy . AIM To compare the analgesic efficacy of caudal block with diclofenac suppository and local anesthetic infiltration in children undergoing laparoscopy . METHODS We studied 50 children undergoing laparoscopy for diagnostic and therapeutic purposes . Their ages ranged from 3 to 13 years , and all belonged to American Society of Anesthesiologists ( ASA ) class I or II . Anesthesia was carried out using the standard procedure . Patients were randomly assigned to one of two groups . Group 1 received caudal block with bupivacaine 1 mL/kg after anesthetic induction . Group 2 received diclofenac suppository 3 mg/kg postinduction and local anesthetic infiltration at the port sites at the end of the procedure . Pain was assessed using the Hannallah objective pain scale at 15 , 30 , 60 , 120 , and 360 minutes postextubation . RESULTS The pain scores were comparable in both groups at all times . Twelve percent of caudal block patients and 20 % of diclofenac patients needed rescue analgesic , a statistically insignificant difference . In 2 patients , caudal block was technically difficult and they were excluded from the study . The incidence of side effects was low in our study . CONCLUSION We find the analgesic efficacy of diclofenac suppository combined with local anesthetic infiltration at port sites comparable to caudal block . Given the necessarily invasive nature of caudal block , we suggest the combined use of diclofenac suppository with local anesthetic infiltration at port sites as a useful and more economical alternative for analgesia following pediatric laparoscopy .

caudal block

diclofenac suppository

caudal block

diclofenac suppository

local anesthetic infiltration

Anesthesia

diclofenac suppository

anesthetic infiltration

diclofenac suppository

anesthetic infiltration

Analgesic efficacy

analgesic

Pain was assessed

Hannallah objective pain scale

pain scores

rescue analgesic

analgesic


Economic evaluation of a nursing-led inpatient unit : the impact of findings on management decisions of service utility and sustainability . AIMS The nursing-led inpatient unit is designed to substitute for a period of care in acute hospital wards and to improve patient outcome prior to discharge to the community . This paper aims to evaluate the cost , from the UK National Health Service perspective , of transfer to a nursing-led inpatient unit for intermediate care and to discuss the impact of these findings to the future development and sustainability of the nursing-led inpatient unit . BACKGROUND Recent economic analyses have showed that nursing-led inpatient units are associated with increased costs of care with length of stay as the main driver of inpatient costs . METHOD The cost-effectiveness analysis was part of a randomized-controlled trial with a sample size of 175 , of which 89 were in the nursing-led inpatient unit arm and 86 in the control arm . Resource use data included length of stay , investigations performed , multiprofessional input and nursing input . Clinical outcome was measured using Barthel Index , a functional status measure . RESULTS Cost per day was lower on the nursing-led inpatient unit although cost per hospital stay was higher due to significantly increased length of stay . Postdischarge community care costs were lower . The incremental cost-effectiveness ratio of the treatment was 1044 pounds sterling per point improvement of the Barthel Index . CONCLUSIONS The nursing-led inpatient unit was associated with higher costs however , the question of whether the nursing-led inpatient unit is cost-effective has not been clearly answered because of the limited follow-up period of the study . The increased cost of care on the nursing-led inpatient unit was not a major factor in local management decisions about the future of the unit . The changes in the context of service provision within which the nursing-led inpatient unit operated as a result of substantial investment in intermediate care did have a major impact .

nursing-led inpatient unit

nursing-led inpatient unit

nursing-led inpatient unit arm and

the control arm

The nursing-led inpatient unit

nursing-led inpatient unit

nursing-led inpatient unit

Economic evaluation

cost

development and sustainability

cost-effectiveness

Resource use

length of stay

investigations performed

multiprofessional input

nursing input .

Clinical outcome

Barthel Index

Cost per day

cost per hospital stay

Postdischarge community care costs


Topiramate improves health-related quality of life when used to prevent migraine . OBJECTIVE To assess changes in health-related quality of life ( HRQoL ) measures among patients receiving topiramate ( TPM ) 100 mg/d in two divided doses for migraine prevention in three randomized , double-blind , placebo-controlled , 26-week trials with similar protocols and study populations . BACKGROUND Migraine substantially impairs HRQoL and work productivity before , during , and after attacks . Approximately 50 % of patients with migraine could be recommended for preventive therapies , yet only 3 % to 5 % of patients receive them . TPM is an effective and generally well-tolerated migraine prophylactic ( preventive ) therapy for adults , as demonstrated in several randomized , double-blind , placebo-controlled trials . The most common adverse events in double-blind , placebo-controlled studies of TPM in migraine prevention are paresthesia , fatigue , anorexia , nausea , taste alteration , and diarrhea . DESIGN AND METHODS The Migraine-Specific Questionnaire ( MSQ , version 2.1 ) was used to assess the effect of TPM 100 mg/d on the functionality and HRQoL of randomized intent-to-treat ( ITT ) and study-completer populations pooled from three randomized , double-blind , placebo-controlled trials . MSQ scores ( 0 to 100 , higher score indicates better functioning ) were assessed for the following three domains : role restriction ( examines the degree to which performance of daily activities is limited by migraine ) , role prevention ( examines the degree to which performance of daily activities is interrupted by migraine ) , and emotional function ( examines feelings of frustration and helplessness due to migraine ) . Between-group differences from baseline in mean MSQ domain scores for TPM 100 mg/d and placebo were compared using a mixed-effects model with piecewise linear regression . Effect sizes were calculated to estimate the magnitude of change in HRQoL that can be associated with TPM therapy . RESULTS TPM 100 mg/d significantly improved all three MSQ domains compared with placebo for both the ITT ( TPM , n = 372 ; placebo , n = 362 ) and study-completer ( TPM , n = 220 ; placebo , n = 216 ) populations ( P < .001 for all three domains , both populations ) . Effect sizes for TPM 100 mg/d varied from 0.40 to 0.78 , indicating that the changes in MSQ scores for TPM 100 mg/d were moderate and may be clinically significant . CONCLUSION TPM 100 mg/d has been shown to be effective in the prevention of migraine headache in adults . As the MSQ results from the three randomized , placebo-controlled trials indicate , HRQoL is significantly improved for up to 6 months following initiation of treatment .

Topiramate

topiramate ( TPM )

TPM

TPM

TPM

TPM

placebo

TPM therapy

TPM

placebo

TPM

placebo

TPM

TPM

TPM

health-related quality of life

HRQoL

work productivity

effective and generally well-tolerated

Migraine-Specific Questionnaire ( MSQ

MSQ scores

emotional function

MSQ domain scores

MSQ domains

MSQ scores

migraine headache

HRQoL

migraine

similar protocols and study populations

migraine headache

adults


Effects of halothane and isoflurane on transient renal dysfunction associated with infrarenal aortic cross-clamping . Aortic cross-clamping for reconstructive aortic surgery is associated with impairment of renal function . Halothane or isoflurane was used to assess the influence of volatile anesthesia on renal hemodynamics during aortic surgery . Nineteen patients with normal preoperative creatinine clearances who were scheduled for reconstructive aortic surgery were randomly divided into two groups : halothane group ( n = 9 ) and isoflurane group ( n = 10 ) . Induction of anesthesia consisted of midazolam , fentanyl , and pancuronium . Anesthesia was maintained with fentanyl and halothane or isoflurane in nitrous oxide and oxygen ( 50/50 ) . Systemic hemodynamics were similar in both groups throughout surgery . Before aortic cross-clamping , effective renal plasma flow ( ERPF ) ( 131I-hippuran clearance ) and glomerular filtration rate ( GFR ) ( 99Tc-DTPA clearance ) were significantly lower in the halothane group ( 118.4 +/- 25.6 and 19.7 +/- 5.2 mL/min , respectively ) than in the isoflurane group ( 253.4 +/- 51.5 and 44.9 +/- 8.4 mL/min ) ( P less than 0.05 for both ) . During cross-clamping , the renal variables were not markedly affected in either group and remained higher in the isoflurane-anesthetized patients ( 232.9 +/- 47.1 and 49.5 +/- 1.2 mL/min for ERPF and GFR , respectively ) than in the halothane-anesthetized patients ( 132.4 +/- 31.6 and 14.8 +/- 3.7 mL/min , respectively ) ( P less than 0.05 ) . After aortic unclamping , ERPF increased markedly in both groups ( 467.8 +/- 122 and 362.5 +/- 57.7 mL/min in the halothane and isoflurane groups , respectively ) , as did GFR ( 74.8 +/- 22 and 71.8 +/- 13.1 mL/min , respectively ) . These results suggest that anesthesia with halothane is associated with transient renal vasoconstriction during abdominal surgery . In contrast , aortic cross-clamping during isoflurane anesthesia was not associated with renal hemodynamic impairment .

halothane

isoflurane

Halothane

isoflurane

halothane group

isoflurane group

midazolam

fentanyl

pancuronium

fentanyl

halothane

isoflurane in nitrous oxide and oxygen

isoflurane

halothane-anesthetized

anesthesia

halothane

transient renal dysfunction

renal function

renal hemodynamics

Systemic hemodynamics

renal variables

ERPF

GFR

transient renal vasoconstriction

renal hemodynamic impairment

transient renal dysfunction


Cervical spine motion : a fluoroscopic comparison during intubation with lighted stylet , GlideScope , and Macintosh laryngoscope . The question of which is the optimum technique to intubate the trachea in a patient who may have a cervical ( C ) -spine injury remains unresolved . We compared , using fluoroscopic video , C-spine motion during intubation for Macintosh 3 blade , GlideScope , and Intubating Lighted Stylet , popularly known as the Lightwand or Trachlight . Thirty-six healthy patients were randomized to participate in a crossover trial of either Lightwand or GlideScope to Macintosh laryngoscopy , with in-line stabilization . C-spine motion was examined at the Occiput-C1 junction , C1-2 junction , C2-5 motion segment , and C5-thoracic motion segment during manual ventilation via bag-mask , laryngoscopy , and intubation . Time to intubate was also measured . C-spine motion during bag-mask ventilation was 82 % less at the four motion segments studied than during Macintosh laryngoscopy ( P < 0.001 ) . C-spine motion using the Lightwand was less than during Macintosh laryngoscopy , averaging 57 % less at the four motion segments studied ( P < 0.03 ) . There was no significant difference in time to intubate between the Lightwand and the Macintosh blade . C-spine motion was reduced 50 % at the C2-5 segment using the GlideScope ( P < 0.04 ) but unchanged at the other segments . Laryngoscopy with GlideScope took 62 % longer than with the Macintosh blade ( P < 0.01 ) . Thus , the Lightwand ( Intubating Lighted Stylet ) is associated with reduced C-spine movement during endotracheal intubation compared with the Macintosh laryngoscope .

Lightwand

or

GlideScope

to

Macintosh laryngoscopy

, with

in-line stabilization

manual ventilation via bag-mask ,

laryngoscopy

, and

intubation

C-spine motion

C-spine motion

Time

C-spine motion using the Lightwand

time to intubate

C-spine motion

longer

C-spine movement


Impact of a single intravenous administration of nicorandil before reperfusion in patients with ST-segment-elevation myocardial infarction . BACKGROUND Intravenous nicorandil , a hybrid compound of ATP-sensitive potassium channel opener and nitric oxide donor , has been reported to ameliorate early functional and clinical problems in patients with acute myocardial infarction . However , its effects on the late phase remain unclear . METHODS AND RESULTS This follow-up study to 5 years of a randomized , double-blinded trial was conducted among 368 patients with first ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention ( PCI ) . They were randomly assigned to receive 12 mg of nicorandil or a placebo intravenously just before reperfusion . We analyzed incidence of cardiovascular death or rehospitalization for congestive heart failure after PCI as well as various aspects of epicardial flow and microvascular function . Mean follow-up was 2.4 years ( SD , 1.4 ) . A total of 12 ( 6.5 % ) patients receiving nicorandil and 30 ( 16.4 % ) receiving placebo had cardiovascular death or hospital admission for congestive heart failure ( hazard ratio , 0.39 ; 95 % CI , 0.20 to 0.76 ; P=0.0058 ) . Postprocedural TIMI 3 flow was obtained in 89.7 % of the nicorandil group and in 81.4 % of the placebo ( hazard ratio , 1.99 ; 95 % CI , 1.09 to 3.65 ; P=0.025 ) . Corrected TIMI frame count was furthermore lower in the nicorandil group ( 21.0+/-9.1 versus 25.1+/-14.1 ; P=0.0009 ) . ST-segment resolution > 50 % was observed in 79.5 % and 61.2 % of the nicorandil and placebo groups , respectively ( hazard ratio , 2.45 ; 95 % CI , 1.54 to 3.90 ; P=0.0002 ) . CONCLUSIONS The addition of intravenous nicorandil to PCI leads to beneficial clinical outcomes and prevents cardiovascular events of long duration and death in patients with ST-segment-elevation myocardial infarction .

nicorandil

nicorandil

nicorandil

placebo

nicorandil

placebo

nicorandil

placebo

nicorandil

nicorandil

placebo

nicorandil

cardiovascular death

rehospitalization

congestive heart failure

cardiovascular death

hospital admission

congestive heart failure

Postprocedural TIMI 3 flow

Corrected TIMI frame count

ST-segment resolution > 50 %

clinical outcomes

cardiovascular events of long duration

death

acute myocardial infarction


Clinical efficacy of fluvoxamine and functional polymorphism in a serotonin transporter gene on childhood autism . We studied the correlation between response to fluvoxamine and serotonin transporter gene promoter region polymorphism ( 5-HTTLPR ) . Eighteen children with autistic disorder completed a 12-week double-blind , placebo-controlled , randomized crossover study of fluvoxamine . Behavioral assessments were obtained before and at 12 weeks of treatment . 5-HTTLPR ( long ( l ) or short ( s ) ) , was analyzed by the PCR method . Ten out of 18 patients responded to fluvoxamine treatment ; allele type analysis revealed that clinical global effectiveness was noted significantly more in the l allele than in the s allele . However , with respect to language use , a significant effectiveness was noted in the s allele . 5-HTTLPR may influence the individual responses to fluvoxamine administration .

fluvoxamine

fluvoxamine

placebo-controlled

fluvoxamine

fluvoxamine

fluvoxamine

Behavioral assessments

allele type analysis

language use

childhood

autism

Eighteen

children

autistic disorder


[ A randomized study of prophylactic intravesical instillation of pirarubicin ( THP ) prior to transurethral resection of superficial bladder cancer ] . A prospective randomized study was conducted to evaluate the efficacy of prophylactic intravesical instillation of pirarubicin ( THP ) prior to transurethral resection ( TUR ) of superficial bladder cancer . A total of 63 patients were randomized into two groups , the THP group and the control group . In the THP group , 30 mg of THP dissolved in 50 ml saline was administered 4 times intravesically for 4 consecutive days before TUR . In the control group , no instillation was performed before TUR . The patients were followed by cystoscopy and urinary cytology every 3 months . The non-recurrence rates in the THP group and control group were 54.1 % versus 37.6 % at 1 year and 40.4 % versus 26.8 % at 2 years , respectively ( P = 0.086 ) . Time to recurrence for tumors larger than 1 cm was significantly longer in the THP group ( P = 0.0137 ) . Time to recurrence for single and grade 1+2 tumors tended to be longer in the THP group ( P = 0.09 , P = 0.079 ) . No significant adverse effects were observed in any patient . Our findings suggest that intravesical THP instillation prior to TUR would be effective for patients with single , low grade lesions larger than 1 cm of superficial bladder cancer .

pirarubicin ( THP )

transurethral resection

THP

50 ml saline

no instillation was performed before

TUR

superficial bladder cancer

non-recurrence rates

adverse effects

effective

superficial bladder cancer


Efficacy and safety of zidovudine and zalcitabine combined with a combination of herbs in the treatment of HIV-infected Thai patients . A randomized double blind placebo controlled trial to determine the efficacy and safety of combined-herbs ( SH ) given with zidovudine ( ZDV ) and zalcitabine ( ddC ) for the treatment of HIV infection in Thai adults was conducted in 3 hospitals in northern Thailand during 2002 to 2003 . The eligible subjects were HIV-infected Thai adults who had never received anti-retrovirals , had a Karnofski Performance Score ( KPS ) of > or = 70 , and had no opportunistic infections . The subjects were randomized to receive either a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and SH 2.5 g three times per day or a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and placebo 2.5 g three times per day for 24 weeks . The main outcome measures were HIV-RNA , CD4 cells , and blood chemistry profiles prior to the treatment and then every 4 weeks for 24 weeks . The baseline characteristics of 60 evaluable subjects , 40 in the SH group and 20 in the placebo group , were not significantly different . HIV RNA at week 4 and thereafter was significantly decreased from the baseline value in both groups ( p < 0.001 ) . However , the decline in HIV RNA in the SH group was significantly more than that in the placebo group . The CD4 cells in the SH group at week 12 and thereafter were significantly increased from the baseline value . Serious adverse events in the two groups were not observed . It is concluded that an addition of SH herbs to two nucleoside reverse transcriptase inhibitors has greater antiviral activity than antiretrovirals only . The SH herbs may be an alternative for the third anti-retroviral agent in the triple drug regimen for the treatment of HIV infected patients in countries with limited resources .

zidovudine and zalcitabine

placebo

zidovudine

zalcitabine

anti-retrovirals

ZDV

ddC

SH

placebo

SH

placebo

SH

SH

Efficacy

safety

efficacy

safety

HIV RNA

HIV RNA

CD4 cells

Serious adverse events

antiviral activity

HIV-infected Thai patients

HIV

Thai adults

HIV-infected

adults

infections

60 evaluable subjects


Usefulness of temporal changes in neurohormones as markers of ventricular remodeling and prognosis in patients with left ventricular systolic dysfunction and heart failure receiving either candesartan or enalapril or both . Although various neurohormones at initial measurement confer prognostic value in heart failure and correlate with the left ventricular ejection fraction ( EF ) and cardiac volumes , the significance of their temporal changes ( Delta ) remains undetermined . This study examined temporal changes in neurohormones related to cardiac remodeling and prognosis in patients with systolic dysfunction and heart failure receiving therapeutic inhibition of the renin-angiotensin-aldosterone system . Temporal changes in plasma renin , angiotensin-II , aldosterone , epinephrine , norepinephrine , B-type natriuretic peptide ( BNP ) , and N-terminal atrial natriuretic peptide ( NT-ANP ) in 768 treated patients with heart failure measured at baseline and 17 and 43 weeks after randomization were examined for their relations with concurrent changes in the EF , cardiac volumes , and risk for subsequent adverse clinical outcomes . Increasing BNP ( p < 0.0001 ) and NT-ANP ( p = 0.01 ) over time were associated with a concurrent decreasing EF , increasing end-diastolic volume ( EDV ) , and increasing end-systolic volume ( ESV ; all p < 0.0001 ) . In multivariable analysis , DeltaBNP and DeltaNT-ANP were independent predictors of DeltaESV and DeltaEDV , whereas DeltaBNP also predicted DeltaEF ( all p < 0.0001 ) . Patients who died or experienced heart failure hospitalization had larger antecedent increases in NT-ANP ( +293.7 vs -21.5 pmol/ml , p = 0.006 ) and lesser decreases in norepinephrine ( -22.3 vs -48.5 pg/ml , p = 0.04 ) . Increasing NT-ANP ( hazard ratio [ HR ] 3.45 , p = 0.009 ) and norepinephrine ( HR 2.04 , p = 0.02 ) over time independently predicted increased risk for subsequent death or heart failure hospitalization . In conclusion , in treated patients with heart failure , increasing NT-ANP and BNP over time predict a decreasing EF and ventricular dilatation , while increasing NT-ANP and norepinephrine independently predict greater mortality and morbidity . Serial measurements of these neurohormones may serve as useful surrogate markers of ventricular remodeling and prognosticators for clinical risk stratification .

candesartan

enalapril

cardiac volumes

changes in neurohormones

Temporal changes in plasma renin

angiotensin-II

aldosterone

epinephrine

norepinephrine

B-type natriuretic peptide ( BNP )

EF

cardiac volumes

BNP

NT-ANP

EF

end-diastolic volume ( EDV )

end-systolic volume

died

NT-ANP

norepinephrine

NT-ANP

death

heart failure hospitalization

EF

ventricular dilatation

mortality

morbidity

ventricular remodeling


Effect of esomeprazole on nighttime heartburn and sleep quality in patients with GERD : a randomized , placebo-controlled trial . OBJECTIVES Sleep disturbances are common in patients with gastroesophageal reflux disease ( GERD ) . This study examined the effects of esomeprazole on nighttime heartburn , GERD-related sleep disturbances , sleep quality , work productivity , and regular activities . METHODS This multicenter , randomized , double-blind , placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn ( recorded by patient diary during screening ) . Patients received oral esomeprazole 40 mg ( n = 220 ) or 20 mg ( n = 226 ) or placebo ( n = 229 ) once daily for 4 wk . The primary outcome was relief of nighttime heartburn . Secondary outcomes included resolution of sleep disturbances , sleep quality measured by the Pittsburgh Sleep Quality Index ( PSQI ) questionnaire , and work productivity measured by the Work Productivity and Activity Impairment Questionnaire . RESULTS Nighttime heartburn was relieved in 53.1 % ( 111/209 ) , 50.5 % ( 111/220 ) , and 12.7 % ( 28/221 ) of patients who received esomeprazole 40 mg , esomeprazole 20 mg , and placebo , respectively . Differences ( 95 % CI ) versus placebo were 40.5 % ( 32.4 % , 48.5 % ) and 37.8 % ( 29.9 % , 45.7 % ) and were highly significant ( p < 0.0001 ) . GERD-related sleep disturbances resolved in significantly more ( p < 0.0001 ) patients who received esomeprazole 40 ( 73.7 % ) or 20 mg ( 73.2 % ) than in those who received placebo ( 41.2 % ) . Both esomeprazole groups had greater PSQI global score changes from baseline ( p < 0.0001 vs placebo ) and more ( p < 0.0001 vs placebo ) work hours saved per week per patient compared with baseline ( esomeprazole 40 mg , 11.6 h ; esomeprazole 20 mg , 12.3 h ; placebo , 6.2 h ) . CONCLUSIONS Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity .

esomeprazole

placebo-controlled

oral esomeprazole

placebo

nighttime heartburn

GERD-related sleep disturbances

sleep quality

work productivity

regular activities

GERD-associated sleep disturbances

moderate-to-severe nighttime heartburn

nighttime heartburn

resolution of

sleep disturbances

sleep quality

the

work productivity

the

Nighttime heartburn

GERD-related sleep disturbances

PSQI global score

patients with GERD

gastroesophageal reflux disease

adults


Randomised clinical trial of physiotherapy after open abdominal surgery in high risk patients . Postoperative physiotherapy has been shown to reduce the incidence of postoperative pulmonary complications after open abdominal surgery . This study aimed to determine if the addition of deep breathing exercises and secretion clearing techniques to a standardised physiotherapist-directed program of early mobilisation improved clinical outcomes in patients undergoing open abdominal surgery . Fifty-six patients undergoing open abdominal surgery , at high risk of developing postoperative pulmonary complications , were randomised before operation to an early mobilisation-only group or an early mobilisation-plus-deep breathing and coughing group . Mobility duration , frequency and intensity of breathing interventions were quantified for both groups . All outcomes were assessed by a blinded outcomes researcher using a standardised outcomes measurement tool developed specifically for this population . Outcomes included incidence of clinically significant postoperative pulmonary complications , fever , length of stay , and restoration of mobility . There were no significant differences between groups in mean age , anaesthetic time , perioperative morbidity , or postoperative mobility . Outcome data were available for 89 % of enrolled subjects . Overall incidence of postoperative pulmonary complications was 16 % . The incidence of postoperative pulmonary complications in the non-deep breathing and coughing group was 14 % , and the incidence of postoperative pulmonary complications in the deep breathing and coughing group was 17 % , ( absolute risk reduction -3 % , 95 % C1 -22 to 19 % ) . There was no significant difference between groups in the incidence of fever , physiotherapist time , or the number of treatments . This study suggests that , in this clinical setting , the addition of deep breathing and coughing exercises to a physiotherapist-directed program of early mobilisation does not significantly reduce the incidence of clinically significant postoperative pulmonary complications in high risk open abdominal surgery subjects .

physiotherapy

Postoperative physiotherapy

deep breathing exercises

secretion clearing techniques

open abdominal surgery

randomised before operation to an early

mobilisation-only group

or an early

mobilisation-plus-deep breathing

and

coughing group

deep breathing

coughing exercises

reduce the incidence

Mobility duration

fever

length of stay

restoration of mobility

mean age

anaesthetic time

postoperative pulmonary complications

postoperative pulmonary complications

postoperative pulmonary complications

fever

physiotherapist time

number of treatments

high risk patients


A hybrid technique using bipolar energy in transurethral prostate surgery : a prospective , randomized comparison . PURPOSE We assessed the efficacy and safety of transurethral resection and vaporization with bipolar PlasmaKinetic energy . MATERIALS AND METHODS During a 2-year period 101 men with benign prostatic hyperplasia were randomly assigned to PlasmaKinetic surgery or standard transurethral prostate resection ( TURP ) . Patient demographics , indications for surgery , preoperative and postoperative International Prostate Symptom Score , uroflowmetry scores , operative time , catheterization duration , hospital stay and complication rates were compared . RESULTS Complete data on 96 patients with a mean age +/- SD of 69.1 +/- 6.1 years was available at a mean followup of 18.3 +/- 6.7 months ( range 12 to 23 ) . In the PlasmaKinetic and TURP groups mean operative time was 40.3 +/- 11.4 ( range 30 to 60 ) and 57.8 +/- 13.4 minutes ( range 45 to 75 ) , respectively ( p < 0.01 ) . The mean volume of saline irrigation during the PlasmaKinetic procedure was significantly lower than that of hyperosmolar solution irrigation during TURP ( p < 0.05 ) . Patients in the PlasmaKinetic and TURP groups were catheterized a mean of 2.3 +/- 0.7 ( range 2 to 4 ) and 3.8 +/- 0.7 days ( range 3 to 5 ) , respectively ( p < 0.05 ) . The mean improvement rate from baseline at month 12 in International Prostate Symptom Score and the maximal urinary flow rate was similar in the 2 groups . Severe irritative symptoms were the most common complaints after PlasmaKinetic surgery , as observed in 6 cases ( 12.2 % ) . Recatheterization was necessary in 3 cases ( 6.1 % ) cases in the PlasmaKinetic group and in 1 ( 2.1 % ) in the TURP group . During followup urethral stricture formation was observed in 3 patients ( 6.1 % ) cases in the former group and in 1 ( 2.1 % ) in the latter group ( p = 0.002 ) . Reoperation was required in 2 ( 4.1 % ) and 1 ( 2.1 % ) cases in the PlasmaKinetic and TURP groups , respectively . CONCLUSIONS : Transurethral surgery with PlasmaKinetic bipolar energy seems to be a promising alternative to prostatic tissue removal with shorter operative , catheterization and hospitalization times , although increased rates of postoperative irritative symptoms and urethral stricture formation must be further evaluated .

hybrid technique

transurethral resection

PlasmaKinetic surgery

efficacy

safety

uroflowmetry scores

operative time

catheterization duration

hospital stay

complication rates

mean operative time

International Prostate Symptom Score

the maximal urinary flow rate

Severe irritative symptoms

Recatheterization

urethral stricture formation

transurethral prostate surgery

men

benign prostatic hyperplasia

mean age +/- SD of 69.1 +/- 6.1 years


Hyperbaric oxygen attenuation of lipopolysaccharide-induced acute lung injury involves heme oxygenase-1 . BACKGROUND Hyperbaric oxygen ( HBO ) attenuates lipopolysaccharide ( LPS ) -induced acute lung injury . This beneficial effect of HBO involves inhibition of inducible nitric oxide synthase ( iNOS ) expression and subsequent nitric oxide ( NO ) biosynthesis . We sought to investigate the role of heme oxygenase-1 ( HO-1 ) on this HBO inhibition of iNOS induction and acute lung injury in septic rat lungs . METHODS Before the experiment , 72 rats were randomly allocated to receive HBO or air treatment . With or without HBO pre-treatment , the rats were further divided into the following subgroups ( n = 6 ) : ( i ) LPS injection , ( ii ) normal saline ( N/S ) injection , ( iii ) hemin ( a HO-1 inducer ) plus LPS , ( iv ) hemin alone , ( v ) tin protoporphyrin ( SnPP ; a HO-1 inhibitor ) plus LPS , and ( vi ) SnPP alone . All rats were maintained for 6 h and then sacrificed with a high-dose pentobarbital injection . Lung injuries and relevant enzymes expression were thus assayed . RESULTS Histological analysis , PMNs/alveoli ratio , and wet/dry weight ratio measurements demonstrated that LPS caused significant lung injury and HBO and/or hemin significantly attenuated this LPS-induced lung injury . Increased pulmonary iNOS expression and NO production were associated with lung injury . Induction of HO-1 , by HBO and/or hemin , significantly attenuated this LPS-induced iNOS expression and acute lung injury . SnPP , on the contrary , offset the effects of HBO and worsened the LPS-induced lung injury . CONCLUSIONS HBO may act through inhibiting pulmonary iNOS expression to attenuate LPS-induced acute lung injury in septic rats . Furthermore , this HBO attenuation of iNOS expression involves HO-1 induction .

Hyperbaric oxygen

Hyperbaric oxygen ( HBO )

HBO or air treatment

HBO

LPS injection

normal saline ( N/S ) injection

hemin ( a HO-1 inducer ) plus LPS

hemin alone

LPS

SnPP alone

high-dose pentobarbital injection .

HBO

HBO

HBO

iNOS expression and NO production

acute lung injury

rat

72 rats

rats

rats

septic rats


Tetrahydrobiopterin in the treatment of children with autistic disorder : a double-blind placebo-controlled crossover study . Twelve children , all boys , aged 4 to 7 years , with a diagnosis of autistic disorder and low concentrations of spinal 6R-l-erythro-5,6,7,8-tetrahydrobiopterin ( tetrahydrobiopterin ) were selected to participate in a double-blind , randomized , placebo-controlled , crossover study . The children received a daily dose of 3 mg tetrahydrobiopterin per kilogram during 6 months alternating with placebo . Treatment-induced effects were assessed with the Childhood Autism Rating Scale every third month . The results showed small nonsignificant changes in the total scores of Childhood Autism Rating Scale after 3- and 6-month treatment . Post hoc analysis looking at the 3 core symptoms of autism , that is , social interaction , communication , and stereotyped behaviors , revealed a significant improvement of the social interaction score after 6 months of active treatment . In addition , a high positive correlation was found between response of the social interaction score and IQ . The results indicate a possible effect of tetrahydrobiopterin treatment .

Tetrahydrobiopterin

placebo-controlled

placebo-controlled

tetrahydrobiopterin

placebo

tetrahydrobiopterin

Treatment-induced effects

Childhood Autism Rating Scale

social interaction score


Double blind , placebo controlled study of metronidazole as a disease modifying agent in the treatment of rheumatoid arthritis . Anecdotal reports suggest that metronidazole may have disease modifying activity in the treatment of rheumatoid arthritis . To assess possible beneficial effects a double blind , comparative trial of metronidazole and placebo was performed . Fifty patients with active rheumatoid arthritis were randomly allocated to receive active drug ( n = 24 ) or placebo ( n = 26 ) and reviewed at weeks 0 , 1 , 4 , 8 , 12 , 16 , and 24 . Detailed assessment of drug safety , biochemical and haematological parameters , and efficacy was made at these dates . Dose regimen was 400 mg twice daily from weeks 0 to eight , increasing to 400 mg three times a day from weeks nine to 24 provided that no adverse effects were recorded . Most patients were unable to tolerate metronidazole because of side effects or lack of efficacy , with only five ( 21 % ) continuing to take the drug at 24 weeks . For those patients attaining 12 weeks of treatment an overall improvement in articular index and morning stiffness was found . No improvement in laboratory indices of disease activity was seen , however . In this study metronidazole did not have disease modifying properties and was unacceptably toxic .

placebo

metronidazole

active drug

beneficial effects

Detailed assessment

drug safety ,

efficacy

tolerate metronidazole

side effects

lack of efficacy

overall improvement in articular index

morning stiffness

improvement

laboratory indices of disease activity

disease modifying properties

unacceptably toxic .


Aortic valve replacement . A randomized study comparing the Björk-Shiley and Lillehei-Kaster disc valves . Late haemodynamics related to clinical results . In this study , 78 randomized patients with either Björk-Shiley ( B-S ) or Lillehei-Kaster ( L-K ) aortic disc valve prostheses were re-admitted for clinical and haemodynamic evaluation . The patients were selected that those with narrow aortic roots were over-represented . Cine-aortography was carried out in 75 patients and left ventricular catheterisation via the transseptal approach was performed in 42 . The clinical improvement was striking , although the number of patients still incapacitated was relatively large in patients with the small L-K valves ( Nos . 14 & 16 ) . Peak-to-peak and mean systolic pressure differences across the valves were significantly lower in the B-S than in the L-K valves , particularly when the small valve sizes were compared . Left ventricular end-diastolic pressure ( LVEDP ) , which was elevated in most patients before operation , decreased significantly to normal levels in the B-S group . In the L-K group , LVEDP did not decrease significantly and was on the average still above the normal level after operation , probably due to the relatively large pressure gradients . The study indicates that the L-K valves Nos . 14 & 16 in particular represents a resistance to flow that is too large to be acceptable in clinical practice .

Aortic valve replacement


[ Usage of titanoreine after procedure for prolapse and hemorrhoids ] . OBJECTIVE To evaluate the effect of titanoreine on early postoperative symptoms after procedure for prolapse and hemorrhoids ( PPH ) . METHODS From November 2002 to July 2003 , 80 patients who received PPH were randomly divided in to titanoreine group ( n=42 ) and control group without titanoreine ( n=38 ) . Symptom relief was recorded 24 hours , 6 days and 12 days after PPH , urine retention 24h after PPH , first stool time , wound healing time , mean hospital stay were also recorded . RESULTS The score of symptom was lower in titanoreine group ( 4.4 ) than that in the control group ( 6.1 ) 24 hours after PPH ( P < 0.05 ) , but no significant difference in symptom grade was found between the two groups 6 days and 12 days after PPH ( P > 0.05 ) . Decrements of symptom grade were lower in titanoreine group than those of control group at any point after PPH ( P < 0.05 ) . There was no significant difference in urine retention rate and mean hospital stay between two groups ( P > 0.05 ) . CONCLUSIONS Titanoreine can effectively relieve the early postoperative symptoms after PPH .

titanoreine

titanoreine

titanoreine

control group without titanoreine

titanoreine

titanoreine

Titanoreine

Symptom relief

urine retention

first stool time

wound healing time

mean hospital stay

score of symptom

symptom grade

Decrements of symptom grade

urine retention rate

mean hospital stay

relieve

prolapse and hemorrhoids

PPH


Comparison of the effectiveness of oral diazepam and midazolam for the sedation of autistic patients during dental treatment . PURPOSE This study was undertaken to compare the effectiveness of oral diazepam and midazolam in sedating autistic patients during dental treatment . METHODS The treatment regimen consisted of nitrous oxide/oxygen inhalation in conjunction with oral administration of either diazepam 0.3 mg/kg or midazolam 0.5 mg/kg in a cross-over design study of 13 subjects aged 5.8 to 14.7 years . A drug was classified as being effective when over 70 % of the patients taking the drug were judged as " success " in all 3 behavioral criteria : ( 1 ) sleeping ; ( 2 ) body movement ; and ( 3 ) crying behaviors . The study was observed by an independent clinician with an intraexaminer reliability of 88 % . RESULTS For sleeping behavior , midazolam was found to be significantly more effective than diazepam as the duration of stimulation increased ( P < .05 ) . For the movement and crying behaviors , midazolam also proved to be significantly more effective from the start of treatment through the 35- and 40-min markers , respectively ( P < .05 ) . For the remainder of treatment , however , there was no statistically significant difference in these behaviors between the trials ( P > .05 ) . Diazepam and midazolam were rated as 77 % and 100 % successful , according to the overall behavior evaluation criteria ( P=.02 ) . CONCLUSIONS Both diazepam and midazolam were shown to be effective sedative agents , successfully and safely used to sedate autistic patients for dental treatment . Midazolam was significantly more effective than diazepam in those portions of the procedure with increased stimulation .

diazepam

midazolam

diazepam

midazolam

nitrous oxide/oxygen inhalation

effectiveness

sedation

effectiveness

effective

sleeping behavior

significantly more effective

movement and crying behaviors

significantly more effective

successful

behavior evaluation

effective

5.8 to 14.7 years


Drug therapy of ventricular tachycardia : a cost comparison of randomized noninvasive and invasive approaches . OBJECTIVE Economic evaluation of noninvasive ( suppression of ventricular arrhythmias detected by ambulatory monitoring ) and invasive ( suppression of arrhythmias induced by programmed stimulation ) approaches to antiarrhythmic drug selection for ventricular tachyarrhythmias . DESIGN/SETTING Randomized clinical trial/tertiary-care hospital . PATIENTS Of 124 consecutive patients referred for treatment of symptomatic ventricular tachyarrhythmias , 57 consenting patients were eligible to have drug therapy selected by either noninvasive or invasive approaches . MEASUREMENTS Costs of initial and follow-up ( 26 +/- 15 months ) admissions for the two groups were compared . This economic evaluation also considered relative efficacies of the approaches using the primary outcome variable of symptomatic , sustained ventricular tachyarrhythmia recurrence ( including sudden death ) . RESULTS Initial hospitalization for therapy selection was less costly by the noninvasive approach ( $ 6,869 +/- 4,019 ) than by the invasive approach ( $ 13,164 +/- 6,740 ) ( P less than 0.001 ) . However , the noninvasive approach generated higher follow-up hospital costs ( $ 9,204 +/- 9,217 ) than the invasive approach ( $ 3,784 +/- 4,944 ) ( P = 0.01 ) . Thus , total hospital costs of the noninvasive ( $ 16,073 +/- 9,423 ) and invasive approaches ( $ 16,949 +/- 7,174 ) were equivalent . The two-year actuarial probability of a recurrent , sustained , symptomatic ventricular tachyarrhythmia was greater in noninvasive ( 0.50 +/- 0.10 ) than in invasive ( 0.20 +/- 0.08 ) approach patients ( P = 0.02 ) . CONCLUSIONS The lower initial hospital costs of the noninvasive approach are offset by greater follow-up costs . Within two years the costs of the two approaches are equivalent . Thus , greater antiarrhythmic efficacy can be achieved by the invasive approach to drug selection without increasing total hospital costs .

noninvasive

and

invasive

approaches .

noninvasive

invasive

noninvasive

invasive

invasive approach

noninvasive approach

noninvasive

invasive

invasive approach

Economic evaluation

Costs of initial and follow-up

economic evaluation

including sudden death

Initial hospitalization

costly

follow-up hospital costs

total hospital costs

symptomatic ventricular tachyarrhythmia

initial hospital costs

costs

antiarrhythmic efficacy

total hospital costs

ventricular tachycardia


Effects of an Internet-based intervention on plasma glucose levels in patients with type 2 diabetes . This study applied a 12-week educational intervention that used both the cellular phone and the Internet to send short message service . Forty-two diabetic patients were asked to access a Web site by using a cellular phone or wire Internet and input their blood glucose levels every day . Patients were sent the optimal recommendations by both the cellular phone and the Internet . After 12 weeks , the patients had a mean decrease of 28.6 mg/dL in fasting plasma glucose and 78.4 mg/dL in 2-hour postprandial blood sugar levels and a mean increase in the care satisfaction score .

Internet-based intervention

12-week educational intervention

optimal recommendations

plasma glucose levels

blood glucose levels

fasting plasma glucose

2-hour postprandial blood sugar levels

care satisfaction score

type 2 diabetes

Forty-two

diabetic


[ Effect of Yufeining on induced sputum interleukin-8 in patients with chronic obstructive pulmonary disease at the stable phase ] . OBJECTIVE To evaluate the effect of Yufeining , a traditional Chinese medicine , on induced sputum interleukin-8 ( IL-8 ) in patients with chronic obstructive pulmonary disease ( COPD ) at the stable phase . METHODS Thirty-six patients with COPD were divided into trial group ( 18 cases ) and control group ( 18 cases ) randomly . The trial group was treated with Yufeining pills taken orally for half a year ; the control group was not given any medicine . Routine lung function was recorded before and after treatment . Total cell count ( TCC ) , differential cell counts ( DCCs ) and IL-8 in induced sputum were determined at the baseline and 6 months later . RESULTS The indices of lung function improved significantly after 6 months ' treatment in trial group ( P < 0.05 ) ; TCC and absolute neutrophil count decreased significantly compared with baseline in the trial group ( P < 0.05 ) ; Sputum IL-8 concentration dropped significantly after 6 months ' treatment , from a mean of 5.216 +/- 2.914 microg/L to 4.222 +/- 2.140 microg/L ( P < 0.05 ) . There were insignificant changes in the parameters in the control group between baseline and 6 months later . CONCLUSION Yufeining could improve lung function , decrease sputum TCC , absolute neutrophil count and IL-8 concentration , and relieve airway inflammation in patients with COPD in the stable phase .

Yufeining

Yufeining

Yufeining pills

sputum interleukin-8

induced sputum interleukin-8 ( IL-8 )

lung function

indices of lung function

TCC and absolute neutrophil count

Sputum IL-8 concentration

lung function

airway inflammation

chronic obstructive pulmonary disease

stable phase

stable phase

Thirty-six

COPD

COPD


[ A clinical study on the effect of Yinxing Damo combined with betahistine hydrochloride injection on vertebral basilar artery ischemic vertigo ] . OBJECTIVE To evaluate the therapeutic efficacy of Yinxing Damo ( YXDM ) combined with Betahistine Hydrochloride Injection ( BHI ) on vertebra basilar artery ischemic vertigo ( VBIV ) . METHODS Ninety patients with VBIV were randomly divided into two groups ; 45 patients ( the treated group ) were treated with YXDM and BHI intravenous dripping , once a day for 14 days . Another 45 patients ( control group ) were treated with Xueshuantong and BHI intravenous dripping , once daily for 14 days . The clinical syndromes and the index of the transcranial Doppler ( TCD ) and hemorheology were observed . RESULTS The total effective rate was 100 % in the treated group , which was better than that in the control group 90.5 % , ( P < 0.05 ) . The indexes of TCD and hemorheology in the treated group were obviously improved after treatment , ( P < 0.01 ) . CONCLUSION YXDM combined with BHT injection had better effect in treating patients with VBIV is an ideal drug for VBIV .

YXDM

BHI

effect

therapeutic efficacy

hemorheology

total effective rate

indexes of TCD and hemorheology

effect

treating patients with VBIV

Ninety


A double-blind , placebo-controlled study of valproate for aggression in youth with pervasive developmental disorders . OBJECTIVE The aim of this study was to study valproate efficacy and safety for aggression in children and adolescents with pervasive developmental disorders ( PDD ) . METHODS In this prospective double-blind , placebo-controlled study , 30 subjects ( 20 boys , 10 girls ) 6-20 years of age with PDD and significant aggression were randomized and received treatment with valproate ( VPA ) or placebo ( PBO ) for 8 weeks as outpatients . Mean VPA trough blood levels were 75.5 mcg/mL at week 4 and 77.8 mcg/mL at week 8 . RESULTS No treatment difference was observed statistically between VPA and PBO groups . The Aberrant Behavior Checklist -- Community Scale ( ABC-C ) Irritability subscale was the primary outcome measure ( p = 0.65 ) , and CGI -- Improvement ( p = 0.16 ) and OAS ( p = 0.96 ) were secondary outcome measures . Increased appetite and skin rash were significant side effects . Only 1 subject was dropped from the study owing to side effects , notably a spreading skin rash , which then resolved spontaneously . Two subjects receiving VPA developed increased serum ammonia levels , one with an associated parent report of slurred speech and mild cognitive slowing . Poststudy , of 16 VPA and PBO subjects receiving VPA , 10 subjects demonstrated sustained response , 4 of whom later attempted taper , with significant relapse of aggression . CONCLUSION The present negative findings can not be viewed as conclusive , partly owing to the large placebo response , subject heterogeneity , and size of the groups . Larger studies are needed to expand upon these findings .

placebo-controlled

valproate

valproate

placebo-controlled

valproate ( VPA )

placebo

( PBO )

VPA

PBO

VPA

VPA

PBO

VPA

placebo

Mean VPA trough blood levels

CGI -- Improvement

OAS

Increased appetite and skin rash

spreading skin rash

serum ammonia levels

relapse of aggression


Safety and efficacy of irinotecan plus high-dose leucovorin and intravenous bolus 5-fluorouracil for metastatic colorectal cancer : pooled analysis of two consecutive southern Italy cooperative oncology group trials . BACKGROUND A biweekly regimen of irinotecan 200 mg/m2 on day 1 and levo-leucovorin ( LV ) 250 mg/m2 plus 5-fluorouracil ( 5-FU ) 850 mg/m2 via intravenous bolus on day 2 was assessed in 2 consecutive randomized trials in metastatic colorectal cancer ( CRC ) . PATIENTS AND METHODS Individual data of 254 patients were merged , and baseline features potentially affecting overall response rate ( ORR ) , progression-free survival ( PFS ) , overall survival ( OS ) , and occurrence of severe toxicity were analyzed by univariate and multivariate analyses . RESULTS In the pooled series , ORR was 33 % ( 95 % confidence interval [ CI ] , 27 % -39 % ) . Liver-only disease ( 47 % vs. 25 % ; P=0.0012 ) and absence of previous weight loss ( 38 % vs. 20 % ; P=0.0189 ) were significantly associated with a higher ORR on the multivariate analysis . Absence of weight loss ( hazard ratio , 1.40 ; 95 % CI , 1.02-1.93 ; P=0.0377 ) was significantly associated with a longer PFS ( 7.5 months vs. 6 months ) . Median OS was 15.1 months ( 95 % CI , 13.5-16.6 months ) . Primary surgery , good performance status ( PS ) , only one metastatic site , and oxaliplatin-based second-line treatment independently predicted a longer OS . Grade 4 neutropenia was significantly associated with a PS > or=1 , whereas risk of grade > or=3 diarrhea was directly related to age and previous weight loss . CONCLUSION Patients with no weight loss and/or preserved PS and with a limited disease extent appeared to obtain the greatest benefit from our irinotecan/5-FU/LV regimen , with acceptable toxicity . Notably , the regimen was effective and well tolerated by elderly patients . This regimen may represent the rationale for assessing the addition of novel antiangiogenic drugs to the treatment of metastatic CRC .

irinotecan plus high-dose leucovorin

irinotecan

levo-leucovorin ( LV )

5-fluorouracil ( 5-FU )

Safety

efficacy

overall response rate ( ORR )

progression-free survival ( PFS )

overall survival ( OS )

occurrence of severe toxicity

ORR

weight loss

Median OS

longer OS

Grade 4 neutropenia

diarrhea

metastatic colorectal cancer :

metastatic colorectal cancer ( CRC ) .

elderly patients .


Pulse versus continuous terbinafine for onychomycosis : a randomized , double-blind , controlled trial . BACKGROUND Effective treatments for onychomycosis are expensive . Previous studies suggest that less costly , pulsed doses of antifungal medications may be as effective as standard , continuous doses . Terbinafine is the current treatment of choice for toenail onychomycosis . OBJECTIVE Our purpose was to determine whether pulse-dose terbinafine is as effective as standard continuous-dose terbinafine for treatment of toenail onychomycosis . METHODS We conducted a double-blind , randomized , noninferiority , clinical intervention trial in the Minneapolis Veterans Affairs Medical Center . The main inclusion criteria for participants were a positive dermatophyte culture and at least 25 % distal subungual clinical involvement . Six hundred eighteen volunteers were screened ; 306 were randomized . Terbinafine , 250 mg daily for 3 months ( continuous ) or terbinafine , 500 mg daily for 1 week per month for 3 months ( pulse ) was administered . The primary outcome measure was mycological cure of the target toenail at 18 months . Secondary outcome measures included clinical cure and complete ( clinical plus mycological ) cure of the target toenail and complete cure of all 10 toenails . RESULTS Results of an intent-to-treat analysis did not meet the prespecified criterion for noninferiority but did demonstrate the superiority of continuous-dose terbinafine for : mycological cure of the target toenail ( 70.9 % [ 105/148 ] vs 58.7 % [ 84/143 ] ; P =.03 , relative risk [ RR ] of 1.21 [ 95 % confidence interval ( CI ) , 1.02-1.43 ] ) ; clinical cure of the target toenail ( 44.6 % [ 66/148 ] vs 29.3 % [ 42/143 ] ; P =.007 , RR =1.52 [ 95 % CI , 1.11-2.07 ) ; complete cure of the target toenail ( 40.5 % [ 60/148 ] vs 28.0 % [ 40/143 ] ; P =.02 , RR=1.45 [ 95 % CI , 1.04-2.01 ) ; and complete cure of all 10 toenails ( 25.2 % [ 36/143 ] vs 14.7 % [ 21/143 ] ; P =.03 , RR =1.71 [ 95 % CI , 1.05-2.79 ) . Tolerability of the regimens did not differ significantly between the groups ( chi2 =1.63 ; P =.65 ) . LIMITATIONS The study population primarily consisted of older men with severe onychomycosis . CONCLUSIONS This study demonstrated the superiority of continuous- over pulse-dose terbinafine . We also found this expensive therapy to be much less effective than previously believed , particularly for achieving complete cure of all 10 toenails .

Pulse

continuous terbinafine

antifungal medications

pulse-dose terbinafine

standard continuous-dose terbinafine

Terbinafine

terbinafine

continuous-dose terbinafine

pulse-dose terbinafine

mycological cure

of the target toenail at 18 months

complete cure of all 10 toenails

mycological cure

clinical cure

complete cure

complete cure

Tolerability

onychomycosis

Six hundred eighteen

of older

men

severe onychomycosis


Family education for people with schizophrenia in Beijing , China : randomised controlled trial . BACKGROUND Much of China lacks well-developed services for people with schizophrenia and their families , and most of the existing services focus on hospitals . There is a need for culturally sensitive family treatments offered by nurses . AIMS To conduct a longitudinal experimental study examining the effect of patient and family education in a sample of Chinese people with schizophrenia . METHOD A randomised controlled trial was conducted in a large hospital with a was conducted in a large hospital with a sample of 101 patients with schizophrenia and their families . Data were collected at admission and at discharge , and then at 3 and 9 months after discharge . The intervention group received family education , and data on their knowledge about schizophrenia , symptoms , functioning , psychosocial behaviour , relapse and medication adherence were collected and compared with the control group . RESULTS There was a significant improvement in knowledge about schizophrenia in the experimental group and a significant difference in symptom scores and functioning at 9 months after discharge . Patients who were nonadherent to medication regimens were more likely to relapse . CONCLUSIONS Family education on schizophrenia by nurses in China was effective in improving knowledge and promoting improvement in patients ' symptoms .

Family education

family treatments

patient and family education

family education

control

Family education

significant difference in

symptom scores and functioning

relapse .

people with schizophrenia

schizophrenia

schizophrenia

101 patients

schizophrenia


Addition of fexofenadine to inhaled corticosteroid therapy to reduce inflammatory biomarkers in atopic asthma . BACKGROUND We previously showed that H1-antihistamines may shift the PC20 ( provocation concentration that caused a decrease in forced expiratory volume in 1 second of 20 % ) threshold to adenosine monophosphate ( AMP ) challenge but may paradoxically prolong recovery . OBJECTIVES To measure AMP recovery using a constant predetermined AMP PC20 and to evaluate whether fexofenadine use confers add-on effects to treatment with either fluticasone propionate alone or combined fluticasone propionate-salmeterol . METHODS Fourteen atopic patients with mild-to-moderate asthma ( forced expiratory volume in 1 second of 76 % ) completed a double-blind , randomized , crossover study consisting of 3-week treatment blocks of either fluticasone propionate-salmeterol , 250 microg twice daily , or fluticasone propionate alone , 250 microg twice daily , in conjunction with either fexofenadine , 180 mg once daily , or matched placebo . Recovery after a predetermined AMP PC20 challenge was measured ( primary outcome ) , along with exhaled nitric oxide levels , plasma eosinophil cationic protein levels , peripheral eosinophil counts , pulmonary function , diary card outcomes , and quality of life ( all secondary outcomes ) . RESULTS There were no differences in any of the primary or secondary outcomes when fexofenadine was added to treatment with either fluticasone propionate-salmeterol or fluticasone propionate alone . The mean AMP recovery time was 25.0 vs 23.4 minutes for fexofenadine and placebo , respectively , as add-on to fluticasone-salmeterol and 22.5 vs 23.9 minutes , respectively , as add-on to fluticasone alone . CONCLUSION Fexofenadine did not affect recovery to a fixed dose of AMP challenge or any other surrogate inflammatory markers when given as add-on therapy to corticosteroid-treatedatopic asthmatic patients .

fexofenadine

inhaled corticosteroid therapy

fexofenadine

fluticasone propionate

fluticasone propionate-salmeterol

fluticasone propionate alone

fexofenadine

placebo

fexofenadine

fluticasone propionate-salmeterol

fluticasone propionate

fexofenadine

placebo

fluticasone-salmeterol

fluticasone

Fexofenadine

inflammatory biomarkers

Recovery

predetermined AMP PC20 challenge

exhaled nitric oxide levels

peripheral eosinophil counts

pulmonary function

diary card outcomes

quality of life

Fourteen atopic patients


[ Study on classification and treatment of vulvovaginal candidiasis ] . OBJECTIVE To determine the clinical manifestations of vulvovaginal candidiasis ( VVC ) and to study the mycologic eradication rate of different miconazole treatment courses for VVC . METHODS Three hundred cases of VVC were recruited . The Candidas were cultured . A prospective and randomized study was performed to compare the treatment effect of 3 day miconazole ( 400 mg/d ) , 6 day miconazole ( 400 mg/d ) , and 7 day miconazole ( 200 mg/d ) for uncomplicated and complicated VVC . RESULTS Among 300 cases of VVC , uncomplicated , complicated and recurrent VVC were 56.0 % , 44.0 % and 9.7 % ( 29/300 ) respectively . C. albicans was isolated most frequently 90.3 % ( 271/300 ) , followed by C. glabrata ( 7.3 % ) , C. tropicalis ( 1.3 % ) , C. krusei ( 0.7 % ) , and C. parapsilosis ( 0.3 % ) . Mycologic eradication rate of 3 day , 6 day and 7 day miconazole courses for uncomplicated VVC at day 14 was 96.0 % , 93.5 % and 98.0 % , respectively ( P > 0.05 ) . Eradication rate of 3 day , 6 day and 7 day miconazole courses for complicated VVC at day 14 was 86.7 % , 92.5 % , and 86.4 % , respectively ( P > 0.05 ) . Eradication rate of 3 day , 6 day and 7 day miconazole courses for uncomplicated VVC at day 35 was 93.8 % , 95.3 % , and 89.8 % , respectively ( P > 0.05 ) . Eradication rate of 3 day , 6 day and 7 day miconazole courses for complicated VVC at day 35 was 89.7 % , 97.3 % and 86.8 % , respectively ( P > 0.05 ) . CONCLUSION Treatment of VVC should be individualized , and women with complicated VVC achieve superior mycologic eradication by a 6 day miconazole course .

miconazole

3 day miconazole

6 day miconazole

7 day miconazole

miconazole

miconazole

miconazole

miconazole

miconazole

mycologic eradication rate

Mycologic eradication rate

Eradication rate

Eradication rate

Eradication rate

mycologic eradication

vulvovaginal candidiasis

vulvovaginal candidiasis ( VVC )

Three hundred

VVC

women

VVC


Treatment of anal fissures using a combination of minoxidil and lignocaine : a randomized , double-blind trial . AIM Anal fissures are associated with hypertonia of the internal anal sphincter and pain . We evaluated the efficacy of local application of a combination of minoxidil and lignocaine in healing anal fissures . METHODS In this prospective , randomized , double-blind study , 90 patients with anal fissure were recruited . Patients received local applications of ointments containing 5 % lignocaine ( n=28 ) , 0.5 % minoxidil ( n=36 ) , or both ( n=26 ) . Healing of anal fissure at 6 weeks was used as the primary end-point . RESULTS Rates of complete healing of fissure were similar in the three groups ( lignocaine alone 8/27 , minoxidil alone 10/34 , combination 7/22 ; p=ns ) . Mean ( SD ) time taken for complete healing with combination treatment [ 1.9 ( 0.6 ) weeks ] was significantly shorter than that with minoxidil alone ( 3.1 [ 1.7 ] weeks ; p=0.001 ) or with lignocaine alone ( 3.3 [ 0.8 ] weeks ; p=0.002 ) . Rates of pain relief were similar in the three groups . Stoppage of bleeding occurred more often with combination treatment than with lignocaine alone . No patient had systemic or local side effects . CONCLUSION Combination treatment with minoxidil and lignocaine helps in faster healing of anal fissures and provides better symptomatic relief than either drug alone .

minoxidil

lignocaine :

minoxidil

lignocaine

both

lignocaine

minoxidil

minoxidil

lignocaine

lignocaine

minoxidil

lignocaine

Healing of anal fissure

Rates of complete healing of fissure

Rates of

pain relief

Stoppage of bleeding

systemic or local side effects

anal fissure


Single-use plaque removal efficacy of three power toothbrushes . OBJECTIVES To compare the safety and plaque removal efficacy of two oscillating/rotating/pulsating toothbrushes ( Oral-B ProfessionalCare 7000 [ PC 7000 ] and Oral-B 3D Excel [ 3DE ] ) and a high-frequency toothbrush ( Sonicare Advance , Philips Oral Healthcare ; SA ) in a single-use , examiner-blind , three period crossover study . METHODS After refraining from all oral hygiene procedures for 23-25 hours , subjects received an oral tissue examination and those with pre-brushing whole mouth mean plaque scores > or = 0.6 based on the Rustogi et al . Modified Navy Plaque Index were randomly assigned to treatment sequence . After brushing with the assigned toothbrush and a commercially available dentifrice for 2 minutes , oral tissues were then re-examined and post-brushing plaque scores recorded . Following a brief washout period between two additional visits , the above procedures were repeated with the two alternate toothbrushes . One examiner , blinded to the treatment sequence , performed all clinical measurements . RESULTS A total of 79 subjects ( 28 males and 51 females ) were enrolled and completed the study . Each toothbrush was found to be safe and significantly reduced plaque levels after a single brushing . The PC 7000 and 3DE were equally more effective in plaque removal than the SA , at all tooth areas , reducing plaque by 59.0 % , 59.7 % and 51.8 % , respectively on whole mouth surfaces , and by 67.5 % , 67.8 % and 59.4 % , respectively on approximal surfaces . CONCLUSIONS The action of the oscillating/rotating/pulsating toothbrushes ( Oral-B ProfessionalCare 7000 and Oral-B 3D Excel ) was more effective in plaque removal than the high-frequency toothbrush ( Sonicare Advance ) .

power toothbrushes

Oral-B ProfessionalCare 7000 [ PC 7000

Oral-B 3D Excel [ 3DE

efficacy

safety

plaque removal efficacy

safe

plaque levels

plaque

males

females


Intensive behavioral treatment for children with autism : four-year outcome and predictors . Twenty-four children with autism were randomly assigned to a clinic-directed group , replicating the parameters of the early intensive behavioral treatment developed at UCLA , or to a parent-directed group that received intensive hours but less supervision by equally well-trained supervisors . Outcome after 4 years of treatment , including cognitive , language , adaptive , social , and academic measures , was similar for both groups . After combining groups , we found that 48 % of all children showed rapid learning , achieved average posttreatment scores , and at age 7 , were succeeding in regular education classrooms . Treatment outcome was best predicted by pretreatment imitation , language , and social responsiveness . These results are consistent with those reported by Lovaas and colleagues ( Lovaas , 1987 ; McEachin , Smith , & Lovaas , 1993 ) .

Intensive behavioral treatment

clinic-directed group

intensive behavioral treatment

autism

rapid learning

average posttreatment scores

children with

autism

Twenty-four

children

autism


Effects of glucose-insulin-potassium infusion on ST-elevation myocardial infarction in patients treated with thrombolytic therapy . The role of glucose-insulin-potassium ( GIK ) infusion in the management of acute myocardial infarction is not well established . This prospective , randomized study comprised 120 patients who had ST-elevation myocardial infarction that was treated within 12 hours from symptom onset with a high dose of GIK ( 25 % glucose , 50 IU of soluble insulin per liter , and 80 mmol of potassium chloride per liter at 1 ml/kg/hour over 24 hours ) as adjunct to thrombolytic therapy ( 1.5 MU of streptokinase/30 to 60 minutes ; GIK group ) or thrombolytic therapy alone ( control group ) . The primary end point of the study was the rate of major adverse cardiac events ( MACEs ) at 1 month , defined as a composite of cardiac death , reinfarction , serious arrhythmias ( ventricular fibrillation and/or tachycardia ) , and severe heart failure . The secondary end points were the rate of MACEs at 1 year and improvement in left ventricular systolic function . The incidence of MACEs at 1 month was significantly lower in the GIK group ( 10 % vs 32.5 % , relative risk 0.24 , 95 % confidence interval 0.09 to 0.63 , p = 0.0043 ) . Patients in the GIK group had significant decreases in ventricular tachycardia and/or fibrillation ( 1.3 % vs 15.0 % , p = 0.003 ) and severe heart failure ( 3 % vs 12.5 % , p = 0.031 ) . The rate of MACEs at 1 year was also significantly lower in the GIK group ( 13 % vs 40.0 % , relative risk 0.22 , 95 % confidence interval 0.09 to 0.55 , p = 0.0012 ) . After 1 year , there was a significant improvement in left ventricular ejection fraction in the GIK group ( from 48 +/- 8 % to 51 +/- 10 % , p < 0.01 ) , which was not observed in the control group . In conclusion , high-dose GIK , used as an adjunct to thrombolytic therapy , was safe and improved clinical outcome at 1 month . The beneficial effect of GIK infusion was maintained up to 1 year .

glucose-insulin-potassium infusion

GIK group

GIK

GIK group

GIK group

control

GIK

GIK

ST-elevation myocardial infarction

acute myocardial infarction

rate of MACEs at 1 year

left ventricular systolic function

incidence of MACEs at 1 month

heart failure

rate of MACEs at 1 year

left ventricular ejection fraction

safe

clinical outcome

ST-elevation myocardial infarction

ST-elevation myocardial infarction


Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study ( PROspective pioglitAzone Clinical Trial In macroVascular Events ) : a randomised controlled trial . BACKGROUND Patients with type 2 diabetes are at high risk of fatal and non-fatal myocardial infarction and stroke . There is indirect evidence that agonists of peroxisome proliferator-activated receptor gamma ( PPAR gamma ) could reduce macrovascular complications . Our aim , therefore , was to ascertain whether pioglitazone reduces macrovascular morbidity and mortality in high-risk patients with type 2 diabetes . METHODS We did a prospective , randomised controlled trial in 5238 patients with type 2 diabetes who had evidence of macrovascular disease . We recruited patients from primary-care practices and hospitals . We assigned patients to oral pioglitazone titrated from 15 mg to 45 mg ( n=2605 ) or matching placebo ( n=2633 ) , to be taken in addition to their glucose-lowering drugs and other medications . Our primary endpoint was the composite of all-cause mortality , non fatal myocardial infarction ( including silent myocardial infarction ) , stroke , acute coronary syndrome , endovascular or surgical intervention in the coronary or leg arteries , and amputation above the ankle . Analysis was by intention to treat . This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN NCT00174993 . FINDINGS Two patients were lost to follow-up , but were included in analyses . The average time of observation was 34.5 months . 514 of 2605 patients in the pioglitazone group and 572 of 2633 patients in the placebo group had at least one event in the primary composite endpoint ( HR 0.90 , 95 % CI 0.80-1.02 , p=0.095 ) . The main secondary endpoint was the composite of all-cause mortality , non-fatal myocardial infarction , and stroke . 301 patients in the pioglitazone group and 358 in the placebo group reached this endpoint ( 0.84 , 0.72-0.98 , p=0.027 ) . Overall safety and tolerability was good with no change in the safety profile of pioglitazone identified . 6 % ( 149 of 2065 ) and 4 % ( 108 of 2633 ) of those in the pioglitazone and placebo groups , respectively , were admitted to hospital with heart failure ; mortality rates from heart failure did not differ between groups . INTERPRETATION Pioglitazone reduces the composite of all-cause mortality , non-fatal myocardial infarction , and stroke in patients with type 2 diabetes who have a high risk of macrovascular events .

pioglitazone

matching placebo

glucose-lowering drugs

macrovascular events

myocardial infarction

stroke

macrovascular complications

macrovascular morbidity

mortality

macrovascular disease

composite of all-cause mortality

non fatal myocardial infarction

silent myocardial infarction

stroke

acute coronary syndrome

amputation above the ankle

primary composite endpoint

composite of all-cause mortality

endpoint

Overall safety

tolerability

safety

heart failure

mortality rates from heart failure

mortality

non-fatal myocardial infarction

stroke

type 2 diabetes

type 2 diabetes

type 2 diabetes

type 2 diabetes

macrovascular disease

type 2 diabetes

macrovascular events