Antipyretic efficacy of ibuprofen vs acetaminophen . OBJECTIVE To compare the antipyretic efficacy of ibuprofen , placebo , and acetaminophen . DESIGN Double-dummy , double-blind , randomized , placebo-controlled trial . SETTING Emergency department and inpatient units of a large , metropolitan , university-based , children 's hospital in Michigan . PARTICIPANTS 37 otherwise healthy children aged 2 to 12 years with acute , intercurrent , febrile illness . INTERVENTIONS Each child was randomly assigned to receive a single dose of acetaminophen ( 10 mg/kg ) , ibuprofen ( 7.5 or 10 mg/kg ) , or placebo . MEASUREMENTS/MAIN RESULTS Oral temperature was measured before dosing , 30 minutes after dosing , and hourly thereafter for 8 hours after the dose . Patients were monitored for adverse effects during the study and 24 hours after administration of the assigned drug . All three active treatments produced significant antipyresis compared with placebo . Ibuprofen provided greater temperature decrement and longer duration of antipyresis than acetaminophen when the two drugs were administered in approximately equal doses . No adverse effects were observed in any treatment group . CONCLUSION Ibuprofen is a potent antipyretic agent and is a safe alternative for the selected febrile child who may benefit from antipyretic medication but who either can not take or does not achieve satisfactory antipyresis with acetaminophen .

ibuprofen

acetaminophen

ibuprofen , placebo

acetaminophen

placebo-controlled

acetaminophen

ibuprofen

placebo

placebo

Ibuprofen

acetaminophen

Ibuprofen

acetaminophen

Antipyretic efficacy

antipyretic efficacy

Oral temperature

adverse effects

antipyresis

temperature decrement

duration of antipyresis

adverse effects

antipyretic

safe

antipyresis

otherwise healthy

children aged 2 to 12 years with

acute , intercurrent , febrile illness

child


Comparison of needlescopic appendectomy versus conventional laparoscopic appendectomy . A randomized controlled trial .

needlescopic appendectomy

conventional laparoscopic appendectomy

needlescopic appendectomy

laparoscopic appendectomy .


Efficacy , tolerability and pharmacokinetics of two nelfinavir-based regimens in human immunodeficiency virus-infected children and adolescents : pediatric AIDS clinical trials group protocol 403 . INTRODUCTION Few combinations of highly active antiretrovirals have been studied in nucleoside reverse transcription inhibitor ( NRTI ) -experienced , human immunodeficiency virus ( HIV ) -infected children . We tested the efficacy , tolerability and pharmacokinetics of 2 combination therapies containing an NRTI , protease inhibitors +/- a nonnucleoside reverse transcription inhibitor ( NNRTI ) . METHODS This was a phase II , randomized , multicenter study . Forty-one children and youths between 5 months and 21 years with prior NRTI and no prior NNRTI or protease inhibitor experience received either nelfinavir ( NFV ) 30 mg/kg twice daily ( bid ) , ritonavir ( RTV ) 400 mg/m bid and buffered didanosine ( ddI ) 240 mg/m daily ( arm A ) or NFV 50-55 mg/kg bid , nevirapine ( NVP ) 120 mg/m bid and stavudine ( d4T ) 1 mg/kg bid ( arm B ) . Patients were evaluated clinically for 48 weeks after initiation of therapy . Intensive pharmacokinetic sampling occurred after 4 weeks of therapy . RESULTS : The proportion of children with HIV-1 RNA < or =400 copies/mL and on randomized treatment at 48 weeks was 65 % among children assigned NFV + RTV + ddI versus 28 % among those assigned NFV + NVP + d4T ( P = 0.039 ) . No significant difference in median CD4 % change from baseline to week 48 was found ( 3 % versus 1 % ) . No significant differences in safety or tolerability between children randomized to NFV + RTV + ddI versus NFV + NVP + d4T were identified . However , a trend toward a higher rate of permanent discontinuation of study treatment was noted among children assigned to NFV + NVP + d4T compared with NFV + RTV + ddI [ 7 of 20 ( 35 % ) versus 2 of 21 ( 10 % ) ; P = 0.12 ] . NFV pharmacokinetic measurements were not statistically different between the treatment groups , yet exposure to the NFV metabolite , M8 , was significantly higher in subjects receiving RTV . The pharmacokinetics for NVP , RTV and d4T were similar to those of previously reported data . CONCLUSION : Combination therapy containing NFV + RTV + ddI appears more efficacious in NRTI-experienced children than a regimen containing NFV + NVP + d4T . Differences in tolerability between the 2 treatment groups were not identified . Systemic exposure of these drugs was similar to that reported in other HIV-infected children and adults .

nelfinavir-based

antiretrovirals

NFV

RTV

ddI

NFV

NVP

NVP

RTV

median CD4 % change

safety or tolerability

tolerability


Adhesion-prevention effects of fibrin sealants after laparoscopic myomectomy as determined by second-look laparoscopy : a prospective , randomized , controlled study . OBJECTIVE To examine the adhesion prevention effects of 2 types of fibrin sealant after laparoscopic myomectomy ( LM ) . STUDY DESIGN A prospective , randomized study ( Canadian Task Force I ) was conducted at a University-affiliated hospital . A total of 91 patients showing a minimal myoma > 5 cm , excluding pedunculated myomas , underwent LM alone : 32 patients in the control group , 29 in the fibrin gel group and 30 patients in the fibrin sheet group . After LM , postoperative adhesions were evaluated by second-look laparoscopy . The frequency of postoperative adhesions was the main outcome . RESULTS The frequency of postoperative adhesions of the uterus was significantly lower ( p < 0.05 ) in the fibrin gel group , with 20/32 ( 62.5 % ) in the control group , 10/29 ( 34.5 % ) in the fibrin gel group and 20/30 ( 67.7 % ) in the fibrin sheet group . Although no significant differences were found in the incidence of de novo adnexal adhesions , the lowest rate was found in the fibrin gel group , with 4/32 patients ( 12.5 % ) in the control group , 2/29 patients ( 6.8 % ) in the fibrin gel group and 5/30 patients ( 16.7 % ) in the fibrin sheet group . No bilateral adnexal adhesions were observed in the 3 groups . CONCLUSION After LM for myomas as large as > or = 5 cm , postoperative adhesions were observed in > or = 50 % of patients . The use of fibrin gel after LM is recommended .

fibrin sealants

laparoscopic myomectomy

LM

fibrin gel

fibrin sheet group

postoperative adhesions

fibrin gel

fibrin gel

fibrin sheet

fibrin gel

fibrin gel

fibrin gel

Adhesion-prevention effects

adhesion prevention effects

postoperative adhesions

second-look laparoscopy

frequency of postoperative adhesions

incidence of de novo adnexal adhesions

No bilateral adnexal adhesions

postoperative adhesions


A comparison of two double-injection techniques for peribulbar block analgesia : infero-temporal plus supero-medial vs. infero-temporal plus medial-percaruncular . BACKGROUND Combinations of infero-temporal and either supero-nasal ( 'inferior-superior ' ) or medial percaruncular ( 'inferior-medial ' ) injections are popular double-injection techniques for establishing peribulbar block analgesia . This study compared the efficacy of these two techniques in achieving ocular and lid akinesia . METHODS One hundred patients were randomized to receive inferior-superior or inferior-medial injections in a study in which injectate , injectate volumes , 5-min ocular akinesia scoring ( 0-8 ) , lid scoring ( 0-2 ) and supplemental injection protocols were standardized . The numbers of supplemental injections required at each observation period and the total volume of injectate required to produce ocular and lid akinesia were compared . RESULTS The two test groups were demographically similar . The inferior-medial combination achieved greater ocular akinesia than the inferior-superior combination 5 min after the initial injections ( mean score +/- standard deviation of 1.74 +/- 1.86 vs. 2.66 +/- 2.39 ; P < 0.05 ) , with a reduced requirement for supplementary injections ( 3 vs. 23 supplementary injections ; P < 0.025 ) . The inferior-superior technique achieved greater lid akinesia at 5 min than the inferior-medial technique ( mean score +/- standard deviation of 0.7 +/- 0.9 vs. 0.3 +/- 0.58 ; P < 0.005 ) . A medial subconjunctival hemorrhage occurred in one patient in the inferior-medial group . CONCLUSION Compared with the inferior-superior technique , the inferior-medial combination achieved more rapid ocular akinesia with less need for supplementation , but induced less efficient lid akinesia and had a propensity to cause iatrogenic subconjunctival hemorrhage . The latter complication is considered by our surgeons to be a contraindication to the inferior-medial technique in patients undergoing trabeculectomy .

supero-nasal ( 'inferior-superior ' )

inferior-superior

inferior-medial injections

ocular akinesia

lid scoring

ocular akinesia

lid akinesia

medial subconjunctival hemorrhage

rapid ocular akinesia

iatrogenic subconjunctival hemorrhage

peribulbar block analgesia

One hundred patients

trabeculectomy


Clinical trials of intrasplenic arterial infusion of interleukin-2 ( IS-IL-2 ) to patients with advanced cancer . We tried a infusion of interleukin-2 ( IL-2 ) of a relatively low dose via an intrasplenic arterial catheter connected to a chronometric infusion ( IS-IL-2 ) . Eighteen patients of colorectal cancer with metastases to the liver or lung or of unresectable hepatoma received a 24 hour continuous infusion with low dose recombinant of IL-2 ( mainly 8 x 10 ( 5 ) JRU/day ) for 25-40 days . All patients tolerated this protocol of the therapy and the main toxic effects were fever and general fatigue . Such serious toxicity as previously reported by high dose IL-2 therapy was not observed . Data of hepatic and renal functions were normal . IS-IL-2 therapy induced a high incidence of eosinophilia ( 12/18 ) and thrombocythemia ( 12/18 ) . Peripheral natural killer ( NK ) and LAK activities were augmented in all patients and total white blood cell counts were increased during IS-IL-2 therapy . An increase in IL-2 receptor expression of peripheral blood mononuclear cells and significant rises in numbers of Leu11 ( CD16 ) + , OKM1 ( CD11 ) + and OKIa1 ( HLA-DR ) + were observed . Of 18 patients 12 were evaluable for their response to therapy . Partial response ( PR ) was observed in one unresectable hepatoma and 11 demonstrated no change ( NC ) or progressive disease ( PD ) . Six patients were not evaluable because of additional therapy ( 3 cases ) or decreasing tumor cell markers having no measurable lesions ( 3 cases ) . Three patients of colorectal cancer from an unresectable group were presumed to have micrometastases to the liver as suggested by an elevated serum CEA level . After receiving IS-IL-2 therapy they demonstrated a decrease in the serum CEA level for more than 3 years after treatment . ( ABSTRACT TRUNCATED AT 250 WORDS )

interleukin-2 ( IS-IL-2 )

low dose recombinant of IL-2

tolerated

toxic effects

fever

general fatigue

toxicity

hepatic and renal functions

eosinophilia

( 12/18 )

thrombocythemia

total white blood cell counts

unresectable hepatoma

patients with advanced cancer .


Over time relationships between early adolescent and peer substance use . Peer and adolescent substance use are highly correlated , but this relationship is not fully understood . In particular , the relative contributions of selection and socialization to substance use progression have not been established . Students ( n=2453 ) in the seven middle schools in one school district were assessed at school at the beginning and end of the sixth , seventh , eighth grade and beginning of the 9th grade . Self-reported smoking and drinking and the number of substance using friends were assessed 5 times over 3 years . The relationship between peer and adolescent substance use were assessed in parallel processes as part of an autoregressive latent trajectory model . Substance use and the number of substance using friends increased in linear fashion from T1 to T5 . Initial substance use predicted an increase in the number of substance using friends over time , indicating an effect of selection , and the initial number of substance using friends predicted substance use progression , providing evidence of socialization . The magnitudes of these relationships were similar . Bivariate , lagged autoregressive analyses of the successive relationships from one assessment to the next showed consistent , significant associations from peer use to adolescent substance use . The association from adolescent to peer use was significant only from 7th to 8th grade . The findings provide evidence of reciprocal influences , but socialization was a more consistent influence than selection .

Self-reported

peer substance

Self-reported smoking and drinking

peer and adolescent substance use

Substance use

the number of substance

substance use

peer use to adolescent substance use

adolescent to peer use


Incidence of puberty in beef heifers fed high- or low-starch diets for different periods before breeding . Spring-born Hereford x Angus heifers ( n = 206 ) were used to determine effects of energy supplementation programs and amount of starch in the diet on incidence of puberty . In Exp . 1 , heifers ( 205 +/- 5 kg ; n = 68 ) grazing dormant native pasture were fed 0.9 kg/d ( as-fed basis ) of a 42 % CP supplement from November until February 14 . Heifers were stratified by weaning weight and allotted randomly to treatment before breeding ( May to July ) . Treatments were 1 ) 0.9 kg ( as-fed basis ) of a 42 % CP supplement/d and pasture ( control ) ; 2 ) a high-starch ( HS ) diet ( 73 % corn ; 53 % starch ) fed in a drylot for 60 d ( HS-60 ) ; 3 ) a HS diet fed in drylot for 30 d ( HS-30 ) ; or 4 ) a low-starch ( LS ) diet ( 49 % corn ; 37 % starch ) self-fed on pasture for 30 d ( LS-30 ) . The HS-60 and HS-30 heifers were limited-fed to gain 0.9 kg/d , and the LS-30 heifers had ad libitum access to the diet . High-starch-60 and LS-30 heifers were heavier ( P < 0.05 ) than control and HS-30 heifers at the beginning of the breeding season . Thirty-one , 25 , and 26 % more HS-60 heifers were pubertal ( P < 0.05 ) on May 1 compared with LS-30 , HS-30 , and control heifers , respectively . At puberty , HS-60 heifers were 24 and 22 d younger ( P < 0.05 ) than LS-30 and control heifers , and 31 kg lighter ( P < 0.01 ) than LS-30 heifers . In Exp . 2 , heifers grazed dormant pasture and were fed 0.9 kg ( as-fed basis ) of a 42 % CP supplement/d from weaning in October to late February ; then heifers were assigned randomly to treatments for 60 d before the breeding season . In two years , control heifers ( n = 46 ) grazed pasture and received 0.9 kg of SBM supplement/d ; LS ( n = 46 ) heifers were self-fed a distiller 's grain and soybean hull-based diet in drylot ; and HS heifers ( n = 46 ) were limited-fed a corn-based diet in drylot . During treatment , HS and LS heifers had greater weight gains than control heifers . Pubertal BW ( 313 +/- 6 kg ) was not influenced by treatment , but HS and LS heifers were younger ( P < 0.03 ) than control heifers at puberty . During a 60-d breeding period , the incidence of puberty was greater ( P < 0.05 ) for HS and LS heifers than for control heifers and was greater ( P < 0.05 ) in HS than in LS heifers in Year 1 . Feeding a LS or a HS diet for 30 d before breeding may be inadequate to stimulate puberty in beef heifers , but feeding a diet with a greater amount of starch for 60 d before breeding may increase the incidence of puberty during breeding of heifers that have inadequate yearling weight .

high- or low-starch diets

CP supplement

CP supplement/d and pasture

a high-starch ( HS ) diet ( 73 %

HS diet fed in drylot

a low-starch ( LS ) diet

self-fed on pasture

42 % CP supplement/d

SBM supplement/d

limited-fed a corn-based diet

HS

LS

LS

HS diet

Incidence of puberty

weight

heavier

weight gains

Pubertal BW

incidence of puberty

puberty

incidence of puberty


Effects of supplementation of whole corn germ on reproductive performance , calf performance , and leptin concentration in primiparous and mature beef cows . A 2-yr study using primiparous and multiparous , spring-calving , crossbred beef cows was conducted to evaluate the effects of supplemental whole corn germ on reproductive performance , calf performance , and serum leptin concentrations . Each year , cows were blocked by age and BCS and assigned randomly to one of three treatments : PRE ( n = 115 ) cows received 1.14 kg/d ( DM basis ) of whole corn germ for approximately 45 d before calving ; POST ( n = 109 ) cows were fed 1.14 kg/d of whole corn germ for approximately 45 d after calving ; and control cows ( n = 118 ) were fed similar energy and protein from dry-rolled corn ( 1.82 kg of DM/d ) for 45 d before and after calving . Additionally , PRE cows were grouped with controls after calving , and POST cows were grouped with control cows before calving , so that corn germ-supplemented cows received the control supplement in the alternate feeding period . Cow BW ( 538 +/- 13 kg ) and BCS ( 5.4 +/- 0.13 ) did not differ among treatments at any time during the experiment . Calf birth weight ( 39 +/- 2 kg ) , weaning weight ( 225 +/- 7 kg ) , and age-adjusted weaning weight ( 234 +/- 8 kg ) did not differ because of dam supplementation regimen . Treatment did not affect the proportion of cows exhibiting ovarian luteal activity before the start of the breeding season ( 67 % ) or pregnancy rate ( 91 % ) . The interval from exposure to bulls until subsequent calving did not differ ( P = 0.16 ) among PRE ( 298 +/- 2.3 d ) , POST ( 303 +/- 2.6 d ) , and control ( 304 +/- 2.3 d ) cows . Leptin concentrations did not differ among treatments and were 2.15 +/- 0.75 , 1.88 +/- 0.76 , and 1.91 +/- 0.75 ng/mL for control , POST , and PRE cows , respectively . Age and week relative to calving influenced leptin concentration . Primiparous cows had similar leptin concentrations to 3-yr-old and mature cows for wk -7 and -6 relative to calving , but lower ( P < 0.10 ) concentrations than mature cows for wk -5 , and lower ( P < 0.05 ) concentrations than either 3-yr-old or mature cows for wk -4 to +7 relative to calving . Serum leptin was correlated with BCS ( P < 0.0001 ; r = 0.35 ) at initiation of the feeding period and was correlated with BCS ( P = 0.02 ; r = 0.12 ) and weight ( P < 0.01 ; r = 0.14 ) at the completion of the supplement period , but it was not correlated with initial BW or interim BCS . Calving interval was not correlated ( P > 0.12 ) with weekly measures of serum leptin concentration . Supplementing beef cows with whole corn germ had no effect on cow performance , calf performance , or serum leptin concentrations of cows .

supplemental whole corn germ

reproductive performance

calf performance

leptin concentration

reproductive performance

calf performance

serum leptin concentrations

Cow BW

Calf birth weight

weaning weight

age-adjusted weaning weight

ovarian luteal activity

Leptin concentrations

leptin concentrations

serum leptin concentration


Comparison of methods for intravenous infusion of fat emulsion during extracorporeal membrane oxygenation . STUDY OBJECTIVES To characterize the effects of infusing fat emulsion during neonatal extracorporeal membrane oxygenation ( ECMO ) by comparing results from patients receiving fat emulsion through the ECMO circuit with those receiving fat emulsion through separate intravenous access . A second goal was to identify the optimal route for administration . DESIGN Prospective , randomized , open-label trial . SETTING Neonatal intensive care unit in a 106-bed quaternary care pediatric hospital . SUBJECTS Nine neonates receiving ECMO who required intravenous nutrition . Intervention . Patients received 1-3 g/kg/day of fat emulsion into either the ecmo circuit or separate intravenous access . MEASUREMENTS AND MAIN RESULTS The ECMO circuit and samples of blood were evaluated hourly for phase separation , layering out of the emulsion from blood , agglutination , and blood clots . After completion , the oxygenators were dissected and examined . Data were compared with an unpaired t test . The characteristics of the groups were similar , except for a higher mean weight in the ECMO circuit group ( 3.6 +/- 0.3 kg vs 2.8 +/- 0.4 kg , p=0.03 ) . The mean +/- SD triglyceride level during the study was 87 +/- 79 mg/dl , with no significant difference between the two groups . Two patients in each group had elevated triglyceride levels . No cases of phase separation occurred . In the five patients who received fat emulsion into the ECMO circuit , three had layering out of the emulsion and agglutination , and all developed clots in the circuit despite adequate anticoagulation . Of the four patients in the intravenous-access group , one had layering and agglutination , and two had blood clots . CONCLUSIONS Although both methods were associated with layering out , agglutination , and clot formation , these effects occurred more frequently with administration into the ECMO circuit , particularly in areas of stasis . This may result in disruption of normal ECMO blood flow and impaired delivery of calories . Fat emulsion should therefore be administered through separate intravenous access during ECMO whenever possible .

infusion of fat emulsion

fat emulsion

fat emulsion

nutrition

fat emulsion

Fat emulsion

weight

mean +/- SD triglyceride level

triglyceride levels

phase separation

layering out of the emulsion

agglutination

clots


Ultrasound therapy for recalcitrant diabetic foot ulcers : results of a randomized , double-blind , controlled , multicenter study . An estimated 15 % of patients with diabetes will develop a foot ulcer sometime in their life , making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population . To determine the safety and efficacy of a new , non-contact , kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized , double-blinded , sham-controlled , multicenter study was conducted in hospital-based and private wound care clinics . Patients ( 55 met criteria for efficacy analysis ) received standard of care , which included products that provide a moist environment , offloading diabetic shoes and socks , debridement , wound evaluation , and measurement . The " therapy " was either active 40 KHz ultrasound delivered by a saline mist or a " sham device " which delivered a saline mist without the use of ultrasound . After 12 weeks of care , the proportion of wounds healed ( defined as complete epithelialization without drainage ) in the active ultrasound therapy device group was significantly higher than that in the sham control group ( 40.7 % versus 14.3 % , P = 0.0366 , Fisher 's exact test ) . The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted . Of interest , wounds were debrided at baseline followed by a quantitative culture biopsy . The results of these cultures demonstrated a significant bioburden ( greater than 10 ( 5 ) ) in the majority of cases , despite a lack of clinical signs of infection . Compared to control , this therapeutic modality was found to increase the healing rate of recalcitrant , diabetic foot ulcers .

Ultrasound therapy

ultrasound treatment

recalcitrant diabetic foot ulcers

foot ulcer

recalcitrant diabetic foot ulcers

proportion of wounds healed

adverse events

bioburden

healing rate

recalcitrant diabetic foot ulcers

recalcitrant diabetic foot ulcers


Differential effects of two dihydropyridine calcium antagonists in humans . We studied the effects after single doses of niguldipine ( 0.3 , 0.6 , and 0.9 mg intravenously ; 8 and 16 mg orally ) and nifedipine ( 2 mg intravenously ; 20 mg orally ) in healthy male volunteers in randomized placebo-controlled experiments . Total peripheral resistance ( TPR ) , heart rate-corrected electromechanical systole ( QS2c ) , and preejection period ( PEPc ) were assessed noninvasively . Both drugs induced a similar pronounced decreased in TRP , indicating peripheral vasodilation , followed by increasing heart rate and cardiac output , a decrease in diastolic blood pressure , and a shortening of the PEPc . QS2c was unchanged after niguldipine . The prolongation of QS2c after oral nifedipine is suggestive of a negative inotropic effect . We conclude that the vasodilatory effects of dihydropyridines may ( as for nifedipine ) or may not ( as for niguldipine ) be associated with changes that are suggestive of negative inotropic effects , and that this difference is detectable by noninvasive methods in healthy subjects .

dihydropyridine calcium antagonists

niguldipine

nifedipine

placebo-controlled

nifedipine

dihydropyridines

nifedipine

niguldipine

Differential effects

Total peripheral resistance ( TPR )

preejection period ( PEPc )

heart rate

cardiac output

prolongation of QS2c

negative inotropic effect

vasodilatory effects

negative inotropic effects

healthy male volunteers


A randomised controlled trial of a CBT intervention for anxiety in children with Asperger syndrome . BACKGROUND The aim of the study was to evaluate the effectiveness of a brief CBT intervention for anxiety with children diagnosed with Asperger syndrome ( AS ) . A second interest was to evaluate whether more intensive parent involvement would increase the child 's ability to manage anxiety outside of the clinic setting . METHODS Seventy-one children aged ten to twelve years were recruited to participate in the anxiety programme . All children were diagnosed with AS and the presence of anxiety symptoms was accepted on parent report via brief interview . Children were randomly assigned to one of three conditions : intervention for child only , intervention for child and parent , wait-list control . RESULTS The two intervention groups demonstrated significant decreases in parent-reported anxiety symptoms at follow-up and a significant increase in the child 's ability to generate positive strategies in an anxiety-provoking situation . There were a number of significant differences between the two interventions to suggest parent involvement as beneficial . CONCLUSIONS The sample of children with AS in this study presented with a profile of anxiety similar to a sample of clinically diagnosed anxious children . The intervention was endorsed by parents as a useful programme for children diagnosed with Asperger syndrome and exhibiting anxiety symptoms , and active parent involvement enhanced the usefulness of the programme . Limitations of the study and future research are discussed .

CBT intervention

brief CBT intervention for anxiety

Asperger syndrome

parent-reported anxiety symptoms

anxiety in

children

with Asperger syndrome .

children

Seventy-one

children

ten to twelve years

children

AS

anxiety symptoms

children

Asperger syndrome

anxiety


Bronchial matrix and inflammation respond to inhaled steroids despite ongoing allergen exposure in asthma . BACKGROUND Inflammatory and structural changes of the airway mucosa are chronic features of asthma . The mechanisms underlying these changes and their modulation by steroid prophylaxis have not been clarified . OBJECTIVE We postulated that asymptomatic ongoing allergen exposure could drive airway inflammation as well as changes in the extracellular matrix ( ECM ) , and that inhaled steroids could prevent this . METHODS Therefore , we exposed patients with mild asthma to 2 weeks of repeated low-dose allergen , with concomitant inhaled steroid or placebo treatment . Bronchial biopsies , which were taken before and after this exposure , were stained and digitally analysed . The ECM proteins in asthmatics were also compared with a normal control group . RESULTS Low-dose allergen exposure alone resulted in a significant increase of bronchial epithelial macrophages . Despite ongoing allergen exposure , inhaled steroids reduced the numbers of mucosal eosinophils , neutrophils and T lymphocytes . At baseline , the mean density of the proteoglycans ( PGS ) biglycan and decorin were , respectively , higher and lower in the bronchial mucosa of asthmatics as compared with normal controls . Steroid treatment , during allergen exposure , increased the mean density of the PGS biglycan and versican . CONCLUSION We conclude that chronic allergen exposure induces inflammatory changes in the bronchial mucosa . Despite ongoing allergen exposure , steroid treatment decreases mucosal inflammatory cells while altering PG density . The latter observation highlights the need to examine steroid-induced changes closely in the airway structure in patients with asthma .

inhaled steroids

steroid

inhaled steroids

low-dose allergen

concomitant inhaled steroid

placebo treatment

steroids

Steroid

steroid

Bronchial matrix and inflammation

bronchial epithelial macrophages

mucosal inflammatory cells

steroid-induced changes

asthma

patients with mild asthma

patients with asthma .


Long-term effects of risperidone in children with autism spectrum disorders : a placebo discontinuation study . OBJECTIVE The short-term benefit of risperidone in ameliorating severe disruptive behavior in pediatric patients with autism spectrum disorders is well established ; however , only one placebo-controlled , long-term study of efficacy is available . METHOD Thirty-six children with an autism spectrum disorder ( 5-17 years old ) accompanied by severe tantrums , aggression , or self-injurious behavior , started 8-week open-label treatment with risperidone . Responders ( n = 26 ) continued treatment for another 16 weeks , followed by a double-blind discontinuation ( n = 24 ; two patients discontinued treatment because of weight gain ) consisting of either 3 weeks of taper and 5 weeks of placebo only or continuing use of risperidone . Relapse was defined as a significant deterioration of symptoms based on clinical judgment and a parent questionnaire . RESULTS Risperidone was superior to placebo in preventing relapse : this occurred in 3 of 12 patients continuing on risperidone versus 8 of 12 who switched to placebo ( p = .049 ) . Weight gain , increased appetite , anxiety , and fatigue were the most frequently reported side effects . CONCLUSIONS This study indicates the effectiveness of risperidone during a period of several months , reducing disruptive behavior in about half of the children with autism spectrum disorders . The results provide a rationale for the continuing use of risperidone beyond 6 months , although considerable weight gain can limit the use of this agent .

risperidone

placebo

severe disruptive behavior

relapse :

Weight gain , increased appetite

anxiety

fatigue

disruptive behavior

weight gain

children

autism spectrum disorders

pediatric patients

autism spectrum disorders

Thirty-six

children

autism spectrum disorder

children

autism spectrum disorders


Supplemental perioperative oxygen and the risk of surgical wound infection : a randomized controlled trial . CONTEXT Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection . OBJECTIVE To test the hypothesis that supplemental oxygen reduces infection risk in patients following colorectal surgery . DESIGN , SETTING , AND PATIENTS A double-blind , randomized controlled trial of 300 patients aged 18 to 80 years who underwent elective colorectal surgery in 14 Spanish hospitals from March 1 , 2003 , to October 31 , 2004 . Wound infections were diagnosed by blinded investigators using Centers for Disease Control and Prevention criteria . Baseline patient characteristics , anesthetic treatment , and potential confounding factors were recorded . INTERVENTIONS Patients were randomly assigned to either 30 % or 80 % fraction of inspired oxygen ( FIO2 ) intraoperatively and for 6 hours after surgery . Anesthetic treatment and antibiotic administration were standardized . MAIN OUTCOME MEASURES Any surgical site infection ( SSI ) ; secondary outcomes included return of bowel function and ability to tolerate solid food , ambulation , suture removal , and duration of hospitalization . RESULTS A total of 143 patients received 30 % perioperative oxygen and 148 received 80 % perioperative oxygen . Surgical site infection occurred in 35 patients ( 24.4 % ) administered 30 % FIO2 and in 22 patients ( 14.9 % ) administered 80 % FIO2 ( P=.04 ) . The risk of SSI was 39 % lower in the 80 % FIO2 group ( relative risk [ RR ] , 0.61 ; 95 % confidence interval [ CI ] , 0.38-0.98 ) vs the 30 % FIO2 group . After adjustment for important covariates , the RR of infection in patients administered supplemental oxygen was 0.46 ( 95 % CI , 0.22-0.95 ; P = .04 ) . None of the secondary outcomes varied significantly between the 2 treatment groups . CONCLUSIONS Patients receiving supplemental inspired oxygen had a significant reduction in the risk of wound infection . Supplemental oxygen appears to be an effective intervention to reduce SSI in patients undergoing colon or rectal surgery . Trial Registration ClinicalTrials.gov Identifier : NCT00235456 .

Supplemental perioperative oxygen

Supplemental perioperative oxygen

supplemental oxygen

30 % perioperative oxygen

80 % perioperative oxygen

80 % FIO2

30 % FIO2

supplemental inspired oxygen

Supplemental oxygen

surgical wound infection

surgical wound infection

Any surgical site infection

return of bowel function

ability to tolerate solid food

ambulation

suture removal

duration of hospitalization

Surgical site infection

risk of SSI

risk of wound infection

SSI


Oral health impacts on daily living related to four different treatment protocols for chronic periodontitis . BACKGROUND The aims of this study were to evaluate the oral health impacts perceived by patients submitted to different treatments of chronic periodontitis and their association with clinical parameters . METHODS Sixty patients were assigned to one of the following therapeutic groups : control , treated with full-mouth scaling and root planing ( SRP ) ; test 1 , treated with SRP and 400 mg systemically administered metronidazole ( MET ) three times per day for 10 days ; test 2 , treated with SRP and professional supragingival plaque removal ( PP ) every week for 3 months ; and test 3 , treated with SRP and MET plus PP . Clinical periodontal measurements and data regarding patients ' oral health impacts ( perceived impacts on bleeding gums , gingival recession , sensitivity to cold , packing foods , aesthetics , bad breath , and tooth mobility ) were collected at baseline and 3 months after therapy . RESULTS All groups presented significant improvement in oral health perceived impacts . There was no statistically significant difference in the improvement of oral health impacts among groups subjected to different treatments . The clinical data of percentage of deep probing depth , deep clinical attachment level , and bleeding on probing were found to be correlated significantly with oral health impacts . CONCLUSIONS Periodontal treatment leads to a significant reduction of self-perceived impacts regardless of the non-surgical treatment protocol employed . Most of the clinical data were associated with oral health impacts .

metronidazole

SRP

supragingival plaque removal ( PP )

SRP

PP

Periodontal treatment

oral health perceived impacts .

oral health impacts

self-perceived impacts

chronic periodontitis

chronic periodontitis

Sixty


Pathology parameters and adjuvant tamoxifen response in a randomised premenopausal breast cancer trial . BACKGROUND Subgroups of breast cancer that have an impaired response to endocrine treatment , despite hormone receptor positivity , are still poorly defined . Breast cancer can be subdivided according to standard pathological parameters including histological type , grade , and assessment of proliferation . These parameters are the net result of combinations of genetic alterations effecting tumour behaviour and could potentially reflect subtypes that respond differently to endocrine treatment . AIMS To investigate the usefulness of these parameters as predictors of the response to tamoxifen in premenopausal women with breast cancer . MATERIALS/METHODS Clinically established pathological parameters were assessed and related to the tamoxifen response in 500 available tumour specimens from 564 premenopausal patients with breast cancer randomised to either two years of tamoxifen or no treatment with 14 years of follow up . Proliferation was further evaluated by immunohistochemical Ki-67 expression . RESULTS Oestrogen receptor positive ductal carcinomas responded as expected to tamoxifen , whereas the difference in recurrence free survival between control and tamoxifen treated patients was less apparent in the relatively few lobular carcinomas . For histological grade , there was no obvious difference in treatment response between the groups . The relation between proliferation and tamoxifen response seemed to be more complex , with a clear response in tumours with high and low proliferation , whereas tumours with intermediate proliferation defined by Ki-67 responded more poorly . CONCLUSIONS Clinically established pathology parameters seem to mirror the endocrine treatment response and could potentially be valuable in future treatment decisions for patients with breast cancer .

tamoxifen

tamoxifen

tamoxifen

tamoxifen

no treatment

tamoxifen

control

tamoxifen

tamoxifen

adjuvant tamoxifen response

recurrence free survival

poorly

premenopausal breast cancer

premenopausal

women

breast cancer

patients with breast cancer


Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer : results from a randomised , placebo-controlled , multicentre study ( Iressa Survival Evaluation in Lung Cancer ) . BACKGROUND This placebo-controlled phase III study investigated the effect on survival of gefitinib as second-line or third-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer . METHODS 1692 patients who were refractory to or intolerant of their latest chemotherapy regimen were randomly assigned in a ratio of two to one either gefitinib ( 250 mg/day ) or placebo , plus best supportive care . The primary endpoint was survival in the overall population of patients and those with adenocarcinoma . The primary analysis of the population for survival was by intention to treat . This study has been submitted for registration with ClinicalTrials.gov , number 1839IL/709 . FINDINGS 1129 patients were assigned gefitinib and 563 placebo . At median follow-up of 7.2 months , median survival did not differ significantly between the groups in the overall population ( 5.6 months for gefitinib and 5.1 months for placebo ; hazard ratio 0.89 [ 95 % CI 0.77-1.02 ] , p=0.087 ) or among the 812 patients with adenocarcinoma ( 6.3 months vs 5.4 months ; 0.84 [ 0.68-1.03 ] , p=0.089 ) . Preplanned subgroup analyses showed significantly longer survival in the gefitinib group than the placebo group for never-smokers ( n=375 ; 0.67 [ 0.49-0.92 ] , p=0.012 ; median survival 8.9 vs 6.1 months ) and patients of Asian origin ( n=342 ; 0.66 [ 0.48-0.91 ] , p=0.01 ; median survival 9.5 vs 5.5 months ) . Gefitinib was well tolerated , as in previous studies . INTERPRETATION Treatment with gefitinib was not associated with significant improvement in survival in either coprimary population . There was pronounced heterogeneity in survival outcomes between groups of patients , with some evidence of benefit among never-smokers and patients of Asian origin .

Gefitinib

best supportive care

placebo-controlled

gefitinib

gefitinib

placebo

gefitinib

effect on survival

survival

survival

median survival

survival

median survival

median survival

tolerated

survival

survival


Chemotherapy for metastatic NSCLC : current status and future direction .

Chemotherapy

Chemotherapy for metastatic NSCLC :


[ The comparison of the effect of enalapril and indapamide on the peripheral blood pressure and central blood pressure through pulse wave analysis ] . OBJECTIVES The purpose of this study was to evaluate the effects of the angiotensin-converting enzyme ( ACE ) inhibitor enalapril and diuretic indapamide on the peripheral blood pressure and the central blood pressure in Chinese patients with essential hypertension . METHODS This study was a double blind , randomized study . Informed consent were given by all patients . After 2 weeks of placebo run-in period , 105 patients with mild or moderate essential hypertension were randomized to receive either enalapril ( 10 mg per day ) or indapamide ( 2.5 mg per day ) for 8 weeks . Radial pulse wave recordings were performed in all the patients before the active treatments were given and at the end of the study . Only those patients who have finished 8 weeks of active treatment in both groups were included into the final analysis . RESULTS One hundred one patients ( 51 in enalapril group and 50 in indapamide group ) completed the study . No significant difference ( all P values > 0.05 ) was found in baseline data between the two groups . After 8 weeks of treatment , all the parameters of pulse wave ( except heart rates in both groups and augmentation index in indapamide group ) decreased significantly . Comparison of the 2 groups showed that there were no significant differences ( all P values > 0.05 ) in all the parameters of pulse wave except that the central systolic blood pressure , augmentation and augmentation index were significantly lower in enalapril group than in indapamide group . In enalapril group , the reduced values of systolic blood pressure and pulse pressure in central aorta were significantly larger than those in brachial artery . However , the difference was not observed in indapamide group . CONCLUSIONS Enalapril and indapamide are both similarly effective in reducing peripheral arterial blood pressure . Moreover , enalapril is more effective in reducing central systolic pressure and augmentation index than indapamide . The difference is probably due to the reduction of wave reflection caused by enalapril .

enalapril

indapamide

diuretic indapamide

placebo

enalapril

indapamide

enalapril

indapamide

indapamide

enalapril

indapamide

enalapril

indapamide

Enalapril

indapamide

enalapril

indapamide

enalapril

effects

parameters of pulse wave

central systolic blood pressure

augmentation and augmentation index

difference

wave reflection


The evaluation of pulmonary hypertension using right ventricular myocardial isovolumic relaxation time . Right ventricular ( RV ) blood pool-derived isovolumic relaxation time ( IVRT ) correlates well with systolic pulmonary arterial pressure ( PAP ) . However , because of complex parameter derivation , the method is rarely used . The aim of this study was to validate the measurement of myocardial velocity imaging-derived RV IVRT ( IVRT ' ) against invasively measured PAP . Transthoracic echocardiography with myocardial velocity imaging and right heart catheterization were performed in 33 patients with pulmonary hypertension . Blood pool IVRT and myocardial IVRTs for the tricuspid valve annulus ring , basal and apical RV free wall segments were measured and compared with data from 33 age- and sex-matched control subjects . Measured IVRTs were significantly longer in patients with pulmonary hypertension than in control subjects . The strongest correlation ( R = 0.74 , P < .0001 ) was found between systolic PAP and the heart rate-corrected IVRT ' derived from the basal RV free wall segment . The basal segment IVRT ' corrected for heart rate correlates well with the invasive PAP measurement and , therefore , can be used to predict systolic PAP . It can even be considered as an alternative to tricuspid regurgitation-derived PAP systolic when tricuspid regurgitation is nonrecordable . A proposed method to derive systolic PAP should be used while screening the patients at risk for pulmonary hypertension , monitoring the disease progression and the effect of treatment .

RV IVRT ( IVRT ' )

invasively measured PAP .

right heart catheterization

Measured IVRTs

systolic PAP

heart rate-corrected IVRT

basal segment IVRT

heart rate

systolic PAP

pulmonary hypertension


Mending the rhythm does not improve prognosis in patients with persistent atrial fibrillation : a subanalysis of the RACE study . AIMS To compare outcome of AF patients with effective rhythm control with patients treated with rate control . METHODS AND RESULTS Out of the 266 AF patients randomized to rhythm control in the RACE study , 49 patients turned to long-term sinus rhythm and were continuously treated with oral anticoagulation . The incidence of the primary endpoint in these patients was compared to that in 178 patients out of the initial 256 rate-control patients of RACE who were in AF and using oral anticoagulation continuously . Baseline characteristics of both groups were not different . After a mean follow-up of 2.3+/-0.6 years , the primary endpoint ( a composite of cardiovascular mortality , heart failure , thrombo-embolic complications ( TECs ) , bleeding , serious adverse effects of antiarrhythmic drugs and pacemaker implants ) was 22.4 % in the rhythm-control group vs. 15.2 % in the rate-control group . Multivariable regression analysis indicated coronary artery disease , heart failure , and digitalis as independent risk indicators of cardiovascular morbidity and mortality . Chronic sinus rhythm did not matter . CONCLUSION Among patients who remained on warfarin , those who mostly were maintained in sinus rhythm under a rhythm-control strategy did not have a superior prognosis compared to those who remained in AF under a rate-control strategy .

rhythm control

long-term sinus rhythm

oral anticoagulation

warfarin

composite of cardiovascular mortality

heart failure

thrombo-embolic complications ( TECs )

bleeding

pacemaker implants

coronary artery disease

digitalis

Chronic sinus rhythm

persistent atrial fibrillation

AF


Randomized , controlled , crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity . CONTEXT Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders , but studies of stimulants in these conditions have been inconclusive . OBJECTIVES To determine the efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity . DESIGN Double-blind , placebo-controlled , crossover trial followed by open-label continuation . SETTING Five academic outpatient clinics . PARTICIPANTS Seventy-two drug-free children , aged 5 to 14 years , with pervasive developmental disorders accompanied by moderate to severe hyperactivity . INTERVENTIONS Prior to randomization , subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate ( low , medium , and high doses ) that were each given for 2 days . The low , medium , and high doses of methylphenidate hydrochloride were based on weight , and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses . Subjects who tolerated the test dose ( n = 66 ) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind , crossover phase . Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose . MAIN OUTCOME MEASURES The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist . Response was defined as " much improved " or " very much improved " on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score . RESULTS Methylphenidate was superior to placebo on the primary outcome measure , with effect sizes ranging from 0.20 to 0.54 depending on dose and rater . Thirty-five ( 49 % ) of 72 enrolled subjects were classified as methylphenidate responders . Adverse effects led to the discontinuation of study medication in 13 ( 18 % ) of 72 subjects . CONCLUSIONS Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders , but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder . Adverse effects were more frequent .

methylphenidate

methylphenidate hydrochloride

placebo

doses of methylphenidate

methylphenidate hydrochloride

placebo

methylphenidate

methylphenidate

Methylphenidate

placebo

methylphenidate

Methylphenidate

much improved

very much improved

effect sizes

Adverse effects

hydrochloride in children

13 ( 18 % ) of 72 subjects .


Single-session behavioral treatment of earthquake-related posttraumatic stress disorder : a randomized waiting list controlled trial . In an attempt to develop a brief treatment for disaster survivors , the present study examined the effectiveness of a single session of modified behavioral treatment in earthquake-related posttraumatic stress disorder . Fifty-nine earthquake survivors in Turkey were randomized into either single-session modified behavioral treatment ( SSBT ) designed to enhance sense of control over earthquake-related fears or waiting list control condition ( WL ) . The WL group received SSBT after a second baseline assessment . Follow-ups were at weeks 6 , 12 , 24 , and at 1-2 years posttreatment . Significant treatment effects were found on all measures at posttreatment . The improvement rate was 49 % at week 6 ; it rose to 80 % by week 12 , 85 % by week 24 , and 83 % by the 1-2-year follow-up . Brief behavioral treatment has promise as a cost-effective intervention for disaster survivors .

behavioral treatment

modified behavioral treatment

waiting list control condition ( WL )

behavioral treatment

earthquake-related fears

Significant treatment effects

improvement rate

cost-effective

disaster survivors

Fifty-nine

earthquake survivors

disaster survivors


A training study of theory of mind and executive function in children with autistic spectrum disorders . This study investigated the relationship between theory of mind and executive functioning in children with autistic spectrum disorders through a training study . Ten children were trained on theory of mind , whilst ten were trained in executive function . Seven children were assigned to a control group , receiving no intervention . Training programmes were administered individually , lasting for 25 minutes per day for 5-10 days . Children were tested before training , after training and at a two-month follow-up . Significant improvements were seen in performance on theory of mind tasks in both trained groups , whilst the control group showed no improvement . No improvement on the executive function tasks was seen in any of the groups . The implications of these findings are discussed .

theory of mind

trained in executive function

no intervention

performance on theory of mind tasks

no improvement

executive function tasks

children

autistic spectrum disorders

Ten

children

ten

Seven


Efficacy of nebulized flunisolide combined with salbutamol and ipratropium bromide in stable patients with moderate-to-severe chronic obstructive pulmonary disease . BACKGROUND The efficacy of nebulized corticosteroids in the prevention of exacerbation of chronic obstructive pulmonary disease ( COPD ) has been poorly studied . OBJECTIVE To evaluate the efficacy and tolerability of nebulized flunisolide ( 1 mg ) + salbutamol/ipratropium bromide ( 1,875/375 microg ) b.i.d . in comparison with placebo + salbutamol/ipratropium bromide . METHODS This was a randomized , parallel-group , double-blind study on 114 patients with COPD of moderate-to-severe degree . The main outcome was the frequency of severe exacerbations over a 6-month period . Before and after treatment , respiratory symptoms , forced expiratory volume in 1 s ( FEV ( 1 ) ) , shuttle walking test distance and St. George 's Respiratory Questionnaire scores were evaluated . RESULTS The total number of exacerbations was slightly lower in the flunisolide group compared to the placebo group ( 19 vs. 34 , p = 0.054 ) ; the number of patients experiencing at least one exacerbation during the study was also decreased ( 16 vs. 26 , p = 0.059 ) . In particular , type 3 Anthonisens 's exacerbations were significantly reduced by flunisolide ( p = 0.044 ) . In the placebo group , scores were higher than in the flunisolide group but nonsignificant for dyspnea , cough , sputum amount and purulence . FEV ( 1 ) was significantly increased compared to baseline in both groups , and the area under the FEV ( 1 ) -time curve during the 6-month period was significantly greater in the flunisolide group ( 5.2 +/- 10.6 vs. 2.1 +/- 5.0 , flunisolide vs. placebo , respectively ; p = 0.047 ) . For shuttle walking test distance and scores of the St. George 's Respiratory Questionnaire , no significant difference between the baseline evaluation and the end of the study was observed in both groups . CONCLUSIONS Nebulized flunisolide is a good alternative to other inhaled corticosteroids when added to nebulized salbutamol/ipratropium bromide in the long-term treatment of moderate-to-severe COPD patients .

corticosteroids

nebulized flunisolide

+ salbutamol/ipratropium bromide

placebo

salbutamol/ipratropium bromide

flunisolide

placebo

flunisolide

placebo

flunisolide

flunisolide

flunisolide

placebo

Nebulized flunisolide

Efficacy

efficacy

efficacy

tolerability

frequency of severe exacerbations

total number of exacerbations

type 3 Anthonisens 's exacerbations

FEV ( 1 )

COPD )

COPD of moderate-to-severe degree

moderate-to-severe COPD


An open multicenter efficacy and safety evaluation of amlodipine in the treatment of symptomatic myocardial ischemia . The efficacy and safety of amlodipine ( 5-10 mg ) once daily were studied in an open study in patients with symptomatic myocardial ischemia . The study is ongoing and this report is based on an interim analysis of data from 78 patients . A 2-week baseline period in which patients maintained their current antianginal therapy was followed by a 10-week treatment period with 5-10 mg of amlodipine/day . Both the median number of angina attacks per week and the median number of nitroglycerin ( NTG ) tablets consumed/week were significantly reduced after amlodipine ( mean daily dose of 8.6 mg ) when compared with baseline ( p < 0.05 ) . A total of 98.4 % of patients ( 63/64 ) experienced a reduction in the frequency of angina attacks/week and 91 % of patients ( 58/64 ) had angina attacks reduced to < or = 2/week . In self-assessments , 95 % of patients ( 55/58 ) reported improved angina control and 91 % ( 53/58 ) felt their ability to perform usual activities had improved . Twenty-seven patients experienced adverse events reported as drug related . The most common adverse event noted was edema . Amlodipine once daily significantly reduced the incidence of angina attacks and the concomitant need of nitroglycerin for relief of symptoms and thus improved the patients ' ability to perform daily activities . Most adverse events reported were mild or moderate and the incidence is as would be expected in this patient population .

amlodipine

amlodipine

antianginal therapy

amlodipine/day

nitroglycerin

amlodipine

Amlodipine

nitroglycerin

efficacy and safety evaluation

efficacy and safety

frequency of angina attacks/week

angina attacks

angina control

ability to perform usual activities

adverse events

adverse event

edema

incidence of angina attacks


Comparative speed of kill of selamectin , imidacloprid , and fipronil- ( S ) -methoprene spot-on formulations against fleas on cats . The speed of kill of selamectin , imidacloprid , and fipronil- ( S ) -methoprene against Ctenocephalides felis infestations on cats for one month following a single treatment was evaluated . Eighty cats were randomly allocated so that there were 20 cats in four different treatment groups . On Days -2 , 7 , 14 , 21 , and 28 , each cat was infested with 100 adult C. felis from the Kansas 1 flea strain . Following initial application only imidacloprid had caused a significant reduction in adult fleas on treated cats within 6 hours , but by 24 hours all three formulations had killed 96.7 % of the fleas . At 7 days post treatment , all three formulations reduced flea populations within 6 and 24 hours by 68.4 % and 99.4 % , respectively . At 21 and 28 days after treatment , none of the formulations killed significant numbers of fleas as compared to controls within 6 hours of infestation . At 28 days after treatment , selamectin , fipronil- ( S ) -methoprene , and imidacloprid had killed 99.0 % , 86.4 % , and 72.6 % of the fleas within 48 hours of infestation , respectively . This study demonstrates that the speed of kill of residual flea products on cats decreases throughout the month following application . It also demonstrated that selamectin provided the highest level of residual activity on cats against the Kansas 1 flea strain .

selamectin

imidacloprid

fipronil- ( S ) -methoprene

imidacloprid

selamectin

fipronil- ( S ) -methoprene

imidacloprid

fleas

reduction in adult fleas

flea populations

numbers of fleas

fleas

flea products

residual activity

fleas

cats

Eighty

Kansas 1 flea


Comparison of antihypertensives after coronary artery surgery . Hypertension following coronary artery bypass grafting is a common problem that may result in postoperative myocardial infraction or bleeding , Hemodynamic effects were compared in 45 hypertensive coronary bypass patients randomized to receive either diltiazem , nitroglycerin , or sodium nitroprusside . Diltiazem was administered as an intravenous bolus of 0.3 mg.kg-1 within 5 min , followed by infusion of 0.1-0.8 mg.kg-1.h-1 in group 1 . Nitroglycerin was infused at a rate of 1-3 microg.kg.h-1 in group 2 , and sodium nitroprusside was given at a rate of 1-3 microg.kg-1.min-1 in group 3 . Hemodynamic measurements were carried out before infusion ( T1 ) and at 30 min ( T2 ) , 2 h ( T3 ) , and 12 h ( T4 ) after initiation of treatment in the intensive care unit . Mean arterial pressure decreased significantly in all groups . There were no differences among groups at T1 and T2 . At T3 , heart rate in group 2 was significantly higher than group 1 . At T3 and T4 , the double product was highest in group 3 ( group 1 vs. 3 , p < 0.001 ) . These results suggest that the hemodynamic effects of the 3 drugs are similar within the first 30 min . However , after 30 min , diltiazem affords better myocardial performance and more effective control of hypertension .

antihypertensives

Diltiazem

Nitroglycerin

sodium nitroprusside

diltiazem

Hypertension

postoperative myocardial infraction

bleeding , Hemodynamic effects

Hemodynamic measurements

Mean arterial pressure

heart rate

hemodynamic effects

myocardial performance

hypertension

coronary artery surgery

coronary artery bypass grafting

hypertensive coronary bypass


Comparison of a biopsychosocial therapy ( BT ) with a conventional biomedical therapy ( MT ) of subacute low back pain in the first episode of sick leave : a randomized controlled trial . This randomized controlled clinical trial compares the effectiveness of a biopsychosocial treatment with a solely conventional biomedical therapy in patients with subacute low back pain using parameters for pain intensity , functional status , depressive dysfunction and work performance . Sixty-four patients with a first-time sick leave between 3 and 12 weeks due to low back pain were randomly assigned to either a conventional biomedical therapy ( MT ; n=33 ) group , or a biopsychosocial therapy ( BT ; n=31 ) group including a psychotherapeutic module ; both in accordance with a standardized 3 weeks inpatient treatment . Pain intensity , functional back capacity , clinical parameters and depressive dysfunction revealed significant improvement in both treatment groups at end of 3 weeks therapy ( T1 ) . However , at 6 months ( T2 ) , analysis revealed significant better results for nearly all parameters in the BT group that showed further improvement from T1 to T2 , whereas the values in the MT group deteriorated from T1 back to the baseline values . During the 2-year period after therapy , 10 % in MT and 59 % in BT required no further sick leave due to low back pain . The results of the study indicate that a psychotherapeutic element in the treatment of low back pain appears to positively influence pain , functional status and work performance when conducted at an early stage of chronification and helps in the achievement of a better outcome .

biopsychosocial therapy ( BT )

conventional biomedical therapy

( MT )

conventional biomedical therapy

biopsychosocial therapy

subacute low back pain

subacute low back pain

Pain intensity

functional back capacity

clinical parameters

depressive dysfunction

T1 to T2

sick leave

low back pain

low back pain

pain

functional status

and work performance

Sixty-four

low back pain


[ Clinical study of feiyanqing rectum condensed liquid in treating 36 cases of children syncytial viral pneumonia ] . OBJECTIVE To evaluate the clinical efficacy and mechanism of Feiyangqin Rectum Condensed Liquid ( FRCL ) in treating children syncytial viral pneumonia . Methods Seventy-two patients were randomly divided into two groups , the 36 patients in the treated group were treated with FRCL , and the other 36 patients in the control group simply treated with Western medicine . Efficacy of treatment on clinical condition and some immune function ( IgA , IgG , CD3 , CD4 ) were observed . RESULTS In the treated group , 28 patients were cured ( 77.8 % ) , treatment was markedly effective in 4 patients ( 11.1 % ) , effective in 2 ( 5.5 % ) and ineffective in 2 ( 5.6 % ) , with the total effective rate of 94.4 % . The corresponding number in the control group was 20 ( 55.6 % ) , 7 ( 19.4 % ) , 6 ( 16.7 % ) , 3 ( 8.3 % ) and 91.7 % , respectively . The cure rate in the treated group was obviously superior to that in the control group ( P < 0.05 ) . FRCL could improve serum IgA , IgG , CD3 , CD4 , and CD4/CD8 , lower serum IgE , these indexes in the treated group were significantly different to those in the control group ( P < 0.05 ) . CONCLUSION FRCL had the action in treating children syncytial viral pneumonia without any adverse reaction , one of its mechanisms might be related to its regulation on immune function .

feiyanqing rectum condensed liquid

FRCL

Western medicine .

FRCL

FRCL

Efficacy

cured

total effective rate

cure rate

children

syncytial viral pneumonia

Seventy-two

36 patients

36 patients


Divalproex sodium vs. placebo in the treatment of repetitive behaviours in autism spectrum disorder . Autism is a neurodevelopmental disorder characterized by impairment in three core symptom domains : socialization , communication , and repetitive/stereotyped behaviours . Other associated symptom domains are also affected including impulsivity/aggression , self-injury , anxiety , and mood lability . Divalproex has been shown to have efficacy in treating epilepsy , bipolar disorder , mood lability , and impulsive aggression . The present study evaluated the use of divalproex in the treatment of repetitive , compulsive-like symptoms of autism spectrum disorder ( ASD ) . Thirteen individuals with ASD participated in an 8-wk , double-blind , placebo-controlled trial of divalproex sodium vs. placebo . There was a significant group difference on improvement in repetitive behaviours as measured by the Children 's Yale-Brown Obsessive Compulsive Scale ( C-YBOCS ) ( p=0.037 ) and a large effect size ( d=1.616 ) . This study provides preliminary support for the use of divalproex in treating repetitive behaviours in ASD . Further research is needed to evaluate the specificity and mechanism of action of these findings .

Divalproex sodium

Divalproex

divalproex

placebo-controlled

divalproex sodium

placebo

divalproex

repetitive behaviours

repetitive behaviours

repetitive behaviours

autism spectrum disorder

compulsive-like symptoms

autism spectrum disorder ( ASD )

Thirteen

ASD

ASD


Biochemical and functional effects of creatine phosphate in cardioplegic solution during aortic valve surgery -- a clinical study . During myocardial ischemia there is a drop in high-energy phosphates in the myocardium . Cold potassium cardioplegia decreases but does not altogether prevent this reduction . Supplementation of cardioplegic solutions with the high-energy compound creatine phosphate ( 10 mmol/L ) compared to plain cardioplegic solutions was investigated in this study . Thirty patients scheduled for aortic valve replacement were included . The patients were randomized to group I ( creatine phosphate ) or group II ( control ) . Postoperative hemodynamic evaluation revealed no significant differences between the groups . However , group I exhibited a tendency toward a better stroke-work index ( 135 +/- 18 % vs. 102 +/- 5 % recovery 15 minutes after bypass and 145 +/- 16 % vs. 119 +/- 11 % recovery 105 min after bypass ) . There were fewer patients in group I ( 5/15 ) needing inotropic support compared to group II ( 9/14 ) . The myocardial content of ATP and creatine phosphate showed no significant differences during ischemia and reperfusion . It is concluded that the myocardial protection during ischemia was sufficient to prevent significant reductions of myocardial ATP and creatine phosphate irrespective of supplementation with CP .

creatine phosphate

creatine phosphate

plain cardioplegic solutions

creatine phosphate

control

creatine phosphate

drop in high-energy phosphates

hemodynamic evaluation

stroke-work index

needing inotropic support

myocardial ATP and creatine phosphate

aortic valve surgery -- a


Minimal tolerance to the bronchoprotective effect of inhaled salmeterol/fluticasone combination on allergene challenge . In order to assess whether the administration of salmeterol/fluticasone propionate combination ( 50/250 mcg by Diskus ) for 1 week induces tolerance to the bronchoprotective effect of salmeterol on allergen challenge , a single-blind , cross-over study was carried out . We studied nine subjects ( eight men and one woman ; mean age+/-SD : 31.3+/-11.0 yr ) with mild intermittent allergic asthma , never treated with regular beta2-agonists or inhaled corticosteroids . In a previous allergen challenge all subjects had shown a positive early airway response ( EAR ) to allergen . They underwent allergen challenge after 1-week treatment with placebo and a single dose of placebo immediately before allergen challenge ( T1 ) , or 1-week treatment with placebo and a single dose of salmeterol/fluticasone immediately before allergen challenge ( T2 ) , or 1-week treatment with salmeterol/fluticasone combination bid and a single dose of salmeterol/fluticasone immediately before allergen challenge ( T3 ) . EAR was evaluated both as maximum decrease in FEV1 ( MaxDeltaFEV1 % ) after allergen challenge and as area under FEV1 -time curve . MaxDeltaFEV1 % during allergen challenge protected by placebo ( T1 ) was significantly greater than MaxDeltaFEV1 % during allergen challenges protected by single dose of salmeterol/fluticasone ( T2 ) and by salmeterol/fluticasone 1-week treatment ( T3 ) . No difference was found in MaxDeltaFEV1 % between T2 and T3 . The same results were observed also after computing the area under the curve for each challenge . When individually considered , all subjects were protected against EAR ( protection index > or = 80 % ) at T2 , while at 3 seven out of nine subjects were still protected against EAR . In conclusion , the simultaneous administration of salmeterol and fluticasone in the same device prevents in almost 80 % of examined subjects the development of tolerance to the protective effect of salmeterol on allergen challenge . This observation may contribute to explain the positive interaction between inhaled beta2-agonists and corticosteroids in the long-term treatment of asthma .

salmeterol/fluticasone

salmeterol/fluticasone propionate

salmeterol

placebo

placebo

allergen challenge ( T1 )

placebo

single dose of salmeterol/fluticasone

allergen challenge ( T2 )

salmeterol/fluticasone

allergen challenge ( T3 )

bronchoprotective effect

tolerance

bronchoprotective

early airway response ( EAR )

EAR

significantly greater

MaxDeltaFEV1 %

No difference

MaxDeltaFEV1 %

area under the curve

protected against EAR

protected against EAR .

tolerance to the protective effect


Virtual reality colonoscopy simulation : a compulsory practice for the future colonoscopist ? BACKGROUND AND STUDY AIM As for any manual procedure , the learning curves for medical interventions can have undesirable phases , occurring mostly in the early experience of applying a technique . There have been impressive advances in endoscopic procedures during recent years , and there is an emerging trend that the number of procedures is increasing in parallel with these . In addition , the introduction of screening programs for colorectal cancer will also increase the numbers of procedures needed . Recent developments in medical simulation seem promising with regard to the possibility of " training out " undesirable parts of the learning curve outside the operating room . The aim of this study was to investigate whether the use of the AccuTouch flexible endoscopy simulator improves the early part of the learning curve in colonoscopy training . METHOD 12 endoscopy trainees , 10 surgeons and two medical gastroenterologists , all with experience in gastroscopy but with no specific colonoscopy experience , were randomly assigned to either simulator training or to a control group . They all received the same theoretical study package and the training group practiced with the AccuTouch colonoscopy simulator until a predefined expert level of performance was reached . All trainees performed their first ten individual colonoscopies described in detail in a separate protocol . RESULTS Trainees in the simulator-trained group performed significantly better ( P=0.0011 ) and managed to reach the cecum in 52 % of their cases ( vs. 19 % in the control group ) , and were 4.53 times more likely to succeed compared with the controls . Additionally , there was a significantly shorter procedure time and less patient discomfort in the hands of the simulator-trained group . CONCLUSION Skills acquired using the AccuTouch simulator transfer well into the clinical colonoscopy environment . The results of this trial clearly support the plan to integrate simulator training into endoscopic education curricula .

Virtual reality colonoscopy simulation

AccuTouch flexible endoscopy simulator

simulator training

control group

AccuTouch colonoscopy simulator

simulator training

early part of the learning curve

managed to reach the cecum

shorter procedure time

less patient discomfort


Phytase and 1alpha-hydroxycholecalciferol supplementation of broiler chickens during the starting and growing/finishing phases . Supplemental 1alpha-hydroxycholecalciferol ( 1alpha-OHD3 ) has been shown to have qualitatively similar and quantitatively additive effects to exogenous phytase . Two experiments were conducted from 0 to 35 d in floor pens to determine the additive effect of phytase and 1alpha-OHD3 when supplemented to Ca- and P-deficient diets . In both experiments , at least 4 replicates per treatment ( 50 chicks per replicate ) were used . Corn-soybean-meal-and soybean-oil-based diets were fed and birds were raised in a house impervious to ultraviolet light . During the starter phase ( ST ) , from 0 to 18 d , chicks were fed a 23 % CP diet containing 0.60 % Ca and 0.47 % total P ( tP ) . During the grower/finisher phase ( GF ) , from 19 to 35 d , birds were fed a 19 % CP diet containing 0.30 % Ca and 0.37 % tP . A combination of 1,000 phytase units/kg of Natuphos phytase and 5 microg/kg of 1alpha-OHD3 ( P+1A ) was supplemented to some of the feed during the ST and GF . Diets containing adequate Ca and P were also fed during the ST ( 0.90 % Ca , 0.68 % tP ) and GF ( 0.80 % Ca , 0.67 % tP ) . Performance characteristics and the incidence of rickets and tibial dyschondroplasia were measured at 18 and 35 d. In experiment 1 , unsupplemented chicks performed well but had considerable leg problems . Chicks fed P+1A during the ST or GF did not perform as well as birds fed P+1A throughout . Birds fed P+1A throughout performed as well birds fed the adequate diets without any indication of leg problems . In experiment 2 , unsupplemented birds performed similarly to unsupplemented birds in experiment 1 . However , chicks fed the supplements or the control diets did not perform as well or accumulate as much bone ash as birds in experiment 1 , although the diets were formulated identically in both experiments . Diets with as little as 0.30 % Ca and 0.37 % tP appear to be adequate for broilers older than 18 d if supplemented with the correct amounts of phytase and 1alpha-OHD3 . However , there are unknown variables that may limit the potential of broilers in terms of bone mineralization and bone pathology , even when adequate diets are fed .

Phytase

phytase

Ca- and P-deficient diets

a house impervious to ultraviolet light

Performance characteristics

leg problems

accumulate as much bone ash

bone mineralization

bone pathology

broiler chickens

at least

house impervious to ultraviolet light

birds

birds


Safety and immunogenicity of IMVAMUNE , a promising candidate as a third generation smallpox vaccine . A Phase I trial was performed to investigate the safety and immunogenicity of the third generation smallpox vaccine MVA-BN ( IMVAMUNE ) , a highly attenuated clone derived from the Modified Vaccinia Virus Ankara strain 571 , in naive and pre-immunized subjects . A total of 86 healthy subjects received the vaccine in five groups using different doses and routes of administration . All 38 subjects seroconverted in the groups receiving the highest dose ( 10 ( 8 ) TCID50 ) . All vaccinations were well tolerated with mainly mild or moderate pain at the injection site being the most frequent symptom . The results indicate that MVA-BN has the potential to be developed as an efficient and safe alternative to the conventional smallpox vaccines such as Lister-Elstree or Dryvax . Unique attributes render it a promising candidate for prophylactic mass immunization , even in subjects for whom conventional smallpox vaccines are contraindicated .

IMVAMUNE

vaccine

Lister-Elstree or Dryvax .

Safety

immunogenicity

safety

immunogenicity

well tolerated

mild or

moderate pain

at the injection site

efficient and safe

naive and pre-immunized subjects

healthy


[ Local therapy of grade 1 and 2 hemorrhoids . Effectiveness of a combination preparation with standardized blood leech extract ] . AIMS Testing the effectiveness of a topical combination preparation containing standardized leech extract , polidocanol and allantoin . STUDY DESIGN Placebo-controlled , double-blind study in 80 patients with first and second degree hemorrhoids ; duration of treatment one week ; examinations performed on admission and on days 3 , 4 , 5 and 8 . RESULTS Both the subjective and objective symptoms and signs improved during the one week of treatment statistically significantly more rapidly under the test preparation as compared with placebo . Histologically demonstrable signs of inflammation were more clearly improved in the preparation group than in the placebo group . No side effects were observed . CONCLUSIONS The good efficacy and tolerability of a topical therapeutic preparation in first and second degree hemorrhoids have been convincingly demonstrated .

Placebo-controlled

test preparation

topical therapeutic preparation

No side effects

grade 1

2 hemorrhoids

first and second degree hemorrhoids


Combined typhoid fever and hepatitis A vaccine : comparison of immunogenicity and safety to concomitant monovalent vaccine over 3 years . BACKGROUND The safety and immunogenicity of Viatim , a combined hepatitis A ( HA ) and typhoid fever ( Vi ) vaccine , were compared with the monovalent component vaccines up to and 1 month after a booster dose at 3 years . METHODS Healthy , adult volunteers were randomized to receive Viatim ( group A , n = 179 ) or separate HA and Vi vaccines ( group B , n = 181 ) ; subgroups were boosted after 3 years with Viatim ( groups C and D , n = 56 and 46 , respectively ) . Local and systemic reactions were recorded for 28 days postvaccination . Seroconversion and seroprotection rates and geometric mean antibody concentrations were measured at 14 and 28 days , 1 , 2 , and 3 years postvaccination , and 28 days after the booster dose . RESULTS Local and systemic safety profiles were equivalent between the two groups . Immediate local reactions were infrequent ( 1 in group A and 2 in group B ) . Local reactions , consisting mostly of mild or moderate pain , were least frequent with monovalent HA . Antibody concentrations to both antigens were similar in groups A and B , in which HA seroprotection rates ( > or = 20 mIU/mL ) were respectively , 98.7 % and 100 % at day 28 , and 99.1 % and 99.0 % after 3 years , achieving 100 % after the booster . Vi seroprotection rates ( > or = 1 microg/mL ) of 85.2 % and 84.9 % after 28 days fell to 32.1 % and 35.6 % after 3 years , increasing to 67.3 % and 69.8 % after the booster dose . CONCLUSIONS The combined HA/Vi vaccine , Viatim , had equivalent tolerability and safety and was as rapidly immunogenic as its component monovalent vaccines when given concurrently . A booster dose after 3 years significantly increased antibody levels with some evidence of relative hyporesponsiveness of the typhoid response .

Viatim

monovalent component vaccines

Viatim

separate HA and Vi vaccines

Viatim

combined HA/Vi vaccine

Viatim

safety

immunogenicity

Seroconversion

seroprotection rates

geometric mean antibody concentrations

Local and systemic safety profiles

Immediate local reactions

Local reactions

mild or moderate pain

Antibody concentrations

HA seroprotection rates

seroprotection rates

antibody levels


Using dietetic assistants to improve the outcome of hip fracture : a randomised controlled trial of nutritional support in an acute trauma ward . OBJECTIVE To examine how improved attention to nutritional status and dietary intake , achieved through the employment of dietetic assistants ( DAs ) , will affect postoperative clinical outcome among elderly women with hip fracture . DESIGN Open prospective randomised controlled trial , comparing conventional nursing care with the additional nutritional support provided by DA . SETTING Thirty-eight bedded acute trauma ward in a teaching hospital . PARTICIPANTS All but 11 of 344 consecutive admissions with acute nonpathological hip fracture were approached . Three hundred and eighteen ( 93 % ) agreed to inclusion . Sixteen were ineligible as they were immediately transferred to another acute ward , were managed conservatively or died preoperatively . PRIMARY OUTCOME MEASURE Postoperative mortality in the acute trauma unit . SECONDARY OUTCOME MEASURES Postoperative mortality at 4 months after fracture , length of stay , energy intake and nutritional status . RESULTS DA-supported participants were less likely to die in the acute ward ( 4.1 versus 10.1 % , P = 0.048 ) . This effect was still apparent at 4 month follow-up ( 13.1 versus 22.9 % , P = 0.036 ) . DA-supported subjects had significantly better mean daily energy intake ( 1,105 kcal versus 756 kcal/24 h , 95 % CI 259-440 kcal/24 h , P < 0.001 ) , significantly smaller reduction in mid-arm circumference during their inpatient stay ( 0.39 cm , P = 0.002 ) and nonsignificantly favourable results for other anthropometric and laboratory measurements . CONCLUSION Dietetic or nutrition assistants are being introduced in units across the UK . This , the largest ever study of nutritional support after hip fracture , shows that their employment significantly reduced patients ' risk of dying in the acute trauma unit ; an effect that persisted at 4 month follow-up .

dietetic assistants

dietetic assistants ( DAs )

conventional nursing care

Dietetic or nutrition assistants

nutritional status

dietary intake

postoperative clinical outcome

Postoperative mortality

length of stay

energy intake

nutritional status

likely to die

mean daily energy intake

patients ' risk of dying

hip fracture

acute trauma ward

elderly

women

hip fracture

Thirty-eight

11 of 344

Three hundred and eighteen ( 93 % )

Sixteen

were ineligible


Prehydration alone is sufficient to prevent contrast-induced nephropathy after day-only angiography procedures -- a randomised controlled trial . BACKGROUND Contrast agents used in angiography procedures for patients with cardiovascular disease are known to cause contrast-induced nephropathy ( CIN ) , which may be partially due to the production of nephrotoxic oxygen-free radicals . It is uncertain whether administration of intravenous ( IV ) anti-oxidant , N-acetylcysteine ( NAC ) , can prevent reduction in renal function and whether this is a cost-effective approach . METHODS Sixty-five day-only patients with renal impairment ( mean serum creatinine concentration 0.16+/-0.03 mmol/l ) due to undergo coronary or peripheral angiography and/or stenting were randomly assigned to IV NAC 300 or 600 mg immediately before and after the procedure or IV fluid alone . RESULTS Of the 60 patients with complete data , none had acute CIN ( increase in serum creatinine concentration > or = 0.044 mmol/l , 48 h after administration of contrast agent ) . Eight patients ( 13 % ) have demonstrated an increase in their serum creatinine concentration > or = 0.044 mmol/l 30 days after administration of contrast agent : 2/19 ( 11 % ) in the control group , 2/21 ( 10 % ) in the 600 mg NAC group and 4/20 ( 20 % ) the 300 mg NAC group ( p = 0.66 ) . The mean volumes of contrast agent used and prehydration given for each of the three groups did not differ significantly ( p > 0.83 ) . There was significant improvement in creatinine clearance within each group from baseline to 30 days ( p < or = 0.03 ) , but no significant difference between the groups at 48 h and 30 days ( p > or = 0.43 ) . Considering the cost of NAC and its administration , we estimate that this would translate to a saving of dollar 26,637 per annum . CONCLUSION For day-stay patients with mild-to-moderate chronic renal impairment undergoing angiography and/or intervention , prehydration alone is less complicated and more cost-effective than a combination of IV NAC ( at doses used ) and hydration .

intravenous ( IV ) anti-oxidant

N-acetylcysteine ( NAC )

IV NAC 300 or 600

NAC

serum creatinine concentration

mean volumes of contrast agent

creatinine clearance

saving

angiography procedures

cardiovascular disease

Sixty-five


Cross-over trial of intensive monotherapy with atorvastatin and combined therapy with atorvastatin and colestimide for Japanese familial hypercholesterolemia . BACKGROUND In familial hypercholesterolemia ( FH ) , low-density lipoprotein-cholesterol ( LDL-C ) -lowering therapy is important to avoid predisposition to coronary artery disease . This study investigated the advantages of combined therapy with atorvastatin and colestimide vs intensive monotherapy with atorvastatin . METHODS AND RESULTS The trial used a randomized cross-over design consisting of 2 16-week periods of open-label drug therapy . Among the 24 initial patients , 17 heterozygous FH patients ( age : 54.1 years ; 5 males ) were enrolled after 20 mg/day atorvastatin failed to achieve their target level . The patients received 20 mg/day atorvastatin and 3 g/day colestimide or 40 mg/day atorvastatin . Fifteen patients completed the trial and their LDL-C reduced from 5.07 +/- 1.10 mmol/L to 3.76 +/- 0.90 mmol/L with the combined therapy and to 3.81 +/- 0.50 mmol/L with the intensive monotherapy . Although the 2 therapies showed comparable mean effects for decreasing LDL-C , similar adverse reaction and cost , each therapy was predominantly more effective in some patients than in others . The triglyceride and high-density lipoprotein cholesterol levels were similar in both therapies . CONCLUSIONS To achieve the therapeutic target of LDL-C level for refractory FH , the LDL-C-lowering therapy selected can be either intensive monotherapy or combined therapy as the next to standard statin therapy .

atorvastatin

atorvastatin

colestimide

atorvastatin

20 mg/day

atorvastatin

atorvastatin

colestimide

atorvastatin

LDL-C

LDL-C

triglyceride

and

LDL-C

familial hypercholesterolemia

familial hypercholesterolemia ( FH )

heterozygous FH

males

Fifteen


Wavefront-guided versus standard LASIK enhancement for residual refractive errors . OBJECTIVE To assess efficacy , safety , predictability , stability , and changes in higher-order aberrations ( HOAs ) and contrast sensitivity ( CS ) after wavefront-guided and standard LASIK enhancement for the correction of residual refractive errors . DESIGN Prospective , randomized , comparative clinical study . PARTICIPANTS Twenty eyes of 20 consecutive patients ( spherical equivalent [ SE ] , -2.01+/-1.36 diopters [ D ] ) treated with wavefront-guided Zyoptix Ablation Refinement software ( ZAR ) LASIK and 20 eyes of 20 consecutive patients ( SE , -1.81+/-1.21 D ) treated with standard Planoscan LASIK , both for residual refractive error enhancement . MAIN OUTCOME MEASURES Efficacy , safety , predictability , stability , HOAs , and CS were evaluated before and after enhancement at 6 months ' follow-up . METHODS Uncorrected visual acuity ( UCVA ) , best-corrected visual acuity ( BCVA ) , manifest refraction , CS by means of the Functional Acuity Contrast Test , and HOAs by means of Zywave aberrometry were evaluated preoperatively and 6 months after retreatment . RESULTS At 6 months postoperatively , UCVA was 20/25 or better in 100 % of the eyes . Efficacy indexes were 1.09 for ZAR patients and 0.95 for Planoscan patients . No eyes lost > or =1 line of BCVA ; in the ZAR group , 2 eyes gained 1 line and 6 eyes gained > or =2 lines ; in the Planoscan group , 3 eyes gained 1 line . The ZAR group showed a percentage of eyes ( 94.4 % ) within the 0.5-D range in SE higher than that shown by the Planoscan group ( 88.8 % ) . After 6 months , the HOA root mean square ( RMS ) increased on average by a factor of 1.44 for the Planoscan group ( P = 0.003 ) . No change or reduction in HOA RMS was found in the ZAR group ( factor of 0.96 ; P > 0.01 ) . Contrast sensitivity was reduced in the Planoscan group only at the highest spatial frequency ( 18 cycles per degree ; P < 0.01 ) . There was a significant reduction of CS as a function of HOA increase for the Planoscan group ( P < 0.0001 ) . No changes were observed for the ZAR group at any spatial frequency ( 1.5-18 cycles per degree ; P > 0.01 ) . CONCLUSIONS Wavefront-guided LASIK using the ZAR algorithm is an effective and safe procedure for treatment of residual refractive errors . Wavefront-guided LASIK does not increase HOAs and does not modify CS compared with preoperative values . Wavefront-guided LASIK seems to be better than standard LASIK for retreatments .

Wavefront-guided

ZAR

Planoscan

ZAR

ZAR

ZAR

ZAR

Wavefront-guided LASIK

Wavefront-guided LASIK

Wavefront-guided LASIK

contrast sensitivity ( CS )

HOAs , and CS

UCVA

Efficacy indexes

No eyes lost

BCVA

HOA root mean square ( RMS )

reduction in HOA RMS

Contrast sensitivity

spatial frequency

Twenty eyes of 20 consecutive patients

20 eyes

20 consecutive patients

residual refractive error enhancement


Acute and long-term safety and tolerability of risperidone in children with autism . Treatment-emergent adverse events ( AEs ) were monitored during an 8-week , double-blind , placebo-controlled trial of risperidone ( 0.5-3.5 mg/day ) in 101 children and adolescents with a lifetime diagnosis of autistic disorder . In addition , 37 placebo nonresponders received open-label risperidone for another 8 weeks . Of all the risperidone responders ( n=65 ) , 63 entered an open extension of another 16 weeks ( 6 months total risperidone exposure ) , and 32 of them were rerandomized to either continued risperidone therapy ( n=16 ) or gradual replacement with placebo ( n=16 ) over 8 weeks . We collected the following measures of safety and tolerability : ( 1 ) laboratory blood assessments ( CBC with differential , electrolytes , and liver function tests ) and urinalyses , ( 2 ) vital signs , ( 3 ) Side Effects Review of AEs thought to be associated with risperidone , ( 4 ) sleep records , ( 5 ) Simpson Angus Neurological Rating Scale ( SARS ) , ( 6 ) Abnormal Involuntary Movement Scale ( AIMS ) , and ( 7 ) height and weight . No clinically significant changes were found on the lab tests . During the 8-week acute trial , the most common AEs on the Side Effects Review , scored as moderate or higher , were as follows ( placebo and risperidone , respectively ) : Somnolence ( 12 % and 37 % ) , enuresis ( 29 % and 33 % ) , excessive appetite ( 10 % and 33 % ) , rhinitis ( 8 % and 16 % ) , difficulty waking ( 8 % and 12 % ) , and constipation ( 12 % and 10 % ) . " Difficulty falling asleep " and anxiety actually favored the risperidone condition at statistically significant levels . The same AEs tended to recur through 6 months of treatment , although often at reduced levels . Using Centers for Disease Control ( CDC ) standardized scores , both weight and body mass index ( BMI ) increased with risperidone during the acute trial ( 0.5 and 0.6 SDs , respectively , for risperidone ; 0.0 and 0.1 SDs , respectively , for placebo ) and into open-label extension ( 0.19 and 0.16 SDs , respectively ) , although the amount of gain decelerated with time . Extrapyramidal symptoms , as assessed by the SARS , were no more common for drug than placebo , although drooling was reported more often in the risperidone group . There were no differences between groups on the AIMS . Two subjects had seizures ( one taking placebo ) , but these were considered unrelated to active drug . Most AEs were mild to moderate and failed to interfere with therapeutic changes ; there were no unanticipated AEs . The side effects of most concern were somnolence and weight gain .

risperidone

placebo-controlled

risperidone

risperidone

risperidone

risperidone

risperidone

risperidone

risperidone ;

risperidone

adverse events

safety and tolerability

laboratory

blood assessments

vital signs

Side Effects Review of AEs

sleep records

height and weight

Somnolence

enuresis

excessive appetite

rhinitis

difficulty waking

constipation

Difficulty falling asleep " and anxiety

AEs

weight and body mass index ( BMI )

Extrapyramidal symptoms

seizures

somnolence

weight gain

children

autism

101 children

adolescents

autistic disorder


Risperidone-induced prolactin elevation in a prospective study of children , adolescents , and adults with mental retardation and pervasive developmental disorders . OBJECTIVE Risperidone is widely prescribed for aggression and self-injury in children , adolescents , and adults with mental retardation ( MR ) and pervasive developmental disorders ( PDD ) . Risperidone elevates prolactin more than other atypical antipsychotic medications . Females may show greater prolactin elevation than males . METHOD In this relatively long-term study of risperidone efficacy and safety for aggression and self-injury in children , adolescents , and adults with MR and PDDs , serum prolactin was measured in a 21-subject subset during the course of a double-blind , placebo-controlled trial . Prolactin was measured in ng/mL at baseline , once during acute treatment , and once during maintenance . RESULTS In children and adolescents ( n=10 ) , mean age of 12.5 years , prolactin increased from mean 13.2+/-8.6 at baseline to 31.0+/-11.6 acutely and remained elevated at 37.9+/-10.4 in maintenance . In adults , mean age of 35.3 years , prolactin increased more markedly from 11.6+/-7.4 baseline ( n=11 ) to 93.3+/-54.2 acutely but decreased to 67.8+/-62.9 in maintenance ( n=7 ) . Prolactin remained significantly elevated above normal in all subjects for at least 26 weeks . Mean prolactin of adult females , while similar to that of adult males at baseline , was 2.2 times male levels acutely and 3.7 times greater in maintenance . CONCLUSION In this small subset , mean prolactin elevation persisted for at least 26 weeks . In adults , females showed significantly greater elevations than males .

risperidone

placebo-controlled

Prolactin

prolactin elevation

prolactin

prolactin elevation

efficacy and safety

serum prolactin

Prolactin

prolactin

prolactin

Prolactin

Mean prolactin

mean prolactin elevation


GH effect on enzyme activity of 11betaHSD in abdominal obesity is dependent on treatment duration . OBJECTIVE In the past years the interaction of GH and 11beta hydroxysteroid dehydrogenase ( 11betaHSD ) in the pathogenesis of central obesity has been suggested . DESIGN We studied the effects of 9 months of GH treatment on 11betaHSD activity and its relationship with body composition and insulin sensitivity in 30 men with abdominal obesity , aged 48-66 years , in a randomised , double-blind , placebo-controlled trial . METHODS Urinary steroid profile was used to estimate 11betaHSD type 1 and 2 ( 11betaHSD1 and 11betaHSD2 ) activities . Abdominal s.c. and visceral adipose tissues were measured using computed tomography . Glucose disposal rate ( GDR ) obtained during a euglycaemic-hyperinsulinaemic glucose clamp was used to assess insulin sensitivity . RESULTS In the GH-treated group the 11betaHSD1 activity decreased transiently after 6 weeks ( P < 0.01 ) whereas 11betaHSD2 increased after 9 months of treatment ( P < 0.05 ) . Between 6 weeks and 9 months , GDR increased and visceral fat mass decreased . Changes in 11betaHSD1 correlated with changes in visceral fat mass between baseline and 6 weeks . There were no significant correlations between 11betaHSD1 and 11betaHSD 2 and changes in GDR . DISCUSSION The study demonstrates that short- and long-term GH treatment has different effects on 11betaHSD1 and 11betaHSD2 activity . Moreover , the data do not support that long-term metabolic effects of GH are mediated through its action on 11betaHSD .

GH

GH treatment

placebo-controlled

Abdominal s.c.

visceral adipose tissues

computed tomography

enzyme activity of 11betaHSD

Abdominal s.c.

visceral adipose tissues

Glucose disposal rate ( GDR )

insulin sensitivity

11betaHSD1 activity

GDR

visceral fat mass

visceral fat mass

11betaHSD 2

11betaHSD2 activity

men

abdominal obesity

aged 48-66 years


Albendazole trial at 15 or 30 mg/kg/day for subarachnoid and intraventricular cysticercosis . Thirty-six patients with subarachnoid and intraventricular cysticercosis were randomly assigned to receive albendazole at 15 or 30 mg/kg/day plus dexamethasone for 8 days . Results favored a higher dose , with larger cyst reduction on MRI at 90 and 180 days and higher albendazole sulfoxide levels in plasma . An albendazole course at 30 mg/kg/day combined with corticosteroids is safe and more effective than the usual dose . A single treatment was insufficient in intraventricular and giant cysts .

Albendazole

albendazole

dexamethasone

albendazole

corticosteroids

larger cyst reduction

albendazole sulfoxide levels in plasma

safe and more effective

insufficient

Thirty-six


Pre-treatment proliferation and the outcome of conventional and accelerated radiotherapy . This study investigated the influence of pre-treatment proliferation characteristics , assessed by Ki-67 staining , in patients treated in the CHART trial of accelerated radiotherapy in head and neck cancer . Histological material from 402 patients was collected and stained for the presence and pattern of Ki-67 staining . Locoregional control and overall survival were the main clinical endpoints . Increasing Ki-67 positivity was associated with decreasing differentiation ( P < 0.001 ) and increasing N-stage ( P < 0.004 ) . Increasing N-stage was also associated with the progression of proliferation pattern from marginal to random ( P < 0.001 ) . Using a multivariate model , a trend was seen towards a greater benefit from CHART in the lower Ki-67 tumours ( P = 0.08 ) ; this became significant by pooling the low and intermediate Ki-67 groups in comparison with the high Ki-67 group ( P = 0.032 ) . Tumours with marginal proliferation pattern showed a lower hazard ratio with CHART versus conventional for locoregional control ( P = 0.005 ) . The data presented in this study do not support that a high pre-treatment Ki-67 is associated with a therapeutic benefit from accelerated radiotherapy .

assessed by Ki-67 staining

accelerated radiotherapy

accelerated radiotherapy

Locoregional control

therapeutic benefit