Botulinum toxin a has antinociceptive effects in treating interstitial cystitis . OBJECTIVES To present clinical evidence with botulinum toxin A ( BTX-A ) suggesting an antinociceptive role in patients with interstitial cystitis ( IC ) . Intriguing evidence in a somatic pain model has suggested that BTX-A injection may have an antinociceptive effect on both acute and chronic ( inflammatory ) pain . METHODS Thirteen female patients ( 6 in the United States and 7 in Poland ) with IC according to the criteria of the National Institute of Diabetes , Digestive and Kidney Disease were included . Under short general anesthesia or sedation , 100 to 200 U of Dysport ( Polish patients ) or Botox ( U.S. patients ) was injected through a cystoscope into 20 to 30 sites submucosally in the trigone and floor of the bladder . Patients were evaluated with the O'Leary-Sant validated IC questionnaire or with voiding charts and a visual analog pain scale 1 month postoperatively and at subsequent 3-month intervals . The Polish patients also underwent pretreatment and post-treatment urodynamic evaluations . RESULTS Overall , 9 ( 69 % ) of 13 patients noted subjective improvement after BTX-A treatment . The Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index mean scores improved by 71 % and 69 % , respectively ( P < 0.05 ) . Daytime frequency , nocturia , and pain by visual analog scale decreased by 44 % , 45 % , and 79 % , respectively ( P < 0.01 ) . The first desire to void and maximal cystometric capacity increased by 58 % and 57 % , respectively ( P < 0.01 ) . CONCLUSIONS Our results suggest that BTX-A has an antinociceptive effect on bladder afferent pathways in patients with IC , producing both symptomatic and functional ( ie , urodynamic ) improvements .

Botulinum toxin

botulinum toxin A ( BTX-A )

BTX-A injection

Dysport

Botox

BTX-A

BTX-A

antinociceptive effects

antinociceptive role

visual analog pain scale

urodynamic evaluations .

subjective improvement

antinociceptive effect

interstitial cystitis ( IC ) .

Thirteen

female

IC

100 to 200 U of Dysport

Botox


Impact of antioxidants , zinc , and copper on cognition in the elderly : a randomized , controlled trial . Participants in the Age-Related Eye Disease Study were randomly assigned to receive daily antioxidants ( vitamin C , 500 mg ; vitamin E , 400 IU ; beta carotene , 15 mg ) , zinc and copper ( zinc , 80 mg ; cupric oxide , 2 mg ) , antioxidants plus zinc and copper , or placebo . A cognitive battery was administered to 2,166 elderly persons after a median of 6.9 years of treatment . Treatment groups did not differ on any of the six cognitive tests ( p > 0.05 for all ) . These results do not support a beneficial or harmful effect of antioxidants or zinc and copper on cognition in older adults .

antioxidants

zinc

copper

antioxidants

vitamin C

vitamin E , 400 IU

beta carotene , 15 mg

zinc

copper ( zinc , 80 mg

cupric oxide , 2 mg

antioxidants plus zinc

copper

placebo

antioxidants or zinc

copper

six cognitive tests

cognition


Gum elastic bougie-guided insertion of the ProSeal Laryngeal Mask Airway . We tested the hypothesis that gum elastic-bougie-guided insertion of the ProSeal Laryngeal Mask Airway is more frequently successful than introducer tool guided insertion after failed digital insertion . One hundred anaesthetized patients ( ASA 1-2 , aged 18 to 80 years ) were randomized for the second insertion attempt using either the gum elastic bougie-guided or introducer tool techniques . The bougie-guided technique involved priming the drain tube with the bougie , placing the bougie in the oesophagus using laryngoscope guidance , digital insertion along the palato-pharyngeal curve , and bougie removal . The introducer tool technique involved attaching the introducer tool , single-handed rotation along the palatopharyngeal curve , and introducer tool removal . Failed insertion was classified as ( i ) failed passage into the pharynx , ( ii ) malposition , or ( iii ) ineffective ventilation . Any blood staining was documented . Insertion was more frequently successful ( 50/50 vs 15/50 , P=0.0002 ) and faster ( 35+/-17 s vs 54+/-45 s , mean+/-SD , P=0.006 ) with the bougie-guided technique . All failed insertions with the introducer tool technique were successful with the bougie-guided technique . The aetiology of failed insertion was similar for the digital and introducer tool techniques in 94 % ( 33/35 ) of patients . There was no blood staining on the bougie , laryngoscope or introducer tool at removal , but blood staining was more common on the ProSeal Laryngeal Mask Airway with the introducer tool technique ( 9/50 vs 2/50 , P=0.03 ) . We conclude that the gum elastic bougie-guided insertion has a higher success rate and causes less trauma than the insertion tool insertion technique after failed digital insertion of the ProSeal Laryngeal Mask Airway .

Gum elastic bougie-guided insertion

gum elastic-bougie-guided insertion

bougie-guided technique

introducer tool technique

gum elastic bougie-guided insertion

blood staining

Insertion

frequently successful

failed insertions

aetiology of failed insertion

blood staining

blood staining

One hundred

18 to 80 years


Syncope Evaluation in the Emergency Department Study ( SEEDS ) : a multidisciplinary approach to syncope management . BACKGROUND The primary aim and central hypothesis of the study are that a designated syncope unit in the emergency department improves diagnostic yield and reduces hospital admission for patients with syncope who are at intermediate risk for an adverse cardiovascular outcome . METHODS AND RESULTS In this prospective , randomized , single-center study , patients were randomly allocated to 2 treatment arms : syncope unit evaluation and standard care . The 2 groups were compared with chi2 test for independence of categorical variables . Wilcoxon rank sum test was used for continuous variables . Survival was estimated with the Kaplan-Meier method . One hundred three consecutive patients ( 53 women ; mean age 64+/-17 years ) entered the study . Fifty-one patients were randomized to the syncope unit . For the syncope unit and standard care patients , the presumptive diagnosis was established in 34 ( 67 % ) and 5 ( 10 % ) patients ( P < 0.001 ) , respectively , hospital admission was required for 22 ( 43 % ) and 51 ( 98 % ) patients ( P < 0.001 ) , and total patient-hospital days were reduced from 140 to 64 . Actuarial survival was 97 % and 90 % ( P=0.30 ) , and survival free from recurrent syncope was 88 % and 89 % ( P=0.72 ) at 2 years for the syncope unit and standard care groups , respectively . CONCLUSIONS The novel syncope unit designed for this study significantly improved diagnostic yield in the emergency department and reduced hospital admission and total length of hospital stay without affecting recurrent syncope and all-cause mortality among intermediate-risk patients . Observations from the present study provide benchmark data for improving patient care and effectively utilizing healthcare resources .

syncope unit evaluation

standard care

Survival

presumptive diagnosis

hospital admission

total patient-hospital days

Actuarial survival

survival free from recurrent syncope

diagnostic yield

hospital admission

total length of hospital stay

mortality

syncope


Blockade of endogenous growth hormone-releasing hormone receptors dissociates nocturnal growth hormone secretion and slow-wave sleep . OBJECTIVES A temporal association between non-rapid eye movement ( NREM ) sleep stages 3 and 4 and nocturnal augmentation of GH release was found long ago , yet the precise mechanism for this association has not been identified . It has been shown , however that pulsatile GHRH administration increases both slow-wave sleep ( SWS ) and GH . Based on these data , a role for GHRH as an inducer of SWS was proposed . To test this hypothesis , we have performed the corollary experiment whereby the action of endogenous GHRH has been antagonized . DESIGN Healthy men ( 20-33 years old ) had an infusion of GHRH antagonist ( ( N-Ac-Tyr ( 1 ) , D-Arg ( 2 ) ) GHRH-29 ( NH ( 2 ) ) ) or saline for a 12-h period , between 2100 and 0900 h. An i.v . bolus of GHRH was given at 0700 h and GH samples were drawn from 0700 to 0900 h to document the efficacy of GH suppression by the GHRH antagonist . METHODS A limited montage sleep study was recorded from 2300 to 0700 h during each admission . Plasma GH concentrations were analyzed by the use of a sensitive chemiluminometric assay . RESULTS Effectiveness of the GHRH antagonist was validated in all subjects by demonstrating 93+/-1.8 % ( P=0.012 ) suppression of GH response to a GHRH bolus . Polysomnography demonstrated that the percentage of SWS was not different when saline and GHRH antagonist nights were compared ( P=0.607 ) ; other quantifiable sleep parameters were also unchanged . CONCLUSIONS We conclude that endogenous GHRH is indispensable for the nocturnal augmentation of GH secretion , but that it is unlikely to participate in the genesis of SWS .

saline for a 12-h period

GHRH

nocturnal growth hormone secretion

slow-wave sleep

slow-wave sleep ( SWS )

GH

GH

Plasma GH concentrations

Effectiveness

suppression of GH response

SWS

sleep parameters

Healthy men ( 20-33 years old )


Pimecrolimus cream 1 % vs. betamethasone 17-valerate 0.1 % cream in the treatment of seborrhoeic dermatitis . A randomized open-label clinical trial . BACKGROUND Seborrhoeic dermatitis is a chronic inflammatory disease with remissions and exacerbations , characterized by erythema , scaling and pruritus primarily on the face , scalp and chest . Corticosteroids and antifungals are the mainstay of therapy . However , chronic use of corticosteroids is associated with side-effects such as skin atrophy and telangiectasia . Pimecrolimus , an inhibitor of calcineurin , has been used successfully in one patient with seborrhoeic dermatitis . OBJECTIVES The objective of this randomized open-label clinical trial was to compare the efficacy and tolerability of pimecrolimus in comparison with a potent corticosteroid ( betamethasone 17-valerate ) in the treatment of seborrhoeic dermatitis . METHODS Twenty patients with seborrhoeic dermatitis were included in this study , 11 patients in the pimecrolimus 1 % cream group and nine patients in the betamethasone 17-valerate 0.1 % cream group . Patients were instructed to use a thin layer of the study products twice daily at the lesional area and to discontinue treatment as soon as symptoms were absent . Clinical measures assessed were erythema , scaling and pruritus which were evaluated using a four-point scale ( 0-3 ) . RESULTS Both pimecrolimus and betamethasone were highly effective in the treatment of seborrhoeic dermatitis . Betamethasone reduced all three parameters , erythema , scaling and pruritus , faster than pimecrolimus , but the differences in reduction were not statistically significant . Relapses were observed more frequently and were more severe with betamethasone than with pimecrolimus . Moreover , pruritus was not observed after discontinuation of treatment from day 15 and beyond in the pimecrolimus group , whereas it was reported in most patients of the betamethasone group . This difference was statistically significant . CONCLUSIONS It appears that pimecrolimus , a nonsteroidal topical treatment , may be an excellent alternative therapeutic modality for treating seborrhoeic dermatitis .

Pimecrolimus cream

betamethasone 17-valerate

Pimecrolimus

pimecrolimus

pimecrolimus 1 % cream group

pimecrolimus

betamethasone

Betamethasone

pimecrolimus

betamethasone

pimecrolimus

pimecrolimus

betamethasone

pimecrolimus

efficacy and tolerability

erythema , scaling and pruritus

effective

erythema

scaling

pruritus

Relapses

pruritus


A randomized crossover study investigating the influence of ranitidine or omeprazole on the pharmacokinetics of cephalexin monohydrate . Limited data characterize pharmacokinetic interactions between cephalexin and ranitidine , and no data exist for an interaction with proton pump inhibitors . The purpose of this study was to investigate the effects of ranitidine or omeprazole administration on the pharmacokinetics and pharmacodynamics of cephalexin . A randomized single- and multiple-dose crossover study was conducted in healthy subjects ingesting cephalexin before and after steady-state administration of ranitidine or omeprazole . Time-concentration profiles were determined and pharmacokinetic parameters were characterized using noncompartmental methods . Pharmacokinetic data were analyzed in accordance with the two 1-sided test for bioequivalence . The percentage of time that serum concentrations remain above the MIC ( 90 ) during the dosing interval ( T > MIC ( 90 ) ) for Streptococcus pyogenes and Staphylococcus aureus associated with the pharmacokinetic profiles was calculated . The coadministration of cephalexin with ranitidine or omeprazole resulted in relatively minor changes in C ( max ) , AUC ( infinity ) , t ( 1/2 ) , or CL/F . t ( max ) was significantly prolonged when cephalexin was administered with ranitidine or omeprazole . Suboptimal T > MIC ( 90 ) was observed for cephalexin irrespective of acid suppression . Delay in absorption of cephalexin resulted in a decrease in the percentage of T > MIC ( 90 ) for certain acid-suppressive regimens and pathogen combinations . With the exception of an increase in t ( max ) , there were no significant pharmacokinetic interactions between cephalexin and ranitidine or omeprazole . Delayed t ( max ) associated with acid suppression may result in a diminished T > MIC ( 90 ) .

ranitidine

omeprazole

ranitidine

omeprazole

cephalexin

cephalexin

ranitidine

omeprazole

Time-concentration

pharmacokinetic parameters

Streptococcus pyogenes

C ( max )

AUC ( infinity )

t ( 1/2 )

, or

CL/F

t ( max )

Suboptimal T > MIC ( 90 )

T > MIC ( 90 )

t ( max )

t ( max )

healthy subjects ingesting cephalexin


Folate levels determine effect of antioxidant supplementation on micronuclei in subjects with cardiovascular risk . We have investigated the effect of modest supplementation with alpha-tocopherol ( 100 mg/day ) , beta-carotene ( 6 mg/day ) , vitamin C ( 100 mg/day ) and selenium ( 50 microg/day ) on oxidative stress and chromosomal damage , and the influence of methylenetetrahydrofolate reductase ( MTHFR ) genotype on these end-points . Subjects were two groups of middle-aged men differing in cardiovascular risk ; 46 survivors of myocardial infarction before age 50 and 60 healthy controls . They were randomly divided into equal groups to receive antioxidants or placebo for 12 weeks . Twenty-eight patients and 58 controls completed the intervention . Micronucleus levels in peripheral lymphocytes and changes seen after intervention were studied in relation to the MTHFR C677T genotype , basal homocysteine and plasma folate levels . Ferric reducing ability of plasma and concentration of malondialdehyde were measured to assess the antioxidant effect of supplementation . There was no association of micronuclei with folate , homocysteine or malondialdehyde levels before supplementation . Micronucleus frequencies and plasma folate levels did not vary significantly with MTHFR genotype . Homocysteine levels in subjects with the TT variant genotype were significantly higher compared with CT or CC ( P = 0.001 ) , especially in subjects with low folate ( P = 0.012 ) . In the placebo control group an increase in micronuclei ( P = 0.04 ) was detected at the end of the intervention period . This effect was not seen in the supplemented group . In antioxidant-supplemented myocardial infarction survivors we found an increase in the ferric reducing ability of plasma ( P < 0.001 ) and a decrease in malondialdehyde ( P = 0.001 ) . Micronucleus frequency showed a decrease , strongest in subjects with normal folate levels ( P = 0.015 ) . In subjects with low folate levels , a high correlation was found between micronuclei after supplementation and homocysteine , both before ( r = 0.979 , P = 0.002 ) and after supplementation ( r = 0.922 , P = 0.009 ) . Thus , folate deficiency may amplify the effect of other risk factors such as elevated homocysteine levels or variant MTHFR genotype , as well as influencing the ability of antioxidant supplementation to protect against genetic damage .

antioxidant supplementation

supplementation with alpha-tocopherol

beta-carotene

vitamin C

selenium

antioxidants

placebo

supplementation

antioxidant supplementation

micronuclei

Micronucleus frequencies

plasma folate levels

Homocysteine levels

micronuclei

ferric reducing ability of plasma

decrease in malondialdehyde

Micronucleus frequency

micronuclei


[ Study on treatment of iron-deficiency anemia by shengxuening ] . OBJECTIVE To observe the therapeutic effect of shengxuening ( SXN ) in treating iron-deficiency anemia ( IDA ) and to explore its molecular mechanism on iron metabolism balance regulation . METHODS Patients with IDA were randomly divided into the treated group and the control group , 50 in each group . They were treated with SXN ( 0.1 g , three times per day ) and ferrous gluconate ( 0.1 g , three times per day ) respectively , for 30 days . Levels of serum iron ( Fe ) , total iron binding capacity ( TIBC ) , transferrin saturation ( TS ) , serum ferritin ( SF ) , transferrin ( Tf ) , soluble transferrin receptor ( sTfR ) and blood routine test , as well as scoring of TCM qi-blood deficiency Syndrome were conducted before and after treatment . RESULTS The total effective rate in the treated group reached 92 % , it was shown that SXN could improve the iron metabolism , increase levels of Fe , TS , SF and reduce levels of TIBC , Tf , sTfR , it has obvious effect in promoting erythrocyte generation and could promote formation of leucocytes and platelets . The total effective rate in the control group was 32 % , which was significantly lower than that in the treated group ( P < 0.01 ) . CONCLUSION The effect of SXN in treating IDA and qi-blood deficiency Syndrome is evident , it could improve the iron metabolism , increase levels of Fe , TS , SF and lower levels of TIBC , Tf , sTfR .

shengxuening

shengxuening ( SXN )

control

SXN ( 0.1 g , three times per day

SXN

iron metabolism

increase levels of Fe , TS , SF

reduce levels of TIBC , Tf , sTfR

total effective rate

iron-deficiency anemia

IDA


[ Comparison of fracture resistance of pulpless teeth restored with fiber reinforced composite posts and three kinds of resin core material ] . OBJECTIVE To compare the fracture resistances of pulpless teeth restored with FRC ( Fiber Reinforced Composite ) posts and three kinds of resin core material . METHODS A total of 42 recently extracted upper incisors were randomly divided into 3 groups . Group A was restored with prefabricated glass-fiber posts and Artglass polymer core ; group B with prefabricated glass-fiber posts and Charisma composite resin core ; and group C with prefabricated glass-fiber posts and AB composite resin core . In every group , the core material was processed by hot-press and non hot-press respectively . The posts size and shape were identical in the 3 groups . All teeth were fully covered with polycarbonate resin crowns . Fracture resistance was measured by applying point force at 130 degrees to the long axis of the teeth on an universal testing machine . RESULTS Mean fracture threshold was 505.4 N +/- 42.0 N and 564.1 N +/- 41.7 N in group A , 411.3 N +/- 23.3 N and 315.3 N +/- 19.1 N in group B and 358.4 N +/- 36.1 N and 423.4 N +/- 47.5 N in group C. In all groups , there was no posts fracture and polycarbonate resin crowns fragmentation . CONCLUSION The composite restoration of FRC posts combined with resin core and resin crown can improve the fracture resistance of the pulpless roots . The strength of resin core material can be increased by hot-press methods .

three kinds of resin core material

hot-press methods

fracture resistance

fracture resistances

Fracture resistance

Mean fracture threshold

fracture resistance


Intranasal nicotine for postoperative pain treatment . BACKGROUND Despite pharmacological treatment , 70-80 % of patients report moderate to severe pain after surgery . Because nicotine has been reported to have analgesic properties in animal and human volunteer studies , the authors assessed the analgesic efficacy of a single 3 mg dose of nicotine nasal spray administered before emergence from general anesthesia . METHODS The authors conducted a randomized , double blind , placebo controlled trial of 20 healthy women ( mean age 45 ( SD 8 ) yr ) who were to undergo uterine surgery through a low transverse incision . After the conclusion of surgery but before emergence from general anesthesia , the anesthesiologist administered either nicotine nasal spray or a placebo . Numerical analog pain score and morphine utilization and hemodynamic values were measured for 24 h. RESULTS The patients treated with nicotine reported lower pain scores during the first hour after surgery ( peak numerical analog score , 7.6 ( SD 1.4 ) versus 5.3 ( SD 1.6 ) ; P < 0.001 ) and used half the amount of morphine as the control group ( 12 ( SD 6 ) versus 6 ( SD 5 ) mg ; P < 0.05 ) . Patients who received nicotine still reported less pain than those in the control group 24 h after surgery ( 1.5 ( SD 0.5 ) versus 4.9 ( SD 1.4 ) ; P < 0.01 ) . Systolic blood pressure was lower in the group that received nicotine ( 105 ( SD 3 ) versus 122 ( SD 3 ) ; P < 0.001 ) , but there was no difference in diastolic blood pressure or heart rate . CONCLUSIONS Treatment with a single dose of nicotine immediately before emergence from anesthesia was associated with significantly lower reported pain scores during the first day after surgery . The decreased pain was associated with a reduction in morphine utilization and the analgesic effect of nicotine was not associated with hypertension or tachycardia .

nicotine

nicotine

placebo

uterine surgery

low transverse incision

nicotine nasal spray

placebo

lower pain scores

amount of morphine

reported less pain

Systolic blood pressure was lower

pain scores

pain

postoperative pain treatment .

healthy

mean age 45 ( SD 8 ) yr


Abstinence incentive effects in a short-term outpatient detoxification program . Despite being widely available , outpatient detoxification has limited efficacy as a stand-alone treatment . This study examined whether abstinence-contingent incentives would improve outcomes for patients entering outpatient opiate detoxification . Participants ( N = 211 ) received a 100 US dollars voucher on the last day of detoxification either contingent on opiate and cocaine abstinence or noncontingently . Urine samples were collected at intake , on Wednesday , Friday ( the last day of detoxification ) , and the following Monday . Among contingent-voucher participants , 31 % were drug-free on Friday compared with 18 % of noncontingent controls ( Z = 2.4 , p < .05 ) . Few ( 12-13 % ) participants tested negative on Monday . Results support the ability of vouchers to produce modest improvements in abstinence initiation rates during brief detoxification but suggest that additional interventions are needed to sustain improvements .

abstinence-contingent incentives

contingent-voucher

Abstinence incentive effects

opiate detoxification .

drug-free


Use of abciximab prior to primary angioplasty in STEMI results in early recanalization of the infarct-related artery and improved myocardial tissue reperfusion - results of the Austrian multi-centre randomized ReoPro-BRIDGING Study . AIMS The aim of the ReoPro-BRIDGING Austrian multi-centre study was to investigate the effects of abciximab ( ReoPro ) on early reperfusion in ST-elevation myocardial infarction prior to or during primary percutaneous coronary angioplasty ( pPCI ) . METHODS AND RESULTS Fifty-five patients with STEMI were randomized either to start abciximab ( 0.25 mg/kg bolus followed by 10 microg/min infusion ) during the organization phase for pPCI ( Group 1 , n=28 ) or immediately before pPCI ( Group 2 , n=27 ) . The time between first bolus of abciximab and first balloon inflation of pPCI was 83+/-18 vs 21+/-13 min in Group 1 vs 2 . The pre-pPCI ST-segment resolution ( 55+/-21.4 % vs 42.4+/-18.2 % , p=0.005 ) , TIMI flow grade 3 ( 29 % vs 7 % , p=0.042 ) , corrected TIMI frame count ( 58.4+/-32.7 vs 78.9+/-28.4 frame , p=0.018 ) % diameter stenosis ( 76.3 /63.5-100/ vs 100 /73.5-100/ ; median /interquartile range/ , p=0.023 ) , were significantly higher in Group 1 vs Group 2 . Quantitative myocardial dye intensity measurement revealed a significantly higher grade of myocardial tissue perfusion ( 1 /0-9.25/ vs 0 /0-3.0/ grey pixel unit , p=0.048 ) in Group 1 before pPCI . Rapid release of cardiac enzymes was observed in Group 1 as compared with Group 2 : rate of rise of CK was 210+/-209 vs 97+/-95 U/l/h ( p=0.015 ) . QRS score indicated a smaller infarct size in Group 1 ( 4.8+/-3.8 vs 7.6+/-3.5 , p=0.011 ) on day 7 . CONCLUSION The use of abciximab in the organization phase for pPCI results in signs of early recanalization of the infarct-related artery and a subsequent improved myocardial tissue reperfusion .

abciximab

primary angioplasty

abciximab ( ReoPro )

abciximab

abciximab

myocardial tissue reperfusion

pre-pPCI ST-segment resolution

TIMI flow grade 3

TIMI frame count

% diameter stenosis

myocardial tissue perfusion

cardiac enzymes

rise of CK

QRS score

infarct size

myocardial tissue reperfusion

STEMI


Buccal misoprostol to decrease blood loss after vaginal delivery : a randomized trial . OBJECTIVE To assess the efficacy of buccal misoprostol to decrease bleeding after vaginal delivery . METHODS This was a randomized study of patients between 22 weeks and 42 weeks of gestation with anticipated vaginal delivery . Patients were given either a 200-mug misoprostol tablet or placebo in the buccal space at the time of cord clamping . A continuous dilute intravenous oxytocin infusion was given to all patients at delivery of the placenta . Postpartum hemorrhage was defined as blood loss exceeding 500 mL . Sample size calculations based on previous studies assumed a 13 % incidence of postpartum hemorrhage in the control group . To show a statistically significant reduction of postpartum hemorrhage a total of 1,604 patients would be required in each group . RESULTS A total of 848 patients were enrolled and 756 randomly assigned , 377 in the misoprostol group and 379 in the placebo group . Demographic , antepartum , and intrapartum characteristics were similar between the groups . The incidence of postpartum hemorrhage , 3 % compared with 5 % , ( relative risk 0.65 , 95 % confidence interval 0.33-1.29 , P = .22 ) , mean estimated blood loss , 322 compared with 329 mL , ( P = .45 ) , and mean minutes of the third stage of labor , 6.7 compared with 6.9 ( P = .52 ) were similar between the groups , misoprostol and placebo , respectively . Hemoglobin difference before and after delivery , need for second or third uterotonic agent , and all measured neonatal variables including birth weights , and umbilical cord pH were similar between the groups . CONCLUSION Buccal misoprostol at cord clamping is no more effective than placebo in reducing postpartum hemorrhage .

Buccal misoprostol

buccal misoprostol

200-mug misoprostol tablet

placebo

oxytocin

misoprostol

placebo

misoprostol

placebo

Buccal misoprostol

placebo

blood loss

bleeding

Postpartum hemorrhage

blood loss

incidence of postpartum hemorrhage

mean estimated blood loss

postpartum hemorrhage .

after vaginal delivery :

after vaginal delivery .

vaginal delivery

1,604 patients

848 patients

377 in the misoprostol group

379 in the placebo group


Not Now ! Supporting interruption management by indicating the modality and urgency of pending tasks . Operators in complex event-driven domains must coordinate competing attentional demands in the form of multiple tasks and interactions . This study examined the extent to which this requirement can be supported more effectively through informative interruption cueing ( in this case , partial information about the nature of pending tasks ) . The 48 participants performed a visually demanding air traffic control ( ATC ) task . They were randomly assigned to 1 of 3 experimental groups that differed in the availability of information ( not available , available upon request , available automatically ) about the urgency and modality of pending interruption tasks . Within-subject variables included ATC-related workload and the modality , frequency , and priority of interruption tasks . The results show that advance knowledge about the nature of pending tasks led participants to delay visual interruption tasks the longest , which allowed them to avoid intramodal interference and scanning costs associated with performing these tasks concurrently with ATC tasks . The 3 experimental groups did not differ significantly in terms of their interruption task performance ; however , the group that automatically received task-related information showed better ATC performance , thus experiencing a net performance gain . Actual or potential applications of this research include the design of interfaces in support of attention and interruption management in a wide range of event-driven environments .

ATC-related workload

interruption task performance


Scent and mood state following an anxiety-provoking task . The purpose of this study was to assess the effects of water , lavender , or rosemary scent on physiology and mood state following an anxiety-provoking task . The nonsmoking participants , ages 18-30 years , included 42 women and 31 men who reported demographic information and measures of external temperature and heart rate were taken prior to introduction of an anxiety-eliciting task and exposure to lavender , rosemary , or water scents . Following the task , participants completed the Profile of Mood States to assess mood , and temperature and heart rate were reassessed . Participants rated the pleasantness of the scent received . When pleasantness ratings of scent were covaried , physiological changes in temperature and heart rate did not differ based on scent exposure , but mood ratings differed by scent condition . Participants in the rosemary condition scored higher on measures of tension-anxiety and confusion-bewilderment relative to the lavender and control conditions . The lavender and control conditions showed higher mean vigor-activity ratings relative to the rosemary group , while both rosemary and lavender scents were associated with lower mean ratings on the fatigue-inertia subscale , relative to the control group . These results suggest that , when individual perception of scent pleasantness is controlled , scent has the potential to moderate different aspects of mood following an anxiety-provoking task .

water , lavender , or rosemary scent

anxiety-eliciting task

lavender , rosemary , or water scents

physiology and mood state

mood

temperature and heart rate

mood ratings

mean vigor-activity ratings


Dual-task-related gait changes in transitionally frail older adults : the type of the walking-associated cognitive task matters . BACKGROUND Changes in gait patterns due to a simultaneously performed cognitive task have been reported previously and associated with an increased falling risk among older adults . Little is known whether the type of cognitive task performed while walking is important concerning possible gait interference in older fall-prone individuals . OBJECTIVE To quantify and compare the effects of two different cognitive tasks on gait in transitionally frail older adults . MEASUREMENTS Gait was tested in 30 transitionally frail older adults ( mean age 82.6 +/- 7.1 years , 90 % female ) while either walking alone , performing a simple arithmetic task , or performing a task of verbal fluency . Walking time in seconds , number of steps , frequency of lateral line stepping-over , and stops were recorded . Health status was assessed using standard instruments of geriatric assessment . The classification of Speechley and Tinetti was used to define the participants ' degree of frailty . RESULTS Walking time and number of steps increased significantly under both dual-task conditions compared to walking alone ( p < 0.001 ) without reaching a significant difference between the two dual-task conditions ( respectively , p = 0.131 and p = 0.407 ) , whereas lateral gait instability ( frequency of lateral line stepping-over ) increased significantly in association with counting backward ( p = 0.006 ) but not with the verbal fluency task ( p = 1 ) . CONCLUSION Among the studied sample of transitional older adults , a walking- associated arithmetic task significantly interfered with lateral gait stability , whereas no lateral gait deviations were seen in association with a verbal fluency task . We , therefore , suggest that the choice of the attention-splitting task in dual-task gait assessment among older adults must be made carefully .

walking-associated cognitive task

simultaneously performed cognitive task

cognitive task

walking alone

performing a simple arithmetic task

Walking time in seconds

number of steps

Health status

Walking time

number of steps

lateral gait instability

walking- associated arithmetic task

lateral gait stability

verbal fluency task

transitionally frail older adults .


A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism . Repetitive behaviors are a core symptom domain in autism that has been linked to alterations in the serotonin system . While the selective serotonin-receptive inhibitor fluvoxamine has been shown to be effective in adults with autism , as yet no published placebo controlled trials with these agents document safety and efficacy in children with autism . This study examines the selective serotonin reuptake inhibitor liquid fluoxetine in the treatment of repetitive behaviors in childhood and adolescent autism spectrum disorders ( ASDs ) . In total , 45 child or adolescent patients with ASD were randomized into two acute 8-week phases in a double-blind placebo-controlled crossover study of liquid fluoxetine . Study design included two randomized 8-week fluoxetine and placebo phases separated by a 4-week washout phase . Outcome measures included measures of repetitive behaviors and global improvement . Low-dose liquid fluoxetine ( mean final dose : 9.9+/-4.35 mg/day ) was superior to placebo in the treatment of repetitive behaviors by CY-BOCS compulsion scale . The effect size was in the moderate to large range , and the doses used were low . Liquid fluoxetine was only slightly , and not significantly , superior to placebo on CGI autism score partially due to a phase order effect . However , fluoxetine was marginally superior to placebo on a composite measure of global effectiveness . Liquid fluoxetine did not significantly differ from placebo on treatment emergent side effects . Liquid fluoxetine in low doses is more effective than placebo in the treatment of repetitive behaviors in childhood autism . Limitations include small sample size and the crossover design of the study . Further replication and long-term maintenance trials are needed .

placebo

liquid fluoxetine

fluoxetine

liquid fluoxetine

placebo

Liquid fluoxetine

fluoxetine

Liquid fluoxetine

repetitive behaviors

Repetitive behaviors

safety

efficacy

repetitive behaviors

measures of repetitive behaviors

global improvement

repetitive behaviors

CY-BOCS compulsion scale

effect size

CGI autism score

treatment emergent side effects

repetitive behaviors

childhood and adolescent

autism

autism spectrum disorders

ASDs

child or adolescent

ASD


Histamine intolerance-like symptoms in healthy volunteers after oral provocation with liquid histamine . Histamine in food at non-toxic doses has been proposed to be a major cause of food intolerance causing symptoms like diarrhea , hypotension , headache , pruritus and flush ( " histamine intolerance " ) . Histamine-rich foods such as cheese , sausages , sauerkraut , tuna , tomatoes , and alcoholic beverages may contain histamine up to 500 mg/kg . We conducted a randomized , double-blind , placebo-controlled cross-over study in 10 healthy females ( age range 22-36 years , mean 29.1 +/- 5.4 ) who were hospitalized and challenged on two consecutive days with placebo ( peppermint tea ) or 75 mg of pure histamine ( equaling 124 mg histamine dihydrochloride , dissolved in peppermint tea ) . Objective parameters ( heart rate , blood pressure , skin temperature , peak flow ) as well as a total clinical symptom score using a standardized protocol were recorded at baseline , 10 , 20 , 40 , 80 minutes , and 24 hours . The subjects received a histamine-free diet also low in allergen 24 hours before hospitalization and over the whole observation period . Blood samples were drawn at baseline , 10 , 20 , 40 , and 80 minutes , and histamine and the histamine-degrading enzyme diamine oxidase ( DAO ) were determined . After histamine challenge , 5 of 10 subjects showed no reaction . One individual experienced tachycardia , mild hypotension after 20 minutes , sneezing , itching of the nose , and rhinorrhea after 60 minutes . Four subjects experienced delayed symptoms like diarrhea ( 4x ) , flatulence ( 3x ) , headache ( 3x ) , pruritus ( 2x ) and ocular symptoms ( 1x ) starting 3 to 24 hours after provocation . No subject reacted to placebo . No changes were observed in histamine and DAO levels within the first 80 minutes in non-reactors as well as reactors . There was no difference in challenge with histamine versus challenge with placebo . We conclude that 75 mg of pure liquid oral histamine -- a dose found in normal meals -- can provoke immediate as well as delayed symptoms in 50 % of healthy females without a history of food intolerance .

placebo-controlled

placebo ( peppermint tea )

histamine

histamine-free diet

no reaction

tachycardia

mild hypotension after 20 minutes

sneezing

itching of the nose

rhinorrhea after 60 minutes

diarrhea ( 4x )

flatulence ( 3x )

headache ( 3x )

pruritus ( 2x )

ocular symptoms

histamine and DAO levels

Histamine intolerance-like symptoms

healthy

females

age range 22-36 years

females


5 % imiquimod cream and reflectance-mode confocal microscopy as adjunct modalities to Mohs micrographic surgery for treatment of basal cell carcinoma . BACKGROUND Imiquimod is an immune response modifier that up-regulates cytokines and has been shown in clinical studies to reduce or clear basal cell carcinoma tumors when applied topically . OBJECTIVE The objectives were to evaluate the efficacy of 5 % imiquimod cream in treating basal cell carcinoma preceding excision by Mohs micrographic surgery and to determine if reflectance-mode confocal microscopy is useful to establish the need for surgical intervention after imiquimod treatment . METHODS Subjects applied study cream to one biopsy-confirmed basal cell carcinoma tumor 5 x/week for 2 , 4 , or 6 weeks in this vehicle-controlled , double-blind study . Confocal microscopy was used for the 6-week treatment group to examine the target tumor area at each interval visit and immediately before Mohs micrographic surgery . After the Mohs micrographic surgery excision , the tissue was evaluated histologically , and the excision area was measured . Confocal microscopy readings were correlated to the histologic diagnosis . RESULTS Tumors cleared or the target tumor area was reduced in subjects in the 4- and 6-week dosing regimens . Confocal microscopy assessments correlated well with the histologic diagnosis . CONCLUSION Imiquimod improved excision results relative to vehicle when used for treating basal cell carcinoma before Mohs micrographic surgery . Confocal microscopy assessments correlated well with tumor response to therapy , suggesting that confocal microscopy may help determine the need for surgery .

imiquimod

reflectance-mode confocal microscopy

Mohs micrographic surgery

Imiquimod

imiquimod

reflectance-mode confocal microscopy

imiquimod

Confocal microscopy

Mohs micrographic surgery

Mohs micrographic surgery excision

Confocal microscopy

Confocal microscopy

Imiquimod

Mohs micrographic surgery .

excision results


Randomized , double-blind , phase III , controlled trial comparing levobupivacaine 0.25 % , ropivacaine 0.25 % and bupivacaine 0.25 % by the caudal route in children . BACKGROUND The rationale for replacing racemic bupivacaine with the s-enantiomers levobupivacaine and ropivacaine is to provide a wider margin of safety with the same analgesic efficacy and less postoperative motor block . In a randomized , double-blind , phase III , controlled trial we compared the caudal administration of levobupivacaine 0.25 % and ropivacaine 0.25 % with bupivacaine 0.25 % in children . METHODS Ninety-nine ASA I-II children less than 10 yr old scheduled for elective sub-umbilical surgery were randomized to receive caudal block with bupivacaine 0.25 % , ropivacaine 0.25 % or levobupivacaine 0.25 % . The primary outcome of the study was the clinical efficacy of the caudal block during the operation . Secondary outcome measures were analgesic onset time , pain relief after the operation and residual motor blockade . RESULTS The proportion of children with effective analgesia during the operation was similar among groups . There were no significant differences in the analgesic onset time of the caudal block . Bupivacaine produced a significant incidence of residual motor block compared with levobupivacaine or ropivacaine at wake-up ( P < 0.01 ) . There were no significant differences in the number of patients receiving rescue analgesia after surgery . However , analgesic block lasted significantly longer in patients receiving bupivacaine ( P=0.03 ) . CONCLUSION During sub-umbilical surgery , caudal levobupivacaine , ropivacaine and bupivacaine provided comparable analgesic efficacy . Bupivacaine produced a higher incidence of residual motor blockade and a longer analgesic block than ropivacaine and levobupivacaine .

levobupivacaine

ropivacaine

bupivacaine

racemic bupivacaine

s-enantiomers levobupivacaine

ropivacaine

levobupivacaine

ropivacaine

bupivacaine

bupivacaine

ropivacaine

levobupivacaine

analgesic efficacy

postoperative motor block .

analgesic onset time ,

pain relief after the operation

residual motor blockade

residual motor block

analgesic efficacy

incidence of residual motor blockade

analgesic block

Ninety-nine

less than 10

sub-umbilical surgery


B-type natriuretic peptide for acute dyspnea in patients with kidney disease : insights from a randomized comparison . BACKGROUND B-type natriuretic peptide ( BNP ) levels are reliably elevated in patients with congestive heart failure ( CHF ) and therefore helpful in its diagnosis . However , kidney disease results in elevated BNP levels independently of CHF . Accordingly , the impact of kidney disease on the benefit of BNP testing needs to be scrutinized . METHODS This study evaluated patients with and without kidney disease [ glomerular filtration rate ( GFR ) less than 60 mL/min/1.73 m ( 2 ) ) presenting with acute dyspnea . A total of 452 consecutive patients ( 240 with kidney disease and 212 without kidney disease ) were randomly assigned to a diagnostic strategy with ( BNP group ) or without ( control group ) the use of BNP levels provided by a rapid bedside assay . RESULTS Patients with kidney disease were older , more often had CHF as the cause of acute dyspnea , and more often died in-hospital or within 30 days as compared to patients without kidney disease . In patients without kidney disease , BNP testing significantly reduced median time to discharge ( from 9.5 days to 2.5 days ) ( P= 0.003 ) and total cost of treatment ( from 7184 dollars to 4151 dollars ) ( P= 0.004 ) . In contrast , in patients with kidney disease , time to discharge and total cost of treatment were similar in both groups . CONCLUSION When applying BNP cut-off values without adjustment for the presence of kidney disease , the use of BNP levels does significantly improve the management of patients without kidney disease , but not of those with kidney disease .

B-type natriuretic peptide

BNP

BNP testing

BNP

BNP levels

CHF as the cause of acute dyspnea

median time to discharge

total cost of treatment

BNP levels

patients with kidney disease :

452 consecutive patients

240 with kidney disease

212 without kidney disease


Comparative bioavailability of two formulations of terbinafine . Data from a cross-over , randomised , open-label bioequivalence study in healthy volunteers . An open-label , randomised , cross-over single dose study , using 2 periods x 2 sequences , with a minimum washout period of 21 days , was conducted in order to assess the comparative bioavailability of two formulations of terbinafine ( CAS 78628-80-5 ) 250 mg tablets . Plasma samples were obtained at baseline , +0.333 ; 0.667 ; 1.00 ; 1.33 ; 1.67 ; 2.00 ; 2.33 ; 2.67 ; 3.00 ; 3.50 ; 4.00 ; 6.00 ; 8.00 ; 12.0 ; 24.0 ; 36.0 ; 48.0 and 72.0 h post-administration . Terbinafine levels were determined by high pressure liquid chromatography with tandem mass detection ( HPLC-MS/MS ) and the lower limit of quantification was set at 9.99 ng/mL . The pharmacokinetic parameters used for the bioequivalence assessment ( AUClast , AUCinf and Cmax ) were determined from the terbinafine concentration data using non-compartmental analysis . Classical 90 % confidence intervals ( 90CI ) were calculated for the overall sample , and for males and females separately , and gender effects were investigated using an appropriate model . The results showed that overall classical 90CI were 96.08-105.40 % for AUCinf , 95.68-105.33 for AUClast and 88.24-112.83 for Cmax , that is , all within the predefined ranges for bioequivalence acceptance . Separate gender analysis showed very similar results for males and females when analysed independently , and no gender effects were detected ( p > 0.05 for all of the tested model effects ) . It may be therefore concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption .

terbinafine

terbinafine ( CAS 78628-80-5 )

Terbinafine

Comparative bioavailability

comparative bioavailability

Plasma samples

Terbinafine levels

high pressure liquid chromatography

pharmacokinetic parameters

healthy

males

females

males

females


Efficiency of adjuvant immunochemotherapy following curative resection in patients with locally advanced gastric cancer . BACKGROUND Despite curative resection , 50 % -90 % of gastric cancer patients die of disease relapse . Although some clinical trials have indicated that chemotherapy and immunochemotherapy may be effective modalities , more recent studies have not been able to define the standard treatment for advanced gastric cancer . The present study evaluated the effect of adjuvant immunochemotherapy with the use of BCG ( bacille Calmette-Guerin ) and FAM ( 5-fluorouracil , adriamycin , mitomycin C ) chemotherapy on the survival of patients with locally advanced resectable gastric cancer . METHODS A total of 156 patients with stage III or IV gastric cancer who had undergone curative resection were randomly assigned to three treatment groups : BCG + FAM ( immunochemotherapy ) , FAM ( chemotherapy ) , and control ( surgery only ) . Treatment was continued for 2 years or until death . Further postsurgical follow up was carried on for up to 10 years . RESULTS Overall 10-year survival was 47.1 % for the immunochemotherapy group ( P < 0.037 vs FAM and P < 0.0006 vs control ) , 30 % for the chemotherapy group ( vs control , NS ) , and 15.2 % for the control group . In patients with pT2/T3 primary tumors , 10-year survival was 55.3 % for BCG + FAM vs 28.2 % for FAM ( P < 0.01 ) and 14.6 % for the control group ( P < 0.00018 ) . BCG + FAM significantly improved the survival of patients with intestinal-type but not diffuse-type cancer . Immunochemotherapy was well tolerated . CONCLUSION This study , based on a limited number of patients , indicates that adjuvant immunochemotherapy ( BCG + FAM ) may prolong the survival of gastric cancer patients after curative gastrectomy ; in particular , in patients with pT2/T3 tumors and intestinal-type primary tumors . There was no survival benefit from FAM adjuvant chemotherapy .

BCG ( bacille Calmette-Guerin )

FAM

adriamycin

mitomycin C

chemotherapy

immunochemotherapy

chemotherapy

control ( surgery only )

FAM

chemotherapy

BCG + FAM

Efficiency

disease relapse

survival of patients

10-year survival

10-year survival

survival of patients

survival

survival benefit

gastric cancer .

gastric cancer

gastric cancer .

resectable gastric cancer .

stage III or IV gastric cancer

curative resection

pT2/T3 primary tumors

gastric cancer

curative gastrectomy


A randomized , evaluator-blind , multicenter comparison of the efficacy and tolerability of Perlane versus Zyplast in the correction of nasolabial folds . Bovine collagen is widely used as a dermal filler for facial soft-tissue augmentation , but it provides only temporary cosmetic improvement . Nonanimal stabilized hyaluronic acid has reduced potential for immunogenicity and hypersensitivity and may provide a more durable aesthetic result . Sixty-eight patients with prominent nasolabial folds were randomized to intradermal treatment with nonanimal stabilized hyaluronic acid gel ( Perlane ) and bovine collagen ( Zyplast ) on contralateral sides of the face . On achievement of " optimal cosmetic result " ( baseline ) , patients were followed up for 6 months ; bilateral retreatment with Perlane was offered at 6 or 9 months after baseline . Responses were evaluated at 2 , 4 , 6 , 9 , and 12 months after baseline . Investigator-based and patient-based ratings indicated that Perlane was more effective than Zyplast in maintaining cosmetic correction . According to investigator-based Wrinkle Severity Rating Scale assessments at 6 and 9 months after baseline , Perlane was superior in 50.0 percent and 48.8 percent of patients , respectively , whereas Zyplast was superior in 10.3 percent and 14.0 percent of patients , respectively ( p < 0.0004 ) . Investigator-based Global Aesthetic Improvement Scale assessment at 9 months after baseline indicated that Perlane was superior in 48.8 percent of patients , whereas Zyplast was superior in 14.0 percent of patients ( p = 0.0025 ) . " Optimal cosmetic result " was achieved with a smaller volume of Perlane than Zyplast ( mean , 1.2 ml versus 2.1 ml ) . Local injection-site reactions ( redness , swelling , pruritus , and induration ) were less frequent with Perlane than with Zyplast . Delayed-onset reactions were rare and did not reoccur after Perlane retreatment . Perlane has acceptable long-term safety and offers a longer-lasting aesthetic improvement than Zyplast .

Perlane

Zyplast

Bovine collagen

Nonanimal stabilized hyaluronic acid

bovine collagen ( Zyplast )

Perlane

Perlane

Zyplast

Perlane

Zyplast

Perlane

Zyplast

Perlane

Zyplast

Perlane

Zyplast

Perlane

Perlane

Zyplast

optimal cosmetic result

cosmetic

superior

superior

superior

superior

" Optimal cosmetic result "

smaller volume

long-term safety

aesthetic improvement


Rapeseed and soybean products as protein sources for growing turkeys of different ages . ( 1 ) Apparent ileal and total tract protein digestibilities of rapeseed meal and cake and soybean meal and cake were assayed in growing turkeys at 4 , 8 and 12 weeks of age . ( 2 ) In addition , the effect of killing technique on apparent ileal protein digestibility values obtained by a slaughter method and effect of rapeseed feeding on size of specific organs were studied . ( 3 ) Protein digestibility coefficients of rapeseed products were mostly 0.10 to 0.15 units lower than those of soybean products . Ileal digestibility of protein increased slightly or remained unchanged from 4 to 8 weeks and decreased thereafter . No effect of feed processing method ( meal vs cake ) on ileal digestibility was observed . ( 4 ) Killing the birds by carbon dioxide inhalation and bleeding led to slightly lower ileal digestibility values than mechanical stunning and neck dislocation . ( 5 ) Total tract digestibility of protein decreased from 4 to 8 weeks of age for soybean meal and rapeseed meal but increased for soybean cake and rapeseed cake . From 8 to 12 weeks of age total tract digestibility of protein decreased for all the products tested . ( 6 ) Feed containing rapeseed led to enlargement of thyroid glands and hearts , but did not affect liver size or mortality .

Rapeseed and soybean products

rapeseed feeding

rapeseed products

soybean products

soybean meal

rapeseed meal

soybean cake

rapeseed cake

rapeseed

liver size or mortality .

4 , 8 and 12 weeks


Genetic polymorphisms of human flavin monooxygenase 3 in sulindac-mediated primary chemoprevention of familial adenomatous polyposis . PURPOSE Sulindac is a nonsteroidal anti-inflammatory drug ( NSAID ) effective in regressing adenomas in patients with familial adenomatous polyposis ( FAP ) . However , a recent randomized trial showed that sulindac , when compared with placebo , failed to prevent the development of adenomatous polyps in genotypically positive but phenotypically negative FAP patients . The present study determined whether polymorphisms in the gene encoding flavin monooxygenase 3 ( FMO3 ) , a hepatic microsomal enzyme that inactivates sulindac , played a role in determining the efficacy of sulindac in preventing polyposis in this cohort of FAP patients . EXPERIMENTAL DESIGN Genotyping was performed on seven established FMO3 polymorphisms previously shown to have functional relevance-M66I , P153L , E158K , V257M , E305X , E308G , and R492W-in 21 and 20 FAP patients , who received sulindac and placebo , respectively . RESULTS None of the 41 patients exhibited heterozygous or homozygous M66I and R492W variant alleles , or homozygous P153L , V257M , and E305X variant alleles . Among sulindac-treated patients who did not develop adenomas ( " responders " ) , 4 ( 33 % ) were homozygous for E158K and 2 ( 17 % ) were homozygous for E308G variant alleles . In contrast , none of the patients on sulindac who developed adenomas ( " nonresponders " ) exhibited homozygosity for either of the two variant alleles . In addition , polymorphisms in the E158K or E308G allele were associated with a significant reduction in mucosal prostanoid levels in patients treated with sulindac . CONCLUSIONS Polymorphisms in FMO3 , particularly at the E158K and E308G loci , may reduce activity in catabolizing sulindac and result in an increased efficacy to prevent polyposis in FAP .

sulindac-mediated

Sulindac

sulindac

placebo

sulindac

sulindac

sulindac

placebo

sulindac-treated

sulindac

sulindac

homozygous for E158K

homozygous for E308G variant alleles

homozygosity

mucosal prostanoid levels


Slotted versus non-slotted locked intramedullary nailing for femoral shaft fractures . Experimentally , two slotted nails , the Grosse-Kempf nail and the AO/ASIF universal femoral nail , were compared to the non-slotted Grosse-Kempf nail and control bone using a cadaver femoral osteotomy . The stiffnesses and strengths of the osteotomies fixed with slotted nails in 10-30 degrees torsion were 6-8 % and the values of non-slotted nails 40 % of control bone . The maximal moments were 14-18 % and 48 % , respectively . In the " clinical range " of torsion , the implant-bone construct never failed or was deformed . Clinically , 46 femoral shaft fractures were randomized to treatment with Gross-Kempf nails , 24 with slotted nails and 22 with non-slotted nails . Four complications in the slotted nail group and three in the non-slotted nail group were considered to be independent of the choice of nail and did not affect the end result . Three splinterings of the distal fragment , one resulting in a change of the osteosynthesis implant to a condylar plate , were considered to result from the high stiffness of the non-slotted nail . Osteosynthesis of femoral shaft fractures using slotted nails has not resulted in healing disturbances , which could be accounted for by the high torsional elasticity of the nail ; there seems to be no indication for high-stiffness nails in femoral fractures .

AO/ASIF universal femoral nail

non-slotted Grosse-Kempf nail

control bone

cadaver femoral osteotomy

slotted nails

Gross-Kempf nails

slotted nails

non-slotted nails

maximal moments

implant-bone construct

complications

splinterings of the distal fragment

change of the osteosynthesis implant

cadaver femoral osteotomy

femoral shaft fractures

slotted nails

non-slotted nails

femoral fractures


Group-based HIV risk reduction intervention for adolescent girls : evidence of feasibility and efficacy . The purposes of this pilot study were ( a ) to assess the feasibility of a community-based , small group HIV risk reduction intervention with adolescent girls , and ( b ) to obtain preliminary evidence of the efficacy of this theoretically-guided intervention using a controlled design . The feasibility of the intervention was demonstrated by successfully implementing it with 33 sexually-active , single girls . Preliminary evidence of the efficacy of the intervention was obtained using a randomized trial with 62 sexually-active , single girls . Data obtained at a 3-month follow-up assessment showed that girls who received the HIV-related intervention improved their HIV-related knowledge and enhanced their motivation for risk reduction compared to girls who received a control ( health promotion ) intervention . Effect sizes suggest that the HIV intervention also reduced several risk behaviors ( e.g. , vaginal sex without a condom , giving oral sex , and alcohol and drug use before sex ) . Challenges to implementation and suggestions for intervention enhancement are discussed .

theoretically-guided intervention

feasibility

efficacy

HIV-related knowledge

motivation for risk reduction

Effect

reduced several risk behaviors

vaginal sex without a condom

giving oral sex

alcohol and drug use before sex

adolescent girls :

adolescent girls


Evaluation of apical sealing ability and adaptation to dentine of two resin-based sealers . The purpose of this study was to evaluate the apical sealing ability and adaptation to dentine of two resin-based root canal sealers . The root canals of 55 human maxillary anterior teeth were prepared using a step-back technique and the smear layer removed with 17 % ethylenediaminetetraacetic acid . The teeth were divided into two groups of 25 teeth and the remaining five teeth served as control . Then the teeth were prepared and obturated with gutta-percha by a lateral condensation and either AH plus and EndoRez used as a sealer . Twenty teeth from each group were used for the apical leakage test and the remaining five teeth from each group were used for examination under the scanning electron microscope ( SEM ) . For apical leakage test , teeth were covered with nail varnish and sticky wax to within 1 mm of the apical foramen and placed in 2 % methylene blue for 7 days . After this period , the teeth were sectioned longitudinally and apical leakage measurements made . The mean value of dye penetration for AH plus was 2.87 +/- 0.43 mm , while that of EndoRez was 4.54 +/- 0.36 mm . The difference between mean of dye penetration was statistically significant ( P < 0.01 ) . The SEM examination showed both sealers had better adaptation and penetration in coronal and middle thirds than apical third of root canal . In apical third , AH plus was adapted better adpated to dentine than EndoRez . In conclusion , AH plus sealer has better apical sealing ability and adaptation to dentine than EndoRez sealer .

two resin-based sealers

two resin-based root canal sealers

AH plus

EndoRez

the teeth were sectioned longitudinally

AH plus

EndoRez

AH plus

EndoRez

AH plus sealer

EndoRez sealer .

dye penetration for AH plus

dye penetration

better apical sealing ability

root canals


A home visiting asthma education program : challenges to program implementation . This study describes the implementation of a nurse home visiting asthma education program for low-income African American families of young children with asthma . Of 55 families , 71 % completed the program consisting of eight lessons . The achievement of learning objectives was predicted by caregiver factors , such as education , presence of father or surrogate father in the household , and safety of the neighborhood , but not by child factors , such as age or severity of asthma as implied by the prescribed asthma medication regimen . Incompatibility between the scheduling needs of the families and the nurse home visitors was a major obstacle in delivering the program on time , despite the flexibility of the nurse home visitors . The authors suggest that future home-based asthma education programs contain a more limited number of home visits but add telephone follow-ups and address the broader needs of low-income families that most likely function as barriers to program success .

home visiting asthma education program

home-based asthma education programs

achievement of learning objectives

child factors

age

severity of asthma

number of home visits

children

asthma

71 %


Efficacy , safety , and steady-state pharmacokinetics of once-a-day controlled-release morphine ( MS Contin XL ) in cancer pain . The efficacy , safety , and pharmacokinetics of a novel once-daily morphine formulation ( OAD morphine ) and a 12-hourly formulation ( twice-daily CR morphine ) were compared in a double-blind , multi-centered crossover study . Chronic cancer pain patients ( n=25 ) were randomized to OAD morphine ( mean 238 +/- 319 mg q24h ) or twice-daily CR morphine ( mean 119 +/- 159 mg q12h ) for one week . They then crossed over to the alternate drug , which also was taken for one week . There was no difference between treatments for evaluations of overall pain intensity , analgesic efficacy , or adverse events . However , whereas pain scores increased during the day on twice-daily CR morphine ( P=0.0108 ) , they remained stable on OAD morphine . Most patients ( 68 % ) chose once-daily dosing for continuing pain management ( P=0.015 ) . The AUC ratio was 100.3 % , indicating equivalent absorption . Fluctuation indices were 93.5 +/- 28.8 % and 179.3 +/- 41.3 % ( P=0.0001 ) for OAD morphine and twice-daily CR morphine , respectively . OAD morphine provides analgesia similar to twice-daily CR morphine with reduced fluctuation in plasma morphine concentration and more stable pain control .

morphine

morphine formulation ( OAD morphine )

morphine

OAD morphine

twice-daily CR morphine

morphine

morphine

morphine

morphine

overall pain intensity

analgesic efficacy

adverse events

pain scores

pain management

AUC ratio

Fluctuation indices

pain control

cancer pain

Chronic cancer pain


Low-dose , vaginally administered estrogens may enhance local benefits of systemic therapy in the treatment of urogenital atrophy in postmenopausal women on hormone therapy . BACKGROUND When genital atrophy exists , systemic hormone therapy ( HT ) has a timing until to induce vaginal proliferation and symptomatic relieve . Thus , in order to obtain a prompt improvement , the association of local therapy acting on the genital epithelium to the systemic treatment should be considered . OBJECTIVE To evaluate the effects of a combined therapy consisting of vaginal estriol with transdermal 17-beta-estradiol ( 50 microg/day ) plus medroxyprogesterone acetate ( 5 mg/day ) per os in shortening the period of uro-genital symptoms . SUBJECTS AND METHODS In a randomized , double blind , controlled with placebo study , 27 women with climacteric symptoms and atrophic vaginitis were treated for 4 months with HT plus vaginal estriol 0.5 mg/day ( group E ) or placebo ( group P ) . Patients use the local medication daily for the first 3 weeks and twice-weekly thereafter . Before entering in the study , patients were asked about HT and selected for inclusion . In the first visit , electible patients after written informed consent were randomized to receive HT plus local estriol or placebo . All the subjects had baseline studies , including medical history , physical examination , blood and urine analysis . In order to evaluate the effect of local treatment on urinary and genital symptoms , a score for genital , urinary and colposcopic complaints ( 0 minimum-100 maximum ) was developed . This score and Blatt-Kuperman were recorded and performed in every control . RESULTS There were no differences on climacteric symptoms relief between the two groups . Additionally , the improvement in urinary symptoms at the end of the study was similar for both groups ( from 16.5 +/- 6.1 to 8.5 +/- 2.4 for E group and from 15.8 +/- 7.8 to 8.8 +/- 2.7 for P group ; P < 0.01 versus basal ) ; however , those women in group E reached significant improvement on urinary complaints since the first month of treatment . Additionally , a significant difference between E and P was observed at months 2 and 3 , although no differences were detected at the end of the study . Papanicolaou smear showed reactive or reparative changes and karyopyknotic index exhibited a significant increase in superficial cells in both groups and at the end of the study . CONCLUSIONS Adding vaginal estriol to HRT may shorten the latency period for urinary symptoms .

estrogens

systemic hormone therapy ( HT )

placebo

HT plus vaginal estriol 0.5 mg/day

placebo

HT plus local estriol

placebo

superficial cells

urogenital atrophy

postmenopausal

women

on hormone therapy

women

climacteric symptoms

atrophic vaginitis


Skeletal muscle total creatine content and creatine transporter gene expression in vegetarians prior to and following creatine supplementation . This study examined the effect of vegetarianism on skeletal muscle total creatine ( TCr ) content and creatine transporter ( CreaT ) gene expression , prior to and during 5 d of Cr supplementation ( CrS ) . In a double-blind , crossover design , 7 vegetarians ( VEG ) and nonvegetarians ( NVEG ) were assigned Cr or placebo supplements for 5 d and after 5 wk , received the alternative treatment . Muscle sampling occurred before , and after 1 and 5 d of treatment ingestion . Basal muscle TCr content was lower ( P < 0.05 ) in VEG compared with NVEG . Muscle TCr increased ( P < 0.05 ) throughout the Cr trial in both groups but was greater ( P < 0.05 ) in VEG compared with NVEG , at days 1 and 5 . CreaT gene expression was not different between VEG and NVEG . The results indicate that VEG have a lower muscle TCr content and an increased capacity to load Cr into muscle following CrS . Muscle CreaT gene expression does not appear to be affected by vegetarianism .

creatine supplementation

Cr supplementation ( CrS )

Cr

placebo supplements

Muscle sampling

Cr

CrS

Basal muscle TCr

CreaT gene expression

muscle TCr content

capacity

Muscle CreaT gene expression

vegetarians


Etanercept plus standard therapy for Wegener 's granulomatosis . BACKGROUND The majority of patients with Wegener 's granulomatosis have disease flares after conventional medications are tapered . There is no consistently safe , effective treatment for the maintenance of remission . METHODS We conducted a randomized , placebo-controlled trial at eight centers to evaluate etanercept for the maintenance of remission in 180 patients with Wegener 's granulomatosis . The primary outcome was sustained remission , defined as a Birmingham Vasculitis Activity Score for Wegener 's Granulomatosis of 0 for at least six months ( scores can range from 0 to 67 , with higher scores indicating more active disease ) . In addition to etanercept or placebo , patients received standard therapy ( glucocorticoids plus cyclophosphamide or methotrexate ) . After remission , standard medications were tapered according to the protocol . RESULTS The mean follow-up for the overall cohort was 27 months . Of the 174 patients who could be evaluated , 126 ( 72.4 percent ) had a sustained remission , but only 86 ( 49.4 percent ) remained in remission for the remainder of the trial . There were no significant differences between the etanercept and control groups in the rates of sustained remission ( 69.7 percent vs. 75.3 percent , P=0.39 ) , sustained periods of low-level disease activity ( 86.5 percent vs. 90.6 percent , P=0.32 ) , or the time required to achieve those measures . Disease flares were common in both groups , with 118 flares in the etanercept group ( 23 severe and 95 limited ) and 134 in the control group ( 25 severe and 109 limited ) . There was no significant difference between the etanercept and control groups in the relative risk of disease flares per 100 person-years of follow-up ( 0.89 , P=0.54 ) . During the study , 56.2 percent of patients in the etanercept group and 57.1 percent of those in the control group had at least one severe or life-threatening adverse event or died ( P=0.90 ) . Solid cancers developed in six patients in the etanercept group , as compared with none in the control group ( P=0.01 ) . CONCLUSIONS Etanercept is not effective for the maintenance of remission in patients with Wegener 's granulomatosis . Durable remissions were achieved in only a minority of the patients , and there was a high rate of treatment-related complications .

Etanercept plus standard therapy

placebo-controlled

etanercept

etanercept

placebo

standard medications

etanercept

etanercept

control group

etanercept

etanercept

etanercept

Etanercept

sustained remission

sustained remission

remission

rates of sustained remission

low-level disease activity

Disease flares

relative risk of disease flares

died

Solid cancers

maintenance of remission

Durable remissions


Spinal 2-chloroprocaine : the effect of added clonidine . Preservative-free 2-chloroprocaine ( 2-CP ) is being investigated for short-acting spinal anesthesia . Clonidine improves the quality of spinal bupivacaine and ropivacaine , but in traditional doses ( 1-2 microg/kg ) it produces systemic side effects . It has not been studied in combination with 2-CP . In this double-blind , randomized crossover study , we compared spinal 2-CP ( 30 mg ) with and without clonidine ( 15 microg ) in eight volunteers . Pinprick anesthesia , motor strength , tolerance to electrical stimulation and thigh tourniquet , and time to ambulation were assessed . Peak block height was similar between 2-CP ( T8 [ range , T6 to L2 ] ) and 2-CP with clonidine ( T8 [ range , T4 to T11 ] ) ( P = 0.57 ) . Sensory anesthesia was prolonged with clonidine at L1 ( 51 +/- 23 min versus 76 +/- 11 min ; P = 0.002 ) , as was complete block regression ( 99 +/- 18 min versus 131 +/- 15 min ; P = 0.001 ) . Lower extremity motor blockade was increased with clonidine ( return to baseline Bromage score : 65 +/- 13 min versus 79 +/- 19 min , P = 0.004 ; return to 90 % gastrocnemius strength : P = 0.003 ) . Clonidine increased tourniquet tolerance from 33 to 45 min ( P = 0.06 ) and increased time to ambulation , spontaneous voiding , and discharge ( 99 +/- 18 min versus 131 +/- 15 min for all ; P = 0.001 ) . There were no differences in hemodynamic measurements , and no subject reported transient neurologic symptoms . We conclude that small-dose clonidine increases the duration and improves the quality of 2-CP spinal anesthesia without systemic side effects .

clonidine

2-chloroprocaine ( 2-CP )

Clonidine

bupivacaine

ropivacaine

spinal 2-CP

with and without clonidine

clonidine

clonidine

Clonidine

clonidine

spinal bupivacaine

ropivacaine

Pinprick anesthesia

time to ambulation

Peak block height

Sensory anesthesia

complete block regression

Lower extremity motor blockade

gastrocnemius strength :

tourniquet tolerance

hemodynamic measurements

transient neurologic symptoms

quality of 2-CP spinal anesthesia

systemic side effects

eight


Pilot study of a moderate dose multivitamin/mineral supplement for children with autistic spectrum disorder . OBJECTIVE Determine the effect of a moderate dose multivitamin/mineral supplement on children with autistic spectrum disorder . DESIGN Randomized , double-blind , placebo-controlled 3-month study . SUBJECTS Twenty ( 20 ) children with autistic spectrum disorder , ages 3-8 years . RESULTS A Global Impressions parental questionnaire found that the supplement group reported statistically significant improvements in sleep and gastrointestinal problems compared to the placebo group . An evaluation of vitamin B ( 6 ) levels prior to the study found that the autistic children had substantially elevated levels of B6 compared to a control group of typical children ( 75 % higher , p < 0.0000001 ) . Vitamin C levels were measured at the end of the study , and the placebo group had levels that were significantly below average for typical children , whereas the supplement group had near-average levels . DISCUSSION The finding of high vitamin B ( 6 ) levels is consistent with recent reports of low levels of pyridoxal-5-phosphate and low activity of pyridoxal kinase ( i.e. , pyridoxal is only poorly converted to pyridoxal-5-phosphate , the enzymatically active form ) . This may explain the functional need for high-dose vitamin B ( 6 ) supplementation in many children and adults with autism .

multivitamin/mineral supplement

placebo-controlled

placebo

vitamin B ( 6 ) supplementation

statistically significant improvements

sleep and gastrointestinal problems

vitamin B ( 6 ) levels

substantially elevated levels of B6

Vitamin C levels

high vitamin B ( 6 ) levels

levels of pyridoxal-5-phosphate

activity of pyridoxal kinase

autistic children


Postoperative magnesium sulphate infusion reduces analgesic requirements in spinal anaesthesia . BACKGROUND AND OBJECTIVES Magnesium sulphate infusion during general anaesthesia reduces anaesthetic consumption and analgesic requirements . The aim of this study was to assess the effects of postoperative magnesium infusion on duration of block , sedation and analgesic consumption after spinal anaesthesia . METHODS Fifty ASA I-II patients were included in the randomized double blind study . Spinal anaesthesia was performed at L3-4 or L4-5 interspace with 12.5 mg 0.5 % heavy bupivacaine , using a 25 G Quincke needle . Patients received a 5 mg kg ( -1 ) bolus of magnesium sulphate followed by a 500 mg h ( -1 ) infusion or saline in the same volumes for 24 h. Time to first pain , analgesic request , return of motor function , visual analogue pain and sedation scores were evaluated every 4 h during the 24 h postoperative period . The t- and U-tests were used for statistical analyses . Data were expressed as mean +/- SD , with P < 0.05 being considered significant . RESULTS Vital signs were stable during spinal anaesthesia and postoperative period . When compared to the control group , time to analgesic need was increased and total analgesic consumption was reduced in the magnesium group ( meperidine consumption 60.0 +/- 73.1 mg control group , 31.8 +/- 30.7 mg magnesium group , P = 0.02 ) . CONCLUSIONS Magnesium sulphate infusion may be used as an adjunct for reducing analgesic consumption after spinal anaesthesia .

magnesium sulphate infusion

Magnesium sulphate

magnesium

Magnesium sulphate

anaesthetic consumption

analgesic requirements .

Time to first pain , analgesic request

return of motor function

visual analogue pain

sedation scores

Vital signs

time to analgesic need

total analgesic consumption

analgesic consumption

Fifty

ASA I-II patients

after spinal anaesthesia


A phase III , double-blind , placebo-controlled , multicenter study on the efficacy of recombinant human antithrombin in heparin-resistant patients scheduled to undergo cardiac surgery necessitating cardiopulmonary bypass . BACKGROUND The study evaluated the efficacy of recombinant human antithrombin ( rhAT ) for restoring heparin responsiveness in heparin resistant patients undergoing cardiac surgery . METHODS This was a multicenter , randomized , double-blind , placebo-controlled study in heparin-resistant patients undergoing cardiac surgery with cardiopulmonary bypass . Heparin resistance was diagnosed when the activated clotting time was less than 480 s after 400 U/kg heparin . Fifty-four heparin-resistant patients were randomized . One cohort received 75 U/kg rhAT , and the other received normal saline . If the activated clotting time remained less than 480 s , this was considered treatment failure , and 2 units fresh frozen plasma was transfused . Patients were monitored for adverse events . RESULTS Only 19 % of patients in the rhAT group received fresh frozen plasma , compared with 81 % of patients in the placebo group ( P < 0.001 ) . During their hospitalization , 48 % of patients in the rhAT group received fresh frozen plasma , compared with 85 % of patients in the placebo group ( P = 0.009 ) . Patients in the placebo group required higher heparin doses ( P < 0.005 ) for anticoagulation . There was no increase in serious adverse events associated with rhAT . There was increased blood loss 12 h postoperatively ( P = 0.05 ) with a trend toward increased 24-h bleeding in the rhAT group ( P = 0.06 ) . There was no difference between the groups in blood and platelet transfusions . CONCLUSION Treatment with 75 U/kg rhAT is effective in restoring heparin responsiveness and promoting therapeutic anticoagulation in the majority of heparin-resistant patients . Treating heparin-resistant patients with rhAT may decrease the requirement for heparin and fresh frozen plasma .

placebo-controlled

recombinant human antithrombin

recombinant human antithrombin ( rhAT )

Heparin

heparin

received 75 U/kg rhAT

received normal saline

rhAT

placebo

rhAT

placebo

heparin

rhAT

rhAT

rhAT

rhAT

heparin responsiveness

no increase in serious adverse events

increased blood loss

24-h bleeding

therapeutic anticoagulation

decrease the requirement for heparin

cardiac surgery

Fifty-four


Effects of an antimicrobial additive to toothbrushes on residual periodontal pathogens . OBJECTIVE Previous studies have reported the link between residual microbial contamination of toothbrushes and periodontal diseases . The goal of this pilot study was to evaluate the effects of an antimicrobial additive ( Microban ) to toothbrushes on residual retention of periodontal pathogens . METHODOLOGY Twenty patients had one side of their mouths brushed with a toothbrush containing the antimicrobial agent ( experimental side ) , and the other side with a toothbrush containing no agent ( control ) . Toothbrushes were air-dried ( 25 degrees C ) for four or 24 hours . Toothbrush heads were vortexed and cultured for Prevotella species ( Ps ) , Porphyromonas gingivalis ( Pg ) , Actinobacillus actinomycetemcomitans ( Aa ) , and non-specific colony-forming units ( NS ) . The plates were incubated and counted . Means and standard deviations were calculated , and data were analyzed using a series of t-tests ( paired and unpaired ) and Wilcoxon matched-pairs signed-rank test . RESULTS No significant inter- or intra-group differences in mean counts were found ; however , when four-hour and 24-hour data for Aa , Pg , or NS were combined , experimental counts were lower than controls in 39/50 ( 78 % ) of the matched pairs ( Wilcoxon signed-rank test p = 0.01 ) . CONCLUSION Toothbrushes containing the antimicrobial additive showed lower microbial counts than those without , but between-group means were not statistically significant .

antimicrobial additive

an antimicrobial additive

Microban

toothbrush containing no agent

antimicrobial additive

mean counts

Aa , Pg , or NS

experimental counts

microbial counts

periodontal diseases

Twenty


Immunogenicity and reactogenicity of two regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio and Haemophilus influenzae type b vaccines administered to infants primed at birth with hepatitis B vaccine . An open , randomized study evaluated the immune response and safety of two different regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b ( DTPa-HBV-IPV-Hib ) immunization in infants primed at birth with hepatitis B vaccine . One-half of the 150 healthy , full-term infants received a DTPa HBV-IPV-Hib vaccine at 1 1/2 , 3 and 5 months of age ; the other received a DTPa-IPV-Hib vaccine at 1 1/2 , 3 and 5 months of age with separate HBV vaccine at 1 and 5 months of age . Immune response was similar following the two regimens with 100 % of the vaccinees seroprotected for HBV , diphtheria , tetanus , Hib and poliovirus types 2 and 3 diseases after the full vaccination course . One vaccinee in the DTPa HBV-HPV- Hib group failed to respond to the poliovirus type 1 antigen . Response to the three pertussis antigens ranged from 92-97 % in the DTPa-IPV-Hib plus separate HBV group and 100 % in the DTPa HBV-IPV-Hib group . The most frequently reported post-vaccination symptoms were irritability in the DTPa-IPV-Hib plus separate HBV group ( 49 % of vaccinees ) and fever , defined as axillary temperature > or =37.5 degrees C , in the DTPa HBV- IPV-Hib group ( 50 % of vaccinees ) .

type b vaccines administered

DTPa HBV-IPV-Hib vaccine

DTPa-IPV-Hib

HBV vaccine

Immunogenicity

reactogenicity

immune response

safety

Response

irritability

fever

infants

hepatitis B

infants

hepatitis B

infants


Primary vitrectomy for combined rhegmatogenous retinal detachment and choroidal detachment with or without oral corticosteroids : a pilot study . PURPOSE The occurrence of choroidal detachment ( CD ) in eyes with primary rhegmatogenous retinal detachment ( RRD ) is relatively uncommon ( 2 % -4.5 % ) . Recent reports suggest that primary vitrectomy yields better anatomic success than scleral buckling . However , for these inflamed eyes with low intraocular pressure , the influence of preoperative oral steroids on reattachment rates has not been elucidated yet . METHODS Twenty eyes with combined RRD and CD that underwent primary vitrectomy were randomized to receive oral steroids ( for 1 week ) or no oral steroids before surgery . RESULTS Preoperative clinical data such as mean age , lens status , Snellen visual acuity , duration of macular detachment , CD ( size and extent ) , and retinal detachment characteristics ( e.g. , extent , number of retinal breaks , atrophic or tractional retinal break , size of retinal break , and location of retinal break ) were similarly distributed in both groups . Single-operation anatomic success was 81.8 % ( 9/11 ) among those patients who received preoperative oral steroids and was 66.7 % ( 6/9 ) among those who did not receive preoperative oral steroids . After reoperation , anatomic success was 100 % in both groups . The mean follow-up was 20.1 months . CONCLUSION The results suggest that administration of oral steroids before primary vitrectomy in eyes with combined RRD and CD improves reattachment rates .

Primary vitrectomy

with or without oral corticosteroids

underwent primary vitrectomy

steroids

steroids

Single-operation anatomic success

anatomic success

oral corticosteroids

low intraocular pressure

Twenty

combined RRD and CD

combined RRD and CD


Prospective randomized controlled trial comparing plasmakinetic vaporesection and conventional transurethral resection of the prostate . OBJECTIVE Plasmakinetic vaporesection of the prostate ( PKVP ) using normal saline irrigation has the theoretical advantage of avoiding transurethral resection syndrome and minimizing blood loss . It may also shorten the operative time since tissue is resected instead of just vaporized . The aim of this study was to evaluate the efficiency , safety and advantages of PKVP compared with standard transurethral resection of the prostate ( TURP ) at a regional acute hospital . METHODS A total of 60 consecutive men admitted from a waiting list for surgery for benign prostatic hyperplasia ( BPH ) were prospectively randomized to either PKVP or TURP . Peri- and postoperative outcome data at 3 months were obtained . RESULTS The PKVP loop achieved a fast and sharp cutting action similar to that with the traditional TURP loop . Data analysis was based on 51 patients . There were no significant differences between the methods in resection time , postoperative catheterization time and hospital stay . The mean reductions in serum sodium 2 hours after PKVP and on postoperative day 1 were 0.52 mmol/L and 3.35 mmol/L , respectively , while mean reductions in haemoglobin were 0.36 g/dL and 0.24 g/dL , respectively . There was no significant difference in haemoglobin reductions between PKVP and TURP ( p = 0.326 at 2 hours ; p = 0.192 on day 1 ) and serum sodium ( p = 0.757 at 2 hours ; p = 0.888 on day 1 ) . Both groups achieved comparable improvement in International Prostate Symptom Score ( p = 0.862 ) , quality-of-life score ( p = 0.169 ) and peak flow rate ( p = 0.96 ) at 3-month follow-up . CONCLUSION PKVP achieved comparable results to traditional TURP and was an effective and safe procedure . However , it did not demonstrate obvious advantages over TURP in this acute regional hospital regular TURP list setting .

plasmakinetic vaporesection

conventional transurethral resection

PKVP

TURP

PKVP

TURP

efficiency

safety

advantages

resection time

postoperative catheterization time

hospital stay

mean reductions in serum sodium

haemoglobin reductions

International Prostate Symptom Score

effective and safe

men

benign prostatic hyperplasia ( BPH )

51 patients


Long-term follow-up of a randomized trial of fludarabine-mitoxantrone , compared with cyclophosphamide , doxorubicin , vindesine , prednisone ( CHVP ) , as first-line treatment of elderly patients with advanced , low-grade non-Hodgkin 's lymphoma before the era of monoclonal antibodies . BACKGROUND This randomized study compared the efficacy and safety of fludarabine-mitoxantrone ( FM ) with mini-CHVP ( cyclophosphamide , doxorubicin , vindesine , prednisone ) in elderly patients with advanced , low-grade non-Hodgkin 's lymphoma . PATIENTS AND METHODS End points were remission rates [ overall response ( OR ) and complete response ( CR ) ] , failure-free survival ( FFS ) , survival and toxicity . One hundred and fifty-five patients were randomized , 144 were evaluable for safety and 142 for response . Each treatment arm was given as six monthly cycles , followed by three bimonthly cycles . FM comprised fludarabine ( 20 mg/m ( 2 ) i.v . ) , days 1-5 , plus mitoxantrone ( 10 mg/m ( 2 ) i.v . ) , day 1 . CHVP cycles comprised cyclophosphamide ( 750 mg/m ( 2 ) i.v . infusion ) , doxorubicin ( 25 mg/m ( 2 ) i.v . ) and vindesine ( 3 mg/m ( 2 ) i.v . ) on day 1 , and prednisone ( 50 mg/m ( 2 ) ) on days 1-5 . RESULTS FM therapy resulted in superior remission rates ( OR 81 % versus 64 % , CR 49 % versus 17 % ; P = 0.0004 ) . Median FFS for FM patients was 36 months , compared with 19 months for CHVP patients , and has not yet been reached for early CR patients at 53 months . Treatment arm was the major risk factor influencing survival . Both treatments were well tolerated , with only few infectious complications . CONCLUSION FM was more effective than CHVP in achieving OR and CR , and favorably affected the outcome .

fludarabine-mitoxantrone

fludarabine-mitoxantrone ( FM )

mini-CHVP

cyclophosphamide

doxorubicin

vindesine

prednisone

fludarabine

mitoxantrone

cyclophosphamide

doxorubicin

vindesine

prednisone

FM

FM

FM

efficacy

safety

remission rates [

overall response ( OR )

and

complete response ( CR )

failure-free survival ( FFS )

survival

toxicity

remission rates

Median FFS

survival

tolerated

infectious complications

effective

OR

CR


Randomized controlled trial to compare the early and mid-term results of stapled versus open hemorrhoidectomy . BACKGROUND The new technique of circular stapler for the treatment of hemorrhoids has shown early promise in terms of minimal or no postoperative pain , early discharge from hospital , and quick return to work . This study was designed to compare stapled technique with the well-accepted conventional Milligan Morgan hemorrhoidectomy . METHODS After fulfilling the selection criteria , 84 patients were randomly allocated to the stapled ( n = 42 ) or open group ( n = 42 ) . All patients were operated on under spinal anesthesia . The 2 techniques were evaluated with respect to the operative time , pain scores , complications , day of discharge , return to work , and level of satisfaction . RESULTS The mean age of patients was 46.02 years ( SD , 12.33 ) in the stapled group and 48.64 years ( 14.57 ) in the open group . Grade III or IV hemorrhoids were more common in men ( ie , 80.9 % and 85.7 % in the stapled and open group , respectively ) . The mean operative time was shorter in the stapled group 24.28 minutes ( 4.25 ) versus 45.21 minutes ( 5.36 ) in the Milligan-Morgan group ( P < .001 ) . The blood loss , pain scores and requirement of analgesics was significantly less in the stapled group . Mean hospital stay was 1.24 days ( 0.62 ) and 2.76 days ( 1.01 ) ( P < .001 ) in the stapled and open group , respectively . The patients in the stapled group returned to work or routine activities earlier ( ie , within 8.12 days [ 2.48 ] ) as compared with 17.62 ( 5.59 ) in the open group . Only 88.1 % of patients were satisfied by the open method compared with 97.6 % after the stapled technique . The median follow-up period was 11 months with a maximum follow-up of 19 months ( range 2-19 months ) . CONCLUSIONS Stapled hemorrhoidectomy is a safe and effective day-care procedure for the treatment of grade III and grade IV hemorrhoids . It ensures lesser postoperative pain , early discharge , less time off work , complications similar to the open technique , and in the end a more satisfied patient with no perianal wound . However , more such randomized trials are essential to deny any long-term complication .

stapled versus open hemorrhoidectomy .

stapled

open

spinal anesthesia .

Stapled hemorrhoidectomy

operative time

pain scores

complications

day of discharge

return to work

level of satisfaction

Grade III or IV hemorrhoids

mean operative time

blood loss

pain scores

requirement of analgesics

Mean hospital stay

returned to work or routine activities

satisfied

safe and effective

postoperative pain

early discharge

less time off work

complications

satisfied patient

hemorrhoidectomy

hemorrhoids

patients was 46.02 years

48.64 years ( 14.57

hemorrhoids


Reducing blood loss at open myomectomy using triple tourniquets : a randomised controlled trial . OBJECTIVES To evaluate triple tourniquets in controlled conditions and for the first time to investigate the hypothesis that leaving a semi-permanent tourniquet around the uterine artery reduces post-operative bleeding from the uterine incisions . DESIGN A randomised controlled trial . SETTING Two University teaching hospitals . POPULATION Twenty-eight patients with symptomatic fibroids and uterine sizes ranging from 14 to 24 weeks of gestation undergoing open myomectomy . METHODS A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries , and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels . At the end of the procedure , the ovarian ties were released but the uterine artery suture remained in situ . MAIN OUTCOME MEASURES Intra-operative blood loss , post-operative blood loss , blood transfusion rates , operative morbidity , uterine blood flow and ovarian function . RESULTS There was significantly less blood lost in the tourniquet group than in the control group ( difference between means 1870 mL , 95 % CI 1159-2580 mL , P < 0.0001 ; transfusion rates of 7 % and 79 % , P= 0.0003 ) . The volume in the pelvic drain 20 min post-operatively and after 48 hours failed to reach statistical significance between the two groups ( P= 0.10 and P= 0.165 ) . There were no differences in uterine artery Doppler resistance indices at five days ( P= 0.54 ) , six weeks ( P= 0.47 ) , three months ( P= 0.49 ) and at six months ( P= 0.18 ) . Day two serum FSH concentrations after surgery were unchanged ( P= 0.45 ) , compared with baseline values . CONCLUSIONS Triple tourniquets are effective in reducing bleeding and transfusion rates . There appears no obvious adverse effect on uterine perfusion or ovarian function .

open myomectomy

triple tourniquets

triple tourniquets

myomectomy

Triple tourniquets

blood loss

less blood lost

volume in the pelvic drain

no differences

serum FSH concentrations

unchanged

bleeding and transfusion rates .

uterine perfusion or ovarian function .

open myomectomy

Twenty-eight

myomectomy


[ Relationship between sCD44v6 expression and TCM differentiation type of gastric carcinoma patients and influence of weitai capsule on the expression ] . OBJECTIVE To explore the relationship of TCM type with serum level of soluble CD44v6 ( sCD44v6 ) and different histologic parameters in gastric carcinoma patients and to observe the influence of Weitai capsule ( WTC ) on the sCD44v6 expression . METHODS TCM typing and sCD44v6 expression were determined in all the enrolled patients ( 30 in the control and 32 in the trial group ) before operation , and 3-4 courses of chemotherapy was applied to them from 3-4 weeks after operation . To the patients of trial group , oral administration of WTC was given additionally with 4 capsules , 3 times a day for consecutive 3 months . RESULTS sCD44v6 was significantly positive correlated with the degree of cancer cell differentiation , infiltration and lymph node metastasis ; ( 2 ) Level of sCD44v6 was the highest in patients of blood stasis type , as compared with that in the patients of Pi-deficiency type or of damp-heat type , the difference was significant ; ( 3 ) After ending treatment , level of sCD44v6 in the trial group was significantly lower than that in the control group . CONCLUSION ( 1 ) Serum level of sCD44v6 could be taken as the criterion for evaluating the development and prognosis of gastric cancer , as well as the therapeutic target for anti-metastasis treatment ; ( 2 ) Serum level of sCD44v6 is related to some extent with TCM type of blood stasis and Pi-deficiency ; ( 3 ) WTC combined with chemotherapy could further inhibit the expression of serum sCD44v6 in gastric carcinoma patients .

weitai capsule

Weitai capsule ( WTC )

chemotherapy

WTC

WTC

chemotherapy

sCD44v6 expression

expression

histologic parameters

sCD44v6 expression

TCM typing

sCD44v6 expression

Level of sCD44v6

level of sCD44v6

Serum level of sCD44v6

Serum level of sCD44v6

expression of serum sCD44v6

gastric carcinoma

gastric carcinoma

blood stasis type

Pi-deficiency type or of damp-heat type


Efficacy screening trials of paroxetine , pentoxifylline , riluzole , pramipexole and venlafaxine in cocaine dependence . AIMS The two studies presented here were conducted to assess the efficacy of paroxetine , pentoxifylline , riluzole , venlafaxine and pramipexole as medications for the treatment of cocaine dependence . DESIGN A multi-arm , modified blinded , placebo-controlled design was used . SETTING The studies were conducted at the Boston VA Healthcare System and the Boston University School of Medicine Medication Development Research Unit ( MDRU ) . PARTICIPANTS Participants met criteria for cocaine dependence during a 2-week screening period . INTERVENTION Following random assignment to one of the treatment groups , subjects received active medication or placebo for 8 weeks in combination with cognitive behavioral counseling . In the first study the efficacy of the antidepressant paroxetine ( 20 mg daily ) , the phosphodiesterase inhibitor pentoxifylline ( 1200 mg daily ) and the glutamate release inhibitor riluzole ( 100 mg daily ) was assessed . The antidepressant venlafaxine ( 150 mg daily ) and the dopamine agonist pramipexole ( 1.5 mg daily ) were evaluated in the second study . MEASUREMENTS Urine benzoylecgonine ( BE ) concentrations , self-report of cocaine use and global impression scores served as primary outcome measures . Secondary measures included assessments of cocaine craving and psychiatric functioning . Adverse events were monitored during the treatment period . FINDINGS None of the active medications produced greater reductions in urine BE concentrations over the treatment period than did placebo . There were trends for BE levels to become reduced in the pentoxifylline group during the first 4 weeks of treatment and for Addiction Severity Index ( ASI ) drug composite scores to be lower in the pentoxyfylline group at end-point compared to the placebo group . Significant within-group reductions in reported cocaine use and craving were found for all treatment groups , but none of the active medications were superior to placebo on these measures . The accuracy of self-reported cocaine use declined over the study period . Overall , the active medications were well tolerated . CONCLUSIONS This study does not support the use of paroxetine , pentoxifylline , riluzole , venlafaxine or pramipexole for the treatment of cocaine dependence . However , these results need to be interpreted with caution because of the small size and lack of homogeneity of the experimental groups .

paroxetine

pentoxifylline

riluzole

pramipexole

venlafaxine

paroxetine

pentoxifylline

riluzole

venlafaxine

pramipexole

placebo-controlled

active medication

placebo

cognitive behavioral counseling

antidepressant paroxetine

glutamate release inhibitor riluzole

antidepressant venlafaxine

dopamine agonist pramipexole

placebo

pentoxifylline

pentoxyfylline

placebo

paroxetine

pentoxifylline

riluzole

venlafaxine

pramipexole

Efficacy

efficacy

efficacy

self-report of cocaine use

global impression scores

assessments of cocaine craving

psychiatric functioning

Adverse events

urine BE concentrations

BE levels

Addiction Severity Index ( ASI )

cocaine use and craving

self-reported cocaine use

tolerated