烟草行业伐伦克林对戒除低烟量烟
草的帮助随机双盲安慰剂对照研
11December2010Volume341,Issue7785
壹.Research
:randomiseddoubleblindplacebocontrolle
dtrial
伐伦克林对戒除低烟量烟草的帮助：随机双盲安慰剂对照研究
:furtheranalysisof
theMulticentrestudyofearlyEpilepsyandSingleSeizures
首次癫痫发作后再发风险及其对驾驶的影响：早期癫痫和单次发作的多中心研
究的进壹步分析
:systema
ticreviewandcase-controlstudy
卡马西平的宫内暴露和先天畸形：系统回顾和病例对照研究
-
:r
andomisedcontrolledtrial
在 -9个月时接种标准麻疹疫苗对儿童死亡率的非特异性效果：随机对照试
验
二.ClinicalReview
Investigatingandmanagingchronicscrotalpain
调查和处理慢性阴囊疼痛
三.Practice
容易忽视：？感染性心内膜炎
:Acuteliverfailureafteradministrationofparacetamolatthemaximum
recommendeddailydoseinadults
本周课程：成人扑热息痛每日最大推荐用量使用时的急性肝衰竭
四.Analysis
Howdopatientsuseinformationonhealthproviders?
病人如何利用关于健康提供者的信息
Whatdopatientswantofperformanceinformation?
病人想要什么样的表现信息？
五.Observations
LobbyWatch:TheInstituteforFiscalStudies
LobbyWatch：财政研究学院
六.Feature
ResearchEthics:Therulesofretraction
研究伦理学：撤销的法则
Briefing:TheBriberyAct:whatitmeansforyou
主要信息：受贿艺术：对你意味着什么呢？
ConflictandRape:Afterwar,whatnext?
冲突和强奸：战后，接下来是什么呢？
Commentary:whatinterventionsworkforvictimsofconflictrelatedrape?
评论：什么样的噶怒措施对冲突中的强奸受害人有用呢？
七.News
小剂量阿司匹林可降低多种癌症死亡的风险
,Canada,andRussiatosoftenoppositiontoclimatetrea
ty
谈判专家努力说服日本，加拿大和俄罗斯软化对气候变化协议的反对
顾问应该对住院病人提供每天 12小时可能的服务
’splansforNHS
保守党资深部长要求审议国民保健服务 Lansley计划
在社会关怀的削减可能把照顾临终病人的压力转嫁给医院
法国医生要求知道药物在市场上停留如此久的原因
欧洲药品管理局扩大获取其文件的范围
新中心对更多的癌症患者开放临床试验
ndoctorsintheUS
和法国医药代表的紧密关系意味着法国医生获得比美国医生更多的平衡信息
加拿大独立审查组药物小组财政紧张
八.Research摘要
:randomiseddoubleblindplacebocontrolle
dtrial
伐伦克林对戒除低烟量烟草的帮助：随机双盲安慰剂对照研究
ObjectiveToassesstheefficacyandsafetyofvarenicline(alicensedcigarettesmokingcessationaid)inhe
lpingusersofsmokelesstobaccotoquit.
DesignDoubleblind,placebocontrolled,parallelgroup,multicentre,randomisedcontrolledtrial.
SettingMedicalclinics(mostlyprimarycare)inNorwayandSweden.
ParticipantsMenandwomenaged≥18whousedsmokelesstobaccoatleasteighttimesaday,withnoabstinencep
eriodoverthreemonthswithinoneyearbeforescreening,
eexcludediftheyusedanyotherformoftobacco(exceptsmokelesstobacco)ormedicationtostopsmokingwith
inthreemonthsofscreeningorhadanypre-existingmedicalorpsychiatriccondition.
InterventionsVarenicline1mgtwicedaily(titratedduringthefirstweek)orplacebofor12weeks,with14we
eks’follow-upaftertreatment.
MainoutcomemeasuresTheprimaryendpointwasthefourweekcontinuousabstinencerateattheendoftreatmen
t(weeks9-
12)-
.
Results431participants(213varenicline;218placebo)wererandomisedandreceivedatleastonedoseofstu
’demographicsandbaselineuseofsmokelesstobaccoweresimilar(89%(189)and90%(1
96),respectively,weremen;;participantsusedsmokelesstobaccoproductsa
bout15timesaday,andabout80%firstusedsmokelesstobaccowithin30minutesafterawakening).Continuous
abstinencerateatweek9-
12washigherinthevareniclinegroupthantheplacebogroup(59%(125)v39%(85);,95%conf
,P<;riskdifference20%;numberneededtotreat5).Theadvantageofvareni
clineoverplacebopersistedthrough14weeksoffollow-up(continuousabstinencerateatweek9-
26was45%(95)v34%(73);,,P=;riskdifference11%;numberneededtotrea
t9).Themostcommonadverseeventsinthevareniclinegroupcomparedwiththeplacebogroupwerenausea(35%(
74)v6%(14)),fatigue(10%(22)v7%(15)),headache(10%(22)v9%(20)),andsleepdisorder(10%(22)v7%(15)).F
ewadverseeventsledtodiscontinuationoftreatment(9%(19)and4%(9),respectively),andseriousadverse
eventsoccurredintwo(1%)andthree(1%)participants,respectively.
responserateintheplacebogroupinthisstudywashigh,suggestingapopulationlessresistanttotreatment
thansmokers.
:furtheranalysisof
theMulticentrestudyofearlyEpilepsyandSingleSeizures
首次癫痫发作后再发风险及其对驾驶的影响：早期癫痫和单次发作的多中心研
究的进壹步分析
ObjectiveTodetermineforhowlongafterafirstunprovokedseizureadrivermustbeseizure-
freebeforetheriskofrecurrenceinthenext12monthsfallsbelow20%,enablingthemtoregaintheirdrivingl
icence.
DesignRandomisedcontrolledtrial:MulticentrestudyofearlyEpilepsyandSingleSeizures(MESS).
SettingUKhospitaloutpatientclinicsfrom1January1993to31December2000.
ParticipantsPeopleenteredMESSiftheyhadhadoneormoreunprovokedseizuresandboththeparticipantandt
rthisanalysiscomprisedparticipantsagedatleast16yearswithasingleunprovokedseizure.
MainoutcomemeasureRiskofseizurerecurrenceinthe12monthsafteraseizure-
freeperiodof6,12,18,or24monthsfromthedateofthefirst(index)
oinvestigatehowantiepileptictreatmentandseveralclinicalfactorsinfluencetheriskofseizurerecurr
ence.
ResultsAtsixmonthsaftertheindexseizuretheriskofrecurrenceinthenext12monthsforthosewhostartant
iepilepticdrugswassignificantlybelow20%(unadjustedrisk14%,95%confidenceinterval10%to18%).Forp
atientswhodidnotstarttreatmenttheriskestimatewaslessthan20%buttheupperlimitoftheconfidenceint
ervalwasgreaterthan20%(18%,13%to23%).Multivariableanalysesidentifiedsubgroupswithasignificant
lygreaterthan20%riskofseizurerecurrenceinthe12monthsafterasixmonthseizure-
freeperiod,suchasthosewitharemotesymptomaticseizurewithabnormalelectroencephalogramresults.
ConclusionAfterasingleunprovokedseizurethisreanalysisofMESSprovidesestimatesofseizurerecurren
sneededastohowsuchdatashouldbeutilised;inparticular,whetherapopulationapproachshouldbetakenwi
cusisontheestimateonlyourunadjustedestimatessuggestthattreatedanduntreatedpatientsareeligible
todriveafterbeingseizure-
,directionisneededastowhetheraconservat
iveorliberalapproachshouldbetaken.
:systema
ticreviewandcase-controlstudy
卡马西平的宫内暴露和先天畸形：系统回顾和病例对照研究
ObjectiveToidentifyspecificmajorcongenitalmalformationsassociatedwithuseofcarbamazepineinthef
irsttrimesterofpregnancy.
DesignAreviewofallpublishedcohortstudiestoidentifykeyindicationsandapopulationbasedcase-
controlstudytotesttheseindications.
SettingReviewofPubMed,WebofScience,andEmbaseforpapersaboutcarbamazepineexposureinthefirsttrim
esterofpregnancyandspecificmalformations,andtheEUROCATAntiepilepticStudyDatabase,includingdat
afrom19Europeanpopulationbasedcongenitalanomalyregistries,1995-2005.
ParticipantsTheliteraturereviewcoveredeightcohortstudiesof2680pregnancieswithcarbamazepinemon
otherapyexposure,andtheEUROCATdatasetincluded98 075registrationsofmalformationscoveringover3.
8millionbirths.
MainoutcomemeasuresOverallprevalenceforamajorcongenitalmalformationafterexposuretocarbamazepi
ses(fivetypesofmalformationidentifiedintheliteraturereview)comparedwithtwogroupsofcontrols:ot
hernon-chromosomalregistrationsofmalformationsandchromosomalsyndromes.
%(95%
)
gistrationsofmalformations,
onlyspecificmajorcongenitalmalformationsignificantlyassociatedwithexposuretocarbamazepinemono
therapy((95%)comparedwithnoantiepilepticdrug),buttheris
kwassmallerforcarbamazepinethanforvalproicacid(,).Therewasnoevidenceforanassociati
onwithtotalanomalouspulmonaryvenousreturn(nocaseswithcarbamazepineexposure),cleftlip(withorwi
thoutpalate)(,),diaphragmatichernia(,),orhypospadias(,)compa
entricleandatrioventricularseptaldefect.
ConclusionCarbamazepineteratogenicityisrelativelyspecifictospinabifida,thoughtheriskislesstha
,therewasnotenoughpowertodetectmoderaterisksforsomera
remajorcongenitalmalformations.
-
:r
andomisedcontrolledtrial
在 -9个月时接种标准麻疹疫苗对儿童死亡率的非特异性效果：随机对照试
验
ObjectiveToexamineinarandomisedtrialwhethera25%
3yearsofageforchildrengiventwostandarddosesofEdmonston-
hsofage(currentpolicy).
DesignRandomisedcontrolledtrial.
SettingTheBandimHealthProject,Guinea-
Bissau,whichmaintainsahealthanddemographicsurveillancesysteminanurbanarea.
-tetanus-
(80%)hadprevious
lytakenpartinrandomisedtrialsofneonatalvitaminAsupplementation.
InterventionChildrenwererandomisedtoreceiveEdmonston-
(groupA),-
Zagrebmeaslesvaccineat9monthsofage(groupB),
onthsofage(groupC).
roup,ingirls,andinthedryseason,butthestudywasnotpoweredtotestwhethereffectsdifferedsignifican
tlybetweensubgroups.
oofchildrenwhoreceivedtwodosesofEdmonston-
-
(95%).Intheanal
ysesofsecondaryoutcomes,()
()
fagewassignificantforgirls(()),althoughthiswa
snotsignificantlydifferentfromtheeffectinboys(())(interactiontest,P=).Theef
Opolicy,
sechildren,thetwodoseEdmonston-
sofage(()).Theeffectwasagainsignificantforgir
,theintention
().
ConclusionsAlthoughtheoveralleffectdidnotreachstatisticalsignificance,theresultsmayindicateth
atatwodoseschedulewithEdmonston-
-
specificeffectsonchildren’ssurvival,particularlyforgirlsandforchildrenwhohavenotreceivedneon
.
