强制性运动疗法对卒中后3～9个月上肢功能恢复的效果：EXCITE随机临床试验

强制性运动疗法对卒中后3～9个月上肢功能恢复的效果：EXCITE随机临床试验 强制性运动疗法对卒中后3,9个月上肢功 能恢复的效果:EXCITE随机临床试验 丁香园神经内科最新进展专栏国际内科双语杂志2007.Vo1.7.No.1 ? 丁香园神经内科最新进展专栏? 原发全身性或节段性肌张力障碍的苍白 球脑深部刺激疗法 PallidalDeep-BrainStimulationinPri- maryGeneralizedorSegmentalDystonia NEJM,2006,355:1978—1990 AndreasKupsch,ReinerBenecke,Jt~rgMOiler,etal Neurostimulationoftheinternalglobuspallidushas beenshowntobeeffectiveinreducingsymptomsofprima— rydystonia.Theauthorstriedtocomparethissurgical treatmentwithshamstimulationinarandomized,con— trolledclinicaltria1. Fortypatientswithprimarysegmentalorgeneralized dystoniareceivedanimplanteddevicefordeep??brainstim?- ulationandwererandomlyassignedtoreceiveeither neurostimulationorshamstimulationfor3months.The primaryendpointwasthechangefrombaselineto3 monthsintheseverityofsymptoms,accordingtothe movementsubscoreontheBurke??Fahn??MarsdenDystonia RatingScale(range,0to120,withhigherscoresindica— tinggreaterimpairment).Twoinvestigatorswhowereun— awareoftreatmentstatusassessedtheseverityofdystonia byreviewingvideotapedsessions.Subsequently,allpa— tientsreceivedopen—labelneurostimulation;blindedas— sessmentwasrepeatedafter6monthsofactivetreatment. Threemonthsafterrandomization,thechangefrom baselineinthemean(?SD)movementscorewassignifi— cantlygreaterintheneurostimulationgroupf一15.8? 14.1points)thaninthesham—stimulationgroup(一1.4 ?3.8points,P<0.001).Duringtheopen—labelexten— sionperiod,thisimprovementwassustainedamongpa— tientsoriginallyassignedtotheneurostimulationgroup, andpatientsinthesham—stimulationgrouphadasimilar benefitwhentheyswitchedtoactivetreatment.Thecom— binedanalysisoftheentirecohortafter6monthsof neurostimulationrevealedsubstantialimprovementinall movementsymptoms(exceptspeechandswallowing), thelevelofdisability,andqualityoflife,ascompared withbaselinescores.Atotalof22adverseeventsOC- MEDfCINEINTERNATIONAL curredin19patients,including4infectionsatthestimu— latorsiteand1leaddislodgment.Themostfrequentad— verseeventwasdysarthria. Bilateralpallidalneurostimulationfor3monthswas moreeffectivethanshamstimulationinpatientswithpri— marygeneralizedorsegmentaldystonia. 既往研究显示苍白球内侧神经刺激对减轻原发性 肌张力障碍的症状有效.此项研究开展了一项随机, 对照的临床试验对这种外科疗法与伪刺激进行对比. 40位患有原发性节段性或全身性肌张力障碍的患 者接受脑深部刺激器的植入,并被随机分配接受神经 刺激或伪刺激,为期3个月.主要终点是根据Burke— Fahn—Marsden肌张力评分量表(量表得分由0至120, 分数越高则病损越严重)的运动部分得出的从基线到 3个月时症状严重程度的改变.两位对治疗情况不了 解的调查者通过录像评估肌张力的严重程度.随后, 所有患者接受开放标记的神经刺激治疗;在6个月的 积极治疗之后,再次进行盲法. ,相对于基线 经统计学处理,随机化之后3个月 的运动评分均数(?SD)的改变,神经刺激组 (一15.8?14.1分)较伪刺激组(一1.4?3.8分, P<0.001)更为显着.在延长的开放性研究期间,对 于原来被分配至神经刺激组的患者,此种改善得到持 续;原来接受伪刺激的患者,当更换为积极治疗后获 得了类似的益处.在接受6个月神经刺激后,对整个 队列进行的组合分析显示与基线分数相比,全部运动 症状(除外言语和吞咽),残损水平和生活质量均有 显着改善.19位患者发生了总计22次不良反应事件, 其中包括4次刺激器处感染和1次导联移位.发生频 率最高的不良反应是构音障碍. 对于原发性全身性或节段性肌张力障碍患者,为 期3个月的双侧苍白球神经刺激较伪刺激更为有效. 强制性运动疗法对卒中后3,9个月上肢 功能恢复的效果:EXCITE随机临床 试验 EffectofConstraint.InducedMovement TherapyonUpperExtremityFunction3 t09MonthsAfterStroke TheEXCITERandomizedClinicalTrial 2104. JAMA.2006;296:2095— @2007TheMedicinePublishinaComDanvLtd 际内科双语杂志2007Vol7.,!工查垦墅至量堑鲎基童 StevenL.W0?,CaroleeJ.Winstein,J.Philip Miller,etal Single—sitestudiessuggestthata2-weekprogramof constraint—inducedmovementtherapy(CIMT)forpatients morethan1yearafterstrokewhomaintainsomehandand wristmovementcanimproveupperextremityfunctionthat persistsforatleast1year. Tocomparetheeffectsofa2-weekmuhisiteprogram ofCIMTvsusualandcustomarycareonimprovementin upperextremityfunctionamongpatientswhohadafirst strokewithintheprevious3to9months,theExtremity ConstraintInducedTherapyEvaluation(EXCITE)trial, aprospective,single—blind,randomized,multisiteclini— caltrialwasconductedat7USacademicinstitutionsbe. tweenJanuary2001andJanuary2003. Twohundredtwenty—-twoindividualswithpredomi?- nantlyischemicstrokewereenrolled.Participantswere assignedtoreceiveeitherCIMT(n=106;wearingare— strainingmittontheless—affectedhandwhileengagingin repetitivetaskpracticeandbehavioralshapingwiththe hemiplegichand)orusualandcustomarycare(n=116; rangingfromnotreatmentafterconcludingformalrehabili— tationtopharmacologicorphysi0therapeuticinterven— tions);patientswerestratifiedbysex,prestrokedomi— nantside,sideofstroke,andlevelofpareticarnlfunc— tion.MainoutcomemeasuresincludedTheWolfMotor FunctionTest(WMFT),ameasureoflaboratorytime andstrength—basedabilityandqualityofmovement(func— tionalability),andtheMotorActivityLog(MAL),a measureofhowwellandhowoften30commondailyactiv一' idesareperformed. Frombaselineto12months,theCIMTgroup showedgreaterimprovementsthanthecontrolgroupin boththeWMFTPerformanceTime(decreaseinmean timefrom19.3secondsto9.3seconds[52%redue— tion]vsfrom24.0secondsto17.7seconds『26%re— duction];between—group_difference,34%[95%confi— denceinterval(CI),12%一51%];P<0.001)and intheMALAmountofUse(ona0—5scale,increase from1.21to2.13vsfrom1.15to1.65;between—group difference,0.43[95%CI,0.05—0.80];P<0.001) andMALQualityofMovement(ona0—5scale,increase MEDICINEINTERNATIONAL from1.26to2.23vs1.18to1.66:between—groupdiffer— ence,0.48[95%CI,0.13—0.84];P<0.001).11he CIMTgroupachievedadecreaseof19.5inself-perceived handfunctiondifficulty(StrokeImpactScalehanddo— main)vsadecreaseof10.1forthecontrolgroup(be— tween—groupdifference,9.42[95%CI,0.27—18.57]; P=0.05). Amongpatientswhohadastrokewithintheprevious 3to9months,CIMTproducedstatisticallysignificantand clinicallyrelevantimprovementsinaYinmotorfunctionthat persistedforatleast1year. 单中心研究显示,对于卒中后超过1年而保存部 分手,腕运动功能的患者,为期2周的强制性运动疗 法(CIMT)能够促进上肢功能,其效果至少可达 1年. 为比较CIMT与常规照料对提高上肢功能的疗效, 肢体强制性诱导疗法评估(EXCITE)试验——一项前 瞻l生的,单盲,随机,多中心的临床试验——于2001 年1月,2003年1月在美国7个学术研究机构实施. 共有222位患者参与试验,其中多数为缺血性卒 中.参与者被分配至CIMT组(n=106;当使用偏瘫 手进行重复性作业练习和行为矫正时,另一侧配戴限 制性手套)或常规照料组(n=116;包括从正规康 复治疗后无治疗的患者到接受药物或物理治疗干预的 患者);根据性别,卒中前主侧利手,卒中侧和瘫痪 上肢的功能水平对患者分层. 主要转归测量参数包括:wolf运动功能测验 (WMFI')和动作活动Et志(MAL).WMFT是一项研 究室进行的,以时间和力量为依据的能力和运动质量 (功能性运动)的测定.MAL是一项患者进行30项常 见13常活动时表现如何和出现频率的测定. 结果表明,从基线到第12个月,较对照组相比, CIMT组无论在WMFT执行时间[CIMT组平均时间从 19.3s降低至9.3s(下降52%),对照组从24.0s降 低至17.7s(下降26%);组间差异34%(95%可信 限为12%,51%);P<0.001],MAL使用量[在一个 0,5分分级体系中,CIMT组从1.21提高到2.13,对 照组从1.15提高到.65;组间差异0.43(95%可信限 为0.05,0.80);P<0.001]和MAL运动质量方面[在 一 个0,5分分级体系中,CIMT组从1.26提高到2.23, 对照组从1.18提高到1.66;组间差异0.48(95%可信 限,0.13,0.84);P<0.001]都表现出更大程度的改 善.以卒中影响量表(StrokeImpactScale)中手功能 02007TheMedicinePublishinaComDanvLtd 70丁香园神经内科最新进展专栏国际内科双语杂志2007.Vo1.7.No.1 部分评价患者自我感知性手功能障碍,CIMT组下降了 19.5,对照组下降了10.1[组间差异为9.42,(95%可 信限,0.27,18.57);P=0.05]. 对于在之前3,9个月患有卒中的患者,CIMT可 以改善上肢运动功能,此种改善至少持续1年,具有 统计学显着性,并与临床相关. 血清高CRP水平不是卒中的独立预测 因素:鹿特丹研究 HighSerumC—ReactiveProteinLevelIs N0tanIndependentPredictorfor Stroke:TheRotterdamStudy Circulation,2006,114:1591—1598 MichielJ.Bos,C.MaartenA.Schipper,PeterJ. Koudstaal,etal CurrentguidelinesrecommendtheassessmentofC— reactiveprotein(CRP)levelswithahigh—sensitivityassay incardiovascularriskprediction.Recentstudieshaveput forwardthatalthoughelevatedCRPisariskfactorforcar- diovasculardisease,itisnothelpfulinthepredictionof cardiovasculardiseaserisk.Inthisresearch,theauthor triedtostudytheimportanceofCRPasariskfactorandas ariskpredictoroffuturestroke. Thepresentstudywasbasedon6430participantsof theRotterdamStudywhoatbaseline(1990—1993)were 55yearsofage,werestrokefree,andhadbloodtaken. Strokeswereclassifiedashemorrhagic,ischemic,orun— specified.Ischemicstrokeswerefurthersubclassified. WhetherstrokeriskvariedwithbaselineCRPserumlevels wasassessedwithCoxproportionalhazardsmodels. WhetherCRPwashelpfulinthepredictionofindividual strokeriskwasassessedwith'receiveroperatingcharacter— isticcurvesandbycomparingthedistributionofstrokes betweenpredictedriskstrata.Duringanaverageof8.2 yearsoffollow—up,498first—everstrokesoccurred.High CRPlevelsweresignificantlyassociatedwithriskofany stroke(age—andsex—adjustedhazardratioperSD,1.14; 95%confidenceinterval,1.04to1.24)andriskofis— chemicstroke(age—andsex—adjustedhazardratioperSD, 1.17;95%confidenceinterval,1.04to1.32).Taking MEDICINEINTERNATIONAL CR~levelsintoaccountdidnotimprovetheindividual strokeriskprediction,however,regardlessofwhetherit wasbasedontheFraminghamstrokeriskscoreoronage andsexonly. AlthoughCRPlevelsareassociatedwithstrokerisk, theiruseintheassessmentofindividualstrokeriskseems limited. 对于心血管风险预测,现有指南建议使用高敏感 性检验方法检测C一反应蛋白(CRP)水平.近期研 究提出,尽管升高的CRP是一项心血管病危险因素, 但对心血管病风险预测没有帮助.本文研究了CRP作 为一项危险因素和一项未来卒中风险预测因素的重 要性. 本项研究基于鹿特丹研究的6430位参与者,其 基线(1990,1993)为年龄55岁,无卒中病史,并 留取血样.卒中被分类为出血性,缺血性和未明确 者.缺血性卒中被进一步分为亚类.使用Cox风险比 例模型评估卒中风险是否因基线血清CRP水平改变. 使用受试者操作特征曲线及通过在预测风险分层中比 较卒中的分布情况评估CRP是否对个体卒中风险预测 有益.在平均8.2年的随访期限内,发生了498例首 次卒中.高CRP水平与任何卒中风险(每差年 龄与性别调整的风险比,1.14;95%置信区间,1.04 , 1.24)和缺血性卒中风险(每标准差年龄与性别调 整的风险比,1.17;95%置信区间,1.04,1.32)显 着相关.但是,无论是基于Framingham卒中风险评分 或仅基于年龄和性别,考虑CRP水平并未改善对个体 的卒中风险预测. 尽管CRP水平与卒中风险相关,其在评估个体卒 中风险时的价值似乎有限. 卒中家族史与卒中后神经功能缺损的 严重程度 Familyhistoryofstrokeandseverityof neurologicdeficitafterstroke Neurology,2006,67:1396—1402 J.F.Meschia,L.D.Case,B.B.Worrall,etal Afamilyhistoryofstrokeisanindependentriskfac— torforstroke.Thisresearchwasconductedtoassess whetherseverityofneurologicdeficitafterstrokeisassoci一 @2007TheMedicinePublishinoComDanvLtd