中国循证医学杂志2011，ll(8)：919～931通心络胶囊与丹参滴丸治疗冠心病心绞痛间接比较的系统评价贾永亮1张时开I鲍菲飞1黄芳艺2梁少伟1,3‘1．中国澳fJ特别行政医澳门大学中华医药研究院(澳门999078)；2．中困澳f】特别行政Ⅸ澳f】大学社会科学及人文学院(澳门999078)；3．Nationale—ScienceInstitute，SchoolofInformatics，UniversityofEdinburgh，EdinburghEH89AB,UnitedKingdom德摘要目的已有数百篇关于复方丹参滴丸和通心络胶囊治疗冠心病心绞痛的随机对照试验报告发表，但尚未见相关系统评价。本研究旨在遵循PRISMA声明，系统评价通心络胶囊与复方丹参滴丸治疗冠心病心绞痛的临床疗效，并提供间接比较通心络胶囊与复方丹参滴丸疗效的方法。方法检索CNKI等电子数据库并筛选出符合纳入标准的RCT，用ladad评分量表进行质量评价。提取包括作者数量、样本量、疗程在内的RCT基本特征和以症状改善为主要治疗指标的数据。并统计不良事件。取优势比(OR)和95％可信区间(CI)衡量效应值，然后采用RevMan5．0软件进行Meta分析、亚组分析、敏感性分析和其它统计分析。结果共纳入65个RCT，合计6969例患者。其ladad评分量表的平均得分为2．11。通心络胶囊对比消心痛的总体疗效OR为3．66[95％CI(2．67，5．02)]，复方丹参滴丸对比消心痛的总体疗效OR为2．38[95％CI(1．90，2．99)o两者总体疗效OR有颞著差别(W=521．5，P=O．04945o统计分析未发现可显著影响结果稳定性的因素。复方丹参滴丸和通心络胶囊不良事件发生率分别为2．37％和2．1l％。结论虽然纳入RCT的质量不高，但通心络胶囊和复方丹参滴丸治疗心绞痛的疗效均显著好于硝酸异山梨酯片，且有较弱的证据表明通心络胶囊的疗效优于复方丹参滴丸。关键词复方丹参滴丸；通心络胶囊；冠心病心绞痛；随机对照试验；系统评价；Meta分析IndirectComparisonofTongxinluoCapsuleandDanshenDrippingPnlforAnginaPectoris：ASystematicReviewJIAYong-liang’，ZHANGShi·kail，BAOFei-feil，HUANGFang-yi2，LEUNGSiu-wail，3‘J．InstituteofChineseMedicalSciences,UniversityofMacau,Macau999078,China；2FacultyofSocialSciencesandHumanities,Unive巧ityofMacau．Macau999078,Chinae3．NationalP—ScienceInstitute,Schooloflnformatics,UniversityofEdinburgh，EdinburghEH89AB,UnitedKingdomAbstractObjectiveDanshendrippingpill(DSP)andtongxinluocapsule(TXL)arepopularChinesemedicinalproductsandoftencomparedwitIlisosorbidedinitrate(ISDN)intreatinganginapectoris．Hundredsofrandomizedcontrolledtrials(RCTs)aboutDSPandTXLhavebeenpublished；however，therehasbeennosystematicreviewoncom—paringDSPwithTXL．ThisstudyaimstoprovideacomprehensivePRISMA—comphantsystematicreviewwithsensitiv-ityanalysisandsubgroupanalysistovaluateindirectlytheeflicaciesofDSPandTXLintreatinganginapcctoris．Meth—odsRCTspublishedbetween1994and2009onDSPandTXLintreatinganginapectorisforfourormoreweekswereretrievedfromdatabases．ThequalitiesofRCTsincludedwereevaluatedwithJadadscale．Meta—analysiswasperformedonoveralleffectsofsymptomaticandelectrocardiographic(ECG)improvements．Oddsratios(OR)and95％confidenceintervals(95％CI)wereusedtomeasuretheeffectsize．Subgroupanalysis，sensitivityanalysisandmeta—regressionwereconductedonbasiccharacteristicsofRCTs．Results65RCTswith6969participantswereincluded．AverageIadadscorewas2．11．OverallORswere3．66(95％CI2．67to5．02)forTXLversusISDNand2．38(95％CI1．90to2．99)forDSPversusISDN．Therewasasignificantdifference(W=521．5，P=0．04945)inORsbetweenDSPandTXL．StatisticalanalysesfoundnosignificantfactorsaffectingoverallefficaciesofTXLandDSP．TheratesofadverseeventsunderDSPandTXLtreatmentswere2．37％and2．11％，respectively．CondusionDSPandTXLaremoreeffectivethanISDNintreatingan—ginapectoris．TXLmightbemor...
