通脉强心胶囊治疗慢性心力衰竭随机对照研究【摘要】目的观察通脉强心胶囊治疗慢性心力衰竭的疗效和安全性。方法采用随机对照试验设计方法，选择120例慢性心力衰竭患者，随机分为治疗组60例和对照组60例，两组均采用最佳西医治疗方案，并在此基础上分别加用通脉强心胶囊和安慰剂胶囊，4周为1疗程，共治疗3疗程。分别于治疗前、治疗1疗程、治疗2疗程、治疗3疗程，计算中医证候评分、心衰积分以及再次住院率和病死率等疗效指标及安全性指标。结果①中医证候疗效比较：治疗组总有效率为88.33%,对照组总有效率为66.67%；两组比较差异有统计学意义(u=2.989,P<0.01)o②心功能疗效:治疗组和对照组总有效率分别为78.33%(47/60)和51.67%(31/60),两组比较差异有统计学意义(u=3.176,PV0.01)；③生活质量：治疗组改善患者生活质量优于对照组(P<0.01)o④再次住院情况,治疗组与对照组比较，总再次住院率分别为:15.78%(9/57)和34.55%(19/55),差异有统计学意义(PV0.01)；⑤安全性观察:治疗组和对照组无明显不良反应。结论通脉强心胶囊能改善慢性心力衰竭心功能，是一种治疗慢性心力衰竭较好的中药制剂。【关键词】慢性心力衰竭;通脉强心胶囊;可重复性；安全性文章编号：1003-1383(2011)05-0550-04中图分类号：R541.6文献标识码：Adoi:10.3969/j.issn.1003-1383.2011.05.002RandomizedcontrolledclinicalstudyofTongmaiQiangxincapsuleintreatmentofchronicheartfailureHEJiang,GUANHui，ZHOUMianyong，LIShihong(DepartmentofCardiology,HospitalofTraditionChineseMedicineofQiannanAutonomousPrefecture,Duyun558000,Guizhou,China)[Abstract】ObjectiveToobservetheefficacyandsafetyofTongmaiQiangxincapsuleintreatmentofchronicheartfailure・MethodsTherandomizedcontrolledtrialdesignmethodwillbeadopted.120patientswithchronicheartfailurewererandomlydividedintotwogroups:thetreatmentgroup(60patients)andthecontrolgroup(60patients).Thebesttreatmentplanofwesternmedicinewasadoptedforbothgroups・Andbasedonthisplan,TongmaiQiangxincapsulesandplacebocapsuleswereaddedrespectively,with4weeksforacourseoftreatmentandthereweretotalthreecoursesoftreatment.TraditionalChineseMedicinesyndromescores,heartfailureintegrals,readmissionrates,mortality,andotherindicatorsofefficacyandsafetywerecalculatedbeforethetreatment,atthe1stcourseoftreatment,the2ndcourseoftreatmentand3rdcourseoftreatmentrespective!y.Results©ComparisonoftheefficacyofTCMsyndrome:thetotaleffectiverateoftreatmentgroupis88.33%andthetotaleffectiverateofthecontrolgroup66.67%・TherewasstatisticaldiffereneeintheefficacyofTCMsyndromebetweenthetwogroups(u=2.989,P<0.01).©Efficacyofcardiacfunction:thetotaleffectiveratesofthetreatmentgroupandthecontrolgroupwere78.33%(47/60)and51.67%(31/60)respectively.Therewasstatisticalsigrdficanceindiffereneebetweenthetwogroups(u=3.176,P<0.01).③Qualityoflife:improvementofqualityoflifeofthepatientsintreatmentgroupwasbetterthanthatofthecontrolgroup(P<0.01).④Statusofreadmission:thetotalreadmissionratesofthetreatmentgroupandthecontrolgroupwere15.78%(9/57)and34.55%(19/55)respective!y.Therewassigrdficantdiffereneeintermsoftotalreadmissionratesbetweenthetwogroups(P<0.01).©Safetyobservation:nosignificantadversereactionsoccurredinthetreatmentgroupandthecontrolgroup・ConclusionTongmaiQiangxincapsulecanimprovethecardiacfunctionofthepatientswithchronicheartfailure.ItisagoodkindoftraditionalChinesemedicineonchronicheartfailure・［Keywordslchronicheartfailure;TongmaiQiangxincapsule;repeatability;safety慢性心力衰竭是临床常见的综合征，已成为严重的公共卫生学问题和临床研究的热点问题。中医药治疗慢性心力衰竭(CHF)具有一定疗效已被临床广泛证实［1］。通脉强心胶囊...