通心络胶囊治疗急性缺血性脑卒中疗效与安全性的系统评价  

Effects and Safety of Tongxinluo Capsule for Acute Ischemic Stroke: A Systematic Review

作　　者：周红青[1] 王德任[1] 张灿飞[2] 张婧[3] 王秋筱[1] 刘鸣[1] 

机构地区：[1]四川大学华西医院神经内科,成都610041 [2]河南科技大学第一附属医院神经内科,河南洛阳471003 [3]首都医科大学宣武医院神经内科,北京100053

出　　处：《中国循证医学杂志》2013年第7期844-851,共8页Chinese Journal of Evidence-based Medicine

摘　　要：目的系统评价通心络胶囊治疗急性缺血性脑卒中的疗效及安全性。方法计算机检索PubMed(1966～2011.12.23)、EMbas(e1966～2011.12.23)、Ovid Cochrane对照试验中心数据库(CENTRAL,2011年10月)、CBM(1978～2011.12.23)、VIP(1989～2011.12.23)、CNKI(1980～2011.12.23)、中国博士学位论文全文数据库(1999～2011.12.23)、中国优秀硕士学位论文全文数据(1999～2011.12.23),同时手工检索及向药厂索要相关资料,全面收集通心络胶囊治疗急性缺血性脑卒中的所有随机对照试验(RCT)。由两名评价者独立进行文献筛选和评价纳入研究的方法学质量后,采用RevMan 5.1软件进行Meta分析。结果纳入39个RCT,共3 906例患者,均为非安慰剂对照试验,研究质量总体不高。随访时间为治疗结束(最短7天)至6月。16个试验(1 445例)的Meta分析结果显示,通心络组神经功能评分改善显著优于对照组[SMD=–1.09,95%CI(–1.68,–0.49)];21个试验(2 500例)的Meta分析显示,治疗结束时通心络组有效率(91.3%)显著高于对照组(74.9%)[RR=1.22,95%CI(1.14,1.30)]。8个试验报道了恶心、胃部不适等主要不良反应。4个试验报告治疗期间对照组5例死亡。无3个月病死或依赖率及生存质量数据。结论现有研究提示,通心络能改善急性缺血性脑卒中患者的神经功能缺损,不良反应少,但对脑卒中患者远期死亡和残疾的疗效尚需进一步研究,开展更多高质量特别是有安慰剂对照的随机对照试验很有必要。Objective To assess the effects and safety of Tongxinluo（TXL） Capsule for patients with acute ischemic stroke.Methods PubMed（1966 to 2011.12.23）,EMbase（1966 to 2011.12.23）,Ovid CENTRAL（2011.10）,CBM（1978 to 2011.12.23）,VIP（1989 to 2011.12.23）,CNKI（1980 to 2011.12.23）,CDFD（1999 to 2011.12.23）,and CDFD（1999 to 2011.12.23） were electronically searched for randomized controlled trials（RCTs） on TXL Capsule for patients with acute ischemic stroke.Meanwhile,relevant data were retrieved by hand search and data from pharmaceutical factories were collected.Two reviewers independently screened literature,extracted data,and assessed the methodological quality.Then,meta-analysis was performed using RevMan 5.1 software.Results Thirty nine RCTs（non-placebo-controlled trials） involving 3 906 patients were included.The quality of the included studies was generally low.The follow-up time started from the end of treatment（minimum： 7 days） to 6 months.The result of meta-analysis（16 trials,1 445 patients） showed that the TXL group was better than the control group in improving neurological function（SMD= 1.09,95%CI 1.68 to 0.49）.The result of meta-analysis（21 trials,2 500 patients） showed that,the effectiveness rate（91.3%） of the TXL group was significantly higher than that of the control group（RR=1.22,95%CI 1.14 to 1.30）.Eight trials reported adverse reactions such as nausea and gastric discomfort.Four trials reported that 5 patients in the control group died during the treatment.No studies reported the data of mortality,dependency rate during 3-month follow up,or quality of life.Conclusion Current studies show that,TXL Capsule improves neurological impairment of patients with acute ischemic stroke which has less adverse reactions.Further studies are still needed to verify the effects of TXL on long-term mortality and disability.It is necessary to conduct more high quality RCTs especially with placebo-controlled trials to confirm the efficacy of Tongxinluo for acute

关 键 词：通心络 急性缺血性脑卒中 META分析 系统评价 随机对照试验 

分 类 号：R277.7[医药卫生—中医学]