生脉注射液防治蒽环类抗肿瘤药心脏毒性的系统评价

中国药物警戒 ›› 2012, Vol. 9 ›› Issue (11): 666-669.

生脉注射液防治蒽环类抗肿瘤药心脏毒性的系统评价

杨敏^{1, 2}, 卢静¹, 牟金金^{1, 2}, 徐挺^1*

1 四川大学华西医院药剂科,四川成都 610041；
2 四川大学华西药学院,四川成都 610041

收稿日期:2012-06-14 出版日期:2012-11-10 发布日期:2015-08-07
通讯作者: 徐挺,男,博士生导师,临床药学。E-mail:tingxv@163.com）
作者简介:杨敏,女,硕士,临床药学。

Systematic Review of Shengmai Injection for Cardiotoxicity Induced by Anthracyclines

YANG Min^{1, 2}, LU Jing¹, MOU Jin-jin^{1, 2}, XU Ting^1*

1 Department of Pharmacy, West China Hospital, Sichuan University, Sichuan Chengdu 610041, China;
2 West China School of Pharmacy, Sichuan University, Sichuan Chengdu 610041, China

Received:2012-06-14 Online:2012-11-10 Published:2015-08-07

摘要/Abstract

摘要： 目的系统评价生脉注射液对蒽环类抗肿瘤药心脏毒性的防治作用。方法全面检索有关生脉注射液防治蒽环类抗肿瘤药心脏毒性的随机对照临床试验,由3位研究人员按照系统评价的要求,对纳入的文献进行严格的质量评价和Meta分析。结果共纳入6个随机对照临床试验,受试对象615人,其中试验组307人,对照组308人。试验组和对照组在所有的结局指标均中,差异均具有统计学意义：心电图异常发生率[RR=0.38,95%CI（0.27,0.54）,P<0.00001],射血分数变化[MD=-2.50,95%CI（-3.83,-1.18）,P =0.0002],以及左室舒张末期内径变化[MD=-0.79,95%CI（-0.93,-0.66）,P<0.00001],左室收缩末期内径变化[MD=-0.58,95%CI（-0.82,-0.35）,P<0.00001],短轴缩短率变化[MD=-3.02,95%CI（-5.02,-1.01）,P =0.003]。结论现有证据表明,生脉注射液可防治蒽环类抗肿瘤药引起的心脏毒性,但需更多严格的随机对照临床试验加以证实。

关键词: 生脉, 蒽环, 抗肿瘤, 心脏毒性, 系统评价

Abstract: ObjectiveTo explore the efficiency of Shengmai injection for cardiotoxicity in tumor patients induced by Anthracyclines. MethodsWe systematically retrieved the randomized controlled trials(RCTs) which were designed for Shengmai injection for cardiotoxicity in tumor patients induced by Anthracyclines.The three researchers selected the references according to the inclusion criterion, then appraised them critically and conducted meta-analysis. ResultsSix RCTs were included at last with 615 patitents, 307 in the experimental group and 308 in the control group.The two groups have statistically significant differences in every outcome we have designed: rate of abnormal electrocardiogram[RR=0.38, 95%CI(0.27,0.54), P<0.00001], change of EF[MD=-2.50, 95%CI(-3.83,-1.18), P=0.0002], change of LVDd[MD=-0.79,95%CI(-0.93,-0.66),P<0.00001], change of LVDs[MD=-0.58,95%CI(-0.82,-0.35),P<0.00001], change of FS[MD=-3.02,95%CI(-5.02,-1.01),P =0.003]. ConclusionOn current evidence, Shengmai injection is probably effective for the prevention and treatment of cardiotoxicity in tumor patients induced by Anthracyclines. However, more high quality clinical trials are needed to confirm this.

Key words: Shengmai, Anthracyclines, antitumor, cardiotoxicity, systematic review

杨敏, 卢静, 牟金金, 徐挺. 生脉注射液防治蒽环类抗肿瘤药心脏毒性的系统评价[J]. 中国药物警戒, 2012, 9(11): 666-669.

YANG Min, LU Jing, MOU Jin-jin, XU Ting. Systematic Review of Shengmai Injection for Cardiotoxicity Induced by Anthracyclines[J]. Chinese Journal of Pharmacovigilance, 2012, 9(11): 666-669.

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