中国药物警戒 ›› 2012, Vol. 9 ›› Issue (10): 584-589.

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血栓通辅助治疗急性脑梗死有效性和安全性的Meta分析

李海涛1, 余正2*   

  1. 1 香港中文大学公共卫生学院,香港;
    2 中国药科大学国际医药商学院,江苏 南京 211198
  • 收稿日期:2012-05-11 出版日期:2012-10-10 发布日期:2015-08-07
  • 通讯作者: 余正,男,硕士,副教授,E-mail:zhengy@yahoo.com.cn
  • 作者简介:李海涛,男,博士在读,讲师,卫生政策和经济、药物经济学。

Meta-Analysis on the Efficacy and Safety of Xueshuantong for Acute Brain Infraction

LI Hai-tao1, YU Zheng2*   

  1. 1 The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China;
    2 School of International Pharmaceutical Medicine, China Pharmaceutical University, Jiangsu Nanjing 211198, China
  • Received:2012-05-11 Online:2012-10-10 Published:2015-08-07

摘要: 目的综合评价血栓通治疗急性脑梗死的有效性和安全性,为临床决策提供科学依据。方法利用计算机检索文献,并进行筛选,在对纳入文献进行方法学质量评价之后,应用RevMan 5.0软件,采用固定效应模型或随机效应模型对纳入文献进行Meta分析。结果本研究共纳入17篇文献,质量评级均为C级。在总有效率方面,血栓通单用VS其他中药单用、血栓通联用其他药物VS中药联用其他药物、血栓通联用其他药物VS中药单用比较,RR及95%CI分别为1.33(1.10~1.44)、1.32(1.20~1.45)、1.37(1.22~1.53),P值均小于0.001,具有统计学意义。敏感性分析后,P值亦均小于0.001,证明了结果的稳定性。结论与本研究中参与比较的中药相比,血栓通不论是单用还是与其他药物联合应用,在治疗急性脑梗死时均能显著提高总有效率。但是由于纳入研究质量较低,样本量较小,因此仍需要大规模、多中心的临床随机对照试验对研究结果进一步加以证实。

关键词: 血栓通, 有效性, 安全性, Meta分析, 急性脑梗死

Abstract: Objective To evaluate efficacy and safety of Xueshuantong for acute brain infraction, from which to provide scientific proofs for clinical decision making. Methods We firstly retrieved and selected publications and then we assessed methodological quality of the included articles. Afterwards, employing Cochrane Collaboration's software RevMan 5.0, we conducted Meta-analyses with fixed or random effect models. Results A total of 11 papers were included in the study and the methodological quality was graded to C. As for total response rate, RRs and 95%CI were 1.33(1.10~1.44), 1.32(1.20~1.45), 1.37(1.22~1.53) and there were statistical differences between Xueshuantong alone and other Traditional Chinese Medicines(TCMs) alone, Xueshuantong+other drugs and TCMs+other drugs, Xueshuantong+other drugs and other TCMs alone. The sensitivity analysis tested and verified the reliability of the results above where P values were less than 0.001. Conclusion The adoption of Xueshuantong for acute brain infraction can improve total response rate as compared with other included Traditional Chinese drug interventions. However, because of low quality and relatively small sample size of the included studies, further multicenter randomized controlled trials with large sample size should be conducted to investigate the effectiveness and safety of Xueshuantong for acute brain infraction.

Key words: Xueshuantong, efficacy, safety, Meta-analysis, acute brain infraction