血栓心脉宁治疗脑梗死的疗效和安全性的系统评价

中国临床药理学与治疗学 ›› 2014, Vol. 19 ›› Issue (9): 1025-1032.

血栓心脉宁治疗脑梗死的疗效和安全性的系统评价

李琳¹, 黄继汉², 张广民³, 刘传贵³, 张平¹, 解雪峰¹, 黄晓晖¹

¹ 安徽医科大学药学院, 合肥 230032,安徽;
² 上海中医药大学药物临床研究中心,上海 201203;
³ 吉林华康药业股份有限公司,敦化 133700,吉林

收稿日期:2013-09-02 修回日期:2014-08-23 出版日期:2014-09-26 发布日期:2014-09-26
通讯作者: 黄继汉,男,博士,研究方向:临床药理学和定量药理学。Tel: 021-51322420 E-mail: whhuangjh@163.com
作者简介:李琳,女,硕士研究生,研究方向:定量药理学和临床药代动力学。 Tel: 0551-65172106 E-mail: 393002353@qq.com
基金资助:
国家自然科学基金(81173133); 上海市教委预算内科研项目(2011JW23)

Effects and safety of Xinmaining for cerebral infarction treatment:a systematic review

LI Lin¹, HUANG Ji-han², ZHANG Guang-min³, LIU Chuan-gui³, ZHANG Ping¹, XIE Xue-feng¹, HUANG Xiao-hui¹

¹ School of Pharmacy,Anhui Medical University,Hefei 230032,Anhui,China;
² Center for Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai 201203, China;
³ Jilin Huakang Pharmaceutical Co.Ltc, Dunhua 133700,Jilin,China

Received:2013-09-02 Revised:2014-08-23 Online:2014-09-26 Published:2014-09-26

摘要/Abstract

摘要： 目的系统评价使用血栓心脉宁治疗脑梗死的疗效和安全性。方法计算机检索中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)、Cochrane图书馆、MEDLINE、Embase等数据库;手工检索纳入试验的所有中文及外文文献及其他相关文献,获取并评价有关血栓心脉宁治疗脑梗死的临床随机对照试验文献,采用Stata 11.0 软件进行Meta分析。结果共有23篇文献符合入选标准, 2 737 例患者。临床评价指标包括治疗总有效率、血液流变学指标变化、血脂指标变化。在总有效率方面,22个RCT的Meta分析结果显示,两组差异有统计学意义[RR=1.14,95%CI(1.11,1.18)];在血液流变学方面,血栓心脉宁组治疗后全血低切黏度、全血高切黏度、血浆比黏度、红细胞压积、纤维蛋白原和全血还原黏度指标的改善均显著优于对照组;在血脂方面,治疗后总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)指标的改善均优于对照组;在安全性方面,仅有1个试验有3例出现轻度不良反应。结论现有的证据表明,不论是单用还是与其它药物联合应用,血栓心脉宁具有提高治疗脑梗死有效率,改善神经功能缺损、血液流变学和血脂参数的作用,且不良反应发生率低,在临床上具有良好的应用前景。但目前的临床研究质量较低,血栓心脉宁治疗脑梗死的疗效与安全性评价还需更多高质量的随机对照试验加以证实。

关键词: 血栓心脉宁, 脑梗死, Meta分析

Abstract: AIM: To conduct a meta-analysis to evaluate the efficacy and safety of Xinmaining for cerebral infarction. METHODS: CBM, CNKI,WanFang Data, Cochrane Library, MEDLINE, EMbase were electronically searched for randomized controlled trials (RCTs) involving Xinmaining in the treatment for cerebral infarction. Meanwhile, all relevant Chinese and English literatures were retrieved by hand search. Stata 11.0 was used for Meta analysis.RESULTS: A total of twenty three randomized controlled trails involving 2737 patients were included . Clinical assessment measures were total response rates, neurological deficit scores, changes of hemorheology and blood lipids. The result of meta-analysis (twenty two trials) showed that there was significant difference on total response rates[RR=1.14,95%CI(1.11,1.18)]; Xinmaining group was superior to the control group in lowering WBLSV,WBHSV,plasma viscosity, HCT ,fibrinogen and WBRV; Xinmaining group showed better results in decreasing TC and TG and increasing HDL-C; Mild adverse effects were reported in only three patients of one trial.CONCLUSION: Current evidences showed that xinmaining could increase the total response rates, reduce the neurological deficit scores, decrease the hemodynamic indexes and improve the blood lipid parameters with a low incidence of adverse effects,which provides a good application prospect in clinical practice. However,the quality of current clinical trials was not high, more high-quality RCTs were needed to provide clear evidences for the efficacy and safety of Xinmaining for cerebral infarction.

Key words: Xinmaining, cerebral infarction, Meta-analysis

中图分类号:

R969.1

李琳, 黄继汉, 张广民, 刘传贵, 张平, 解雪峰, 黄晓晖. 血栓心脉宁治疗脑梗死的疗效和安全性的系统评价[J]. 中国临床药理学与治疗学, 2014, 19(9): 1025-1032.

LI Lin, HUANG Ji-han, ZHANG Guang-min, LIU Chuan-gui, ZHANG Ping, XIE Xue-feng, HUANG Xiao-hui. Effects and safety of Xinmaining for cerebral infarction treatment:a systematic review[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(9): 1025-1032.

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