丹参川芎嗪注射液辅助治疗急性脑梗死疗效与安全性的系统评价

Systematic review on efficacy and safety of Danshen Chuanxiongqin Injection in treatment of acute cerebral infarction

系统评价丹参川芎嗪注射液辅助治疗急性脑梗死疗效与安全性,为临床安全、有效用药提供循证医学参考。系统检索中国期刊全文数据库（CNKI）,万方数据库,中国生物医学文献数据库（Sino Med）,Cochrane Library,EMbase,Pub Med,收集丹参川芎嗪注射液治疗急性脑梗死的临床随机对照试验（RCTs）,检索时限均为建库至2018年4月,采用Cochrane风险评价表评价其研究质量,提取资料后通过Rev Man 5.3软件和State 13.0软件进行数据分析。进行文献质量评价后,共纳入30篇RCTs文献,累计3 233例患者。Meta分析结果显示：在西医常规治疗的基础上,联用丹参川芎嗪注射液与对照组仅用西医常规治疗相比,在治疗急性脑梗死方面具有较好的疗效,可显著提高患者临床总有效率（RR=1.22,95%CI[1.18,1.27],P〈0.000 01）和日常生活活动能力（MD=9.42,95%CI[8.12,10.72],P〈0.000 01）,改善患者神经功能缺损情况（MD=-3.99,95%CI[-4.89,-3.07],P〈0.000 01）以及显著降低全血高切黏度、全血低切黏度、血浆黏度及纤维蛋白原水平等患者血液流变学指标（P〈0.01）。临床治疗急性脑梗死,在常规治疗的基础上联用丹参川芎嗪注射液辅助治疗可以显著提高其临床疗效且安全性好。但目前仍缺乏大型多中心临床随机试验对治疗结果的高质量证据支持。

To systemically evaluate the therapeutic efficacy and safety of Danshen Chuanxiongqin Injection in treatment of acute cerebral infarction and provide the reference of evidence-based medicine for its clinical safety and effective drug use. Databases including CNKI,Wan Fang Data,Sino Med,the Cochrane Library,EMbase and Pub Med were searched from inception to April 2018 to collect the randomized controlled trials（ RCTs） on Danshen Chuanxiongqin Injection in the treatment of acute cerebral infarction. The quality of all included studies was evaluated by two independent reviewers following the cochrane systematic review method and using Revman5. 3 software and State13. 0 for Meta-analysis. A total of 30 RCTs involving 3 233 patients with acute cerebral infarction were included in the study after literature quality evaluation. Meta-analysis showed that as compared with the control group of conventional western medicine alone,Danshen Chuanxiongqin Injection combined with conventional western medicine can achieve better efficacy in treatment of acute cerebral infarction,increase the clinical total effective rate（ RR = 1. 22,95% CI [1. 18,1. 27],P 〈0. 000 01） and activities of daily living（ MD = 9. 42,95% CI [8. 12,10. 72],P 〈0. 000 01）,and improve the degree of neurological impairment（ MD =-3. 99,95% CI [-4. 89,-3. 07],P 〈0. 000 01）. Furthermore,the result showed that Danshen Chuanxiongqin Injection in the treatment of acute cerebral infarction can significantly decrease the whole blood high-shear viscosity,whole blood low-shear viscosity,plasma viscosity,fibrinogen level and other hemorheological indexes（ P 〈0. 01）. This Meta-analysis demonstrated that Danshen Chuan xiongqin injection in the treatment of acute cerebral infarction is safe and effective,but lacks the large multicenter clinical randomized trials to support the treatment outcome.