疏血通注射液治疗进展性脑梗死的Meta评价

Systematic review of Shuxuetong injection for progressive ischaemic stroke

目的:系统评价疏血通注射液治疗进展性脑梗死的有效性和安全性。方法:计算机检索Cochrane图书馆(2012年第5期),Medline,EMbase,中国生物医学文献数据库(CBM),中文科技期刊全文数据库(VIP),中国期刊全文数据库(CNKI)和万方数据在线知识服务平台,纳入有关疏血通注射液治疗进展性脑梗死的随机对照试验和半随机对照试验,对纳入的研究进行方法学质量评价,并使用RevMan 5.1软件进行统计分析。结果:共纳入11个随机对照试验,972受试者。仅1篇研究报告了病死率,全部研究均未报告病例远期随访情况。Meta分析结果显示,在总有效率上,11个与常规治疗的比较研究显示两组间差异有统计学意义(OR 4.46,95%CI[3.02,6.59]);在神经功能缺损评分方面,7个与常规治疗的比较研究显示2组间差异具有统计学意义(MD 5.86,95%CI[4.80,6.93])。本组纳入11篇研究报道的不良反应/不良事件表现轻微。结论:现有的质量有限的证据增加了本次系统评价结论产生偏倚的风险,基于目前的证据无法得出疏血通注射液治疗进展性脑梗死有效性和安全性的结论。疏血通治疗进展性脑梗死的疗效和安全性需要更多高质量临床试验加以证实。

Objective： To assess the clinical efficacy and safety of Shuxuetong injection against progressive ischaemic stroke. Method： Randomized controlled trials （RCTs） and quasi randomized controlled trials （quasi-RCTs）, which focused on treating patients with progressive ischaemie stroke using Shuxuetong injection were identified from Cochrane library, Medline, EMbase, CBM database, CNKI database, VIP database and Wanfang database. Data was extracted and evaluated with designed form. RevMan 5.1 software was used for data analysis. Result： Eleven RCTs with 972 patients were included in this review. Only one research reported the mortality rate. None of the trials mentioned dependency of the patients during the follow-up period. The results of Meta analysis were listed as follows. Compared with normal treatment measures, total effective rate of 11 RCTs suggested that Shuxuetong were more effective with OR 4.46, 95% CI [ 3.02-6. 59 ]. A greater difference in patients using Shuxuetong injection was found in 7 RCTs about the NDS with MD 5.86, 95% C1 [4. 80-6. 93] , compared with normal treatment measures. Researches with ADR/AE information of Shuxuetong injection showed that the symptoms of ADR/AE were moderate. Conclusion： Conclusions from this review may have a high risk of bias because of the low quality of the researches, hence it was not adequate to draw any reliable conclusions about the efficacy of Shuxuetong injection in progressive ischaemic stroke. More trials with high quality are required in the following researches.