目的系统评价益气活血法联合西药常规治疗急性缺血性脑卒中的临床疗效与安全性。方法检索PubMed、Springer、中国学术期刊全文数据库、万方数据知识服务平台中益气活血法治疗缺血性脑卒中的临床随机对照实验文献,按照Cochrane协作网推荐的方法(Jadad评分法)评价纳入研究文献的质量后,采用RevMan 4.2.3软件进行Meta分析。结果经筛选纳入28篇文献,共2 385例,其中治疗组(益气活血法联合西药)1 251例,对照组(单纯西药治疗)1 134例,各研究基线具有可比性。Meta分析结果显示:益气活血法联合西药常规治疗在提高总的临床治疗疗效[RR=4.24,95%CI(2.26,5.51)],降低神经功能缺损评分[WMD=-3.13,95%CI(-4.01,-2.26)],降低中医证候积分[WMD=-5.23,95%CI(-8.53,-1.93)],改善生活活动能力[WMD=12.79,95%CI(4.29,21.29))]和降低血浆黏度[WMD=-0.54,95%CI(-0.90,-0.17)]方面均优于治疗组。结论益气活血法联合西药常规治疗疗效优于对照组,受纳入文献质量和数量的限制,尚需更多高质量多中心大样本的临床随机双盲对照研究加以验证。
Objective To review systemically the curative effect and safety of the therapy of supplementing qi and activating blood in treatment of syndrome of qi deficiency and blood stasis of acute cerebral ischemic stroke (ACIS). Methods The databases, including PubMed, Springer, China Journal Full-Text Database (CJFD) and WanFang Database, were retrieved for collecting the literature about clinical randomized controlled trials (RCT) involved the treatment of ACIS with the therapy ofsupplementing qi and activating blood. The quality of collected literature was reviewed according to the Jadad scoring method recommended by Cochrane Collaboration, and RevMan 4.2.3 software was used in Meta-analysis. Results There were 28 literature included involved 2 385 cases, among them 1 251 in treatment group (treated with therapy of supplementing qi and activating blood combining Western medicinal) and 1 134 in control group (treated only with Western medicinal). The baseline data was comparable in all trials. The results of Meta-analysis showed that the treatment group was better than control group in improving total curative effect [RR =4.24, 95% CI (2.26, 5.51 ) ], decreasing NIHSS [ WMD = - 3.13, 95% CI ( - 4.01, - 2.26 ) ], reducing TCM syndrome integrals [ WMD = - 5.23, 95% CI ( - 8.53, - 1.93 ) ], improving activity of daily living [ WMD = 12.79, 95% CI (4. 29, 21.29) ] and reducing plasma viscosity [ WMD = - 0. 54, 95% CI ( - 0. 90, - 0. 17 ) ]. Conclusion The curative effect is better in treatment group than that in control group. As the limitation of literature quality and quantity, more muhiple-center and large-sample clinical RCT with higher quality are required for further identifying the results.