桂枝茯苓丸佐治急性缺血性脑卒中临床疗效及安全性的Meta分析

Efficacy and Safety of Guizhi Fuling Pill for Acute Ischemic Stroke: A Meta-Analysis

目的系统评价桂枝茯苓丸治疗急性缺血性脑卒中的临床疗效及安全性。方法计算机检索中国科技期刊全文数据库(VIP)、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)和万方数据库(wanfang)、Web of Science、Medline及Pub Med。检索时间均为从该数据库最早收录时间至2017年2月,手工检索作为辅助,收集桂枝茯苓丸治疗急性缺血性脑卒中的临床随机对照试验(RCT)和半随机对照试验(quasi-RCT),依据Cochrane协作网系统评价方法进行评价,使用Revman5.3进行Meta分析。结果经筛选纳入6篇文献,共451例。Meta分析结果显示:桂枝茯苓丸组临床有效率[RR=1.16,95%CI(1.06,1.26),P=0.000 7],2个采用NIHSS评估神经功能缺损试验(107例)结果显示[WMD=0.55,95%Cl(-0.69,1.79),P=0.39]。描述性分析结果显示不良反应发生率低,复发率低。结论桂枝茯苓丸联合常规治疗具有一定疗效,且不良反应少,安全性较高,然而对神经功能缺损症状改善未见显著疗效。但由于现有研究数量和质量限制,今后仍需要进行更多高质量的随机对照试验研究以提供更可靠的循证医学证据。

Objective To assess the effects and safety of Guizhi Fuling（GZFL） pill for patients with acute ischemic stroke. Methods All randomized controlled trials（RCTs） and quasi-randomized control trial（quasi-RCTs） on GZFL pill for patients with acute ischemic stroke were collected by electronically searching VIP, CNKI, CBM, Wanfang, Wed of Science,Medline and Pub Med Database from the earlist establishment time to February 2017. A meta-analysis of relevant data were performed by using Rev Man 5.3 software according to Cochrane system-atic review. Results Six RCTs or quasi-RCTs involving 451 patients were included. The baseline data was comparable in all trials. The result of meta-analysis showed that the effetive rate in the GZFL capsule treatment group could be enhanced[RR=1.16,95% CI（1.06,1.26）, P=0.000 7]. Meta-analysis of 2 trials（n=107）, in which neurological deficits were assessed by NIHSS, show that GZFL pill fail to decrease NIHSS scores[WMD=0.55,95% Cl（-0.69, 1.79）, P=0.39. And the analysis results show that lower rate of adverse effects and recurrence.Conclusion GZFL pill combined with routine treatment is effective in the treatment of acute ischemic stroke and have less adverse effects. Yet, it fail to improve neurological deficits. But our researches need to be verified by more high-quality RCTs due to the relative low quality.