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目的系统评价灯盏生脉胶囊佐治缺血性脑卒中的临床疗效及其二级预防作用。方法计算机检索Pubmed、EMbase、Cochrane Library和CNKI、CBM、VIP、Wanfang Data,检索时限为建库至2016年2月,同时手工检索相关杂志和网页搜索谷歌学术,纳入关于灯盏生脉胶囊佐治缺血性脑卒中的随机对照试验。由2名研究者独立地按照纳入和排除标准筛选文献、提取相关数据并进行质量评价,采用Rev Man5.3对结局指标进行meta分析。结果共纳入文献18篇,患者4 416例。Meta分析结果显示,与对照组相比,试验组能降低脑卒中复发率[RR=0.53,95%CI(0.39,0.71),P<0.000 1]和病死率[RR=0.28,95%CI(0.11,0.68),P<0.005],且在临床疗效[RR=1.22,95%CI(1.15,1.29),P<0.000 01]及日常生活能力[MD=9.19,95%CI(3.41,14.98),P=0.002]上要优于对照组;在残障功能改善程度[MD=?0.04,95%CI(?0.16,0.07),P=0.47][RR=1.11,95%CI(0.89,1.40),P=0.35]和不良反应发生率[RR=0.68,95%CI(0.34,1.37),P=0.29]上2组间无明显差异。结论灯盏生脉胶囊佐治缺血性脑卒中与常规治疗相比能够降低脑卒中复发率和病死率,且在临床疗效和日常生活能力上要优于常规治疗。在残障功能改善程度上两者无明显差别。灯盏生脉胶囊联合常规治疗未明显增加不良反应发生。
Objective To systematically evaluate the clinical efficacy and its secondary prevention effect of Dengzhan Shengmai Capsule in treating ischemic stroke. Methods PubMed, EMbase, Cochrane Library and CNKI, CBM, VIP and Wanfang Data were searched by computer. The search period was from the date of establishment to February 2016, meanwhile manual search of related magazines and web search Google Scholar was conducted, Randomized controlled trials of stroke. Two investigators independently screened the literature according to inclusion and exclusion criteria, extracted relevant data and assessed the quality, and used Rev Man5.3 to conduct a meta-analysis of outcome measures. Results A total of 18 articles were included and 4 416 patients were included. Meta-analysis showed that the experimental group was able to reduce the recurrence rate of stroke compared with the control group [RR = 0.53, 95% CI (0.39, 0.71), P <0.0001] and mortality [RR = 0.28, 95% CI P <0.0001] and daily living ability [MD = 9.19, 95% CI (3.41, 14.98) , P = 0.002] was superior to the control group; in the improvement of disability function [MD =? 0.04,95% CI (? 0.16,0.07), P = 0.47] [RR = 1.11,95% CI (0.89,1.40) , P = 0.35] and incidence of adverse reactions [RR = 0.68,95% CI (0.34,1.37), P = 0.29]. There was no significant difference between the two groups. Conclusion Dengzhan Shengmai capsule adjuvant ischemic stroke compared with conventional treatment can reduce the recurrence rate and mortality of stroke, and clinical efficacy and daily living ability is superior to conventional treatment. There was no significant difference in the degree of improvement in disability. Dengzhan Shengmai capsule combined with conventional treatment did not significantly increase the adverse reactions.