丁苯酞软胶囊治疗进展性卒中的系统评价

Butylphthalide Soft Capsule for the Treatment of Progressive Stroke: A Systematic Review

关键词:  进展性卒中  丁苯酞  系统评价  meta分析

Key words:  progressive stroke  butylphthalide  systematic review  meta-analysis

摘要:

目的 系统评价丁苯酞软胶囊治疗进展性卒中的疗效和安全性。方法 检索Cochrane图书馆、万方、CNKI等数据库收集关于丁苯酞治疗进展性卒中的随机对照试验（randomized controlled trials，RCTs），时间截至2018年12月，根据明确的纳入与排除标准筛选相关研究，采用RevMan 5.3软件进行统计分析。结果 共纳入26个RCTs（2 519例患者），meta分析结果示，与对照组比较，丁苯酞治疗进展性卒中疗效更好（RR=1.23，95%CI 1.17~1.29，P<0.000 01）；丁苯酞治疗进展性卒中在神经功能缺损评分（The National Institutes of Health Stroke Scale，NIHSS）（MD=-3.01，95%CI -3.49~-2.52，P<0.000 01）、卒中评分量表（Chinese Stroke Scale，CSS）评分（MD=-3.39，95%CI -4.70~-2.08，P<0.000 01）及日常生活活动能力评分量表（Barthel Index，BI）评分（MD=9.84，95%CI 6.06~13.62，P<0.000 01）改善方面均优于对照组，差异有统计学意义。2组在不良反应方面差异无统计学意义（RR=1.27，95%CI 0.50~3.18，P=0.61）。结论 丁苯酞软胶囊能有效改善进展性卒中患者的神经功能，且不增加不良反应。

Abstract:

OBJECTIVE To systematically assess the clinical efficacy and safety of butylphthalide soft capsule for patients with progressive stroke. METHODS Databases including Cochrane library, Wan Fang data and CNKI and so on were searched to collect randomized controlled trials(RCTs) about butylphthalide for patients with progressive stroke from inception to December 2018. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Then, RevMan 5.3 software was used to perform meta-analysis. RESULTS Twenty-six RCTs involving 2 519 patients were included. Results of meta-analysis showed that the butylphthalide group were superior to those of the control group in the clinical efficacy rate(RR=1.23, 95%CI 1.17-1.29, P<0.000 01), The National Institutes of Health Stroke Scale score(MD=-3.01 95%CI-3.49——2.52, P<0.000 01), Chinese Stroke Scale score(MD=-3.39, 95%CI -4.70——2.08, P<0.000 01) and Barthel Index score(MD=9.84, 95%CI 6.06-13.62, P<0.000 01), and these differences were statistically significant, while there was no statistical difference between the two groups in the incidence of adverse events(RR=1.27, 95%CI 0.50-3.18, P=0.61). CONCLUSION Butylphthalide soft capsule can improve the neurological function for patients with progressive stroke without increasing the incidents of adverse events.