银杏叶提取物注射液治疗老年缺血性脑血管病的疗效与安全性的系统评价

目的:系统评价银杏叶提取物注射液治疗老年缺血性脑血管病的疗效和安全性。方法:计算机检索PubMed、Cochrane Library、中国期刊全文数据库、中国生物医学文献数据库、万方数据知识服务平台和中文科技期刊数据库,收集银杏叶提取物注射液治疗老年缺血性脑血管病的随机对照试验(RCT)或半随机对照试验(qRCT)。由两名研究者按照纳入与排除标准独立筛选文献,提取资料并采用改良的Jadad评分量表对文献进行质量评价,用Rev Man 5.0统计软件进行Meta分析。结果:纳入12项RCT,共计1 115例患者。其中,舒血宁注射液10项,共计935例患者;金纳多注射液2项,共计180例患者。Meta分析结果显示,舒血宁注射液治疗老年缺血性脑血管病的有效率显著高于对照组[OR=2.74,95%CI(1.76,4.26),P<0.000],而两组不良反应发生率比较差异无统计学意义[OR=2.02,95%CI(0.82,4.94),P=0.12];金纳多注射液治疗老年缺血性脑血管病的有效率显著高于对照组[OR=4.72,95%CI(1.65,13.47),P=0.004],两组均未报道不良反应。结论:银杏叶提取物注射液治疗老年缺血性脑血管病安全有效,由于纳入文献数量较少、质量较低,此结论尚需更多高质量临床研究进一步证实。

A Systematic Evaluation of Effectiveness and Safety of Ginkgo biloba Extract Injection in the Treatment of Ischemic Cerebrovascular Disease in the Elderly

OBJECTIVE： To systematically evaluate the effectiveness and safety of Ginkgo biloba extract injection in treatment of ischemic cerebrovascular disease in the elderly. METHODS： All randomized controlled trials （RCTs） and quasi-randomized controlled trials （qRCT） on G. biloba extract injection for ischemic cerebrovascular disease in the elderly were retrieved from databases including PubMed, Cochrane Library, CNKI, CBM, Wanfang database and VIP. Two researchers selected the literatures according to the inclusion criteria and exclusion criteria, then extracted information of the included literature and made judgment of quality of the literature by Jadad scale, finally made Meta-analysis by Rev Man 5.0 statistical software. RESULTS： Totally, 12 studies were included, involving 1 115 patients. There were 10 included studies of Shuxuening injection, involving 935 patients, and 2 included studies of Jinnaduo injection, involving 180 patients. Results of Meta-analysis showed that clinical effectiveness of Shuxuening injection and Jinnaduo injection were better than control group in the treatment of ischemic cerebrovascular disease in the elderly; there was statistical significance [OR=2.74,95% CI （ 1.76,4.26）, P〈0.000; OR=4.72,95% CI （ 1.65,13.47）, P=0.004]. There was no statistical significance in the incidence of ADR between 2 groups [OR=2.02,95%CI（0.82,4.94）,P=0.12]. CONCLUSIONS： G. biloba extract injection is effective and safe for ischemic cerebrovascular diseases in the elderly. However, more high-quality RCTs are still needed because of the limitation of the methodological quality of included studies.