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[摘要]
目的 系统性评价银杏萜内酯类注射液治疗缺血性脑卒中的疗效及安全性。方法 检索中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP)、中国生物医学文献数据库(CBM)、万方数据库、EMBASE、Pubmed和The Cochrane Library,检索截止日期为2017年12月。纳入银杏萜内酯类注射液治疗缺血性脑卒中的随机对照试验研究,采用RevMan5.2软件对临床疗效及神经功能缺损评分进行Meta-分析。结果 最终纳入临床研究13项,涉及患者1 330例。Meta-分析结果显示,银杏内酯注射液治疗缺血性脑卒中患者的临床疗效优于对照组[RR=1.14,95%CI(1.03,1.25),Z=2.59,P=0.009];银杏内酯B注射液治疗缺血性脑卒中患者的临床疗效与对照组相当[RR=1.13,95%CI(0.95,1.33),Z=1.36,P=0.17];银杏二萜内酯葡胺注射液治疗缺血性脑卒中患者的临床疗效优于对照组[RR=1.17,95%CI(1.08,1.27),Z=3.69,P=0.0002];银杏内酯注射液改善缺血性脑卒中患者的神经功能缺损评分与对照组相当[MD=-0.43,95%CI(-4.32,3.46),Z=0.22,P=0.83];银杏内酯B注射液改善缺血性脑卒中患者的神经功能缺损评分与对照组相当[[MD=-0.87,95%CI(-2.64,0.91),Z=0.96,P=0.34];银杏二萜内酯葡胺注射液改善缺血性脑卒中患者的神经功能缺损评分优于对照组[MD=-1.62,95%CI(-2.63,-0.60),Z=3.13,P=0.002];纳入研究均未报道银杏萜内酯类注射液引起严重不良反应。结论 银杏萜内酯类注射液治疗缺血性脑卒中患者可提高临床疗效、减少神经功能缺损,但缺乏临床意义证据。尚需更多高质量研究以增加证据的强度。
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[Abstract]
Objective To systematically access the effectiveness and safety of bilobalide injections for the treatment of patients with ischemic stroke.Methods The randomized clinical trials (RCTs) were retrieved by searching CBM, CNKI, WanFang Data, VIP Database, EMBASE, PUBMED, and The Cochrane Library until December. Patients with ischemic stroke were included into RCTs research and studies were extracted the feature information. Related journals and conference papers were searched manually. Clinical efficacy and neurological deficit score was Meta-analyzed by RevMan5.2 software.Results Meta-analysis showed that the bilobalide injection was superior to the control group for the treatment of patients with ischemic stroke in improving clinical curative effect[RR=1.14, 95%CI(1.03, 1.25), Z=2.59, P=0.009]; There was no difference between bilobalide B injection and the control group in improving clinical curative effect[RR=1.13, 95%CI(0.95, 1.33), Z=1.36, P=0.17]; While, diterpene ginkgolides meglumine injection were superior to the control group in improving clinical curative effect[RR=1.17, 95%CI(1.08, 1.27), Z=3.69, P=0.000 2]; Meantime, there was no differences between the bilobalide injection and the control group for the treatment of patients with ischemic stroke in improving neurological severity scores[MD=-0.43, 95%CI(-4.32, 3.46), Z=0.22, P=0.83]; Similarly, the same as the bilobalide B injection in improving clinical curative effect[MD=-0.87, 95%CI(-2.64, 0.91), Z=0.96, P=0.34]; While, diterpene ginkgolides meglumine injection were superior to the control group in improving neurological severity scores[MD=-1.62, 95%CI(-2.63, -0.60), Z=3.13, P=0.002]. The serious adverse reactions caused by types of bilobalide injections were not reported in this study.Conclusion Bilobalide injections were superior to the control group in improving clinical curative effect and neurological severity scores in patients with ischemic stroke. More high quality research was needed to increase the strength of the evidence.
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[基金项目]
国家中医临床研究基地业务建设科研专项(JDZX2012133)