The efficacy and safety of diterpene ginkgolides meglumine injection in stroke: a Meta-analysis
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摘要: 目的 银杏二萜内酯葡胺注射液（diterpene ginkgolides meglumine injection，DGMI）在临床广泛用于脑梗死的治疗，然而其疗效和安全性尚无一致结论，笔者通过Meta分析综合评价其在脑梗死治疗中的疗效及安全性。 方法 通过检索万方、维普、CNKI、PubMed等数据库，筛选合格的随机对照研究（RCT），根据Cochrane系统评价方法对纳入文献进行资料提取和质量评价，然后采用Stata软件进行Meta分析。 结果 共纳入9个RCT，包括1 129例患者，其中DGMI治疗组706例，对照组423例。Meta分析结果显示：①对于脑梗死急性期：在治疗有效率方面，DGMI组优于常规治疗组，差异有统计学意义［RR=1.19，95% CI（1.09，1.31），P<0.000 1］；在改善神经功能缺损方面，DGMI组显著优于常规治疗组［SMD=3.23，95% CI（2.87，3.60），P<0.000 1］；在日常生活能力改善方面，DGMI组也同样显著优于常规治疗组［SMD=3.23，95% CI（2.87，3.60），P<0.000 1］。②对于脑梗死恢复期：在治疗有效率方面，DGMI组优于舒血宁组，差异有统计学意义［RR=1.17，95% CI（1.05，1.30），P<0.05］；在改善神经功能缺损方面，DGMI组显著优于舒血宁组［SMD=-0.69，95% CI（-0.88，-0.49），P<0.000 1］。在不良反应发生率方面，DGMI组相较于其他银杏制剂或常规治疗组无显著性差异（P>0.05）。 结论 银杏二萜内酯葡胺注射液治疗脑梗死急性期和恢复期疗效均优于常规治疗组，且两组之间不良反应发生率无显著性差异。本研究结果还需要更多高质量的RCT加以证实。
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关键词:
- 银杏二萜内酯葡胺注射液 /
- 脑梗死急性期 /
- 脑梗死恢复期 /
- 荟萃分析 /
- 随机对照研究
Abstract: Objective Diterpene ginkgolides meglumine injection (DGMI) is widely used in patients with stroke, but its efficacy and safety are not consistent. We performed a Meta-analysis to comprehensively evaluate the efficacy and safety of DGMI in acute ischemic stroke and recovered stroke. Methods The wanfang, VIP, CNKI and PubMed were searched, the randomized controlled trials (RCTs) were enrolled. Data collection and quality evaluation of the included RCTs were performed according to Cochrane systematic evaluation method. Meta-analysis was performed by using Stata software. Results 9 RCTs involving 1 129 subjects were included with 706 subjects in DGMI treatment group and 423 subjects in control group. ① For acute ischemic stroke, DGMI group had superior effective rate compared to conventional therapy group (RR=1.19, 95%CI:1.09, 1.31, P<0.000 1), improvement of neurologic impairments (SMD=3.23, 95%CI:2.87, 3.60, P<0.000 1) and improvement of living quality (SMD=3.23, 95%CI:2.87, 3.60, P<0.000 1). ② For recovered stroke, DGMI group had better effective rate than Shuxuening injection group (RR=1.17, 95%CI:1.05, 1.30, P<0.05) and improvement of neurologic impairments (SMD=-0.69, 95%CI:-0.88, -0.49, P<0.000 1). There was no significant difference in adverse events between DGMI and control groups (P>0.05). Conclusion DGMI had superior efficacy over control group for both acute ischemic stroke and recovered stroke. There was no significant difference in adverse events between these two groups. However, we still need better quality RCTs to confirm these results. -
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