单唾液酸四己糖神经节苷脂治疗急性缺血性脑卒中的系统综述与Meta分析

GM1 ganglioside therapy in acute ischemic stroke:a systematic review and Meta-analysis

目的:评价单唾液酸四己糖神经节苷脂(GM1)治疗急性缺血性脑卒中的疗效。方法:计算机检索PubMed,Embase,The Cochrane Library,ClinicalTrial.gov,SinoMed,中国知网、维普和万方数据库在2018年4月27日之前公开发表的随机对照临床试验(RCT),并对符合入选标准的文献采用Cochrane偏倚评价工具进行质量评价,提取研究特征和疗效评价相关数据,使用STATA 14.0进行Meta分析。结果:最终纳入23项RCT研究,共计2320人。13项研究(1325人)报告了1个月NIHSS评分变化,合并的效应值MD及95%CI为-3.60(-4.89,-2.32)。亚组分析结果显示,空白对照研究合并的效应值MD及95%CI为-4.42(-5.31,-3.53),阳性对照研究合并的效应值MD及95%CI为-1.80(-3.58,-0.03)。10项研究(1062人)报告了3个月Barthel指数变化,合并的效应值MD及95%CI为12.13(7.29,16.98)。亚组分析结果显示,空白或安慰剂对照研究合并的效应值MD及95%CI为14.24(10.40,18.08),阳性对照研究合并的效应值MD及95%CI为5.30(-0.43,11.02)。2项研究(118人)合并的6个月Barthel指数变化的效应值MD及95%CI为12.96(5.14,20.78)。1项研究(96人)报告的3个月改良Rankin量表评分的效应值MD及95%CI为-0.96(-1.46,-0.46)。结论:神经节苷脂GM1可能会改善急性缺血性脑卒中患者的神经功能缺损和日常生活能力。

Objective:To assess the efficacy of GM1 ganglioside for treatment of acute ischemic stroke.Methods:From inception to April 27,2018,databases like Pubmed,Embase,Cochrane Library,CNKI,VIP,Wanfang and SinoMed were systemically searched for RCT publications during the period.Strict screening and quality assessment of the obtained literature by Cochrane assessment tool was conducted to extract relevant data.The meta-analysis was performed using STATA 14.0 software.Results:Twenty-three studies involving 2320 patients were finally included in this study.Meta-analysis results showed that:The MD and 95%CI of 1 month NIHSS improvement in 13 studies(1325 patients)was-3.60(-4.89,-2.32).Subgroup analysis showed that the values of MD and 95%CI of 1 month NIHSS improvement were-4.42(-5.31,-3.53)for blank control group and-1.80(-3.58,-0.03)for positive control group.The MD and 95%CI of 3 month Barthel indeximprovement in 10 studies(1062 patients)was 12.13(7.29,16.98).Subgroup analysis showed that the values of MD and 95%CI of 3 month Barthel index improvement were 14.24(10.40,18.08)for blank/placebo control group and 5.30(-0.43,11.02)for positive control group.The MD and 95%CI of 6 month Barthel index improvement in 2 studies(118 patients)was 12.96(5.14,20.78).The MD and 95%CI of 3 month Modified Rankin Scale in 1 study(96 patients)was-0.96(-1.46,-0.46).Conclusion:Ganglioside GM1 may improve the neurological defect and activities of daily living in patients with acute ischemic stroke.