神经节苷脂佐治脑梗死疗效的Meta分析

Meta-analysis on effect of compound ganglioside injection in treating cerebral infarction

目的系统性评价神经节苷脂(gangliosidosis,GM1)佐治脑梗死(cerebral infarction,CI)的临床疗效及安全性。方法利用计算机检索中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(维普)、万方数据库、Medline、Embase医学文献检索全文数据库(各数据库检索时间均为自建库起到2015年10月),同时检索相关文献的参考文献,并辅以手工检索相关杂志和会议论文等。收集有关神经节苷脂治疗脑梗死的随机或半随机对照试验,根据Cochrane Handbook推荐的文献质量评价办法对符合纳入标准的文献进行质量评价,并应用RevMan5.3软件进行统计学处理。最终纳入23个随机对照试验(randomised controlled trial,RCT),总计2 076例患者,其中神经节苷脂治疗组1 041例,常规治疗对照组1 035例。结果 Meta分析结果显示,在常规治疗基础上加用神经节苷脂可提高脑梗死患者CI的治疗有效率[RR=1.28,95%CI(1.23~1.34)],治愈率[RR=1.46,95%CI(1.28~1.67)],神经功能缺损评分(NDS)比较[MD=-9.08,95%CI(-11.61^-6.54)],差异均有统计学意义。所纳入研究共出现皮疹5例,谷丙转氨酶(GPT)升高7例,停药后均消失,均无肝肾功能损害。结论目前有效的证据表明应用神经节苷脂佐治脑梗死CI可以提高临床疗效,但由于所纳入研究质量不高,尚需更多设计良好、规模较大的RCT研究进一步加以验证。

Objective To systematically evalutate the clinical efficacy and safty of compound ganglioside injection（GM1）in treating cerebral infarction（CI） of adults. Methods Computer retrievals were made in CNKI, VIP, Wanfang Data, Medline, Embase and relevant literattu＇e references（before October 2015） ,and manual retrievals were made for journals and conference papers. We collected randomized controlled trials concerning compound GM1 in the treatment of CI. The quality of included references was evaluated according to literatures recommended by Cochrane Handbook. RevMan 5.3 software was applied in the statistical treatment. Finally, a total of 36 randomized controlled trials were included,covering 2 076 patients （including 1 04t patients in the compound GM1-treated group and 1 035 patients in the control group ）. Results Meta-analysis results showed that the routine treatment combined with compound GM1 could improve the treatment efficiency of CI [RR= 1.28, 95% CI （ 1.23～ 1.34） ],improve the cure rate [RR= 1.46, 95 %CI（ 1.28～1.67）] and reduce the neurological deficit scores [MD =- 9.08, 95 % CI（- 11.61～-6.54）] with statistical differences. Of the included studies 5 cases of skin rash appeared, 7 cases of alanine Aminotransferase （GPT） increased. After stopping drugs, these above disappeared without damage to liver and kidney function. Conclusion So far,limited evidences in this study proved that the application of compound GM1 in the treatment of CI can enhance the clinical efficiency. However, because of the low quality of the included trials,more well-designed and large scale multi-center randomized controlled trials shall be made in the future.