银杏二萜内酯葡胺注射液联合西药治疗脑梗死的疗效和安全性Meta分析

Meta-analysis on diterpene ginkgolides meglumine injection with Western Medicine in treating cerebral infarction

目的系统评价银杏二萜内酯葡胺注射液(DGMI)联合西药治疗脑梗死的临床疗效和安全性。方法计算机检索中国知网、维普数据库、万方数据库、CBM、PubMed、Cochrane Library等网络数据库,以及手工检索各类纸质出版期刊和会议论文,收集所有关于DGMI联合西药治疗脑梗死的随机对照试验文献,根据Cochrane系统评价员手册进行风险偏倚评估,并通过RevMan5.3软件对纳入文献的结局指标数据进行Meta分析。结果最终纳入26项研究,合计2332例患者,其中观察组1165例,对照组1167例。观察组中DGMI 20 mg静脉滴注2周124例,DGMI 25 mg静脉滴注1周83例,3周53例,其余均为DGMI 25 mg静脉滴注2周。Meta分析结果显示,DGMI联合西药治疗脑梗死的临床总有效率明显优于单纯常规西药治疗〔RR=1.22,95%CI(1.17~1.28),P<0.05〕,在改善BI评分和NIHSS评分方面亦明显优于单纯常规西药治疗〔分别MD=10.24,95%CI(7.53~12.95),P<0.05;MD=-3.08,95%CI(-3.94~-2.22),P<0.05〕。使用DGMI治疗后,出现的不良反应主要有恶心、头晕、皮疹、腹痛、肝功能异常、血小板减少等,用药安全性两组患者之间差异无统计学意义〔RR=0.76,95%CI(0.49~1.19),P=0.23〕。结论在常规西药治疗基础上,加用DGMI可以提高脑梗死治疗的临床疗效,降低神经功能缺损程度,提高日常生活活动能力,且不增加不良反应的发生率。

Objective To evaluate the efficacy and safety of diterpene ginkgolides meglumine injection(DGMI)combined with western medicine in the treatment of cerebral infarction.Methods We searched online databases such as CNKI,VIP,WanFang,CBM,PubMed,and Cochrane Library,as well as manually searched various paper publishing magazines and conference papers.We collect all the RCTs of DGMI combined with western medicine for cerebral infarction.The risk bias assessment was conducted using the Cochrane reviewers′manual,and meta analysis was conducted on the outcome indicator data in the included literature using RevMan5.3 software.Results 26 studies were eventually included,totaling 2332 patients,including 1165 in the observation group and 1167 in the control group.In the observation group,124 cases received DGMI 20 mg intravenous drip for 2 weeks,83 cases received DGMI 25 mg intravenous drip for 1 week,53 cases received DGMI 25 mg intravenous drip for 3 weeks,and the rest received DGMI 25 mg intravenous drip for 2 weeks.The results of meta-analysis showed that the total effective rate of DGMI combined with western medicine in the treatment of cerebral infarction was significantly better than that of conventional western medicine[RR=1.22,95%CI(1.17-1.28)],the difference was statistically significant(P<0.05).At the same time,it was significantly better than conventional western medicine in improving BI score and NIHSS score[MD=10.24,95%CI(7.53-12.95),P<0.05;MD=-3.08,95%CI(-3.94--2.22),P<0.05].After treatment with DGMI,the main adverse reactions include nausea,dizziness,rash,abdominal pain,abnormal liver function,thrombocytopenia,etc.In the safety of medication[RR=0.73,95%CI(0.44-1.22)],the difference between the two groups was not statistically significant(P=0.23).Conclusions Under the treatment of conventional western medicine,the addition of DGMI can significantly improve the clinical efficacy of cerebral infarction treatment,reduce the degree of neurological deficit,improve the ability of daily life,and will not significantly increase the adverse reactions.