银杏内酯注射液联合阿替普酶治疗急性缺血性卒中的Meta分析

Clinical efficacy of ginkgolide injection combined with alteplase in the treatment of acute ischemic stroke:a meta-analysis

目的系统评价银杏内酯注射液联合阿替普酶治疗急性缺血性卒中(AIS)的疗效与安全性。方法采用Cochrane系统评价方法,检索中国期刊全文数据库、万方数据库、维普中文科技期刊全文数据库、中国生物医学文献数据库、中国硕士和博士论文全文数据库、Clinical Trials.gov、PubMed、Embase、The Cochrane Library和Web of Science等数据库,截止日期为2020年7月。筛选关于银杏内酯注射液联合阿替普酶治疗AIS的随机对照试验(RCT)文献。由两名评价员对所有纳入临床研究独立进行数据分析提取及质量评价,采用revman5.3软件进行Meta分析。结果共纳入9项RCT、765例AIS患者,全部为中文文献。Meta分析结果显示,与阿替普酶治疗比较,银杏内酯类注射液联合阿替普酶治疗显著改善AIS患者神经功能缺损(MD=-3.08,95%CI:-3.74~-2.43,P<0.00001),临床有效率显著提高(OR=3.93,95%CI:2.37~6.52,P<0.00001),患者生活质量(MD=7.06,95%CI:3.71~10.40,P<0.0001)及Barthel指数显著改善(MD=8.96,95%CI:6.00~11.92,P<0.00001),而不良反应发生率比较差异无统计学意义(OR=0.76,95%CI:0.42~1.40,P=0.38)。结论银杏内酯注射液联合阿替普酶治疗AIS患者可显著改善神经功能缺损,提高临床疗效和患者生活质量,但仍需要更多大样本、多中心、高质量研究证实。

Objective To systematically evaluate the efficacy and safety of ginkgolide injection combined with alteplase in the treatment of acute ischemic stroke(AIS).Methods The Cochrane system evaluation method was used to search randomized controlled trials(RCT)of ginkgolide injection combined with alteplase in the treatment of AIS from China Academic Journals Full-text Database,Wanfang Database,VIP Chinese Scientific Journals Full-text Database,Chinese Biomedical Literature Database,Chinese Master's and Doctoral Thesis Full-text Database,Clinical Trials.gov,PubMed,Embase,The Cochrane Library and Web of Science and other databases.Search time was limited to July 2020.Two reviewers independently conducted data analysis and quality evaluation and used RevMan 5.3 software for meta-analysis.Results A total of 9 RCTs and 765 stroke patients were included,all of which were Chinese literature.Meta-analysis results showed that compared with alteplase treatment,ginkgolide injection combined with alteplase treatment had significantly improved neurological deficits in AIS patients(MD=-3.08,95%CI:-3.74 to-2.43,P<0.00001),significantly improved clinical effective rate(OR=3.93,95%CI:2.37 to 6.52,P<0.00001),improved quality of life(MD=7.06,95%CI:3.71 to 10.40,P<0.0001),and improved Barthel index(MD=8.96,95%CI:6.00 to 11.92,P<0.00001).There was no significant difference in the adverse reactions between ginkgolide injection combined with alteplase and alteplase alone(OR=0.76,95%CI:0.42 to 1.40,P=0.38).Conclusion Ginkgolide injection combined with alteplase in the treatment of AIS patients can significantly improve neurological deficits,clinical efficacy and patient quality of life,which still needs more large samples,multi-center,high-quality research to confirm.