奥扎格雷钠注射液治疗进展性脑卒中的有效性和安全性的Meta分析  

Efficacy and Safety of Ozagrel Sodium Injection in the Treatment of Progressing Stroke:a Meta Analysis

作　　者：李晓旭 刘芳[1] 汤骐羽 LI Xiao-xu;LIU Fang;TANG Qi-yu(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Department of Pharmacology,Ulanqab Central Hospital,Ulanqab 012000,China;Clinical Trials Center,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]乌兰察布市中心医院药剂科,乌兰察布012000 [3]国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京100021

出　　处：《中国合理用药探索》2022年第1期15-26,共12页Chinese Journal of Rational Drug Use

基　　金：乌兰察布市中心医院院级课题(2020y12)。

摘　　要：目的:系统评价奥扎格雷钠注射液治疗进展性脑卒中的有效性和安全性。方法:计算机检索Cochrane library、PubMed、Embase、Medline、Clinical trials.gov、IgakuChouZasshi(ICHUSHI)、中国生物医学文献数据库、维普中文科技期刊数据库、万方数据库、中国知网,检索时间均为建库至2020年7月。手工检索相关期刊以及文献资料,2名作者独立阅读所有奥扎格雷钠注射液治疗急性进展性脑卒中的随机对照试验(RCT) 研究文献,筛选符合纳入标准的研究,提取资料后采用Cochrane系统评价员手册5.2版推荐的偏倚风险评估工具评价文献质量,采用RevMan 5.3软件进行 Meta 分析。结果:共纳入22项RCT,共计2340例患者,其中治疗组1186例,对照组1154例。各项纳入研究的基线资料具有可比性,其中有21项采用随机方法,仅有1项采用随机数字表法,且均未提及盲法和分配隐藏情况。Meta分析结果显示:与对照组相比,奥扎格雷钠组总有效率升高,具有统计学差异[RR=1.28,95%CI:(1.22,1.34),P<0.000 01];14项研究(1665例患者)提供了治疗前和治疗后14天的神经功能缺损(NDS)评分,与对照组比较,奥扎格雷钠组神经功能缺损有所改善,具有统计学差异[RR=-0.80,95%CI:(-1.02,-0.59),P<0.000 01];奥扎格雷钠组出血相关不良反应事件发生率与对照组无统计学差异[RD=0.00,95%CI:(-0.01,0.02),P=0.48],且均未观察到严重不良反应;两组急性期死亡情况比较无统计学差异[RD= -0.01,95%CI:(-0.02,0.00),P=0.20]。结论:奥扎格雷钠注射液能减少进展性脑卒中患者的神经功能缺损,提高临床治疗有效率,且无严重不良反应。Objective:To systematically evaluate the efficacy and safety of ozagrel sodium injection in the treatment of progressive stroke.Methods:Cochrane library,PubMed,Embase,Medline,Clinical trials.gov,IgakuChouZasshi(ICHUSHI),Chinese Biomedical Literature Database,Weipu Chinese Science and Technology Journal Database,Wanfang Database,China CNKI were retrieved by computer.The retrieval time is from the database construction to July 2020.Manual retrieval of relevant journals and references included in the literature.Two authors reviewed all the literature of randomized controlled trials(RCT)of ozagrel sodium injection in the treatment of acute progressive stroke independently,screening the studies that meet inclusion criteria.After data extraction,the quality of the literature was evaluated using the risk of bias assessment tool recommended in the Cochrane Systematic Evaluator’s Manual 5.2,and RevMan 5.3 software was used for Meta Analysis.Results:A total of 22 RCTs were included,involving 2340 patients.There were 1186 cases in the treatment group and 1154 cases in the control group.The included baseline data were comparable,of which 21 reports used random method,only 1 mentioned the random number method,and none of them mentioned blind method and allocation hiding.The results of Meta Analysis showed:compared with the control group,the total effective rate of ozagrel sodium group increased,with statistical difference[RR=1.28,95%CI:(1.22,1.34),P<0.00001].14 study(1665 cases)provided neurological function defect scores before treatment and 14 days after treatment.Compared with the control group,ozagrel sodium group can significantly improve the neurological function defects,with statistical difference[RR=0.80,95%CI:(–1.02,–0.59),P<0.00001].There was no statistical difference in the incidence of bleeding-related adverse events between the ozagrel sodium group and the control group.[RD=0.00,95%CI:(–0.01,0.02),P=0.48].No serious adverse reactions were observed.There was no statistical difference between the two groups

关 键 词：奥扎格雷钠注射液 进展性脑卒中 系统评价 META分析 随机对照试验 

分 类 号：R973.2[医药卫生—药品]