灯盏细辛注射液治疗急性脑梗死的系统评价和Meta分析

Efficacy and Safety of Dengzhan Xixin Injection forAcute Cerebral Infarction:A Systematic Review and Meta-analysis

目的系统评价灯盏细辛注射液治疗急性脑梗死的有效性和安全性。方法计算机检索CNKI、Wanfang、VIP、SinoMed、Cochrane Library、PubMed、Embase、Web of Science、Clinical-Trials.gov,筛选出灯盏细辛注射液治疗急性脑梗死的随机对照试验(randomized controlled trial,RCT),并根据Cochrane Handbook 5.1评价标准和工具,进行文献筛选、资料提取和质量评价,并用RevMan 5.3软件对最终纳入的研究进行Meta分析。结果共检索出1477篇文章,最终纳入35篇,总样本量为4379例,试验组2240例,对照组2139例。Meta分析结果显示:在疗效标准一致的情况下,常规治疗+灯盏细辛的总有效率优于常规治疗(RR=1.24,95%CI[1.20,1.28],P<0.00001);常规治疗+灯盏细辛的总有效率优于常规治疗+维脑路通(RR=1.39,95%CI[1.21,1.59],P<0.00001);常规治疗+灯盏细辛在改善NIHSS评分方面优于常规治疗(MD=-2.83,95%CI[-3.59,-2.07],P<0.00001);常规治疗+灯盏细辛在改善日常生活能力方面优于常规治疗(MD=17.22,95%CI[6.84,27.61],P=0.001)。结论基于现有数据和方法显示,灯盏细辛注射液联合西医常规治疗或其他西药治疗急性脑梗死具有一定的疗效,能改善神经功能缺损情况,提高日常生活能力,改善血液流变学指标。无证据证明其存在严重的不良反应,但由于方法学质量不高等原因,其安全性尚需进一步研究和明确。本研究纳入研究质量不高,证据有限,尚需更多设计严谨、高质量的随机、对照、双盲、多中心试验以增加证据强度。

Objective To evaluate the efficacy and safety of Dengzhan Xixin Injection in the treatment of acute cerebral infarction.Method The randomized controlled trials(RCTs)of Dengzhan Xixin Injection in the treatment of acute cerebral infarction were selected bysearching CNKI,Wanfang,VIP,SinoMed,Cochrane Library,PubMed,Embase,Web of Science and Clinical-Trials.gov by computer.And Handbook 5.1 evaluation criteria and tools were used for literature screening.The data extraction and quality evaluation,and Meta-analysis was carried out with RevMan 5.3 software.Results A total of 1477 articles were retrieved and 35 articles were included.The total sample size was 4379 cases,2240 cases in the trial group and 2139 cases in the control group.The results of Meta-analysis showed thatunder the condition of the same therapeutic effect,the total effective rate of conventional treatment combined with Dengzhan Xixin Injection was better than that of conventional treatment(RR=1.24,95%CI[1.20,1.28],P<0.00001).The total effective rate of conventional treatment combined with Dengzhan Xixin Injection was better than that of conventional treatment combined with troxerutin(RR=1.39,95%CI[1.21,1.59],P<0.00001).The conventional treatment combined with Dengzhan Xixin Injection was better than that of conventional treatment in improving NIHSS score(MD=-2.83,95%CI[-3.59,-2.07],P<0.00001).The conventional treatment combined with Dengzhan Xixin Injection was better than that of conventional treatment in improving activity of daily living(MD=17.22,95%CI[6.84,27.61],P=0.001).Conclusion Dengzhan Xixin Injection combined with conventional treatment or other western medicine for acute cerebral infarction has a certain effect,and can improve the neurological deficit,activity of daily living and hemorheology indicators.There is no evidence of serious adverse reactions,but its safety needs further study and clarification because of the low quality of methodology.In this study,the quality of the study is low,the evidence is limited,and more well-designed,high-quality randomized,controlled,double-blind,multi-center trials are needed to increase the strength of the evidence.