清热解毒类中药注射液治疗急性缺血性脑卒中的网状Meta分析

Network Meta-analysis of Heat-clearing and Detoxifying Traditional Chinese Medicine Injections in the Treatment of Acute Ischemic Stroke

目的:运用网状Meta分析评价清热解毒类中药注射液治疗急性缺血性脑卒中的临床疗效。方法:系统检索中国期刊全文数据库(CJFD)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、中国生物医学文献数据库(CBM)、PubMed、Web of Science、Cochrane Library等中英文数据库,检索时间为建库至2020年11月。由2名研究者背对背进行文献的筛选与资料的提取,采用Cochrane偏倚风险评估工具进行质量评价,运用Review Manager5.4.1、Stata15.1、ITC,以及R软件的gemtc程序包进行数据分析。结果:共纳入40项研究,结果示:提高临床总有效率方面,苦碟子注射液(OR=5.02,95%CI为3.26~7.74,P<0.00001),清开灵注射液(OR=4.05,95%CI为1.98~8.28,P<0.00001),醒脑静注射液(OR=3.49,95%CI为2.73~4.47,P<0.00001),分别与西医常规联用,均优于单用西医常规,且苦碟子注射液联合西医常规最佳。在改善神经功能缺损方面,苦碟子注射液(MD=-3.24,95%CI为-4.52~-1.97,P<0.00001);清开灵注射液(MD=-4.04,95%CI为-7.32~-0.76,P=0.02);醒脑静注射液(MD=-3.86,95%CI为-4.66~-3.05,P<0.00001);分别与西医常规联用,均优于单用西医常规,且醒脑静联合西医常规效果佳。在改善日常生活能力方面,苦碟子注射液(MD=11.66,95%CI为5.74,17.59,P=0.0001);醒脑静注射液(MD=10.88,95%CI为4.94,16.83,P=0.0003);分别与西医常规联用,均优于单用西医常规;二者比较,疗效相当(P=0.89>0.05)。结论:清热解毒类中药注射液与西医常规联用可提高急性缺血性脑卒中患者的临床总有效率,改善神经功能及日常生活能力,但疗效排序各异,可能与纳入研究质量偏低有关,后续仍需开展高质量的随机对照试验进一步验证。

Objective:To evaluate the clinical efficacy of heat-clearing and detoxifying TCM injections in the treatment of acute ischemic stroke by network Meta-analysis.Methods:Chinese and English databases,including the Chinese Journal Full-text Database(CJFD),China Science Periodical Database(CSPD),Chinese Citation Database(CCD),China Biology Medicine disc(CBM),PubMed,Web of Science,and Cochrane Library,were searched from the date of construction to November 2020.Two researchers screened the literature and extracted the data back to back,evaluated the quality using the Cochrane bias risk assessment tool,and analyzed the data using Review Manager5.4.1,Stata15.1,ITC and gemtc package of R software.Results:A total of 40 studies were finally included.The results showed that 1)in the improvement of the total clinical effective rate,Kudiezi Injection(OR=5.02,95%CI was 3.26 to 7.74,P<0.00001),Qingkailing Injection(OR=4.05,95%CI was 1.98 to 8.28,P<0.00001),and Xingnaojing Injection(OR=3.49,95%CI was 2.73 to 4.47,P<0.00001)combined with Western medicine respectively were superior to Western medicine alone,and Kudiezi Injection combined with Western medicine was the best;2)in the improvement of neurological deficits,Kudiezi Injection(MD=-3.24,95%CI was-4.52 to-1.97,P<0.00001),Qingkailing Injection(MD=-4.04,95%CI was-7.32 to-0.76,P=0.02),Xingnaojing Injection(MD=-3.86,95%CI was-4.66 to-3.05,P<0.00001)combined with Western medicine respectively were also superior to Western medicine alone.Xingnaojing Injection combined with Western medicine showed better effect;3)in the improvement of activities of daily living,Kudiezi Injection(MD=11.66,95%CI was 5.74 to 17.59,P=0.000)and Xingnaojing Injection(MD=10.88,95%CI was 4.94 to 16.83,P=0.0003)combined with Western medicine respectively were superior to Western medicine,and there was no statistical difference between them(P=0.89>0.05).Conclusion:Heat-clearing and detoxifying TCM injections combined with Western medicine can improve the total clinical effective rate of patients with acute ischemic stroke,and their neurological function and activities of daily living,but the orders of efficacy are different,which may be related to the low quality of the included studies.In the future,high-quality randomized controlled trials are still needed for further verification.