中药注射液辅助治疗脓毒症的系统评价和Meta分析

Systematic evaluation and meta analysis of adjuvant treatment of sepsis by traditional chinese medicine injection

目的近年来有许多关于中药注射治疗脓毒症的报道,但其是否能改善脓毒症尚不清楚。本研究将进行荟萃分析,以评估中药注射在治疗脓毒症的疗效和安全性。方法在Pubmed数据库、Cochrane图书馆、Embase数据库、CINAHL、中国知网(CNKI)、中国生物医学文献服务系统(CBM)、中国科学期刊数据库(VIP)、万方数据库(WFD)等多个数据库,进行综合系统检索,检索日期从各数据库创建至2022年10月11日。独立进行文献筛选、数据提取,并运用Cochrane手册5.3的方法对纳入文献进行质量系统评价,将筛选的文献运用STATA15软件进行疗效评价分析。结果共纳入35篇符合条件的随机对照试验,涉及2580名脓毒血症患者。与对照组相比,联合中药注射液治疗的患者能降低28d死亡率(OR=1.17,95%CI:1.01~1.39,I2=0.00%),APACHEⅡ积分(SMD=-0.75,95%CI:-0.97~-0.53,I2=81.9%),并能改善炎性细胞因子IL-6、WBC、TNF-α,CRP水平(SMD=-0.75,95%CI:-0.95~-0.55,I2=41.8%;SMD=-0.69,95%CI:-1.13~-0.29,I2=86.5%;SMD=-0.58,95%CI:-0.9~-0.26);缩短ICU住院时间(SMD=-0.8,95%CI:-1.46~-0.14,I2=90.6%)。3项试验报告了不良反应,涉及30名患者,主要以静脉炎、皮疹多见。结论建议脓毒血症患者可应用中药注射联合治疗,以获得潜在治疗效果。

Objective In recent years,there have been many reports on the treatment of sepsis by injection of Traditional Chinese medicine,but it is not clear whether injection of Traditional Chinese medicine can improve sepsis.This study will conduct a meta-analysis to evaluate the efficacy and safety of TCM injections in the treatment of sepsis.Methods A comprehensive systematic retrieval was conducted in Pubmed,Cochrane Library,Embase,CINAHL,CNKI,CBM,VIP,Wanfang and other databases from the establishment of each database to October 11,2022.Independently conducted literature screening and data extraction,and carried out systematic quality evaluation of the included literatures using the method of Cochrane Manual 5.3.The selected literatures were evaluated and analyzed using STATA15 software.Results A total of 35 eligible randomized controlled trials involving 2580 patients with sepsis were included.All trials took place in China and the literature was published from2009 to 2020.The results showed that compared with the control group,CHIs patients could reduce 28d mortality(OR=1.17,95%CI:1.01~1.39,I2=0.00%)and APACHEⅡscore(SMD=-0.75,95%CI:-0.97~-0.53,I2=81.9%),and improved the levels of inflammatory cytokines IL-6,WBC and CRP(SMD=-0.75,95%CI:-0.95~-0.55,I2=41.8%;SMD=-0.69,95%CI:-1.13~-0.29,I2=86.5%;SMD=-0.58,95%CI:-0.9~-0.26);Shorter ICU stay(SMD=-0.8,95%CI:-1.46~-0.14,I2=90.6%).Adverse reactions were reported in three trials involving 30 patients,mainly phlebitis and rash.Conclusions Based on the results of this study,we suggest that patients with sepsis can be treated with injection of Traditional Chinese medicine combined with Western medicine to obtain the potential therapeutic effect.