中医外治法治疗急性放射性肠炎的Meta分析及试验序贯分析

目的:系统评价中医外治法治疗急性放射性肠炎的临床疗效和安全性。方法:通过检索万方数据库、中国知网、重庆维普数据库、中国生物医学文献数据库、PubMed、Embase、Cochrane Library等,收集中医外治法(包括中药保留灌肠、针灸、穴位注射等)对比常规西药治疗急性放射性肠炎的随机对照试验(RCT),采用Cochrane风险偏倚评估工具对最终纳入的研究进行方法学质量评价,提取数据并用RevMan5.3软件进行Meta分析,采用倒漏斗图检验发表偏倚,使用TSA 0.9软件进行试验序贯分析。结果:共纳入14项RCT,涉及1036例患者。Meta分析结果显示:试验组有效率高于对照组OR=4.88,95%CI(3.38,7.04),P<0.00001],腹痛积分MD=-0.76,95%CI(-1.43,-0.09),P=0.03]、腹泻积分MD=-0.50,95%CI(-0.62,-0.39),P<0.00001]、黏液脓血便积分MD=-0.38,95%CI(-0.47,-0.29),P<0.00001]、里急后重积分MD=-0.48,95%CI(-0.59,-0.38),P<0.00001]、KPS积分MD=7.37,95%CI(4.06,10.68),P<0.0001]、肠黏膜评分MD=-1.29,95%CI(-2.10,-0.48),P=0.002]均明显优于对照组,IL-1水平降低程度明显优于对照组MD=-4.57,95%CI(-6.85,-2.30),P<0.0001]。两组均未出现严重的不良反应。试验序贯分析表明,中医外治法治疗急性放射性肠炎的疗效证据确切。结论:中医外治法治疗急性放射性肠炎的疗效可能优于常规西药,且不良反应少。但该结论仍需更大样本、多中心、不同人种、随访时间更长的高质量随机对照试验加以验证。

Traditional Chinese Medicine External Therapy for the Treatment of Acute Radiation Enteritis:A Meta-Analysis and Trial Sequential Analysis

Objective:To systematically evaluate the clinical efficacy and safety of Traditional Chinese Medicine(TCM)external therapy for the treatment of acute radiation enteritis.Methods:We searched Wanfang database,CNKI,Chongqing VIP database,CBM,PubMed,Embase and Cochrane Library,and then collected the randomized controlled trial(RCT)of TCM external therapy(including retention enema,acupuncture and acupoint injection)compared with conventional western medicine in the treatment of acute radiation enteritis.Cochrane risk bias assessment tool was used to evaluate the methodological quality of the final included study.The data was extracted and then RevMan 5.3 software was used for meta-analysis.And funnel chart test was used to evaluate the publication bias.TSA 0.9 software was used for Trial Sequential Analysis.Results:Totally 14 RCTs were included,involving 1036 patients.According to the results of meta-analysis,the treatment group showed higher effective rate than control groupOR=4.88,95%CI(3.38,7.04),P<0.00001].The treatment group showed better abdominal pain scoreMD=-0.76,95%CI(-1.43,-0.09),P=0.03],diarrhea scoreMD=-0.50,95%CI(-0.62,-0.39),P<0.00001],mucopurulent bloody stool scoreMD=-0.38,95%CI(-0.47,-0.29),P<0.00001],tenesmus scoreMD=-0.48,95%CI(-0.59,-0.38),P<0.00001],KPSMD=7.37,95%CI(4.06,10.68),P<0.0001]and intestinal mucosa scoreMD=-1.29,95%CI(-2.10,-0.48),P=0.002]than control group.And the treatment group showed lower IL-1 level than control groupMD=-4.57,95%CI(-6.85,-2.30),P<0.0001].No serious adverse reactions occurred in both groups.The TSA showed that the evidence of therapeutic effect of external therapy of TCM on acute radiation enteritis is accurate.Conclusion:The therapeutic effect of external treatment of TCM on acute radiation enteritis may be better than that of conventional western medicine,and the adverse reactions are less.Howe ver,this conclusion still needs to be verified by a larger sample,multicenter,different race,longer follow-up time and high-quality randomized controlled trial.