机构地区:[1]上海中医药大学附属曙光医院传统中医科,上海201203 [2]上海中医药大学,上海201203 [3]上海中医药大学附属曙光医院内镜中心,上海201203
出 处:《天津中医药》2020年第12期1390-1396,共7页Tianjin Journal of Traditional Chinese Medicine
基 金:上海市卫计委卫生行业临床研究专项(20184Y0047);国家自然科学基金青年项目(81804037)。
摘 要:[目的]系统评价中药复方灌肠治疗溃疡性结肠炎(UC)随机对照试验(RCT)的临床疗效及安全性。[方法]两位研究者独立系统检索中药复方灌肠治疗UC的全部临床RCT中英文文献。数据库包括:中国生物医学文献数据库(CBM)、中国知网知识发现网络平台(CNKI)、重庆维普科技数据库(VIP)和万方数据知识数据库(Wanfang Database)、Pubmed、Embase、Cochrane电子期刊全文数据库,检索时间均从建库至2019年2月9日。两位研究者独立提取资料,如遇分歧,请求第三方协助解决。同时使用Review Manager 5.3及Stata15.0软件进行本研究的数据处理。[结果]最终共纳入17篇文献,共计1597例UC患者。中药复方灌肠治疗UC的临床总有效率优于对照组[I2=0%,RR=1.31,95%CI(1.25,1.37),P<0.00001],亚组分析显示,中药复方灌肠较氨基水杨酸类溶液灌肠[I2=0%,RR=1.31,95%CI(1.24,1.38),P<0.00001]或栓剂纳肛[I2=16%,RR=1.32,95%CI(1.16,1.51),P<0.0001]或柳氮磺胺吡啶(SASP)灌肠[I2=0%,RR=1.29,95%CI(1.23,1.36),P<0.00001]或美沙拉嗪灌肠[I2=4%,RR=1.37,95%CI(1.22,1.54),P<0.00001]都有较好的疗效;中药复方灌肠改善中医症状积分优于对照组[I2=23%,MD=-1.42,95%CI(-2.38,-0.46),P=0.004];中药复方灌肠改善肠黏膜积分优于对照组[I2=0%,MD=-0.29,95%CI(-0.50,-0.07),P=0.01];中药复方灌肠改善Mayo积分优于对照组[I2=89%,MD=-2.50,95%CI(-4.25,-0.75),P=0.005];中药复方灌肠的不良反应发生率较对照组无明显差异[I2=59%,RR=0.41,95%CI=(0.05,3.29),P=0.40]。亚组分析显示,中药复方灌肠不良反应发生率较美沙拉嗪栓纳肛[I2=0%,RR=0.14,95%CI(0.02,1.11),P=0.06]或SASP灌肠[I2=82%,RR=1.20,95%CI(0.02,77.88),P=0.93]皆无明显差异;中药复方灌肠治疗UC的复发率较对照组更低[I2=0%,RR=0.34,95%CI(0.16,0.72),P=0.005]。[结论]中药复方灌肠治疗UC较氨基水杨酸类药物的临床疗效更佳且安全性更高。[Objective]To systematically evaluate the efficacy and safety of the randomized controlled trial of Chinese medicineby clysisfor the treatment of ulcerative colitis(UC).[Methods]The Chinese and English literatures of all clinical randomized controlled trials(RCT)on the treatment of UC by clysisusing traditional Chinese medicine compound prescription were searched independently and systematically by two individuals.The database includesChina biomedical literature database(CBM),China national knowledge infrastructure(CNKI),VIP Database for Chinese Technical Periodicals(VIP),Wan Fang Database,PubMed Database,Embase,Cochrane Library.The retrieval time is from the database construction to February 2019.The two researchers independently extracted the data.In case of disagreement,they asked the other one to help solve the problem.Meanwhile,Review Manager5.3 software and Stata15.0 software were used to process the data of this study.[Results]A total of 17 literatures were included,including 1597 patients with UC.The curative effect of the experimental group was superior to the control group[I2=0%,RR=1.31,95%CI=(1.25,1.37),P<0.00001].Subgroup analysis showed that it had better efficacycompared with clysis by aminosalicylic acid solution[I2=0%,RR=1.31,95%CI=(1.24,1.38),P<0.00001],aminosalicylic acid suppository[I2=16%,RR=1.32,95%CI=(1.16,1.51),P<0.0001],SASP[I2=0%,RR=1.29,95%CI=(1.23,1.36),P<0.00001],or mesalazine[I2=4%,RR=1.37,95%CI=(1.22,1.54),P<0.00001].The clinical symptom scoreof clysiswith traditional Chinese medicine was higher than that of the control group[I2=23%,MD=-1.42,95%CI=(-2.38,-0.46),P=0.004].The intestinal mucosal score ofclysis with traditional Chinese medicine was higher than that of the control group[I2=0%,MD=-0.29,95%CI=(-0.50,-0.07),P=0.01].Themayo scoreofclysiswith traditional Chinese medicine was higher than control group[I2=89%,MD=-2.50,95%CI=(-4.25,-0.75),P=0.005].There was no significant difference in the incidence of adverse reaction between the two groups[I2=59%,RR=0.41,95%CI=(0.05,3.29),P=0.4
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