中药复方灌肠治疗溃疡性结肠炎临床疗效Meta分析

Meta-analysis of the efficacy of traditional Chinese medicine by clysis in the treatment of ulcerative colitis

关键词:  中药复方  氨基水杨酸类  灌肠  溃疡性结肠炎  Meta分析

Key words:  traditional Chinese medicine  amino salicylic acid  clysis  ulcerative colitis  Meta-analysis

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1 597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<0.000 01]，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<0.000 01]或栓剂纳肛[I²=16%，RR=1.32，95%CI（1.16，1.51），P<0.000 1]或柳氮磺胺吡啶（SASP）灌肠[I²=0%，RR=1.29，95%CI（1.23，1.36），P<0.000 01]或美沙拉嗪灌肠[I²=4%，RR=1.37，95%CI（1.22，1.54），P<0.000 01]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。

Abstract:

[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 1 597 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<0.0000 1].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<0.000 01],aminosalicylic acid suppository[I²=16%,RR=1.32,95% CI=(1.16,1.51),P<0.000 1],SASP[I²=0%,RR=1.29,95% CI=(1.23,1.36),P<0.000 01],or mesalazine[I²=4%,RR=1.37,95% CI=(1.22,1.54),P<0.000 01]. 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=0.40]. Subgroup analysis showedthat there was no significant difference in the incidence of adverse reaction between the traditional Chinese medicinegroup andmesalazine[I²=0%,RR=0.14,95% CI=(0.02,1.11),P=0.06] or SASP[I²=82%,RR=1.20,95% CI=(0.02,77.88),P=0.93] group. The recurrence rate of traditional Chinese medicine compound clysis was lower than that of the control group[I²=0%,RR=0.34,95% CI=[0.16,0.72],P=0.005).[Conclusion] Compared with aminosalicylic acid drugs,the clysis of traditional Chinese medicine compoundhas better clinical efficacy and higher safety in the treatment of UC.