含苦参中药制剂治疗溃疡性结肠炎的有效性及安全性Meta分析

Meta-analysis of the Efficacy and Safety of Proprietary Chinese Medicine Containing Kushen(Sophora Flavescens) on Ulcerative Colitis

目的:系统评价含苦参中药制剂治疗溃疡性结肠炎的临床疗效。方法:检索PubMed、EMBASE、中国生物医学文献数据库、中国知网学术期刊全文数据库、维普中文科技期刊数据库中2000年1月至2018年7月应用含苦参中药制剂治疗溃疡性结肠炎的随机对照试验,对纳入文献进行质量评价和Meta分析。结果:共纳入9个RCTs,样本量总计883例。治疗组总有效率明显高于常规西药组(美沙拉嗪肠溶片、柳氮磺胺嘧啶片)[OR=0.13,95%CI(0.08,0.18),P<0.000,01],治疗组患者不良反应发生率明显低于常规西药组[OR=0.22,95%CI(0.08,0.58),P=0.003]。治疗组仅予含苦参中药制剂时总有效率优于对照组[OR=2.90,95%CI(1.78,4.74),P<0.000,1],且优于联合应用含苦参中药制剂。结论:应用含苦参中药制剂在治疗溃疡性结肠炎患者具有一定效果,未来可开展多中心、大样本、随机、双盲、隐藏分配的RCT试验进一步确定苦参制剂疗效。

Objective:To systematically evaluate clinical effects of proprietary Chinese medicine containing Sophora Flavescens on ulcerative colitis(UC).Method:Searching PubMed,EMBASE,Chinese Biochemical Literature Database,Academic Periodical Full-text Database of China National Knowledge Infrastructure,VIP Database of proprietary Chinese Scientific and Technical Journal from Jan.2000 to Apr.2008 about randomized controlled trials of treating ulcerative colitis by prescription of Chinese medicine containing Sophora Flavescens and making quality evaluation and Meta analysis to final documents according to inclusion exclusion criteria.Results:9 RCTs involving a total samples of 883 cases were included.After treating by Chinese medicine containing Sophora Flavescens,the overall response rate(ORR)has increased[OR=0.13,95%CI(0.08,0.18),P<0.000,01],and the incidence of adverse drug reactions in the treatment group has decreased[OR=0.22,95%CI(0.08,0.58),P=0.003].The treatment group only given proprietary Chinese medicine containing Sophora Flavescens has increased apparently ORR[OR=2.90,95%CI(1.78,4.74),P<0.000,1],which was better than the treatment group combined with mesalazine or salicylazosulfapyridine.Conclusion:Prescription of proprietary Chinese medicine containing Sophora Flavescens has a certain effects on UC patients'clinical efficacy.However,since some RCTs selected showed lower quality,further study need to be directed to identify efficacy of Sophora Flavescens on UC by Multi-center Randomized Double-blinded and Placebo-controlled ClinicaI Study.