中药口服配合灌肠治疗溃疡性结肠炎疗效和安全性的系统评价被引量：33

Systematic Review on the Therapeutic Effects and Safety of Ulcerative Colitis Treated with Oral Administration and Enema of Chinese Herbal Medicine

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摘要目的系统评价中药汤剂口服配合中药灌肠治疗溃疡性结肠炎(UC)的疗效及安全性。方法从万方数据库、维普中文科技期刊数据库(VIP)、中国知网全文期刊数据库(CNKI)和Pubmed英文数据库中检索关于中药口服配合灌肠治疗UC的临床随机对照试验文献,筛选出符合纳入标准及排除标准的文献,提取数据并做质量评价后,使用Rev Man5.2软件对数据进行Meta分析。结果共纳入18篇文献,1507例患者;临床总有效率合并效应值RR=1.24,95%CI=[1.18~1.30],P<0.000 01,差异有统计学意义;高质量文献总有效率合并效应值RR=1.31,95%CI=[1.18~1.46],P<0.000 01,差异有统计学意义;近期黏膜愈合率合并效应值RR=1.61,95%CI=[1.35~1.93],P<0.000 01,差异有统计学意义;复发率合并效应值OR=0.26,95%CI=[0.12~0.56],P<0.001,差异有统计学意义。结论中药口服配合灌肠治疗UC的临床总有效率及近期黏膜愈合率均高于柳氮磺胺吡啶片常规口服治疗;中药口服配合中药灌肠治疗UC复发率低于柳氮磺胺吡啶片常规口服治疗,且不良反应少;中医药的随机对照试验存在方法学质量的不足,需要大样本、高质量、多中心的随机对照试验进一步提供明确的证据。 Objective To review systematically the therapeutic effects and safety on ulcerative colitis（UC）treated with the oral administration and enema with Chinese herbal medicine.Methods The literatures were retrieved from Wanfang,VIP,CNKI and Pubmed English databases on the clinical randomized controlled trials（RCT）of UC treated with the oral administration and enema with Chinese herbal medicine.The literatures in compliance with the inclusive and exclusive criteria were screened.After the data extraction and quality evaluation,RevMan5.2 software was used for the Meta analysis on the data.Results Totally,18 literatures were included,with 1507 patients involved.The differences in the merged effect values of clinical total effective rates were significant statistically[RR=1.24,95%CI=（1.18-1.30）,P〈0.000 01].The differences in the merged effect values of the recent mucosal healing rate were significant statistically[RR=1.61,95%CI=（1.35-1.46）,P〈0.000 01].The differences in the merged effect values of the recurrence rate were significant statistically[OR=0.26,95%CI=（0.12-0.56）,P〈0.001].Conclusion The total effective rate and the recent mucosal healing rate in the treatment of UC with the oral administration and enema with Chinese herbal medicine were higher than the conventional oral medication of salazosulfapyridine tablets.The recurrence rate in the treatment with the oral administration and enema with Chinese herbal medicine is lower than the conventional oral medication of salazosulfapyridine tablets,with less adverse reactions.The methodological quality of RCT in TCM is limited and the large-size sample,high-quality and multi-central RCT is required to provide further definite evidences.