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作 者:崔萍 刘金响 史英[2] 张聪伟 李敏 CUI Ping;LIU Jinxiang;SHI Ying;ZHANG Congwei;LI Min(Affiliated Hospital of Shaanxi University of Chinese Medicine,Xianyang 712000,China;The Second Affiliated Hospital of Shaanxi University of Chinese Medicine,Xianyang 712000,China)
机构地区:[1]陕西中医药大学附属医院,陕西咸阳712000 [2]陕西中医药大学第二附属医院,陕西咸阳712000
出 处:《药物评价研究》2022年第2期355-363,共9页Drug Evaluation Research
基 金:国家自然科学基金青年基金项目(81803951);陕西省科技厅课题(2019SF-099)。
摘 要:目的系统分析锡类散灌肠辅助治疗溃疡性结肠炎的疗效和安全性。方法检索中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普中文期刊全文数据库(VIP)、万方数据库、Cochrane Library、PubMed、Embase等中英文数据库,检索时限为各数据库建库至2021年10月,筛选锡类散灌肠辅助治疗溃疡性结肠炎的随机对照试验(RCTs),采用RevMan 5.3软件进行Meta分析。结果共纳入14篇RCTs,包括1083病例,其中试验组(锡类散灌肠)541例、对照组542例。Meta分析结果显示,锡类散灌肠辅助治疗在总有效率[RR=1.21,95%CI(1.15,1.27)]、治愈率[RR=1.36,95%CI(1.18,1.58)]、复发率[RR=0.34,95%CI(0.18,0.66)]、疾病活动指数[MD=−0.45,95%CI(−0.45,−0.20)]、结肠镜检查积分[SMD=−0.38,95%CI(−0.61,−0.15)]方面均优于对照组(P<0.01),不良反应[RR=1.04,95%CI(0.69,1.57),P=0.70]与对照组没有显著差异。结论锡类散灌肠治疗溃疡性结肠炎具有显著的疗效,一定程度上可以降低治疗后的溃疡性结肠炎的复发率,改善患者的症状促进肠道黏膜修复,但是尚需进行严格的、多中心、双盲RCTs来证实。Objective To systematically analyze efficacy and safety of Xilei Powder in adjuvant treatment of ulcerative colitis(UC)by enema.Methods Literature search was conducted across CNKI,CBM,VIP,Wanfang Data,Cochrane Library,PubMed,and Embase to search for randomized controlled trial(RCT)of Xilei Powder in adjuvant treatment of UC by enema,from the establishment of the database to October 2021.Randomized controlled tests(RCTs)were screened and Meta-analysis was performed on the included studies using RevMan 5.3 software.Results A total of 14 RCTs were included for analysis,including 1083 cases.There were 541 cases in experimental group(Xilei Powde by enema)and 542 cases in control group.Meta-analysis results showed that experimental group better than control group(P<0.01)in the total effective rate[RR=1.21,95%CI(1.15,1.27)],cure rate[RR=1.36,95%CI(1.18,1.58)],recurrence rate[RR=0.34,95%CI(0.18,0.66)],disease activity index[MD=−0.45,95%CI(−0.45,−0.20)],colonoscopy score[SMD=−0.38,95%CI(−0.61,−0.15)],and there was no significant difference in adverse events[RR=1.04,95%CI(0.69,1.57),P=0.70].Conclusion Xilei Powder in the treatment of UC by enema has significant curative effect,to some extent,can reduce the recurrence rate after treatment of ulcerative colitis,improve the patient's symptoms,promote the intestinal mucosa repair,as uneven quality of clinical research,it remains to be strict,multicenter,randomized,double-blind controlled study to confirm.
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