清肠栓治疗溃疡性结肠炎的随机对照研究  

Randomized Control Study of "Qingchang Suppository" on Ulcerative Colitis

作　　者：龚雨萍[1] 柳文[1] 马贵同[1] 胡鸿毅[1] 谢建群[1] 唐志鹏[1] 郝薇薇[1] 卞慧[1] 朱凌宇[1] 武和平[1] 朱生樑[2] 张亚声[3] 

机构地区：[1]上海中医药大学附属龙华医院消化内科,上海200032 [2]上海中医药大学附属岳阳中西医结合医院消化内科,上海200437 [3]上海市第一人民医院中医科,上海200080

出　　处：《上海中医药大学学报》2007年第6期33-36,共4页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：国家中医药管理局基金资助项目(02-03LL06)

摘　　要：目的:评价清肠栓治疗溃疡性结肠炎的安全性和有效性。方法:采用随机、开放、平行对照、多中心临床试验设计,共入选病例94例,其中治疗组47例、对照组47例,分别予以清肠栓和柳氮磺胺吡啶栓各1支,纳肛,每晚1次,连续治疗2个月,观察治疗前后的肠镜、病理检查及肠道湿热证中医证候的变化。结果:治疗组综合疗效总有效率为91.49%,对照组为87.23%,两组比较综合疗效差异无统计学差异(P>0.05)。治疗组中医证候疗效总有效率为97.87%,对照组为91.48%,治疗组中医证候疗效优于对照组(P<0.05);随访1年,治疗组复发率为9.30%,低于对照组(26.83%);两组均未发生不良事件。结论:清肠栓治疗左半结肠以下的轻、中度活动期溃疡性结肠炎肠道湿热证疗效确切,复发率低,安全可靠。Objective： To evaluate the clinical efficacy and safety of ＂Qingchang Suppository＂ （QCS） on ulcerative colitis（UC）. Methods： Randomized, open, parallel control, multicentre clinical trial was designed. Ninty-four patients were randomly divided into two groups： QCS group and salicylazosulfapyridine （SASP） suppository（sASPS） group, 47 patients in each group. The patients were treated with the suppository every night for two months. The change of enteroscopy, pathology and the syndrome of damp- heat in the intestinal tract were observed. Results： The total effective rate in QCS group and SASPS group were 91.49% and 87.23% respectively, and there was no significant difference between the two groups, P〉0.05. The total curative rate of traditional Chinese medical syndrome in QCS group was 97.87%, higher than 91.48% in control group. 0ne-year relapse rate in QCS group was 9.3%, outweighed 26.83% in control group. Conelmiom QCS is effective and safe for mild to mederate UC with syndrome of damp-heat in the intestinal tract located on or below left hemicolon.

关 键 词：溃疡性结肠炎 肠道湿热证 清肠栓 柳氮磺胺吡啶栓 肠镜 

分 类 号：R259[医药卫生—中西医结合]