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罗格列酮与5-氨基水杨酸联合治疗溃疡性结肠炎的临床试验。

A clinical trial of combined use of rosiglitazone and 5-aminosalicylate for ulcerative colitis.

作者信息

Liang Hong-Liang, Ouyang Qin

机构信息

Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.

出版信息

World J Gastroenterol. 2008 Jan 7;14(1):114-9. doi: 10.3748/wjg.14.114.

DOI:10.3748/wjg.14.114
PMID:18176972
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2673374/
Abstract

AIM

To investigate the therapeutic effects of the combined use of rosiglitazone and aminosalicylate on mild or moderately active ulcerative colitis (UC).

METHODS

According to the national guideline for diagnosis and treatment of inflammatory bowel disease (IBD) in China, patients with mild or moderately active UC in our hospital were selected from July to November, 2004. Patients with infectious colitis, amoebiasis, or cardiac, renal or hepatic failure and those who had received corticosteroid or immunosuppressant treatment within the last month were excluded. Following a quasi-randomization principle, patients were allocated alternatively into the treatment group (TG) with rosiglitazone 4 mg/d plus 5-ASA 2 g/d daily or the control group (CG) with 5-ASA 2 g/d alone, respectively, for 4 wk. Clinical changes were evaluated by Mayo scoring system and histological changes by Truelove-Richards' grading system at initial and final point of treatment.

RESULTS

Forty-two patients completed the trial, 21 each in TG and CG. The Mayo scores in TG at initial and final points were 5.87 (range: 4.29-7.43) and 1.86 (range: 1.03-2.69) and those in CG were 6.05 (range: 4.97-7.13) and 2.57 (range: 1.92-3.22) respectively. The decrements of Mayo scores were 4.01 in TG and 3.48 in CG, with a remission rate of 71.4% in TG and 57.1% in CG, respectively. Along with the improvement of disease activity index (DAI), the histological grade improvement was more significant in TG than in CG (P < 0.05).

CONCLUSION

Combined treatment with rosiglitazone and 5-ASA achieved better therapeutic effect than 5-ASA alone without any side effects. Rosiglitazone can alleviate colonic inflammation which hopefully becomes a novel agent for UC treatment.

摘要

目的

探讨罗格列酮与氨基水杨酸联合应用对轻、中度活动期溃疡性结肠炎(UC)的治疗效果。

方法

根据中国炎症性肠病(IBD)诊断与治疗的全国性指南,选取2004年7月至11月我院轻、中度活动期UC患者。排除感染性结肠炎、阿米巴病、心脏、肾脏或肝脏衰竭患者以及近1个月内接受过皮质类固醇或免疫抑制剂治疗的患者。按照半随机化原则,患者分别交替分配至治疗组(TG),每日服用罗格列酮4 mg加5-氨基水杨酸(5-ASA)2 g,或对照组(CG),仅每日服用5-ASA 2 g,疗程4周。在治疗初始和结束时,采用Mayo评分系统评估临床变化,采用Truelove-Richards分级系统评估组织学变化。

结果

42例患者完成试验,TG和CG各21例。TG治疗初始和结束时的Mayo评分分别为5.87(范围:4.29 - 7.43)和1.86(范围:1.03 - 2.69),CG分别为6.05(范围:4.97 - 7.13)和2.57(范围:1.92 - 3.22)。TG的Mayo评分下降值为4.01,CG为3.48,TG缓解率为71.4%,CG为57.1%。随着疾病活动指数(DAI)的改善,TG的组织学分级改善比CG更显著(P < 0.05)。

结论

罗格列酮与5-ASA联合治疗比单纯5-ASA治疗效果更好,且无任何副作用。罗格列酮可减轻结肠炎症,有望成为治疗UC的新型药物。

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