周末使用5-氨基水杨酸（美沙拉嗪）灌肠作为溃疡性结肠炎维持治疗的效果：一项随机对照研究的结果

Effect of weekend 5-aminosalicylic acid (mesalazine) enema as maintenance therapy for ulcerative colitis: results from a randomized controlled study.

作者信息

Yokoyama Hiroshi, Takagi Sho, Kuriyama Shinichi, Takahashi Shuichiro, Takahashi Hiroki, Iwabuchi Masahiro, Takahashi Seiichi, Kinouchi Yoshitaka, Hiwatashi Nobuo, Tsuji Ichiro, Shimosegawa Tooru

机构信息

Division of Gastroenterology, Department of Internal Medicine, Tohoku University Graduate School of Medicine, and Department of Gastroenterology, National Hospital Organization Sendai Medical Center, Japan.

出版信息

Inflamm Bowel Dis. 2007 Sep;13(9):1115-20. doi: 10.1002/ibd.20158.

DOI:10.1002/ibd.20158

PMID:17455207

Abstract

BACKGROUND

5-aminosalicylic acid (5-ASA) is known to be effective in the treatment of active ulcerative colitis (UC). The aim of the current study was to investigate the effect of 5-ASA enemas, as a maintenance therapy for UC, when administered twice weekly as a weekend treatment regimen, compared to daily oral 5-ASA alone. We hypothesized that the weekend enema therapy would be better tolerated by patients who worked or attended school.

METHODS

Between January 2004 and August 2005, patients with UC, in whom remission of the condition had just been induced, were randomly assigned to either: the weekend 5-ASA enema group (n=11), who received 1 g 5-ASA enemas twice a week on Saturday and Sunday plus oral 5-ASA 3 g/day for 7 days, or to the daily oral 5-ASA use only group (n=13), who received only oral 5-ASA 3 g/day for 7 days. The primary endpoint of the study was defined as the incidence of relapse. The study was stopped after 24 patients had been enrolled because an interim analysis showed a significant benefit of the weekend 5-ASA enema group.

RESULTS

In the weekend enema group, 2 patients (18.2%) had relapses compared with 10 (76.9%) in the oral 5-ASA only group. The multivariate hazard ratio of relapse associated with weekend 5-ASA enema, relative to the oral alone group, was 0.19 (95% confidence interval, 0.04-0.94).

CONCLUSIONS

This study demonstrated the beneficial effects of adding weekend 1 g 5-ASA enema to daily 3 g oral 5-ASA as maintenance therapy for UC.

摘要

背景

已知5-氨基水杨酸（5-ASA）对治疗活动期溃疡性结肠炎（UC）有效。本研究的目的是调查5-ASA灌肠剂作为UC维持治疗的效果，将其作为周末治疗方案每周给药两次，并与单独每日口服5-ASA进行比较。我们假设周末灌肠疗法对工作或上学的患者耐受性更好。

方法

在2004年1月至2005年8月期间，将刚诱导病情缓解的UC患者随机分为：周末5-ASA灌肠组（n = 11），在周六和周日每周接受1 g 5-ASA灌肠剂两次，外加每日口服5-ASA 3 g，共7天；或仅每日口服5-ASA组（n = 13），仅接受每日口服5-ASA 3 g，共7天。该研究的主要终点定义为复发率。在纳入24例患者后研究停止，因为中期分析显示周末5-ASA灌肠组有显著益处。