口服球形吸附性碳治疗克罗恩病顽固性肛瘘：一项多中心、随机、双盲、安慰剂对照试验

Oral spherical adsorptive carbon for the treatment of intractable anal fistulas in Crohn's disease: a multicenter, randomized, double-blind, placebo-controlled trial.

作者信息

Fukuda Yoshihiro, Takazoe Masakazu, Sugita Akira, Kosaka Tadashi, Kinjo Fukunori, Otani Yoshimasa, Fujii Hisao, Koganei Kazutaka, Makiyama Kazuya, Nakamura Toshio, Suda Takeyasu, Yamamoto Shojiro, Ashida Toshifumi, Majima Akira, Morita Norikazu, Murakami Kazunari, Oshitani Nobuhide, Takahama Kazuya, Tochihara Masahiro, Tsujikawa Tomoyuki, Watanabe Makoto

机构信息

Clinical Nutrition and Health Science and General Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.

出版信息

Am J Gastroenterol. 2008 Jul;103(7):1721-9. doi: 10.1111/j.1572-0241.2008.01860.x. Epub 2008 Jul 4.

DOI:10.1111/j.1572-0241.2008.01860.x

PMID:18616656

Abstract

OBJECTIVES

Anal fistulas are common in individuals with Crohn's disease (CD). We sought to evaluate the efficacy of oral spherical adsorptive carbon (AST-120) (Kremezin; Kureha Corporation, Tokyo, Japan) for the treatment of intractable anal fistulas in patients with CD.

METHODS

In this multicenter, randomized, double-blind, placebo-controlled trial, patients with CD and at least one active anal fistula under treatment were assigned to receive either AST-120 or placebo for 8 wk. Improvement was defined as a reduction of 50% or more from baseline in the number of draining fistulas observed at both 4 and 8 wk. Remission was defined by closure of all draining fistulas at both 4 and 8 wk. The Perianal Disease Activity Index (PDAI) and Crohn's Disease Activity Index (CDAI) were also assessed.

RESULTS

In total, 62 patients were randomized, of whom 57 received AST-120 (N = 27) or placebo (N = 30). The improvement rate in the AST-120 group (37.0%) was significantly greater than that in the placebo group (10.0%) (P= 0.025). The corresponding remission rates were 29.6% and 6.7%, respectively (P= 0.035). PDAI significantly improved at both 4 and 8 wk with AST-120, compared to placebo (P= 0.004 and P= 0.005, respectively). CDAI was also significantly improved at both 4 and 8 wk in the AST-120 group, compared to the placebo group (P= 0.007 and P= 0.001, respectively). AST-120 treatment was well tolerated and no life-threatening adverse events were observed.

CONCLUSION

AST-120 is useful for the control of intractable anal fistulas in CD patients.

摘要

目的

肛瘘在克罗恩病（CD）患者中很常见。我们旨在评估口服球形吸附碳（AST - 120）（可利美特；日本东京久光制药株式会社）对CD患者顽固性肛瘘的治疗效果。

方法

在这项多中心、随机、双盲、安慰剂对照试验中，患有CD且至少有一个正在接受治疗的活动性肛瘘患者被分配接受AST - 120或安慰剂治疗8周。改善定义为在第4周和第8周观察到的引流瘘管数量较基线减少50%或更多。缓解定义为在第4周和第8周所有引流瘘管均闭合。还评估了肛周疾病活动指数（PDAI）和克罗恩病活动指数（CDAI）。

结果

总共62例患者被随机分组，其中57例接受了AST - 120（n = 27）或安慰剂（n = 30）。AST - 120组的改善率（37.0%）显著高于安慰剂组（10.0%）（P = 0.025）。相应的缓解率分别为29.6%和6.7%（P = 0.035）。与安慰剂相比，AST - 120在第4周和第8周时PDAI均显著改善（分别为P = 0.004和P = 0.005）。与安慰剂组相比，AST - 120组在第4周和第8周时CDAI也均显著改善（分别为P = 0.007和P = 0.001）。AST - 120治疗耐受性良好，未观察到危及生命的不良事件。