Open label trial of clarithromycin therapy in Japanese patients with Crohn's disease
Open label trial of clarithromycin therapy in Japanese patients with Crohn's disease
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DOI：
10.1111/j.1440-1746.2006.04533.x
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发表时间：
2007-07-01
影响因子：
4.1
通讯作者：
Chiba, Tsutomu
中科院分区：
文献类型：
--
作者：
Inoue, Satoko;Nakase, Hiroshi;Chiba, Tsutomu
背景和目的：克罗恩病的发病机制尚不清楚，但许多研究表明，管腔细菌在这种疾病患者的慢性肠道炎症中起重要作用。克拉霉素是一种具有免疫调节活性的大环内酯类抗生素。本研究的目的是评价克拉霉素治疗在日本克罗恩病患者的效果。方法：14例活动性克罗恩病患者（12例回结肠型，1例结肠型，1例小肠型）口服克拉霉素200 mg，每日2次，共4周。在4周内显示临床应答的患者继续治疗长达24周。4例患者还接受了硫唑嘌呤治疗。临床活动进行了评估，克罗恩病活动指数（CDAI）在入口处和4，12，24周后开始clarithromycin.Results：平均CDAI评分为343.5。在4周内，14例患者中有8例（57.1%）显示临床改善，8例患者中有5例（35.7%）达到缓解。所有这8例患者在4周后继续克拉霉素治疗，6例（42.9%）在12周时临床缓解。在总共14例患者中，4例（28.6%）继续使用克拉霉素超过24周，并保持缓解。同时接受硫唑嘌呤治疗的患者对克拉霉素治疗的反应更好。在研究期间没有观察到严重的副作用。结论：这项开放标签研究显示，克拉霉素治疗活动性克罗恩病的日本患者令人鼓舞的结果。
Background and Aim: The pathogenesis of Crohn's disease is unclear, but many studies suggest that luminal bacteria play an important role in chronic intestinal inflammation in patients with this condition. Clarithromycin is a macrolide antibiotic with immunomodulatory activity. The aim of this study was to evaluate the effect of clarithromycin therapy in Japanese patients with Crohn's disease.Methods: Fourteen patients with active Crohn's disease (12 with ileocolonic, one with colonic, one with small bowel type) were treated with oral clarithromycin 200 mg twice daily for 4 weeks. Patients who showed a clinical response within 4 weeks continued the therapy for up to 24 weeks. Four patients also received azathioprine. Clinical activity was assessed with the Crohn's Disease Activity Index (CDAI) at entry and at 4, 12, and 24 weeks after starting clarithromycin.Results: The mean CDAI score at entry was 343.5. Within 4 weeks, eight (57.1%) of the 14 patients showed clinical improvement, and five (35.7%) of the eight patients achieved remission. All of those eight patients continued clarithromycin therapy after 4 weeks, and six (42.9%) were in clinical remission at 12 weeks. Of the 14 total patients, four (28.6%) continued clarithromycin for more than 24 weeks, and have remained in remission. Patients who received azathioprine concomitantly had a better response to clarithromycin therapy. No severe side-effects were observed during the study period.Conclusions: This open label study showed encouraging results of clarithromycin therapy in Japanese patients with active Crohn's disease.