随机,双盲,安慰剂控制的抗菌菌疗法 (RHB-104) 在活跃克罗恩病中的随机,双盲,安慰剂控制的研究
David Y Graham1, Saleh A Naser2, Thomas Borody3
1Departments of Medicine, Molecular Virology, and Microbiology, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, TX 77030, USA.
针对Mycobacterium avium亚种结核病 (MAP) 的三次抗菌疗法显著改善了克罗恩氏病的缓解和临床反应. 这种治疗表明了有利的临床和实验室结果,与安慰剂相似的安全性.
科学领域:
- 胃肠病学 胃肠病学
- 微生物学 微生物学
- 临床药理学 临床药理学
背景情况:
- 克罗恩氏病是一种具有复杂病因的慢性炎症性肠病.
- 菌亚种 (Mycobacterium avium paratuberculosis,简称MAP) 是克罗恩病的疑似但未被证实的致病因子.
- 克罗恩病的现有治疗方法有局限性,需要新的治疗方法.
研究的目的:
- 评估针对MAP的三重抗菌疗法 (RHB-104) 的有效性和安全性,针对活跃克罗恩病患者.
- 测试抗MAP疗法可以有利地影响克罗恩病活动和进展的假设.
主要方法:
- 一个双盲,多中心,随机对照试验 (Clinicaltrials.gov:NCT01951326) 涉及331名活跃克罗恩病的成年患者.
- 患者接受了RHB-104 (克拉里斯罗米辛,利法布丁,克洛法齐明) 或安慰剂,最长长52周,同时接受标准治疗.
- 主要终点是第26周的缓解 (克罗恩病活动指数[CDAI]<150);次要终点包括临床反应和便中calprotectin (FCP) 水平.
主要成果:
- 与安慰剂 (22.4%) (p=0.0048) 相比,RHB-104组的患者在26周内显著更大比例 (36.7%) 实现了缓解.
- 在RHB-104组,26周和52周的临床响应率也显著更高.
- 在多个时间点,RHB-104治疗导致了FCP水平的统计显著下降,在不同组之间,严重不良事件的发生率相似.
结论:
- 针对MAP (RHB-104) 的三重抗菌疗法在改善活跃克罗恩病的临床和实验室测量方面表现出显著的有效性.
- 这项研究支持了MAP作为克罗恩氏病发病的潜在因素的作用以及抗MAP治疗的实用性.
- RHB-104为克罗恩病患者提供了一个潜在的有价值的新疗法选择,具有可接受的安全性.
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