托法西提尼布与口服普雷迪尼索隆用于诱导中度活性的性结肠炎的缓解 [ORCHID]:一个前性的,开放的,随机的,试点研究
Arshdeep Singh1, Vandana Midha2, Kirandeep Kaur3
1Department of Gastroenterology, Dayanand Medical College, Ludhiana, Punjab, 141001, India.
Journal of Crohn's & colitis
|September 1, 2023
概括
托法西替尼和普雷迪尼索隆在8周的时间内,在中度活性的性结肠炎 (UC) 中诱导缓解的疗效和安全性相似. 在这项试点研究中,两种治疗都没有在实现复合缓解方面表现出显著的差异.
科学领域:
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
- 免疫学 免疫学 免疫学
背景情况:
- 口服皮质类固醇是适度活跃的性结肠炎 (UC) 的标准,但有不良影响.
- 托法西提尼布为UC管理提供了一个替代的治疗选择.
- 将托法西提尼布与普雷迪尼索隆进行比较对于优化UC治疗策略至关重要.
研究的目的:
- 为了比较托法西提尼布与普得尼索隆的疗效和安全性,以诱导中度活性UC的缓解.
- 评估8周复合缓解率作为主要终点.
- 评估两个治疗组的症状缓解和不良事件的时间.
主要方法:
- 一个单中心,前性,开放标签,随机化,主动控制的试点研究.
- 包括18岁或以上的中度活跃UC患者.
- 随机分配到8周的口服普雷迪尼索隆 (每天40毫克,每周逐渐减少) 或托法西提尼布 (每天两次10毫克).
主要成果:
- 在8周后,托法西提尼布 (16.28%) 和普雷迪尼索隆 (8.57%) 组之间的复合缓解率没有显著差异 (p=0.31).
- 在两组中都观察到类似的症状缓解时间 (10天).
- 不良事件包括肺结核和性 (每例1例),疹 (托法西提尼布1例),没有严重的不良事件或主要的不良心血管事件.
结论:
- 托法西替尼和口服普雷迪尼索隆在8周内在中度活性UC中诱导缓解时表现出可比的疗效和安全性.
- 这些发现表明托法西提尼布可以作为一种可行的替代品,用于初始UC治疗的皮质类固醇.
- 需要对更大的队列进行进一步的研究来证实这些初步结果.
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