在轻度至中度性结肠炎的诱导和维持治疗中使用MMX美沙胺
Stephen B Hanauer1, Gary R Lichtenstein2, Michael A Kamm3
1Section of Gastroenterology and Nutrition, University of Chicago, Chicago, Illinois.
在性结肠炎患者中,MMX梅萨拉有效诱导缓解. 显著的多数患者实现了缓解,并保持了长达12个月的无复发状态,并具有良好的安全性.
科学领域:
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
背景情况:
- 性结肠炎 (UC) 是一种慢性炎症性肠病.
- 实现和维持缓解对于管理UC至关重要.
- 目前的治疗方法旨在缓解症状并治愈粘膜.
研究的目的:
- 评估MMX多矩阵系统 (MMX) 梅萨拉胺在性结肠炎中诱导和维持缓解的疗效和安全性.
- 评估与MMX美沙胺治疗相关的长期缓解率和不良事件.
主要方法:
- 两项为期8周的随机化,安慰剂控制的研究 (SPD476-301和SPD476-302) 评估了缓解诱导.
- 随后进行了一项为期12个月的研究,评估了对MMX梅沙胺有反应的患者的缓解维持.
- 患者每天服用2.4克或4.8克的MMX梅萨拉.
主要成果:
- 63.6%的患者 (220/346) 在MMX梅沙胺治疗8至16周后实现了缓解.
- 在那些达到缓解的患者中,89.9% (196/218) 在12个月后仍然没有复发.
- 总体而言,56.6%的患者 (196/346) 在12个月内实现并维持了缓解.
- MMX梅沙胺的安全性概况与安慰剂可比.
结论:
- 在患有活跃的,轻度至中度的性结肠炎的患者中,MMX梅萨拉有效诱导和维持缓解.
- 治疗导致症状完全消失和粘膜愈合.
- 用MMX梅萨拉长期治疗表明持续的安全性和有效性.
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