口服甲基普雷尼索隆对IgA脏病患者临床结果的影响:TESTING随机临床试验
Jicheng Lv1, Hong Zhang2, Muh Geot Wong3
1Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China2The George Institute for Global Health, University of New South Wales, Sydney, Australia.
JAMA
|August 2, 2017
概括
皮质类固醇如甲基普雷迪尼索隆可以为IgA脏病患者提供脏保护,但会增加严重感染的风险. 这项研究提前停止,限制了对治疗益处的最终结论.
科学领域:
- 肝脏病学
- 免疫学
- 临床试验
背景情况:
- 指导方针建议在IgA脏病 (IgAN) 中使用皮质类固醇.
- 这些治疗的有效性和安全性仍然不确定,需要进一步调查.
研究的目的:
- 在患有IgA脏病的患者中评估皮质类固醇的疗效和安全性.
- 评估甲基普雷尼索隆对结局和不良事件的影响.
主要方法:
- 一个多中心,双盲,随机临床试验 (TESTING研究) 涉及 IgAN 和蛋白尿 > 1 g/ d 的患者.
- 参与者接受了2个月的口服甲基普雷尼索隆或安慰剂,随后是断奶期.
主要成果:
- 由于甲基普雷尼索隆组的严重不良事件过多,主要是严重的感染,该试验被提前中止.
- 虽然甲基普雷尼索隆组中主要结局 (例如,末期病) 的发生率较低,但最终结论有限.
结论:
- 在IgAN患者中,甲基普雷尼索隆治疗与严重不良事件,特别是感染的风险增加有关.
- 尽管有潜在的益信号,但试验的提前终止阻止了对IgAN皮质类固醇有效性的最终结论.
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