针对渐进性膜性病的免疫抑制:英国随机对照试验
Andrew Howman1, Tracey L Chapman, Maria M Langdon
1Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Lancet (London, England)
|January 15, 2013
概括
对于患有异常性膜性病症和功能下降的患者来说,六个月的普雷迪尼索隆和ambucil疗法与单独的支持性护理相比,显著地保持了功能. 应该避免使用西克洛斯波林.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 异形膜性病 (IMN) 经常导致末期病.
- 对于IMN患者的免疫抑制疗法存在有限的试验证据,这些患者的功能下降.
- 这项研究解决了在这个特定的患者小组中需要基于证据的治疗的需求.
研究的目的:
- 评估免疫抑制在IMN和分泌功能下降的患者中维护功能方面的疗效.
- 为了比较单独的支持性护理与免疫抑制疗法 (普雷尼索隆/木或环素).
主要方法:
- 这是一项随机对照试验,涉及英国37个脏部门的108名患者.
- 患者仅接受支持性护理,或支持性护理加6个月的普雷尼索隆/ambucil,或支持性护理加12个月的环素.
- 主要结局是功能进一步下降20%;使用治疗意图分析.
主要成果:
- 与支持性护理相比,普雷尼索隆和ambucil显著降低了功能进一步下降20%的风险 (HR 0.44,p=0.0042).
- 西克洛斯波林在单独支持性护理方面没有显著的益处 (HR 1.17,p=0.54).
- 严重的不良事件在普雷迪尼索隆/ambucil 组中更高.
结论:
- 六个月的普得尼索隆和ambucil是IMN患者的推治疗,功能恶化.
- 在这种患者群体中,应避免使用环素.
- 可能需要进一步的研究来优化治疗策略和管理不良事件.
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