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皮尔芬尼在患有异常性肺纤维化 (CAPACITY) 的患者中:两项随机试验
Paul W Noble1, Carlo Albera, Williamson Z Bradford
1Duke University School of Medicine, Durham, NC 27710, USA. paul.noble@duke.edu
Lancet (London, England)
|May 17, 2011
概括
一种抗纤维素药物pirfenidone在异常性肺纤维化患者中进行了研究. 它表现出有利的益处风险概况,减少肺功能衰退和死亡率,使其成为可行的治疗选择.
科学领域:
- 肺部病理学 肺部病理学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 异形性肺纤维化 (IPF) 是一种渐进的,致命的肺病,其特点是不可避免的肺功能下降.
- 能力计划 (研究004和006) 旨在证实皮尔芬尼在减缓IPF进展方面的有效性.
研究的目的:
- 评估口服皮尔芬尼在患有异常性肺纤维化患者的疗效和安全性.
- 确认皮尔芬尼能够减少IPF患者肺功能恶化的能力.
主要方法:
- 两项同时进行的随机,安慰剂对照试验 (CAPACITY研究004和006) 涉及779名年龄在40-80岁的IPF患者.
- 患者接受口服皮尔芬尼 (2403毫克/天或1197毫克/天) 或安慰剂至少72周.
- 主要终点是72周预测强迫生命能力 (FVC) 的百分比变化;进行了治疗意图分析.
主要成果:
- 在004研究中,与安慰剂相比, pirfenidone 2403 mg/day显著降低了FVC下降 (4.4%的差异,p=0.001),较少的患者经历了≥10%的下降 (20%vs35%).
- 研究006在72周的FVC变化中没有显示出统计学上显著的差异,但pirfenidone在48周之前表现出一致的效果.
- 与安慰剂相比,Pirfenidone 2403 mg/天与不良事件 (恶心,消化不良,皮疹) 的增加有关,但总体和IPF相关死亡人数较少.
结论:
- 皮尔芬尼在治疗异常性肺纤维化时表现出有利的益处风险概况.
- 皮尔芬尼对被诊断患有异常性肺纤维化患者来说是一个合适的治疗选择.
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