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Updated: Jun 7, 2025

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临床试验中患者报告的慢性咳评估:辅助或主要终点?
Ewan Christopher Mackay1, Richard Douglas Turner2,3, Peter Siu Pan Cho1,4
1Department of Respiratory Medicine, Chest Unit, Cheyne Wing, King's College Hospital, London, UK.
Journal of thoracic disease
|November 18, 2024
概括
慢性咳的治疗方法正在改善,但试验中的结果措施需要改进. 本综述审查了慢性咳患者报告的结果指标 (PROM) 以及它们在临床试验中的使用.
科学领域:
- 肺病学和临床治疗学
背景情况:
- 慢性咳影响到5-10%的人口,以有限的有效治疗方法提出管理挑战.
- 新型抗咳疗法正在出现,需要最佳的临床试验结果措施.
研究的目的:
- 审查慢性咳目前患者报告的结果措施 (PROMs).
- 讨论PROMs作为慢性咳临床试验中主要结果指标的潜力.
主要方法:
- 对慢性咳现有验证的PROM进行文献综述.
- 对临床试验中PROM使用的监管前景的分析.
主要成果:
- 存在各种PROM,评估诸如咳严重程度,过敏和生活质量等方面.
- 监管机构鼓励使用PROM,但提出了关于有效性和解释的担忧.
结论:
- 慢性咳 (PROM) 对患者慢性咳的经验提供了宝贵的见解.
- 需要进一步的研究来解决监管问题,并优化PROM在临床试验中的整合.
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