在随机对照试验中报告并发和救援局部治疗,评估亚托皮性皮肤炎的全身治疗:范围审查
Sophie Leducq1,2,3, Wei Chern Gavin Fong1, Hywel C Williams1
1Centre of Evidence Based Dermatology, School of Medicine, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
The British journal of dermatology
|January 30, 2025
概括
在阿托皮性皮炎 (AD) 临床试验中报告局部治疗方法是不一致的,特别是对于救援疗法. 需要标准化报告,以提高AD系统治疗试验的透明度.
科学领域:
- 皮肤病学 皮肤病学
- 临床试验方法论 临床试验方法论
- 药理学 药理学是指药理学的学科.
背景情况:
- 随机对照试验 (RCT) 针对阿托皮性皮肤炎 (AD) 系统性治疗正在增加.
- 在这些试验中,经常使用并发和救援局部疗法.
- 对局部治疗的不一致报告可以引入偏见并影响治疗反应的解释.
研究的目的:
- 在AD RCT中评估同步和救援局部治疗报告的清晰度.
- 检查这些局部治疗的关键参数的详细报告.
主要方法:
- 包括从活体系统性审查中对系统性AD治疗的67个RCT.
- 专注于抗炎局部疗法,不包括软化剂.
- 分析了局部治疗津贴,禁令和特定参数的报告.
主要成果:
- 大多数试验 (96%) 清楚地报告了并发局部使用,但较少的 (73%) 报告了救援局部使用.
- 虽然类型经常被报告,但有关强度,持续时间,频率和数量的细节对于并发和救援局部药物都是有限的.
- 报道救援主题标准很差 (24%),经常依赖调查人员的自由裁量权. 只有最近的出版年份 (≥2020) 与更好的救援专题报告有关.
结论:
- 在AD RCT中报告同时进行的局部治疗通常是充足的.
- 关于救援局部治疗的报告实践不一致且不足.
- 在AD试验中报告局部治疗的标准化方法对于提高透明度和可解释性至关重要.
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