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在随机对照试验中,安慰剂或载体对干眼症状的影响:系统审查和元分析

Alan Huang¹, Annie Zhang², Daniel Lee²

¹Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Survey of ophthalmology

|August 29, 2025

概括

在干眼疾病 (DED) 试验中,安慰剂效应对症状和症状都具有重要意义. 女性的性别和更糟糕的基线症状影响了对安慰剂的DED症状反应.

科学领域:

眼科眼科
临床试验
基于证据的医学

背景情况:

干眼病 (DED) 是一种常见的眼科疾病.
在DED临床试验中使用安慰剂或载体是标准的.
在DED试验中,安慰剂/载体效应的影响尚不清楚.

研究的目的:

评估DED载体或安慰剂效应的存在和程度.
确定与这些影响相关的因素.
为未来的DED试验设计提供信息.

主要方法:

载体或安慰剂对照的DED试验的系统审查和元分析.
关于试验特征和结果的提取数据 (Schirmer测试,TBUT,染色,OSDI).
使用随机效应模型和元回归来分析安慰剂/载体效应和预测因素.

主要成果:

在OSDI (症状) 和TBUT,角膜染色和结膜染色 (迹象) 中观察到显著的安慰剂/载体效应.
较高的女性参与者百分比和较差的OSDI基线预测了OSDI更大的安慰剂/载体反应.
对DED症状的安慰剂/载体效应没有发现预测因素.

结论:

在DED试验中,安慰剂/载体效应是显著的,必须在试验设计中加以考虑.
在基线时,女性的性别和症状严重程度与对DED症状的更大的安慰剂效应有关.
需要进一步研究以了解DED试验中安慰剂效应的机制和缓解策略.

关键词:

眼睛干燥的疾病干眼综合征皮质结膜炎病一种假药其他车辆

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