一个系统的审查基于性别的报告在局部眼药物临床试验
Helen Zhao1, Rachel E Davis2, Alexander S Davis2
1School of Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Ophthalmology. Glaucoma
|March 30, 2025
概括
绿眼的临床试验经常报告性别,但很少通过性别分析疗效或不良事件. 将性别作为一种生物变量是了解青光眼治疗差异的关键.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 性作为一种生物变量 (SABV)
背景情况:
- 2016年NIH的指导建议在临床研究中将性别视为生物变量 (SABV).
- 之前的研究表明,在生物医学研究中持续未能实施SABV.
- 青光眼表现出性别特异性的风险因素,这表明生物性别影响疾病的进展.
研究的目的:
- 调查局部绿眼病药物的临床试验是否符合SABV指南.
- 评估将SABV纳入绿眼病药物试验的设计和分析.
主要方法:
- 使用PubMed和谷歌学者对局部玻璃眼药物的随机对照试验 (2002-2022) 的系统综述.
- 评估了与SABV相关的性别,疗效和不良事件 (AE) 的报告和分析.
- 纳入标准侧重于开角玻璃眼或眼睛高血压患者群体.
主要成果:
- 在包括的122项研究中,89%报告了受试者的性别,在31,644名受试者中,52.6%是女性.
- 只有4%的研究分析了根据性别的疗效或副作用,或者在讨论/结论中提到SABV.
- 2016年后的NIH指导和NIH资金与增加的SABV含量没有相关性;25%的孕妇或哺乳期患者被排除在外.
结论:
- 眼局部药物试验通常报告性别,但忽视基于性别的疗效和副作用分析.
- 在青光眼试验中实施SABV对于全面了解基于性别的治疗影响至关重要.
- 增加样本大小可能是必要的,以充分分析SABV在绿眼的临床试验.
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