预防老年患者手术后狂妄症的美拉托尼:一个多中心随机的安慰剂控制的试点研究
Maram Khaled1,2, Jason Chui3, Joycelyne Ewusie4
1Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
Medicine
|February 25, 2025
概括
这项研究发现,在老年人中,使用黑激素与安慰剂预防术后狂妄症 (POD) 没有显著差异. 需要进行更大规模的试验来确认黑激素的存在.
科学领域:
- 老年医学 老年医学
- 麻醉学 麻醉学
- 药理学 药理学是指药理学的学科.
背景情况:
- 在老年人中,术后妄想 (POD) 具有显著的发病率和死亡率风险.
- 由于POD的治疗选择有限,预防策略至关重要.
- 黑素在POD预防中的潜在作用是由其对睡眠-清醒周期和血清素代谢的影响所暗示的,但证据仍然是不确定的.
研究的目的:
- 评估黑激素在接受非心脏手术的老年人中预防POD的可行性和初步临床效果.
- 为了评估招募率,药物坚持和3个月的随访完成.
- 为了检查POD的发病率,睡眠质量,机构出院和认知状态.
主要方法:
- 一个多中心,双臂,并行组,可行性随机对照试验.
- 120名65岁以上的患者被随机分配,接受手术前和术后7天3mg口服黑激素或安慰剂.
- 每天两次进行妄想评估,并在术后3个月后进行随访.
主要成果:
- 85名患者被随机分配,其中92.9%的患者坚持服用药物,87.1%的患者完成了3个月的随访.
- 在9名患者 (7名黑激素患者,2名安慰剂患者) 中发生了POD,两组之间没有统计学上显著的差异.
- 没有观察到睡眠质量,机构出院或认知状态的显著差异.
结论:
- 一个最终的试验需要超过1000名患者来最终评估黑激素在减少POD发病率中的作用.
- 可行性挑战,包括与流行病相关的干扰,影响招聘和研究持续时间.
- 未来的试验设计必须包括修改以解决可行性和适应流行病后医疗保健变化.
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