痴呆症护理研究和心理社会因素
Lawrence S Honig1, Wendy P Gonzalez1, Jee Min Kim1
1Columbia University Irving Medical Center, New York, NY, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
概括
在早期阿尔茨海默氏症中使用lecanemab的现实世界显示了与临床试验相比的安全性和耐受性. 这种抗粉胺疗法提供了潜在的好处,尽管副作用的风险很小.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 生物标志物 生物标志物
背景情况:
- 莱卡尼马布和多纳尼马布是抗粉样蛋白抗体,可减缓早期阿尔茨海默病的进展.
- 莱卡尼马布获得了FDA批准和医疗保险覆盖,但访问受到推和付款人标准的限制.
- 进入障碍的部分原因是应用临床试验排除和对不良事件率的担忧.
研究的目的:
- 评估处方lecanemab的现实实践经验.
- 评估lecanemab在不同患者群体中的安全性,耐受性和使用情况.
- 将现实世界的不良事件率与临床试验中观察到的不良事件率进行比较.
主要方法:
- 标签上处方lecanemab给超过190多名不同患者 (年龄35-90岁) 用粉样蛋白确认.
- 通过各种输液和MRI设施监测患者.
- 收集了有关患者人口统计,APOE基因型,输液和不良事件的数据.
主要成果:
- 副作用的发生率与临床试验相似,有15%的人经历了输液反应.
- ARIA-E发生在10.6%的患者中,ARIA-H的发病率较低.
- 只有1%的患者有症状性ARIA;9%的患者因ARIA,输液反应或缺乏兴趣而停止治疗.
结论:
- 在现实世界中,lecanemab的使用似乎与临床试验中关于安全性和耐受性的研究结果相当.
- 观察到易于使用,良好的耐受性和相对安全性.
- 临床证据和生物可信性应该指导访问讨论,而不是施加障碍.
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