类药物和免疫媒介性死肌病:风险的变化
Thierry Trenque1, Jed Hadjoudj2, Agathe Trenque2
1Reims University Hospitals, Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 51092 Reims, France; University of Reims Champagne-Ardenne, Faculty of Medicine, EA 3797, 51095 Reims, France.
概括
阿托瓦斯塔丁与免疫媒介性死肌病 (IMNM) 的最高风险有关,这是一种由他类药物诱导的疾病. 这项研究表明IMNM是他类药物的类效应.
科学领域:
- 药物监督 药物监督 药物监督
- 免疫学 免疫学 免疫学
- 神经学 神经学
背景情况:
- 免疫媒介性死性肌肉病变 (IMNM) 是他类药物治疗的严重不良影响.
- IMNM的特点是存在针对3 - 基-3 - 甲基氨酸-辅酶A减少酶 (抗HMGCR) 的自身抗体.
研究的目的:
- 调查特定的他类药物与患IMNM的风险之间的关联.
- 分析与他类药物使用相关的IMNM病例的全球和国家报告.
主要方法:
- 从1985年到2020年,对法国国家药监数据库 (FNPV) 的描述性分析.
- 用MedDRA术语对IMNM进行个案安全报告 (ICSR) 的定量和定性审查.
- 与世界卫生组织的Vigibase数据库进行比较分析.
- 报告几率比率 (ROR) 的计算,以评估他类药物和IMNM之间的关联.
主要成果:
- FNPV确定了25例IMNM病例,其中阿托瓦斯塔丁是最常被怀疑的他类药物 (n=21).
- 维吉巴斯记录了567个IMNM通知.
- 对于阿托瓦斯塔丁,皮塔瓦斯塔丁,西姆瓦斯塔丁,普拉瓦斯塔丁和罗斯瓦斯塔丁,观察到显著的报告几率比率 (ROR).
结论:
- 在研究的他类药物中,阿托瓦斯塔丁表明诱导IMNM的风险最高.
- 这些发现表明IMNM是与他类药物使用相关的潜在类效应.
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