关于使用日本药物不良事件报告数据库报告的静止素相关免疫媒介性瘤性肌肉病的报告趋势
Akina Takami1, Gen Terashima2, Takumi Tajima2
1Department of Health Policy and Public Health, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. mariechanmail@g.ecc.u-tokyo.ac.jp.
Drugs - real world outcomes
|January 31, 2025
概括
在2016年发布修订后,与他类药物使用相关的免疫媒介性死性肌肉病变 (IMNM) 病例数在日本显著增加. 这一趋势凸显了在安全更新后监测不良事件的重要性.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 药品安全 药品安全
背景情况:
- 对于他类药物的封装插件预防措施于2016年10月更新,以解决免疫媒介性缩肌病 (IMNM).
- 评估这些修订后的预防措施对报告的IMNM病例的影响对于患者安全至关重要.
研究的目的:
- 评估在2016年修订药物安全预防措施之前和之后,日本与他类药物相关的IMNM的趋势.
- 量化归因于他类药物治疗的IMNM病例的发生率.
主要方法:
- 利用日本药物不良事件报告和日本医学数据中心 (JMDC) 数据库进行病例识别和发病率估计.
- 识别的IMNM病例使用了MedDRA版本27.1.1.中的首选术语"免疫媒介肌炎".
- 分析了从2004年4月到2023年3月的病例报告.
主要成果:
- 在145份报告中,共发现了172例与他类药物相关的IMNM病例.
- 罗斯瓦斯塔丁是最常见的怀疑类药物 (34.3%),其次是皮塔瓦斯塔丁 (25.0%) 和阿托瓦斯塔丁 (22.1%).
- 报告的IMNM病例从2015年的3例上升到2019年的51例,估计每年发病率很少超过每10万患者中的5例.
结论:
- 在发布修订后的包装插件预防措施后,观察到与他类药物相关的IMNM病例的增加趋势.
- 这些发现强调了药物监测在检测和监测药物诱导的不良事件方面的重要性.
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