评估蒙特卢卡斯特使用者的故意自我伤害风险:使用ICD-10编码的更新的Sentinel系统分析
Jummai Apata1, Jennifer G Lyons2, Marie C Bradley1
1Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, MD, USA.
概括
这项研究发现,与吸入性皮质类固醇 (ICS) 相比,蒙特卢卡斯特对喘患者的自我伤害风险没有增加. 使用ICD-10代码比ICD-9代码更好地检测自我伤害事件.
科学领域:
- 药物监督 药物监督 药物监督
- 喘治疗安全性 喘治疗安全性
- 神经心理学不良事件 神经心理学不良事件
背景情况:
- 蒙特卢卡斯特携带一个盒子警告神经精神事件.
- 之前的一项研究 (2000-2015) 没有发现使用蒙特卢卡斯特与使用ICS使用ICD-9-CM代码的吸入性皮质类固醇 (ICS) 的自我伤害风险增加.
研究的目的:
- 评估蒙特卢卡斯特使用与喘患者的故意自我伤害之间的关联.
- 为了比较使用ICD-10-CM代码与ICD-9-CM代码的自我伤害事件检测.
主要方法:
- 新的使用者队列研究 (2015年10月 - 2022年6月) 发生性蒙特卢卡斯特或ICS使用者 (10岁以上).
- 使用ICD-10-CM代码测量的故意自伤.
- 用于共变量平衡的治疗权重的逆概率 (IPTW);执行子组和灵敏度分析.
主要成果:
- 与ICS使用相比,蒙特卢卡斯特使用和自我伤害之间没有发现关联 (HR:0.96 [0.85,1.08]).
- 结果在年龄,性别,精神病史和盒式警告前/后子组中一致.
- 敏感性分析证实了主要结果.
结论:
- 该研究没有发现与ICS相比,蒙特卢卡斯特与自我伤害的风险增加.
- 在ICD-10-CM代码中,自伤事件的发生率高于ICD-9-CM代码.
- 不能排除对蒙特卢卡斯特的其他神经精神病特异性反应.
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