基于全球药监数据库 (VigiBase) 的特拉马多尔呼吸系统抑郁症的风险因素
Sunny Park1, Geon-Ho Lee2, Soyun Kim2
1College of Pharmacy and Research Institute of Pharmaceutical Sciences, Korea University, Sejong 30019, Republic of Korea.
Pharmaceuticals (Basel, Switzerland)
|February 24, 2024
概括
特拉马多尔使用带有呼吸系统抑郁的显著风险,这是一个严重的不良事件. 这种风险在儿童,青少年和与其他中枢神经系统抑郁药物结合使用时增加.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 疼痛管理 疼痛管理
背景情况:
- 特拉马多尔是一种广泛使用的止痛药,通常被认为是安全的.
- 然而,监管机构对其可能导致呼吸抑制的可能性表示担忧.
研究的目的:
- 调查与特拉马多尔相关的呼吸系统抑郁症的风险和促成因素.
- 利用了来自VigiBase药监数据库的现实数据.
主要方法:
- 对特拉马多尔和特拉马多尔/白醇报告进行了不成比例分析.
- 评估因素包括年龄,性别,药物滥用,同时服用药物和死亡.
主要成果:
- 在140,721份特拉马多尔报告中,1126份 (0.8%) 涉及呼吸系统抑郁,其中81.3%被归类为严重.
- 鉴定了急性中央呼吸系统抑郁症 (ACRD) 信号,儿童患者和吸毒者的发病率更高.
- 同时使用CYP2D6抑制剂,阿片类药物,二类药物和抗抑郁药物增加了ACRD风险.
结论:
- 特拉马多尔具有严重的,可能致命的呼吸系统抑郁症的显著风险.
- 这种风险在儿科患者群体,有药物滥用史的人群中特别高,以及与其他中枢神经系统抑制剂联合处方时.
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