根据药物监督,识别与口腔相关的药物
Xinyue Zhang1, Xueqing Li2, Wuda Huoshen2
1Department of Endodontics, The Affiliated Stomatology Hospital, Southwest Medical University, Luzhou, Sichuan, China; Luzhou Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, The Affiliated Stomatology Hospital, Southwest Medical University, Luzhou, Sichuan, China.
这项研究确定了289种与口腔有关的药物,包括免疫抑制剂和抗胰岛素药物. 建议加强口服监测这些药物的患者,以减轻与药物诱导的口腔相关的风险.
科学领域:
- 药监和药物安全 药监和药物安全
- 药理学中的现实世界的证据
- 临床药理学 临床药理学
背景情况:
- 口腔是常见的,痛苦的病变影响生活质量.
- 某些药物,特别是抗代谢物和mTOR抑制剂,是可疑的原因.
- 缺乏使用大规模现实世界的数据对药物诱导的口腔的系统评估.
研究的目的:
- 使用现实世界的数据,系统地识别与口腔相关的药物.
- 评估特定药物类别与口腔发育风险之间的关联.
- 为加强患者监测策略提供证据.
主要方法:
- 采用了双验证策略,结合了药监信号挖掘和多变量后勤回归.
- 从美国FDA FAERS数据库分析了口腔术语的不良事件报告.
- 采用了四种不成比例分析方法来检测信号和用于验证的逻辑回归,并对混因素进行调整.
主要成果:
- 确定了289个统计学上显著的药物-口腔关联信号.
- 信号强度最高的药物包括环素,菌酸盐和aredia.
- 确认了免疫抑制剂,抗组胺剂,止痛药,双酸盐,沙坦和抗生素的显著关联,而雌醇和多塞塔克塞尔的概率比率很高.
结论:
- 大约289种药物,包括免疫抑制剂和心血管药物,与口腔风险有显著的关联.
- 建议加强口服监测,以确定药物长期治疗的患者.
- 需要进一步的前性和实验性研究来确定因果关系.
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