舌下/口腔布普伦诺啡和牙问题:一个药监测研究
Romain Barus1, François Montastruc1, Claire de Canecaude1
1Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, Toulouse, France.
Expert opinion on drug safety
|August 16, 2023
概括
语言下/口服布普伦诺芬使用可能与牙问题的风险增加有关. 这一发现并没有改变这种药物治疗阿片类药物使用障碍的既定好处.
科学领域:
- 药物监督 药物监督 药物监督
- 牙科不良反应药物反应
- 阿片类药物使用障碍治疗治疗
背景情况:
- 语言下/口腔布普伦诺芬与牙科问题之间的关系尚不清楚.
- 对牙科药物不良反应的分析使用VigiBase®进行,这是世卫组织药监数据库.
研究的目的:
- 为了研究下语言/口腔布普伦诺芬与牙问题之间的潜在关联.
- 为了比较报告率的牙科问题与下语言/口腔布普伦诺芬与其他布普伦诺芬配方和甲.
主要方法:
- 使用报告几率比率 (ROR) 进行了不成比例分析.
- 使用ROR> 1的95%置信区间的下限确定了显著信号,至少有3个病例和p值<0.05.
- 根据报告员资格和大陆进行了敏感性分析.
主要成果:
- 在30769份布普伦诺芬报告中,有20例牙问题病例被认定为下语言/口腔布普伦诺芬.
- 与其他布普伦诺芬配方 (ROR = 15.10) 和美沙 (ROR = 6.02) 相比,下舌/口腔布普伦诺芬显示过度报告牙问题.
- 这种过度报告的趋势在所有灵敏度分析中都是一致的,但在欧洲有所例外.
结论:
- 舌下/口腔布普伦诺芬可能与报告的牙问题的更高风险有关.
- 这些发现并不能削弱口服布诺芬在治疗阿片类药物使用障碍方面的治疗益处.
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