实施风险最小化措施,降低瘤亡因子药物使用者的结核病风险
Nouf Al-Fadel1, Abdulaali Almutairi1, Tahrir Aldhirgham2
1Drug Safety and Risk Management Department, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Pharmacoepidemiology and drug safety
|August 24, 2023
概括
在实施风险最小化措施 (RMMs) 后,因弗力西马布使用者对结核查的坚持得到改善. 然而,在开始抗瘤亡因子-α (抗TNF-α) 治疗之前的整体查仍然不够理想,需要进一步调查.
科学领域:
- 药物监督 药物监督 药物监督
- 传染病流行病学 传染病流行病学
- 临床药房 临床药房
背景情况:
- 抗瘤坏死因子-α (抗TNF-α) 疗法,如因弗利西马布和阿达利穆马布,在开始之前需要进行结核病 (TB) 查.
- 风险最小化措施 (RMMs) 对于在抗TNF-α治疗期间确保患者安全至关重要.
- 评估对结核病查指南的遵守对于防止潜伏结核病感染的重新激活至关重要.
研究的目的:
- 为了评估新患者对结核病查的RMM的遵守,处方的抗TNF-α药物.
- 在沙特阿拉伯的一家三级医院实施RMM之前和之后比较结核病查率.
主要方法:
- 一项回顾性研究包括了新使用infliximab或adalimumab的新用户.
- 根据患者的首次处方日期,患者被分为RMM实施前和后的组.
- 主要结局是治疗开始前一个月内接受结核病查 (胸部X射线或QuantiFERON测试) 的患者比例.
主要成果:
- 在RMM实施后的infliximab使用者观察到结核病查率的显著增加:胸部X射线率从7.5%上升到13.8%,QuantiFERON测试率从4.5%上升到24.1% (p <0.001).
- 在Adalimumab批准和RMM引入时,25.2%的患者接受了结核病查.
- 在开始抗TNF-α治疗之前,结核病查的整体依从性并不是最佳的.
结论:
- 实施RMM导致因弗力西马布发起者的结核病查率提高.
- 在开始使用因弗利西马布或阿达利穆马布之前,结核病查的坚持需要进一步改进.
- 未来的研究应该探索在开始抗TNF-α治疗的患者中,优化结核病查遵守障碍.
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