在由皮下给药转换为皮下给药时,优化剂量方案 芬太尼尔的皮下给药转换为皮下给药
Bram C Agema1, Kim Vrielink2, Esther Oomen-de Hoop2
1Department of Medical Oncology (B.C.A., K.V., E.O.D.H., F.V.T., E.G., C.C.D.V.D.R., S.L.W.K., A.W.O., R.H.J.M.), Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands; Department of Clinical Pharmacy (B.C.P.K., S.L.W.K.), Erasmus MC University Medical Center, Rotterdam, The Netherlands; Rotterdam Clinical Pharmacometrics Group (B.C.P.K.), Erasmus University Medical Center, Rotterdam, The Netherlands.
在涂上皮肤贴片后立即停止皮下芬太尼,可以确保癌症患者获得相当的芬太尼暴露和安全的疼痛管理. 这种更新的轮换时间表在息治疗中是有效的.
科学领域:
- 药理动力学和药理动力学
- 瘤学和息治疗
- 疼痛管理 疼痛管理
背景情况:
- 皮下 (SC) 芬太尼允许对紧急癌症疼痛进行快速定位.
- 过渡到透皮 (TD) 芬太尼尔贴片是常见的做法.
- 在TD贴片应用后继续使用SC芬太尼可能会导致毒性.
研究的目的:
- 为了验证新的芬太尼轮换时间表.
- 评估轮换前后芬太尼暴露的药理动力学 (PK) 相当性.
- 在剂量转换期间确保安全有效的阿片类药物管理.
主要方法:
- 未来收集PK样本和临床数据.
- 研究持续时间:轮换前12小时至轮换后12小时.
- 芬太尼暴露的药理动力学分析 (AUC) 和临床结果.
主要成果:
- 转换后/转换前AUC比率的90%CI为1.05-1.16,在0.8-1.25等效区间内.
- 恶心和汗水强度在旋转后显著下降 (P=0.047和P=0.034).
- 疼痛强度和其他不良事件没有显著差异;一名患者因毒性而需要阿片类药物调整.
结论:
- 更新后的SC到TD芬太尼轮换方案确保了同等的芬太尼暴露.
- 1:1剂量转换和立即停止使用SC芬太尼是安全有效的.
- 这种新的剂量方案可以在常规息治疗中安全地实施.
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