根据度-时间曲线估计布苏尔面积的有限采样策略:基于唾液中的峰值和低谷度
Baohua Xu1,2, Jianxing Zhou1,2, You Zheng1,2
1School of Pharmacy, Fujian Medical University, Fuzhou, Fujian, China.
唾液监测提供了一种非侵入性的方法,用于对布苏尔 (化疗药物) 治疗药物进行监测. 一个2点的唾液采样策略准确地预测了血busulfan的暴露,从而实现了个性化剂量.
科学领域:
- 药理动力学和治疗药物监测
- 瘤学和血液学 在线
- 临床化学和生物标志物
背景情况:
- 目前的布苏尔法治疗药物监测依赖于频繁的血采样,这是侵入性的.
- 唾液为药物水平评估提供了一个有希望的,非侵入性的替代矩阵.
- 个性化布苏尔方剂量对于优化治疗疗效和最大限度地减少毒性至关重要.
研究的目的:
- 在血和唾液中研究静脉注射busulfan的药理学特征.
- 开发和验证使用唾液进行有限采样策略 (LSS) 以预测血busulfan暴露 (AUC0-∞,p).
- 评估使用基于唾液的LSS用于个性化busulfan剂量的可行性.
主要方法:
- 从37名中国患者的血和唾液中对静脉注射busulfan的药理动力学分析.
- 皮尔森相关性分析,以评估血和唾液busulfan AUC0-∞之间的关系.
- 多重线性回归以建立LSS模型,使用预测误差,平均预测误差和根平均平方误差进行评估.
- 类内相关系数和Bland-Altman分析用于协议评估;准确性和稳定性验证的引导.
主要成果:
- 62.2%的患者达到硫血AUC0-∞的目标值,p.
- 在血和唾液busulfan AUC0-∞之间发现了显著的相关性 (r=0.63,p<0.01).
- 开发的LSS模型显示偏差和精度<15%,ICC>0.9和 ±15%内的协议极限.
结论:
- 使用唾液的2点限量采样策略是一种可靠和方便的方法,用于预测静脉注射布苏尔方在血曲线下的面积.
- 这种基于唾液的方法促进了个性化的布苏尔法剂量,改善了治疗管理.
- 非侵入性唾液监测可能会取代传统的血采样,用于对布苏尔法治疗药物进行监测.
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