为新生儿和婴儿制订基于证据的碳酸剂量指南
Shelby Barnett1, Guy Makin2,3, Deborah A Tweddle4,5
1Translational & Clinical Research Institute, Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK. shelby.barnett@ncl.ac.uk.
British journal of cancer
|October 10, 2023
概括
优化婴儿卡博普拉丁剂量对于有效的儿童癌症治疗至关重要. 建议使用新的基于证据的6-9毫克/公斤剂量来达到目标AUC,改善患者的治疗结果.
科学领域:
- 儿科瘤学 儿科瘤学
- 临床药理学 临床药理学
- 药理动力学 药理动力学
背景情况:
- 卡博普拉丁在儿童癌症患者的最佳剂量需要基于证据的方法.
- 目前针对儿童的卡博普拉丁剂量指南的目标是曲线下的目标面积 (AUC) 为5.27.8 mg/ml·min.
- 现有的基于体重的剂量 (6.6 mg/kg/天或 4.4 mg/kg 对于<5 kg) 可能无法在婴儿中始终达到目标暴露.
研究的目的:
- 为了优化婴儿和幼儿 (≤10公斤) 基于体重的碳酸剂量.
- 确保在这个脆弱人群中有效地准5.27.8毫克/毫升·分钟之间的AUC.
- 为了减少碳烯暴露的变化,并提高治疗效率.
主要方法:
- 收集了82名体重≤10公斤的患者 (165个治疗周期) 的实际临床药理数据.
- 从第一天的血液样本使用贝叶斯模型来确定碳酸AUC和清除值.
- 评估当前剂量变化,并计算最佳剂量以达到目标AUC.
主要成果:
- 在患者<5公斤和510公斤之间没有观察到碳烯清除的显著差异.
- 目前用于婴儿 (<5公斤) 的4.4毫克/公斤剂量不足,<55%的婴儿达到5.2毫克/毫升/分钟的目标AUC.
- 建议优化每日剂量为6 mg/kg和9 mg/kg,目标AUC分别为5.2 mg/ml·min和7.8 mg/ml·min,患者体重≤10公斤.
结论:
- 实施优化的碳白剂量将最大限度地减少新生儿和婴儿药物暴露的变化.
- 基于证据的剂量策略对于提高儿科癌症患者治疗结果至关重要.
- 这项研究为在最年轻的癌症患者中改进碳酸剂量提供了关键数据.
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