考虑2001年至2022年期间在日本批准的抗癌药物的食品效应研究
Maho Shibuya1, Hayataka Kubota1, Hideki Maeda1
1Regulatory Science, Faculty of Pharmacy, Meiji Pharmaceutical University, Tokyo, Japan.
Clinical and translational science
|July 15, 2025
概括
对口服抗癌药物的食物效应 (FE) 研究很常见,大多数是在健康受试者身上进行的,而不是患者. 这一趋势反映了从细胞毒剂转向向疗法和免疫检查点抑制剂的转变.
科学领域:
- 药理动力学 药理动力学
- 临床药理学 临床药理学
- 药物开发 药物开发
背景情况:
- 食物效应 (FE) 研究评估食物如何影响药物吸收.
- 传统上,FE研究使用健康的志愿者,但由于潜在的不良影响,对于抗癌药物来说,这经常受到质疑.
- 对口服抗癌药物进行FE研究的实践尚不清楚.
研究的目的:
- 调查日本批准的口服抗癌药物食品效应 (FE) 研究的特征.
- 分析FE研究从2001年到2022年的发展趋势.
主要方法:
- 在2001年至2022年期间,日本批准的70种口服抗癌药物的回顾性分析.
- 检查了95个FE研究,这些研究对67种药物进行了检查.
- 统计分析 (chi-square测试) 以确定影响FE研究进行的因素.
主要成果:
- 95.7% (67/70) 的口服抗癌药物接受了FE研究.
- 66.3% (63/95) 的这些研究是在健康受试者身上进行的.
- 大多数研究都是单剂量,单剂量臂,非随机化,交叉设计,有11-30名参与者.
- 84.2% (80/95) 的FE研究是在日本以外进行的.
- 对于具有海外数据的药物,非细胞毒性药物,在国外开发的药物,以及具有>100个关键试验参与者的药物,FE研究的可能性更高.
结论:
- 对口服抗癌药物的FE研究经常在健康受试者身上进行,这与最初的假设相反.
- 转向分子向药物和免疫检查点抑制剂的转变与FE研究中继续使用健康受试者有关.
- 临床试验设计正在适应新的抗癌药物模式.
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