基于CRM-TE模型的抗肿瘤药物最适剂量估计方法  

The Method for Optimal Doses Estimation of Antineoplastic Drugs based on the CRM-TE Model

作　　者：周克强 李爽[1] 徐佳钦 李康[1] Zhou Keqiang;Li Shuang;Xu Jiaqin(Department of Medical Statistics,Harbin Medical University(150081),Harbin)

机构地区：[1]哈尔滨医科大学卫生统计学教研室,150081

出　　处：《中国卫生统计》2023年第2期195-198,共4页Chinese Journal of Health Statistics

基　　金：国家自然科学基金(81973149)。

摘　　要：目的研究一种新的抗肿瘤药物剂量探索模型(continual reassessment method based on toxicity and efficacy,CRM-TE),这种模型可以在I期临床试验中同时考虑毒性和疗效的药物作用,给II期临床试验推荐最适剂量(recommend the optimal dose,RP2D)。方法基于连续重评估模型(continual reassessment model,CRM)对药物的剂量-毒性和剂量-疗效曲线分别进行估计,并根据给出的权衡函数选择最适剂量。结果本文提出最适剂量估计方法与目前现有的同类型方法相比,能够在保证安全性的前提下,同时综合考虑不同剂量下的疗效,使选择的RP2D更为合理。结论本文为药物临床试验最适推荐剂量提供了一种新的方法,对于抗肿瘤等药物剂量探索具有一定的实用价值。Objective To study a new antineoplastic drug dose exploration model(CRM-TE),which can consider both the toxicity and efficacy of the drug in the phase I clinical trial,and recommend the optimal dose(RP2D)for the phase II clinical trial.Methods Based on the continual reassessment model(CRM),the dose-toxicity and dose-efficacy curves of the drug are estimated separately,and the optimal dose is selected according to the given trade-off function.Results Compared with the current existing methods of the same type,this article proposes that the optimal dose estimation method can comprehensively consider the efficacy of different doses under the premise of ensuring safety,so that the selected RP2D is more reasonable.Conclusion This article provides a new method for the optimal recommended dosage for drug clinical trials,which has certain practical value for the exploration of the dosage of antineoplastic drugs.

关 键 词：临床试验 最适剂量 权衡函数 

分 类 号：R197[医药卫生—卫生事业管理]