逐步连续重新评估方法——改进的确定药物最大耐受剂量的方法  

Stepwise CRM based on a setup rule for phase Ⅰ clinical trials

作　　者：史丽君[1] 陶剑[1] 史宁中[1] 

机构地区：[1]东北师范大学数学与统计学院

出　　处：《东北师大学报（自然科学版）》2005年第3期1-6,共6页Journal of Northeast Normal University(Natural Science Edition)

基　　金：国家自然科学基金资助项目(青年项目10201006)

摘　　要：在研究了新药第Ⅰ阶段临床试验最大耐受剂量估计方法的基础上,给出了基于启动规则的逐步连续重新评估方法(CRM),并与传统的Up-and-Down方法进行了模拟比较,结果表明:逐步CRM方法减少了受试人数,降低了受试者中毒人数的百分比,从而提高了该方法的临床可接受性.The clinical trial of experimental drug is normally done in three phases. A phase I clinical trial is primarily concerned with assessing the drug＇s safety,and one of the main objectives is to estimate the maximum tolerated dose of the dose. The continual reassessment method（ CRM） is a Bayesian procedure for identifying the maximum tolerated dose. The CRM has been shown to have significant advantages over the traditional Up- and- Down method. However, its acceptance may be in doubt, the reason is that the enrolled subjects may experiencing excess toxicity. To overcome disadvantage, an improved stepwise CRM based on a setup rule is proposed. Comparing with two other methods, the stepwise CRM reduces the total number of enrolled subjects and avoids severe toxicity exposure at higher dose levels. As a result, it is expected that the new method is acceptable to clinical trials.

关 键 词：最大耐受剂量 逐步CRM 启动规则 毒性 人体安全性 药物实验 

分 类 号：R965.3[医药卫生—药理学]