混合设计新序列在药物可互换性中的探究  

Exploration of a new hybrid design sequence in drug interchangeability

作　　者：凌佳[1] 刘圣洁 言方荣 LING Jia;LIU Shengjie;YAN Fangrong(College of Education,Jiangsu Open University,Jiangsu Province,Nanjing210019,China;College of Science,China Pharmaceutical University,Jiangsu Province,Nanjing210009,China)

机构地区：[1]江苏开放大学教育学院,江苏南京210019 [2]中国药科大学理学院,江苏南京210009

出　　处：《中国医药导报》2020年第27期8-11,32,共5页China Medical Herald

基　　金：国家社会科学基金项目(16BTJ021)。

摘　　要：目的提出一种混合设计新序列(TTRR、RRTT、RTTR、TRRT)来探究其在药物可互换性方面的适用情况。方法基于Chow等提出的药物可交换标准(SCDI)为评价标准,考虑药物个体间变异,探索新序列在药物可互换性中的适用情况,并和常用序列(TRTR、RTRT)进行比较。结果通过计算机对不同情境的模拟,发现新序列大体上呈现一致趋势并且在药物可互换关键部分σWR、σD等变动时,本研究提出的新序列表现出比常用序列更加敏感的特点。结论虽然新序列比常用序列在药物可互换中对于变异变动时更加敏感,但多出的两个序贯使得其在样本量方面表现欠佳。Objective To propose a new hybrid design sequence(TTRR,RRTT,RTTR,TRRT)to explore its application in drug interchangeability.Methods Based on criterion for drug interchangeability(SCDI)scaled by Chow,etc.as evaluation criteria,the application of the new sequence in drug interchangeability was explored by considering the variation among drug individuals,and was compared with the common sequence(TRTR,RTRT).Results Through computer simulation of different situations,it was found that the new sequence presented a consistent trend.In addition,the new sequence presented in this study was more sensitive than the common sequence when the key partsσWR,σD of drug interchangeability were changed.Conclusion Although the new sequences are more sensitive to variation than the common sequence in drug interchangeability,the additional two sequences make it less effective in sample size.

关 键 词：序列 药物可互换性 药物可交换标准 平均生物等效性 

分 类 号：R969[医药卫生—药理学]