抗肿瘤药效研究中疗效与安全性综合评价指标的选择  

Selection of comprehensive evaluation indexes for efficacy and safety in anti-tumor drug effect research

作　　者：隋德志 李长智 刘欣荣[1] 邓意辉[1] 宋艳志[1] SUI Dezhi;LI Changzhi;LIU Xinrong;DENG Yihui;SONG Yanzhi(College of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2024年第2期154-160,194,共8页Journal of Shenyang Pharmaceutical University

基　　金：国家自然科学基金资助项目(81703456);沈阳药科大学中青年教师职业发展极化资助项目(ZQN2021009)。

摘　　要：目的传统抗肿瘤药效评价指标中体质量、肿瘤体积和抑瘤率可以分别体现制剂的安全性和疗效,但是单一指标并不能兼顾这两点。为此,新的抗肿瘤药效评价指标被提出,其中抑瘤指数可以全面地呈现药物的治疗效果。方法以表柔比星相关制剂的药效学实验数据为例,对“新”和“旧”抗肿瘤评价指标的统计结果进行分析。结果聚乙二醇修饰脂质体组内小鼠的抑瘤率(0.80±0.05)与唾液酸修饰脂质体组内小鼠的抑瘤率(0.89±0.01)无显著性差异(P≥0.05),但是聚乙二醇修饰脂质体组内小鼠的抑瘤指数(40±9)显著低于唾液酸修饰脂质体组内小鼠的抑瘤指数(82±7,P<0.001)。结论“新”抗肿瘤评价指标更适合用于抗肿瘤研究的数据分析。Objective Body mass,tumor volume,and tumor inhibition rate in traditional anti-tumor evaluation indicators can respectively reflect safety and efficacy of preparation.But a single indicator cannot consider both points.For this reason,a new evaluation index of anti-tumor drug efficacy has been proposed,among which the tumor inhibition index can comprehensively evaluate the efficacy of drug.Methods Taking the pharmacodynamic experiment data of epirubicin-related preparations as an example,we analyzed calculation results of“new”and“old”anti-tumor evaluation indexes.Results Tumor inhibition rate of mice in PEG-modified liposome group(0.80±0.05)was not significantly different from that of sialic acid-modified liposome group(0.89±0.01,P≥0.05),but tumor inhibition index of mice in PEG-modified liposome group(40±9)was significantly lower than that of sialic acid-modified liposome group(82±7,P<0.001).Conclusion In this experiment found that“new”anti-tumor evaluation index is more suitable for data analysis of anti-tumor research.

关 键 词：抑瘤指数 抑瘤率 安全性 疗效 

分 类 号：R917[医药卫生—药物分析学]