中药新药Ⅰ期耐受性试验常见不良事件监测及管理探讨  

Monitoring and management of adverse events in phase I tolerance trials of new traditional Chinese medicines

作　　者：李艳芬[1] 黄宇虹[1] 孙金霞[1] 王保和[1] 

机构地区：[1]天津中医药大学第二附属医院临床药理科,天津300150

出　　处：《中国新药杂志》2010年第15期1302-1304,共3页Chinese Journal of New Drugs

基　　金：国家"十一五"攻关课题(2008ZX09312-001)

摘　　要：Ⅰ期耐受性试验是初步的人体安全性评价试验,其目的是研究人体对药物的耐受程度,确定安全耐受的人用剂量并了解在此剂量下的不良反应,为Ⅱ期临床试验给药提供安全的剂量范围。其方案制定的主要依据是动物的药理、毒理资料,而人与动物之间存在物种差异,试验过程中不良事件的发生率和不可预见性的风险比重较大,因此Ⅰ期耐受性试验中不良事件监测极为重要。Phase Ⅰ tolerance trial is the preliminary test for safety evaluation in human. The purpose is to evaluate toleranee of the human body to test medicines, and determine the safe dose range for phase Ⅱ trials. The plan of tolerance trial is mainly based on animal studies of pharmacology and toxicology, but the species differences exist between human and animals. In tolerance trials, occurrence rate of adverse events and proportion of unpre- dictable risk are evident, so monitoring of adverse events is very important in phase Ⅰ tolerance trial.

关 键 词：中药新药 Ⅰ期耐受性试验 不良事件 监测管理 

分 类 号：R95[医药卫生—药学] R286