生物等效性试验中三酰甘油升高原因分析

Analysis of the causes of triglyceride elevation in bioequivalence trial

目的分析生物等效性试验中三酰甘油(TG)升高不良事件的原因。方法回顾性收集我院参加生物等效性试验的健康受试者146例,分析健康受试者的年龄、性别、体重指数、吸烟饮酒史、体力活动级别、住院天数以及TG入组值对TG出组值的影响。结果年龄、性别和TG入组值对TG出组值的影响,差异均有统计学意义[比值比(OR)分别为2.54,9.74和8.01,均P<0.05],体重指数、吸烟饮酒史、体力活动级别和住院天数对TG出组值均无显著影响。结论年龄、性别和TG入组值均能影响TG出组值,因此,在筛选健康受试者时要注意年龄因素,适当对性别比例、TG入组值加以控制,以降低TG升高不良事件的发生,提高生物等效性试验的质量。

Objective To analyze the causes of adverse events in the rise of triglycerides(TG)in the bioequivalence trial.Methods The data of 146 healthy subjects who participated in the bioequivalence trial in our hospital was retrospectively collected,the effects of age,gender,body mass index,smoking and drinking history,physical activity level,hospitalization days and TG entry value on TG outgroup value of healthy subjects were analyzed.Results The age,gender and TG entry value had a certain influence on TG outgroup value,and the differences were statistically significant[odds ratio(OR)were 2.54,9.74 and 8.01,respectively,P<0.05].The body mass index,smoking and drinking history,physical activity level and hospitalization days had no significant effects on the TG outgroup value.Conclusion Age,gender and TG entry value can affect TG outgroup value.Therefore,in order to reduce the incidence of adverse events caused by elevated TG and improve the quality of bioequivalence test,we should pay attention to the age factor in screening healthy subjects,and appropriately control the sex ratio and TG value.