药物Ⅰ期临床试验中受试者非药物相关三酰甘油、尿酸异常的相关因素OACSTPCD

Objective To analyze the influential factors of non-drug related triglyceride(TG)and uric acid(UA)abnormali-ties in subjects in phase Ⅰ clinical trials for drugs.Methods A total of 96 subjects in phase Ⅰ clinical trial for drugs carried out in Bei-jing Shijitan Hospital Affiliated to Capital Medical University from February 2021 to February 2022 were selected as the research sub-jects.The serum TG and UA levels of the subjects were monitored at six time points of D1(on the day of screening),D3,D5,D15,d43 and d99.The abnormality of TG and UA levels during their participation in the trial and their related factors were analyzed.Results There were 42 cases(43.75％)with abnormal serum TG level and 66 cases(68.75％)with abnormal serum UA level.There were significant differences in the serum TG and UA levels of subjects at each monitoring time point(P<0.05).The serum TG levels of subjects at D3-D99 were higher than those of D1,and the serum UA levels of subjects D5,D43 and D99 were higher than those of D1.The differences were statistically significant(P<0.05).The abnormality of serum TG level of the subjects was correlated with the serum TG level at D1 time point and body mass index(BMI)level(P<0.05),and the abnormality of serum UA level of the subjects was correlated with the serum UA level at D1 time point(P<0.05).The area under receiver operating characteristic curve(AUCROC)of TG at D1 time point and BMI predicting the abnormality of TG was 0.857 and 0.684(P<0.05),respectively.AU-CROC of UA level at D1 time point predicting abnormality of UA was 0.845(P<0.05).Conclusions In the phase Ⅰ clinical trial for drugs,the subjects have high proportions of non-drug related TG and UA abnormalities,and their risks are related to baseline TG and UA levels as well as the degree of obesity of the subjects.