新药Ⅰ期临床试验健康受试者筛选案例分析——实验室指标纳入标准探讨

The criteria of eligible laboratory items of healthy volunteers-case analysis of screening of the healthy subjects for a new drug in phase I trial

目的:探讨Ⅰ期临床试验受试者纳入标准。方法:对117例健康成年人进行Ⅰ期临床试验受试者筛选,对检查结果进行了分析。结果:各项指标完全正常的健康人比例为10.71%,因实验室检查结果异常排除54例(47.32%),包括:血液学检查29例(53.70%)、腹部B超19例(35.19%)、心电图(ECG)4例(7.41%)、胸透2例(3.70%)。实际纳入的受试者58例(49.57%)。结论:理想的健康受试者比例较低,可考虑选择相对健康候选者作为I期临床试验的受试者;Ⅰ期临床试验需建立适当的实验室筛选指标参考范围;为避免Ⅰ期临床试验偏倚,可考虑设计安慰剂对照组。

Objective： To investigate the criteria of eligible laboratory items of healthy volunteers in phase I trial.Methods： Laboratory items of 117 healthy adults in the phase I trial were analyzed.Results： The ratio of healthy subjects with all normal laboratory items was 10.71%.Fifty-four subjects（47.32%） were excluded from the trial because of abnormal items,which including 29（53.70%） for hematology,19（35.19%） for abdominal B-sonography testing,4（7.41%） for electrocardiograph（ECG）,and 2（3.70%） for chest X-rays.Fifty-eight subjects（49.57%） were eventually chosen into the trial.Conclusion： Subjects of phase I clinical trial should be chosen from relatively healthy candidates,as the proportion of subjects in ideal health condition is low.It is necessary to establish proper scope of laboratory testing items in phase I trial for reference.Placebo-controlled groups could be used to avoid systematic error in phase I trial.