抗抑郁药临床试验中受试者样本代表性研究  

A study of representativeness of subjects in clinical trials of antidepressants in China

作　　者：田腾飞[1] 肖乐[1] 胡昌清[2] 耿莹[3] 冯媛 丰雷[2] 杨蕊[1] 王刚 

机构地区：[1]首都医科大学附属北京安定医院抑郁症治疗中心国家精神心理疾病临床医学研究中心, 100088 [2]首都医科大学附属北京安定医院精神疾病诊断与治疗北京市重点实验室, 100088 [3] 国家食品药品监督管理总局药品审评中心 [4] 北京脑重大疾病研究院抑郁症研究所

出　　处：《中华精神科杂志》2015年第2期76-80,共5页Chinese Journal of Psychiatry

基　　金：“十二五”国家科技重大新药创制项目（2012zX09303014-002）;国家重点基础研究发展计划（973计划）项目（2013CB531305）;北京市科技计划项目（D12100005012003）

摘　　要：目的 调查国内抗抑郁药临床试验中受试者样本代表性的现状,探讨影响样本代表性的因素.方法 连续筛查就诊于首都医科大学附属北京安定医院抑郁症治疗中心门诊或住院的抑郁症患者,使用MINI定式化访谈工具确定诊断,采用HAMD17评估患者抑郁症状的严重程度,设计问卷调查患者参与药物临床试验的意愿.根据抗抑郁药临床试验的普遍排除标准对抑郁症患者进行筛查,估算符合标准的患者比例,分析影响样本代表性的因素.结果 连续取样302例,拒绝访谈50例,最终纳入252例,患者的平均年龄为（40.5±13.1）岁,其中女性患者173例（68.7％,173/252）,门诊患者203例（80.6％,203/252）.57.5％（145/252）的患者表示不愿意参与药物临床试验,73.8％（186/252）的患者至少被1项标准排除,最终有资格参与临床试验的患者只有35例（13.9％,35/252）.结论 抗抑郁药临床试验的受试者样本代表性较差,临床试验结果的可推广性受到限制,排除标准和患者的意愿是影响样本代表性的主要因素.Objective To investigate the representativeness of patients participating in clinical trials of antidepressants in China,and explore factors that affect the representativeness of sample.Methods Outpatients or inpatients with major depressive disorder（MDD） who came to depression treatment center of Beijing Anding Hospital,Capital Medical University seeking for treatment were consecutively screened.The MINI-International Neuropsychiatric Interview and the HAMD17 were used for diagnostic assessment and severity evaluating.A questionnaire was designed to investigate patients＆#39; willingness to participate in drug clinical trials.Common exclusion criteria used in clinical trials of antidepressants were applied to screen MDD patients to determin the proportion of patients who would be eligible for a clinical trial.Results 302 patients were consecutively screened and 50 of them rejected our interview.Data were collected from 252 patients,whose mean age was （40.5 ± 13.1） years when being screened,including 173 female and 79 male,203 outpatients and 49 inpatients.57.5% （145/252）of the patients had no willing to participate in clinical trials,and 73.8% （186/252） were excluded by at least one exclusion.There were only 35 （13.9%,35/252） patients who were finally eligible to participate in clinical trials.Conclusions Subjects participated in antidepressant trials represent a minority of patients with MDD in clinical practice.Exclusion criteria and patients＆#39; willingness to participate in a drug clinical trial are two main factors affecting the representativeness of sample.

关 键 词：抗抑郁药 临床试验 样本代表性 推广性 

分 类 号：R969.4[医药卫生—药理学]