抗抑郁药临床试验受试者脱落情况及影响因素  

Analysis of participants drop-out in antidepressant clinical trials and related influencing factors

作　　者：钟潇琦 汪钦林 梁卉薇[1] 李烜[1] 杨婵娟[1] Zhong Xiaoqi;Wang Qinlin;Liang Huiwei;Li Xuan;Yang Chanjuan(The Affiliated Brain Hospital of Guangzhou Medical University,Guangzhou 510370,China)

机构地区：[1]广州医科大学附属脑科医院,广东广州510370

出　　处：《四川精神卫生》2021年第5期440-443,共4页Sichuan Mental Health

基　　金：广东省自然科学基金项目(项目名称:探索磷脂酰丝氨酸对携带SERINC2突变的双相障碍患者的干预作用,项目编号:2018A030313283)。

摘　　要：目的分析抗抑郁药临床试验受试者脱落情况,讨论受试者脱落的影响因素。方法对广州医科大学附属脑科医院2013年-2020年完成的9项抗抑郁药临床试验受试者资料进行回顾性分析,采用自编调查表采集受试者人口学资料、疾病特点及试验完成情况,分析受试者的脱落情况及影响因素。结果共入组157例,完成120例,脱落37例。脱落原因分别为:疗效差13例(35.14%),发生不良反应12例(32.43%),撤回知情同意书8例(21.62%),失访4例(10.81%)。相关分析结果显示,受试者脱落与焦虑程度(r=0.224,P<0.01)和不良事件(r=0.158,P<0.05)呈正相关,与受教育程度(r=-0.209,P<0.01)和总体疗效(r=-0.545,P<0.01)呈负相关。二元Logistic回归分析结果显示,受教育程度(β=-0.611,OR=0.543,P<0.05)、就诊次数(β=-1.831,OR=0.160,P<0.01)和总体疗效(β=-2.286,OR=0.102,P<0.01)是受试者脱落的影响因素。结论受教育程度低、首次就诊、疗效不佳、焦虑程度重以及发生不良事件是抗抑郁药临床试验受试者脱落的影响因素。Objective To analyze the drop-out rate of participants in antidepressant clinical trials and to explore the related influencing factors.Methods A retrospective analysis was carried out on the participants of 9 antidepressant clinical trials conducted at the Affiliated Brain Hospital of Guangzhou Medical University from 2013 to 2020.A self-compiled questionnaire was used to collect the subjects'demographic data,disease characteristics and the final completion of the trial,thereafter,the participant drop out rate and related influencing factors were discussed.Results A total of 157 cases were enrolled,including 120 cases completed and 37 cases dropped out the trail.The causes of drop-out were poor efficacy in 13 cases(35.14%),presence of adverse reactions in 12 cases(32.43%),withdrawal of informed consent in 8 cases(21.62%)and loss of follow-up in 4 cases(10.81%).Correlation analysis showed that participant drop-out was positively correlated with the level of anxiety(r=0.224,P<0.01)and presence of adverse events(r=0.158,P<0.05),meantime,negatively correlated with the level of education(r=-0.209,P<0.01)and overall efficacy(r=-0.545,P<0.01).Binary Logistic regression analysis showed that education level(β=-0.611,OR=0.543,P<0.05),number of visits(β=-1.831,OR=0.160,P<0.01)and overall efficacy(β=-2.286,OR=0.102,P<0.01)were the influencing factors of participant drop-out.Conclusion Low education level,first visit,poor outcome,high level of anxiety,and adverse events are the factors affecting participant drop-out in antidepressant clinical trials.

关 键 词：抗抑郁药 临床试验 受试者 脱落 影响因素 

分 类 号：R749[医药卫生—神经病学与精神病学]