抗抑郁药临床试验受试者脱落情况及影响因素
Participants drop-out in anti-depressant clinical trials and analysis of possible influencing factors
投稿时间:2021-02-25  修订日期:2021-10-13
DOI:
中文关键词:  抗抑郁药  临床试验  受试者  脱落  影响因素
英文关键词:Anti-depressant  Clinical Trial  Participant  Drop-out  Influencing factors
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作者单位地址
钟潇琦 广州医科大学附属脑科医院精神科 广东省广州市荔湾区明心路36号
汪钦林 广州医科大学附属脑科医院精神科 
梁卉薇 广州医科大学附属脑科医院精神科 
李烜 广州医科大学附属脑科医院精神科 
杨婵娟* 广州医科大学附属脑科医院精神科 广东省广州市荔湾区明心路36号
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中文摘要:
      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 194例受试者中,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%),不良反应12例(32.43%),撤回知情同意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)、不良事件(r=0.158,P<0.05)呈正相关性,与受教育程度(r=-0.209,P<0.01)、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、疗效不佳以及焦虑程度重、发生不良事件是抗抑郁药临床试验受试者脱落的不良影响因素。
英文摘要:
      Objective To investigate participant dropout in anti-depressant clinical trials and explore influencing factors. Methods Data from 9 clinical trials for anti-depressants from 2013 to 2020 conducted in The Affiliated Brain Hospital of Guangzhou Medical University, including patient demographics, disease characteristics, trial completion, and so on, were retrospectively analyzed. SPSS 22.0 package was used to investigate participant dropout and explore influencing factors. Results Among 194 identified participants, 157 were eventually enrolled; 37 were dropout cases. Reasons for dropout included poor therapeutic effect in 13 cases (35.14%), the presence of adverse events in 12 cases (32.43%), withdrawal of informed consent in 8 cases (21.62%), and loss to follow up in 4 cases (10.81%). Correlation analysis found that trial dropout was correlated positively with the level of anxiety (r=0.224, P<0.01) and the presence of adverse events (r=0.158,P<0.05), and negatively with the level of education (r=-0.209, P<0.01), overall therapeutic effect (r=-0.545, P<0.01). Binary logistic regression analysis showed that level of education (β=-0.611, OR=0.543, P<0.05), number of visits (β=-1.831, OR=0.160, P<0.01), and overall therapeutic effect (β=-2.286,OR=0.102, P<0.01) were influencing factors for trial dropout. Conclusion Increased dropout rates were associated with lower level of education, first medical contact, poor overall therapeutic effect, higher level of anxiety and the presence of adverse effect.
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