心境障碍患者药物临床试验参与意愿及相关因素分析

Analysis of the attitudes and influencing factors of mood disorders patients participation in drug clinical trials

用连续入组的方式通过调查问卷的方法对抑郁症和双相情感障碍门诊患者进行横断面调查,对心境障碍患者参与药物临床试验的意愿及影响因素等主要观察指标进行统计分析。共收集有效问卷1338份。阅读药物临床试验相关知识后,愿意参加者283例(21.15%),视情况而定者557例(41.63%),不愿意者498例(37.22%)。愿意参加的原因中"出于对医师的信任"比例最高(愿意者56.47%,视情况而定者63.55%);参加临床试验最关心的事情均主要是"药物是否安全"(愿意者73.21%,视情况而定者88.67%)及"治疗是否有效"(愿意者70.36%,视情况而定者74.59%);不愿意参加临床试验的原因中比例最高者均为"担心安全性及药物不良反应"(视情况而定者74.95%,不愿意者73.48%)。心境障碍患者愿意参加药物临床试验的比例不高,可以针对被调查者重点关注的问题采取有针对性的措施进行应对,进一步解决当前药物临床试验招募困难的现状。

This is a cross-sectional survey conducted using continuous enrollment method.The main observation indicators,including the willingness and related factors of patients with mood disorders were analyzed.A total of 1338 valid questionnaires were collected.Approximately 21.15%of depressive disorder and bipolar disorder outpatients indicated that they would be willing to participate in a mood disorder clinical trial,37.22%patients refused to participate,41.63%patients depended on the situation.The main reason for willingness to participate in clinical trials was"trust in doctors"(willing 56.47%,it depends 63.55%).The main concern of subjects participating in clinical trials was mainly the safety(willing 73.21%,it depends 88.67%)and effectiveness(willing 70.36%,it depends 74.59%)of drug or treatment.The highest proportion for those who did not want to participate in clinical trials was worrying about the safety and adverse reactions of drug or treatment(it depends 74.95%,unwilling 73.48%).The proportion of patients with mood disorders who were willing to participate in drug clinical trials was not so high.Targeted measures should be taken to cope with the concerns of the respondents and further solve the current difficulties in the recruitment of clinical trials.