在抑郁症的抗抑郁试验和荟萃分析中需要评估的重要不良事件：一项包含患者和医疗保健专业人员的大型国际偏好研究。
Important adverse events to be evaluated in antidepressant trials and meta-analyses in depression: a large international preference study including patients and healthcare professionals.
机构信息
CRESS, INSERM, INRA, F-75004 Paris, France, University of Paris, Paris, France.
Department of Psychiatry, University of Oxford, Oxford, UK.
出版信息
Evid Based Ment Health. 2022 Dec;25(e1):e41-e48. doi: 10.1136/ebmental-2021-300418. Epub 2022 Jul 29.
BACKGROUND
Non-serious adverse events (NSAEs) should be captured and reported because they can have a significant negative impact on patients and treatment adherence. However, the reporting of NSAEs in randomised controlled trials (RCTs) is limited.
OBJECTIVE
To identify the most important NSAEs of antidepressants for patients and clinicians, to be evaluated in RCTs and meta-analyses.
METHODS
We conducted online international surveys in English, German and French, including (1) adults prescribed an antidepressant for a depressive episode and (2) healthcare professionals (HCPs) prescribing antidepressants. Participants ranked the 30 most frequent NSAEs reported in the scientific literature. We fitted logit models for sets of ranked items and calculated for each AE the probability to be ranked higher than the least important AE. We also identified additional patient-important AEs not included in the ranking task via open-ended questions.
FINDINGS
We included 1631 patients from 44 different countries (1290 (79.1%) women, mean age 39.4 (SD 13), 289 (37.1%) with severe depression (PHQ-9 score ≥20)) and 281 HCPs (224 (79.7%) psychiatrists). The most important NSAEs for patients were insomnia (95.9%, 95% CI 95.2% to 96.5%), anxiety (95.2%, 95% CI 94.3% to 95.9%) and fatigue (94.6%, 95% CI 93.6% to 95.4%). The most important NSAEs for HCPs were sexual dysfunction (99.2%, 95% CI 98.5% to 99.6%), weight gain (98.9%, 95% CI 97.7% to 99.4%) and erectile problems (98.8%, 95% CI 97.7% to 99.4%). Participants reported 66 additional NSAEs, including emotional numbing (8.6%), trouble with concentration (7.6%) and irritability (6%).
CONCLUSIONS
These most important NSAEs should be systematically reported in antidepressant trials.
CLINICAL IMPLICATIONS
The most important NSAEs should contribute to the core outcome set for harms in depression.
背景
非严重不良事件（NSAEs）应该被捕捉并报告，因为它们可能对患者和治疗依从性产生重大负面影响。然而，随机对照试验（RCTs）中 NSAE 的报告是有限的。
目的
确定对患者和临床医生最重要的抗抑郁药 NSAEs，以便在 RCT 和荟萃分析中进行评估。
方法
我们在英语、德语和法语中进行了在线国际调查，包括（1）开处方抗抑郁药治疗抑郁发作的成年人和（2）开抗抑郁药的医疗保健专业人员（HCPs）。参与者对科学文献中报告的 30 种最常见的 NSAEs 进行了排名。我们为排序项的集合拟合了逻辑模型，并计算了每个 AE 被排在最重要的 AE 之前的概率。我们还通过开放式问题确定了排名任务中未包含的其他患者重要的 AE。
结果
我们纳入了来自 44 个不同国家的 1631 名患者（1290 名（79.1%）女性，平均年龄 39.4（SD 13），289 名（37.1%）患有严重抑郁症（PHQ-9 评分≥20））和 281 名 HCPs（224 名（79.7%）精神科医生）。患者最重要的 NSAEs 是失眠（95.9%，95%CI 95.2%至 96.5%）、焦虑（95.2%，95%CI 94.3%至 95.9%）和疲劳（94.6%，95%CI 93.6%至 95.4%）。HCPs 最重要的 NSAEs 是性功能障碍（99.2%，95%CI 98.5%至 99.6%）、体重增加（98.9%，95%CI 97.7%至 99.4%）和勃起问题（98.8%，95%CI 97.7%至 99.4%）。参与者报告了 66 种其他 NSAEs，包括情感麻木（8.6%）、注意力集中困难（7.6%）和易怒（6%）。
结论
这些最重要的 NSAEs 应该在抗抑郁药试验中系统报告。
临床意义
最重要的 NSAEs 应该有助于抑郁相关危害的核心结局集。
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