Background Studies report an increased risk of self-harm or suicide in people prescribed mirtazapine compared with other antidepressants. Objectives To compare the risk of serious self-harm in people prescribed mirtazapine versus other antidepressants as second-line treatments. Design and setting Cohort study using anonymised English primary care electronic health records, hospital admission data and mortality data with study window 1 January 2005 to 30 November 2018. Participants 24 516 people diagnosed with depression, aged 18–99 years, initially prescribed a selective serotonin reuptake inhibitor (SSRI) and then prescribed mirtazapine, a different SSRI, amitriptyline or venlafaxine. Main outcome measures Hospitalisation or death due to deliberate self-harm. Age–sex standardised rates were calculated and survival analyses were performed using inverse probability of treatment weighting to account for baseline covariates. Results Standardised rates of serious self-harm ranged from 3.8/1000 person-years (amitriptyline) to 14.1/1000 person-years (mirtazapine). After weighting, the risk of serious self-harm did not differ significantly between the mirtazapine group and the SSRI or venlafaxine groups (HRs (95% CI) 1.18 (0.84 to 1.65) and 0.85 (0.51 to 1.41) respectively). The risk was significantly higher in the mirtazapine than the amitriptyline group (3.04 (1.36 to 6.79)) but was attenuated after adjusting for dose. Conclusions There was no evidence for a difference in risk between mirtazapine and SSRIs or venlafaxine after accounting for baseline characteristics. The higher risk in the mirtazapine versus the amitriptyline group might reflect residual confounding if amitriptyline is avoided in people considered at risk of self-harm. Clinical implications Addressing baseline risk factors and careful monitoring might improve outcomes for people at risk of serious self-harm. No data are available. Data used in the study were provided under licence by CPRD ([www.cprd.com][1]) and cannot be shared by the authors. All code lists and the statistical code (in the form of Stata do-files) used to prepare and analyse the data are available on Zenodo.org (). [1]: http://www.cprd.com/

中文翻译：

---

抑郁症患者使用米氮平与严重自残之间的关联：一项使用英国电子健康记录的积极比较队列研究

背景 研究报告称，与其他抗抑郁药相比，服用米氮平的人自残或自杀的风险增加。目标 比较处方米氮平与其他抗抑郁药作为二线治疗的人发生严重自残的风险。设计和设置队列研究使用匿名的英国初级保健电子健康记录、住院数据和死亡率数据，研究窗口为 2005 年 1 月 1 日至 2018 年 11 月 30 日。参与者 24516 名诊断患有抑郁症的人，年龄在 18-99 岁之间，最初开了一种选择性血清素再摄取抑制剂 (SSRI)，然后开了米氮平、另一种 SSRI、阿米替林或文拉法辛。主要结果测量因故意自伤而住院或死亡。计算年龄-性别标准化率，并使用治疗加权的逆概率来解释基线协变量进行生存分析。结果 严重自残的标准化发生率从 3.8/1000 人年（阿米替林）到 14.1/1000 人年（米氮平）不等。加权后，米氮平组与 SSRI 或文拉法辛组之间发生严重自残的风险没有显着差异（HR（95% CI）分别为 1.18（0.84 至 1.65）和 0.85（0.51 至 1.41））。米氮平组的风险显着高于阿米替林组 (3.04 (1.36 to 6.79))，但在调整剂量后有所减弱。结论 在考虑基线特征后，没有证据表明米氮平与 SSRIs 或文拉法辛之间存在风险差异。如果在被认为有自残风险的人群中避免使用阿米替林，则米氮平组与阿米替林组的风险较高可能反映了残留的混杂因素。临床意义解决基线风险因素和仔细监测可能会改善有严重自残风险的人的结果。没有可用数据。研究中使用的数据由 CPRD ([www.cprd.com][1]) 许可提供，作者不得共享。用于准备和分析数据的所有代码列表和统计代码（以 Stata do 文件的形式）都可以在 Zenodo.org 上找到（临床意义解决基线风险因素和仔细监测可能会改善有严重自残风险的人的结果。没有可用数据。研究中使用的数据由 CPRD ([www.cprd.com][1]) 许可提供，作者不得共享。用于准备和分析数据的所有代码列表和统计代码（以 Stata do 文件的形式）都可以在 Zenodo.org 上找到（临床意义解决基线风险因素和仔细监测可能会改善有严重自残风险的人的结果。没有可用数据。研究中使用的数据由 CPRD ([www.cprd.com][1]) 许可提供，作者不得共享。用于准备和分析数据的所有代码列表和统计代码（以 Stata do 文件的形式）都可以在 Zenodo.org 上找到（). [1]：http://www.cprd.com/