Vona-Giralt Gemma, Vilaplana-Carnerero Carles, Ouchi Dan, Gomez-Lumbreras Ainhoa, Morros Rosa, Giner-Soriano Maria
Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain.
Expert Opin Drug Saf. 2023 Mar;22(3):213-219. doi: 10.1080/14740338.2022.2120608. Epub 2022 Sep 5.
Since isotretinoin marketing, reports of psychiatric events have been noted. Howeverto date, a relation between these events and acne or isotretinoin treatment has not been clearly established. Our objective was to analyze the incidence of psychiatric events in women receiving isotretinoin.
Self-controlled study including women treated with isotretinoin from July 2014 to December 2018. Data source was SIDIAP, a primary health care-based database from Catalonia, Spain. Risk of psychiatric events was analyzed during the isotretinoin exposure and during the previous and posterior periods of non-exposure.
We included 4,738 women in the study, 25.3% of them had history psychiatric disorders prior to receiving isotretinoin. During the follow-up, 782 (16.5%) patients were diagnosed with new mental disorders and 925 (19.5%) received new psychotropic drug prescriptions. We found a trend to an increase of new events when the previous non-exposure and the isotretinoin exposure periods were compared, with no significant differences. Incident psychiatric events during isotretinoin exposure was significantly higher in those patients with previous psychiatric history.
We cannot conclude any causality between acne and isotretinoin and the appearance of new psychiatric events. However, we contribute to the evidence with a more robust methodological approach, which minimizes the effect of confounding variables.
自异维甲酸上市以来，已有精神事件的报告。然而，迄今为止，这些事件与痤疮或异维甲酸治疗之间的关系尚未明确确立。我们的目的是分析接受异维甲酸治疗的女性中精神事件的发生率。
自我对照研究，纳入2014年7月至2018年12月接受异维甲酸治疗的女性。数据来源是SIDIAP，这是一个来自西班牙加泰罗尼亚的基于初级卫生保健的数据库。分析了异维甲酸暴露期间以及之前和之后的非暴露期间精神事件的风险。
我们纳入了473名女性进行研究，其中25.3%在接受异维甲酸治疗前有精神疾病史。在随访期间，782名（16.5%）患者被诊断患有新的精神障碍，925名（19.5%）患者接受了新的精神药物处方。当比较之前的非暴露期和异维甲酸暴露期时，我们发现新事件有增加的趋势，但无显著差异。有精神疾病史的患者在异维甲酸暴露期间的新发精神事件显著更高。
我们不能得出痤疮和异维甲酸与新精神事件的出现之间存在任何因果关系。然而，我们通过一种更稳健的方法学方法为证据做出了贡献，该方法最大限度地减少了混杂变量的影响。
