Department of Dermatology, National Defense Medical Center, Tri-Service General Hospital and School of Medicine, Number 325, Section 2, Chang-gong Rd, Nei-Hu District, Taipei 114, Taiwan.
Department of Dermatology, National Defense Medical Center, Tri-Service General Hospital and School of Medicine, Number 325, Section 2, Chang-gong Rd, Nei-Hu District, Taipei 114, Taiwan; Department of Medical Research, National Defense Medical Center, Tri-Service General Hospital, Graduate Institute of Medical Sciences, 7115R, No.325, Section 2, Cheng-Kung Road, Neihu District, Taipei 114, Taiwan.
J Affect Disord. 2022 Jan 1;296:277-282. doi: 10.1016/j.jad.2021.09.055. Epub 2021 Sep 22.
After isotretinoin's approval to treat patients with recalcitrant acne, there have been continued debates around its psychiatric safety profile. This study aimed to assess the risk of psychiatric disorders in patients with acne who are taking isotretinoin.
We used de-identified information from Taiwan's National Health Insurance Research Database from 2000 to 2015 to examine the risk for psychiatric disorders among patients with acne who were taking isotretinoin. We performed subgroup analyses based on the dosage and duration of isotretinoin administration.
This study included 29,943 participants during a 16-year follow-up period. We found no significantly increased risk for psychiatric disorders among patients taking isotretinoin compared with patients who did not receive isotretinoin treatment (adjusted hazard ratio [aHR]: 1.009, 95% confidence interval [CI]: 0.422-1.696). Subgroup analyses showed no significantly increased risk for psychiatric disorders in patients taking different doses of isotretinoin (≤ 20 mg per day, aHR: 0.892, 95% CI: 0.371-1.501; > 20 mg per day, aHR: 1.068, 95% CI: 0.446-1.798). There was also no significant increase in risk for patients undergoing isotretinoin treatment over different periods (≤ 6 months, aHR: 0.924, 95% CI: 0.392-1.612; > 6 months, aHR: 1.196, 95% CI: 0.488-2.004).
We did not analyze the risk of suicidal ideation, and it could be underestimated in medical claims databases.
We found no increased risk of psychiatric disorders among Taiwanese patients with acne who were taking isotretinoin. Higher dosage or longer duration of isotretinoin treatment did not increase the risk for developing a psychiatric disorder.
异维 A 酸获准用于治疗顽固型痤疮后，其精神安全性一直存在争议。本研究旨在评估痤疮患者使用异维 A 酸的精神疾病发病风险。
我们使用 2000 年至 2015 年台湾全民健康保险研究数据库的匿名资料，分析痤疮患者使用异维 A 酸的精神疾病发病风险，并根据异维 A 酸的剂量和治疗时间进行亚组分析。
本研究共纳入 29943 名患者，随访时间 16 年。与未接受异维 A 酸治疗的患者相比，接受异维 A 酸治疗的患者精神疾病发病风险无显著增加（校正风险比 [aHR]：1.009，95%置信区间 [CI]：0.422-1.696）。亚组分析显示，不同剂量异维 A 酸治疗的患者精神疾病发病风险无显著增加（≤20mg/d，aHR：0.892，95%CI：0.371-1.501；>20mg/d，aHR：1.068，95%CI：0.446-1.798）。治疗时间不同的患者精神疾病发病风险也无显著增加（≤6 个月，aHR：0.924，95%CI：0.392-1.612；>6 个月，aHR：1.196，95%CI：0.488-2.004）。
本研究未分析自杀意念风险，且该风险可能在医疗理赔数据库中被低估。
本研究未发现台湾痤疮患者使用异维 A 酸会增加精神疾病发病风险。较高剂量或较长时间的异维 A 酸治疗不会增加发生精神障碍的风险。
