Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, South Korea.
Department of Pathology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, South Korea.
J Psychopharmacol. 2022 Sep;36(9):1041-1050. doi: 10.1177/02698811221104055. Epub 2022 Jun 13.
Retrospective studies using spontaneous reporting system databases have provided a great understanding of adverse drug reactions (ADRs) in the real world, complementing the data obtained from randomized controlled trials. However, there have been few reports on large-scale epidemiological studies on the adverse effects of antipsychotics in Asia.
This study aimed to investigate the characteristics of antipsychotic ADRs using a nationwide pharmacovigilance database.
Data were collected from the Korea Adverse Event Reporting System database between 2010 and 2019. The study subjects were selected using the International Classification of Disease codes for diseases related to psychosis and Electronic Data Interchange codes for amisulpride, aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone. The causality assessment of "possible," "probable," or "certain" by the World Health Organization-Uppsala Monitoring Center System causality category was selected. All data were descriptively analyzed.
In total, 5067 adverse events associated with antipsychotic drugs were reported. The antipsychotics that commonly resulted in ADRs were quetiapine (47.7%), olanzapine (11.3%), and clozapine (10.7%). Serious ADRs were most commonly observed with clozapine. Gastrointestinal and central nervous system problems occurred within a month when ADRs were classified according to the time of onset. In contrast, metabolic and bone marrow-related symptoms occurred after long-term use. Sedation and nausea were the most common ADRs in children and adolescents, whereas constipation and dizziness were common in adults and the elderly.
This study extends our knowledge of antipsychotic ADRs in the Asian population.
使用自发报告系统数据库的回顾性研究极大地了解了真实世界中的药物不良反应 (ADR)，补充了从随机对照试验中获得的数据。然而，亚洲关于抗精神病药不良影响的大规模流行病学研究报告甚少。
本研究旨在使用全国药物警戒数据库调查抗精神病药 ADR 的特征。
数据来自 2010 年至 2019 年的韩国不良事件报告系统数据库。研究对象使用与精神病相关疾病的国际疾病分类代码和氨磺必利、阿立哌唑、氯氮平、氟哌啶醇、奥氮平、帕利哌酮、喹硫平、利培酮和齐拉西酮的电子数据交换代码进行选择。选择世界卫生组织-乌普萨拉监测中心系统因果关系类别中的“可能”、“很可能”或“肯定”的因果关系评估。所有数据均进行描述性分析。
共报告了 5067 例与抗精神病药物相关的不良事件。导致 ADR 的常见抗精神病药为喹硫平（47.7%）、奥氮平（11.3%）和氯氮平（10.7%）。最常见的严重 ADR 是氯氮平。根据 ADR 发病时间进行分类，胃肠道和中枢神经系统问题发生在一个月内，而代谢和骨髓相关症状发生在长期使用后。镇静和恶心是儿童和青少年最常见的 ADR，而便秘和头晕是成人和老年人的常见 ADR。
本研究扩展了我们对亚洲人群中抗精神病药 ADR 的认识。
