A descriptive analysis of spontaneous reports of antipsychotic-induced tardive dyskinesia and other extrapyramidal symptoms in the Japanese Adverse Drug Event Report database.

IF 2 Q3 NEUROSCIENCES
Neuropsychopharmacology Reports Pub Date : 2024-03-01 Epub Date: 2023-10-26 DOI:10.1002/npr2.12385
Yosuke Saga, Chih-Lin Chiang, Akihide Wakamatsu
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Abstract

AimThe aim of this study is to summarize the spontaneous reports of tardive dyskinesia (TD) and extrapyramidal symptoms (EPSs) that occurred in Japan over the past decade. MethodsThe study analyzed TD and EPS cases reported in the Japanese Adverse Drug Event Report database between April 2011 and March 2021. The cases were stratified by the diagnoses of schizophrenia, bipolar disorders, and depressive disorders. ResultsIn total, 800 patients including a total of 171 TD cases and 682 EPS cases were reported in the JADER database across psychiatric diagnosis. The cases were caused by first-generation antipsychotics (FGA, TD: n = 105, EPS: n = 245) and second-generation antipsychotics (SGA, TD: n = 144, EPS: n = 598). The SGA were categorized based on Neuroscience-based Nomenclature (NbN) regarding pharmacological domain and mode of action, which were reported evenly as the offending agents. Among reported treatment and outcome in TD cases (n = 67, 37.6%) and EPS cases (n = 405, 59.3%), the relatively limited number of TD cases were reported as recovered/improved was also limited (n = 32, 47.8%) compared to those of EPS cases (n = 266, 65.7%). Some cases still had residual symptoms or did not recover fully (TD: n = 21, 31.3%, EPS: n = 77, 19.0%). CONCLUSION: Tardive dyskinesia and EPS have been widely reported in Japan over the past decade across psychiatric diagnoses and antipsychotic classes. LIMITATIONS: It is important to acknowledge the presence of reporting bias and the lack of comparators to accurately assess risks. Owing to the nature of spontaneous reporting, the estimation of prevalence is not feasible.

日本药物不良事件报告数据库中抗精神病药物诱导的迟发性运动障碍和其他锥体外系症状的自发报告的描述性分析。
目的总结近十年来日本发生的迟发性运动障碍(TD)和锥体外系症状(EPSs)的自发报告。方法分析2011年4月至2021年3月期间日本药品不良事件报告数据库中报告的TD和EPS病例。根据精神分裂症、双相情感障碍和抑郁障碍的诊断对病例进行分层。结果在JADER数据库中,共报告了800例患者,包括171例TD病例和682例EPS病例。这些病例是由第一代抗精神病药物引起的(FGA,TD:n = 105,每股收益:n = 245)和第二代抗精神病药物(SGA,TD:n = 144,每股收益:n = 598)。SGA是根据基于神经科学的命名法(NbN)关于药理学领域和作用模式进行分类的,这些领域和作用方式被均匀地报告为犯罪因素。在报告的TD病例的治疗和结果中(n = 37.6%)和EPS病例(n = 405例,59.3%),相对有限的TD病例数也有限(n = 32.47.8%)与EPS病例(n = 266例,65.7%)。一些病例仍有残余症状或未完全康复(TD:n = 21,31.3%,每股收益:n = 77.19.0%)。结论:在过去的十年里,日本在精神病诊断和抗精神病药物类别中广泛报道了迟发性运动障碍和EPS。局限性:重要的是要承认存在报告偏差和缺乏准确评估风险的比较标准。由于自发报告的性质,估计流行率是不可行的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Neuropsychopharmacology Reports
Neuropsychopharmacology Reports Psychology-Clinical Psychology
CiteScore
3.60
自引率
4.00%
发文量
75
审稿时长
14 weeks
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