抗精神病药物诱导的迟动性障碍症和其他超体症状的报告频率:基于日本自发报告系统数据库的分析
Yosuke Saga1, Hiroshi Horio1, Chih-Lin Chiang1
1Medical Affairs Department, Johnson & Johnson, Tokyo, Japan.
Neuropsychopharmacology reports
|September 12, 2025
概括
在日本,第一代和第二代抗精神病药物 (FGA和SGA) 增加了晚期发动性障碍 (TD) 和额外金字塔症状 (EPS) 的风险. 与FGA相比,SGA显示TD和帕金森症的报告频率较低.
科学领域:
- 药物监督 药物监督 药物监督
- 神经科学是一个神经科学.
- 临床药理学 临床药理学
背景情况:
- 第一代和第二代抗精神病药物 (FGA和SGA) 与非自愿运动障碍有关.
- 在日本人群中,这些抗精神病药物对晚期发动性障碍 (TD) 和额外金字塔症状 (EPS) 的风险概况需要进一步描述.
研究的目的:
- 用自发药物不良反应 (ADR) 报告在日本人口中评估与FGA和SGA相关的TD和EPS风险.
- 为了比较TD和EPS的SGA和FGA之间的风险信号.
主要方法:
- 从2011年4月1日至2020年3月31日期间的日本不良药事件报告 (JADER) 数据库中分析自发的ADR报告.
- 报告几率比率 (ROR) 的计算,以评估抗精神病药物和TD/EPS之间的关联.
- 基于药理作用的SGA作为整个类和子组的评估.
主要成果:
- 总共分析了1,197,065个不良反应,包括760个TD和6059个EPS病例.
- 与非抗精神病药物相比,FGA和SGA都显示了TD和EPS的显著风险信号.
- 与FGA相比,SGA显示TD (ROR 0.62) 和帕金森症 (ROR 0.43) 的报道频率较低,但不包括akathisia或dystonia.
结论:
- 在日本人口中,FGA和SGA都与TD和EPS的风险增加有关.
- 虽然SGA与FGA相比,与某些运动障碍的报告频率较低相关,但这两类药物都有风险.
- 可能需要进一步的研究来阐明SGA内部的特定子组风险.
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