布雷克西普拉在患有精神分裂症的青少年中的安全性和耐受性:一项长期的开放性研究
Sarah D Atkinson1, Alpesh Shah2, Maria Victoria Burgess3
1Evolution Research Group, Rochester, New York.
JAACAP open
|June 16, 2025
概括
布雷克西普拉是一种安全的非典型抗精神病药物,用于精神分裂症青少年,其安全性与成年人相似. 建议小儿病患者仔细监测体重增加.
科学领域:
- 精神病学是一个精神病学.
- 药理学 药理学是指药理学的学科.
- 青少年医学 青少年医学
背景情况:
- 精神分裂症影响青少年,需要有效和安全的长期治疗选择.
- 非典型的抗精神病药物,如布雷克西普拉,用于治疗精神分裂症.
- 青少年群体的长期安全数据对于治疗选择至关重要.
研究的目的:
- 评估布雷克斯皮普拉作为被诊断为精神分裂症的青少年的维持治疗的长期安全性和耐受性.
- 描述治疗出现的不良事件 (TEAE) 及其严重程度.
- 评估导致研究中止的不良事件.
主要方法:
- 一个正在进行的,为期24个月的,多中心,单臂,开放标签研究的中间分析.
- 口服布雷克斯皮普拉 (1-4毫克/天,灵活剂量) 用于13-17岁的精神分裂症青少年.
- 主要终点包括TEAE的发生率,严重程度,严重的TEAE,以及因不良事件而停止治疗.
主要成果:
- 在169名患者中,有114人正在进行治疗,23人完成了24个月,32人停止了治疗.
- 最常见的TEAE包括昏昏欲睡 (10.2%),头痛 (9.0%) 和体重增加 (9.0%).
- 临床上有意义的体重增加发生在19.8%的患者中;1.2%因不良事件而停止治疗.
结论:
- 布雷克斯皮普拉在患有精神分裂症的青少年中显示出与成人相一致的安全性.
- 青少年患者的体重增加需要仔细监测正常生长模式.
- 布雷克斯皮普拉在这个人群中通常是一种耐受良好的维持治疗选择.
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