里斯比里在痴呆症患者中的有效性和安全性:RIDDLE试点研究
Journal of clinical psychopharmacology
|November 27, 2023
概括
这项试点研究发现,低剂量RISPERIDONE在患有妄症的老年患者中耐受性良好. 需要进一步进行大规模试验,以证实其在妄治疗中的有效性和安全性.
科学领域:
- 老年医学 老年医学
- 心理药理学 心理药理学
- 临床试验 临床试验
背景情况:
- 妄想症的管理主要集中在治疗原因和预防并发症.
- 对于激动和行为症状,可能需要药理干预.
- 这项试点研究评估了一项随机对照性临床试验的可行性,该试验用于妄中RISPERIDONE.
研究的目的:
- 评估随机的安慰剂对照试验的可行性.
- 评估瑞斯佩里在治疗狂妄症中的疗效和安全性.
主要方法:
- 采用了一种随机,双盲,安慰剂控制的试验设计.
- 参与者是65岁及以上的住院患者,被诊断患有妄想症.
- 狂妄症评分尺度修订98 (DRS-R-98) 测量了狂妄症的严重程度和运动动荡.
主要成果:
- 招募了14名参与者 (57%是男性,平均年龄为86岁).
- 在RISPERIDONE和安慰剂组之间没有观察到DRS-R-98得分的显著差异.
- 没有发生严重的不良反应或因不良事件而停止治疗.
结论:
- 低剂量RISPERIDONE (≤1 mg/天) 在妄患者中表现出良好的耐受性.
- 更大的多中心试验是必要的,以确定risperidone的安全性和有效性.
- 该试点为未来第二阶段试验的设计提供了信息,强调需要增加研究人员和多中心方法.
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