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布雷克西普拉治疗阿尔茨海默氏症痴呆症的激发:一项随机研究
Yu Nakamura1, Jun Adachi2, Naoki Hirota2
1Faculty of Medicine/Graduate School of Medicine, Kagawa University, Kita-gun, Kagawa, Japan.
概括
布雷克西普拉在10周内有效地减少了阿尔茨海默氏症痴呆症 (AAD) 的日本患者的激动. 两种1毫克和2毫克剂量都显示出显著的改善,表明该药物在AAD症状管理中耐受性良好.
科学领域:
- 老年精神病学是一门精神病学专业.
- 神经药理学神经药理学
- 临床神经学 临床神经学
背景情况:
- 兴奋是阿尔茨海默氏症痴呆症 (AAD) 的常见和令人痛苦的症状.
- 需要有效和安全的药理干预措施来对抗ADD刺激.
- 布雷克西普拉是一种非典型的抗精神病药物,具有治疗神经精神病症状的潜力.
研究的目的:
- 评估布雷克斯皮普拉在治疗日本AAD患者动荡的疗效和安全性.
- 为了确定这个患者群体中布雷克斯皮普拉的最佳剂量.
主要方法:
- 第二/三期,多中心,随机,双盲,安慰剂控制,并行组研究.
- 布雷克斯皮普拉 (每天1毫克或每天2毫克) 或安慰剂治疗期为10周.
- 主要终点:科恩-曼斯菲尔德激发库存 (CMAI) 总得分的变化.
主要成果:
- 与安慰剂相比,布雷克斯皮普拉1mg和2mg组的CMAI得分在统计学上显著改善.
- 2毫克剂量显示最小平方平均差异为-7.2 (p < 0.0001),而1毫克剂量显示-3.7 (p = 0.0175).
- 治疗引起的不良事件发生率为1毫克的76.8%,2毫克的84.6%,安慰剂的73.8%.
结论:
- 布雷克斯皮普拉1毫克/天和2毫克/天10周的剂量是有效的,并且可以很好地容忍日本患者的AAD动荡.
- 证实了布雷克斯皮普拉1毫克/天对ADD激发的疗效.
- 副作用的发生率高于之前的研究,但两种剂量一般都耐受良好.
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