治疗耐药精神分裂症时用德克斯特罗梅索芬增加克洛扎宾的剂量:一种随机的,群体顺序的适应性设计,受控的临床试验
Naveen Chandrashekar Hegde1, Biswa Ranjan Mishra2, Debadatta Mohapatra2
1Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Asian journal of psychiatry
|March 4, 2026
概括
添加德克斯特罗梅索芬显著改善了治疗耐药精神分裂症 (TRS) 的症状严重程度,当添加到克洛扎宾. 这项概念验证试验证明了有效性和良好的耐受性,需要进一步调查.
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.
- 神经科学是一个神经科学.
背景情况:
- 耐治疗精神分裂症 (TRS) 提出了重大的临床挑战.
- 德克斯特罗梅索芬是一种NMDA受体对抗剂,具有西格玛-1激动性,在TRS中显示出潜在的治疗相关性.
- 克洛扎平是TRS的关键治疗方法,但疗效可能有限.
研究的目的:
- 评估在治疗耐药精神分裂症 (TRS) 患者接受克洛札的辅助用德克斯特罗梅索芬的疗效和安全性.
- 测试该假设,德克斯特罗梅索芬增强改善了TRS的临床结果.
主要方法:
- 一个为期12周的随机,双盲,安慰剂对照试验.
- 参与者接受了德克斯特罗梅索芬 (30毫克/天) 或安慰剂,以及克洛扎.
- 主要结局:阳性和阴性综合征量表 (PANSS) 评分的变化.
主要成果:
- 与安慰剂相比,德克斯特罗梅索芬显著降低了PANSS得分 (平均差异: -10.68,p=0.004).
- 观察到改善的PANSS分级,响应率 (NNT=2.19) 和临床全球印象 (CGI) 评分.
- 血清zapine,zapine耐药性,迷你精神状态检查 (MMSE) 评分或治疗出现的不良事件 (TEAE) 没有显著差异.
结论:
- 辅助德克斯特罗梅索芬改善了克洛扎治疗TRS患者的症状严重程度和反应率.
- 在这个概念验证研究中,这种增强物被很好地容忍.
- 需要进行更大,更长期的多中心研究来证实这些发现.
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