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鼻内胰岛素用于改善多发性硬化症患者的认知功能
Scott D Newsome1, Kathryn C Fitzgerald1, Abbey Hughes2
1Johns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
概括
在24周的试验中,鼻内胰岛素没有改善多发性硬化症 (MS) 患者的认知功能. 虽然这种疗法安全且耐受良好,但在MS患者的认知障碍方面,该疗法与安慰剂相比没有任何好处.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 认知障碍是患有多发性硬化症 (PwMS) 的人面临的重大挑战.
- 胰岛素在中枢神经系统 (CNS) 功能中起着至关重要的作用,包括学习和记忆.
- 鼻内胰岛素以前在改善健康个体和神经退行性疾病患者的认知功能方面表现有前途.
研究的目的:
- 调查鼻内胰岛素治疗PwMS认知障碍的疗效和安全性.
- 为了评估不同剂量的鼻内胰岛素 (每天两次10 IU和20 IU) 与安慰剂相比.
主要方法:
- 进行了一项Ib/II期,随机,双盲,安慰剂对照试验.
- 105名PwMS被纳入并随机分配,接受24周内鼻内胰岛素 (10 IU或20 IU每天两次) 或安慰剂.
- 认知功能使用符号数字模式测试 (SDMT) 和其他二次结果措施进行评估.
主要成果:
- 在PwMS中,鼻内胰岛素被发现是安全的,并且耐受性很好.
- 通过SDMT测量认知功能的显著差异没有观察到,在鼻内胰岛素组和安慰剂组之间.
- 所有的二次结局措施也显示与安慰剂相比没有显著差异.
结论:
- 在测试剂量和持续时间下,鼻内胰岛素在PwMS中没有在改善认知功能方面表现出优于安慰剂的优势.
- 限制有效性的潜在因素包括试验持续时间,样本大小,数据缺失以及结果测量灵敏度.
- 对中枢神经系统输送的鼻入治疗药物的进一步研究值得考虑.
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