Department of Neurology, Xuanwu Hospital, Capital Medical University, Changchun Street 45, Beijing 100053, China.
Department of Geriatric Neurology, Chinese PLA General Hospital, Fuxing Road 28, Beijing 100853, China.
Arch Gerontol Geriatr. 2020 Jul-Aug;89:104091. doi: 10.1016/j.archger.2020.104091. Epub 2020 May 4.
The neuroprotective effect of valproic acid has been observed in the animal models of neurodegeneration, which suggests it as a potential candidate for clinical trials. In this paper, we aimed to systematically analyze the efficacy and safety of valproic acid in the treatment of dementia.
We searched the electronic databases PubMed, EMBASE, CINAHL, Cochrane Library and China National Knowledge Infrastructure until March 2020 for the eligible randomized controlled trials, as well as the unpublished and ongoing trials. We pooled the results using a random-effects model.
We included seven studies with 770 randomized patients with dementia, which compared valproic acid with placebo. Indeed, there were no significant differences found in the scores of Mini-mental State Examination, Cohen-Mansfield Agitation Inventory and number of patients with adverse events. Valproic acid is generally well-tolerated in patients with dementia, even in long-term therapy for 24 months.
Insufficient evidences are found to support valproic acid in the treatment of dementia for cognitive, psychiatric symptoms or disease-modifying. The anticipations for a success in the trial of valproic acid for dementia in the future look not optimistic based on the available evidence.
丙戊酸在神经退行性疾病的动物模型中表现出神经保护作用，这表明它可能成为临床试验的候选药物。本文旨在系统分析丙戊酸治疗痴呆的疗效和安全性。
我们检索了电子数据库 PubMed、EMBASE、CINAHL、Cochrane Library 和中国国家知识基础设施，以获取合格的随机对照试验，以及未发表和正在进行的试验。我们使用随机效应模型汇总结果。
我们纳入了 7 项研究，共 770 名痴呆症随机患者，将丙戊酸与安慰剂进行了比较。实际上，在认知、精神症状或疾病修饰方面，丙戊酸在改善简易精神状态检查评分、科恩-曼斯菲尔德激越量表评分和不良事件患者数量方面均未显示出显著差异。丙戊酸在痴呆症患者中通常具有良好的耐受性，即使在长达 24 个月的长期治疗中也是如此。
目前尚无足够的证据支持丙戊酸用于痴呆的认知、精神症状或疾病修饰治疗。根据现有证据，丙戊酸治疗痴呆症的临床试验成功预期并不乐观。
