Placebo-controlled study of divalproex sodium for agitation in dementia.
Placebo-controlled study of divalproex sodium for agitation in dementia.
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DOI：
10.1097/00019442-200102000-00009
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发表时间：
2001-12
期刊：
影响因子：
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通讯作者：
A. Porsteinsson;P. Tariot;Rosemary Erb;C. Cox;Elizabeth Smith;Laura J Jakimovich;J. Noviasky;N. Kowalski;C. Holt;C. Irvine
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文献类型：
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作者：
A. Porsteinsson;P. Tariot;Rosemary Erb;C. Cox;Elizabeth Smith;Laura J Jakimovich;J. Noviasky;N. Kowalski;C. Holt;C. Irvine
作者在一项为期 6 周的随机研究中评估了双丙戊酸钠治疗与痴呆相关的躁动的有效性、耐受性和安全性，该研究对 56 名疗养院患有躁动和痴呆的患者进行了为期 6 周的随机研究，这些患者接受安慰剂或个体化剂量的双丙戊酸钠治疗。除一名医师监察员和一名药剂师外，参与者对治疗不知情。当考虑到几个协变量时，简明精神病评定量表躁动评分中药物/安慰剂的差异变得具有统计学意义（P=0.05）。在临床总体印象量表中，服用双丙戊酸的患者中有 68% 的躁动症状减轻，而安慰剂组的这一比例为 52%（调整后的分析中 P=0.06）。双丙戊酸组有 68% 的人出现副作用，而安慰剂组有 33% 的人出现副作用（P=0.03），并且一般被评为轻微。这项安慰剂对照研究尽管存在一些局限性，但表明双丙戊酸钠治疗痴呆症躁动可能具有短期疗效、耐受性和安全性，并支持进一步的安慰剂对照研究。
The authors assessed the efficacy, tolerability, and safety of divalproex sodium for the treatment of agitation associated with dementia in a 6-week, randomized study of 56 nursing home patients with agitation and dementia treated with either placebo or individualized doses of divalproex sodium. Participants were blinded to treatment except for a physician-monitor and a pharmacist. When several covariates were taken into account, the drug/placebo difference in Brief Psychiatric Rating Scale Agitation scores became statistically significant (P=0.05). Sixty-eight percent of patients on divalproex were rated as showing reduced agitation on the Clinical Global Impression scale, vs. 52% on placebo (P=0.06 in the adjusted analysis). Side effects occurred in 68% of the divalproex group vs. 33% of the placebo group (P=0.03) and were generally rated as mild. This placebo-controlled study, despite some limitations, suggests possible short-term efficacy, tolerability, and safety of divalproex for agitation in dementia and supports further placebo-controlled studies.