A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia
A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia
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DOI：
10.1017/s146114570800970x
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发表时间：
2009-03-01
影响因子：
4.8
通讯作者：
Toba, Kenji
中科院分区：
文献类型：
--
作者：
Mizukami, Katsuyoshi;Asada, Takashi;Toba, Kenji
对106例阿尔茨海默病(AD)(包括混合型痴呆)或路易体痴呆患者进行了日本传统药物(Kampo)治疗痴呆(BPSD)行为和心理症状的疗效和安全性评价。将患者随机分为A组(TJ-54治疗I期，不治疗II期，每期4wk)或B组(I期不治疗，II期不治疗)。分别使用神经精神病学问卷(NPI)和简易精神状态检查(MMSE)评估BPSD和认知功能。采用日常生活能力评定量表(IADL)和住院患者Barthel指数评定患者的日常生活能力(ADL)。安全性评价中，对不良事件进行了调查。与TJ-54治疗相关的平均总不良反应评分在两个阶段都有显著改善(威尔科克森检验，第一阶段为p=0.040，第二阶段为p=0.048)。在TJ-54治疗期间，A组和B组的平均不良反应评分显著改善(分别为p=0.002和p=0.007)，但在未治疗期间未见明显改善。在NPI分量表中，在妄想、幻觉、激越/攻击性、抑郁、焦虑和易怒/易怒方面有显著改善。A组TJ-54持续1个月，无任何心理戒断症状。TJI-54对认知功能和日常生活能力均无影响。未见严重不良反应。本研究表明，TJ-54是治疗BPSD患者的一种有效且耐受性良好的药物。
The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p = 0.040 in period I and p = 0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p = 0.002 and p = 0.007, respectively) but not during periods of no treatment. Among the NPI subscales, significant improvements were observed in delusions, hallucinations, agitation/aggression, depression, anxiety, and irritability/lability. The effects of TJ-54 persisted for 1 month without any psychological withdrawal symptoms in group A. TJI-54 did not show any effect on either cognitive function or ADL. No serious adverse reactions were observed. The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD.