Kudoh Chiaki, Arita Ryutaro, Honda Mitsuru, Kishi Taichi, Komatsu Yasuhiro, Asou Hiroaki, Mimura Masaru
KUDOH Clinic for Neurosurgery and Neurology, Tokyo, Japan.
Center for Kampo Medicine, Keio University School of Medicine, Tokyo, Japan.
Psychogeriatrics. 2016 Mar;16(2):85-92. doi: 10.1111/psyg.12125. Epub 2015 Apr 27.
Only a few approved drugs are capable of alleviating the cognitive and behavioural symptoms of people living with Alzheimer's disease (AD). In recent years, however, the number of studies examining the clinical effects of herbal medicines on cognitive function in patients with AD has increased considerably. This study evaluated the long-term effects of a traditional Japanese medicine (Kampo medicine) known as ninjin'yoeito (NYT) on cognitive impairment and mood status in patients with AD over a 2-year period.
Twenty-three patients with mild-to-moderate probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association criteria were included. Each participant had exhibited an insufficient response to treatment with donepezil alone before the start of the trial. Eleven patients received treatment with donepezil alone, and the remaining patients received a combined treatment of donepezil and NYT for 2 years. Patients were assessed by the Mini-Mental State Examination and the Alzheimer's Disease Assessment Scale-cognitive component-Japanese version for cognitive function, and the Neuropsychiatric Inventory was used to evaluate the patients' mood status at baseline and every 6 months for 2 years.
The Mini-Mental State Examination results showed no significant differences between the two groups. Significant improvements were observed on the Alzheimer's Disease Assessment Scale-cognitive component-Japanese version and the Neuropsychiatric Inventory depression scores of patients who received the combined therapy with donepezil and NYT (Alzheimer's Disease Assessment Scale-cognitive component-Japanese version, 12 months: P < 0.01, 18 months: P = 0.04, 24 months: P < 0.01; Neuropsychiatric Inventory depression, 6 months: P < 0.05, 24 months: P < 0.05).
A 2-year follow-up of patients receiving donepezil and NYT treatment showed an improved cognitive outcome and alleviation of AD-related depression.
仅有少数几种获批药物能够缓解阿尔茨海默病（AD）患者的认知和行为症状。然而，近年来，研究草药对AD患者认知功能临床疗效的研究数量大幅增加。本研究评估了一种名为人参养荣汤（NYT）的传统日本汉方药物在2年期间对AD患者认知障碍和情绪状态的长期影响。
纳入23例符合美国国立神经疾病和中风研究所及阿尔茨海默病及相关疾病协会标准的轻度至中度可能AD患者。在试验开始前，每位参与者对单用多奈哌齐治疗的反应均不足。11例患者仅接受多奈哌齐治疗，其余患者接受多奈哌齐与NYT的联合治疗，为期2年。通过简易精神状态检查表和阿尔茨海默病评估量表认知部分日语版评估患者的认知功能，并使用神经精神科问卷在基线以及2年期间每6个月评估患者的情绪状态。
简易精神状态检查表结果显示两组之间无显著差异。接受多奈哌齐与NYT联合治疗的患者在阿尔茨海默病评估量表认知部分日语版和神经精神科问卷抑郁评分方面有显著改善（阿尔茨海默病评估量表认知部分日语版，12个月：P<0.01，18个月：P=0.04，24个月：P<0.01；神经精神科问卷抑郁，6个月：P<0.05，24个月：P<0.05）。
对接受多奈哌齐和NYT治疗的患者进行的2年随访显示，认知结果有所改善，且与AD相关的抑郁得到缓解。
