Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of TCM, 528 Zhang-Heng Road, Pu-Dong New Area, Shanghai 201203, China.
Department of Neurology, Pudong New Area Hospital of Traditional Chinese Medicine, 460 Xiuchuan Road, Pu-Dong New Area, Shanghai 201200, China.
Evid Based Complement Alternat Med. 2014;2014:913687. doi: 10.1155/2014/913687. Epub 2014 May 18.
We evaluated the effects of the traditional Chinese medicine (TCM) Shen-Zhi-Ling oral liquid (SZL) on the behavioral and psychological symptoms of dementia (BPSD) in patients with Alzheimer's disease (AD). Among 98 patients with AD and BPSD enrolled (mean age, 57.2 ± 8.9 years old), 91 (M = 55, F = 36; mean age, 57.2 ± 9.7 years old) completed the study. Patients took either SZL (n = 45) or placebo granules (n = 46) in a double-blind manner for 20 weeks while maintaining other anticognitive medications unchanged. Changes in BPSD between week 0, week 10, week 20, and week 25 were assessed using the behavioral pathology in Alzheimer's disease (BEHAVE-AD) rating scale and the neuropsychiatric inventory (NPI), detrended fluctuation analysis (DFA) represented by diurnal activity (DA), evening activity (EA), and nocturnal activity (NA) according to actigraphic recordings. SZL but not placebo oral liquid delayed the development of BPSD significantly according to the changes in some of the clinical scores and the EA and NA parameters of DFA at week 20 compared with week 0. No side effects were observed in laboratory tests. The results indicate that SZL might delay the development of BPSD in AD patients and thus is a potentially suitable drug for long-term use.
我们评估了中药参智灵口服液（SZL）对阿尔茨海默病（AD）患者行为和心理症状的影响（BPSD）。在 98 名患有 AD 和 BPSD 的患者中（平均年龄 57.2±8.9 岁），有 91 名（男性 55 名，女性 36 名；平均年龄 57.2±9.7 岁）完成了这项研究。患者以双盲方式服用 SZL（n=45）或安慰剂颗粒（n=46），同时保持其他认知药物不变，共 20 周。在 0 周、10 周、20 周和 25 周，使用行为病理学在阿尔茨海默病（BEHAVE-AD）评定量表和神经精神问卷（NPI）评估 BPSD 的变化，根据活动记录仪的记录，用去趋势波动分析（DFA）表示日间活动（DA）、傍晚活动（EA）和夜间活动（NA）。与安慰剂口服液相比，SZL 口服液在第 20 周时，在某些临床评分和 DFA 的 EA 和 NA 参数的变化上，明显延迟了 BPSD 的发展，而第 25 周时无差异。实验室检查未发现副作用。结果表明，SZL 可能会延迟 AD 患者 BPSD 的发展，因此是一种潜在适合长期使用的药物。
