补肾化痰方联合盐酸多奈哌齐对中重度阿尔茨海默病伴精神行为症状的临床研究

目的评价补肾化痰方联合盐酸多奈哌齐对中重度阿尔茨海默病（AD）伴精神行为症状（BPSD）的疗效及安全性。方法将127例AD患者按照随机数字表法分为研究组62例和对照组65例，研究组患者服用补肾化痰代表方复方海蛇胶囊和盐酸多奈哌齐，对照组患者单用盐酸多奈哌齐；观察12周。治疗前及治疗12周末分别采用痴呆行为量表（BEHAVE－AD）评价精神行为症状，严重障碍量表（SIB）评定患者的认知功能。结果治疗12周末，研究组BEHAVE－AD分值下降较对照组更显著（P〈0．01）；研究组治疗后SIB评分与对照组的差异有统计学意义（P〈0．01）；研究组改善BPSD有效率明显高于对照组（P〈0．01）。两组不良反应症状均轻微，且发生率差异无统计学意义（P〉0．05）。结论补肾化痰代表方复方海蛇胶囊联合盐酸多奈哌齐治疗BPSD的疗效优于单用盐酸多奈哌齐。

Clinical study of reinhartdt and sea cucumber capsule combined with donepezil in treatment of psychological and behavioral symptomsin patients with Alzheimers disease

Objective To study the efficacy and safety of Reinhartdt and sea cucumber capsule （RSC） combined with donepezil on behavioral and psychological symptoms of dementia （BPSD） in patients with Alzheimer＇s Disease. Methods One hundred and sixty seven patients were randomized into combined group and donepezil group, and both groups were treated re- spectively for 12 weeks. The curative effect was evaluated according to SIB and BEHAVE-AD score. Results Compared with the baseline, BEHAVE-AD scores decreased significantly both in the two groups after 12 weeks of treatment （both P〈0.01）, but the improvement in the combined treatment group was more obvious than that in Donepezil group （P〈0.01）. Among the two groups, SIB score increased significantly only in the combined treatment group （P〈0.01）. No obvious adverse reaction occurred in the two groups. Conclusion RSC combined with donepezil is more effective in treatment of BPSD than single donepezil.