摘要
目的:观察充分治疗剂量的多奈哌齐联合阿立哌唑或利培酮治疗阿尔茨海默病(Alzheimer Disease,AD)的临床效果及安全性差异。方法:由于行为症状住院的AD患者被纳入为期12周的随机、双盲、对照试验。研究对象(64例)被随机平均分为每日1次阿立哌唑10 mg或利培酮1 mg。同时所有患者均服用每日1次多奈哌齐10 mg。患者在基线时以及用药后第8周和12周由精神科医生采用阳性和阴性症状量表(The Positive and Negative Syndrome Scale,PANSS)和神经行为功能认知量表(NIH Toolbox Cognition Battery,NIHTB-CB)评估临床精神病理学和认知情况。PANSS评分和认知表现被用作结果测量。结果:受试者因素显示两组患者PANSS阴性分量表之间的差异显著(Greenhouse-Geisser校正:F=4.37,P=0.04);并且在时间上并不相似(逐组相互作用,Greenhouse-Geisser校正:F=20.22,P <0.001);两组在第12周的差异显著(t=3.75,P <0.001);终点与基线相比的变化,阿立哌唑和利培酮分别为:(-3.02±1.71)和(-0.35±0.73);在第12周时,阿立哌唑的PANSS阴性分量表与基线相比有显著性差异(t=5.50,P <0.001)。在第0周和第12周,两组神经认知之间差异没有任何显著统计学意义(P>0.05)。与基线相比,阿立哌唑组在第12周时逻辑记忆方面显著提高(P <0.05)。结论:多奈哌齐联合阿立哌唑可作为一种潜在的治疗AD阴性症状的辅助治疗策略。
Objective: To observe the efficacy of donepezil plus aripiprazole or risperidone on alzheimer disease. Methods: Inpatients with AD, who had been hospitalized because of behavioral symptoms, were recruited to a twelve-week randomized, doubleblind, controlled trial. Participants(64 cases) were randomized to give risperidone one mg or aripiprazole 10 mg, one time per day. At the same time, all patients were treated with donepezil 10 mg, one time per day. Clinical psychopathology and cognition were assessed by PANSS and NIHTB-CB by a psychiatrist at baseline and after 8 and 12 weeks of the medication started. The PANSS scores and cognitive performance were used as the outcome measures. Results: The difference between the two groups was significant in the negative Score of PANSS(F=4.37;P=0.04). Time in the two groups was not similar(F=20.22, P<0.001). The difference between the two treatments was significant at the endpoint(12 weeks)(t=3.75, P<0.001). The changes at the endpoint and baseline were(3.02±1.71) and(0.35±0.73) for aripiprazole and risperidone, respectively. A significant difference was observed on the negative subscale of PANSS at week 12 compared with baseline in the aripiprazole group(t=5.50, P<0.001). At 0 week and 12 weeks, there was no statistically significant difference between the two groups in neurocognition(P>0.05). Compared with baseline, logical memory was improved in the aripiprazole group at 12 weeks(P<0.05). Conclusion: The present study indicates donepezil with aripiprazole can be applied as a potential adjunctive treatment strategy for negative symptoms of AD.
出处
《中医临床研究》
2019年第31期126-130,共5页
Clinical Journal Of Chinese Medicine
