多奈哌齐治疗阿尔茨海默病的快速卫生技术评估

Rapid Health Technology Assessment of Donepezil in the Treatment of Alzheimer’s Disease

目的:评价多奈哌齐治疗阿尔茨海默病(AD)的有效性、安全性和经济性,为临床合理用药提供循证依据。方法:计算机检索PubMed、Embase、CochraneLibrary、中国知网、万方数据库、中国生物医学文献数据库和卫生技术评估(HTA)机构官方网站,收集多奈哌齐治疗AD的系统评价/Meta分析、经济学评价和HTA报告,检索时限均为建库至2021年2月。对符合纳入与排除标准的文献进行资料提取和质量评价,将研究结果汇总并进行定性描述分析。结果:共纳入26项研究,包括15项系统评价/Meta分析、11项经济学研究,未纳入HTA报告。分析结果显示,在有效性方面,与安慰剂比较,多奈哌齐可明显改善AD患者的认知功能、日常生活活动能力、精神行为和总体功能(P<0.05);与卡巴拉汀比较,多奈哌齐可明显改善AD患者的认知功能(P<0.05);与加兰他敏比较,多奈哌齐可明显改善AD患者的认知功能和总体功能(P<0.05),但在改善精神行为症状方面,两者比较差异无统计学意义(P>0.05);与美金刚比较,多奈哌齐在改善AD患者的认知功能、精神行为症状、日常生活活动能力方面的差异无统计学意义(P>0.05),在改善总体功能方面的效果劣于美金刚(P<0.05)。安全性方面,多奈哌齐组患者的耐受性、病死率与安慰剂组比较差异均无统计学意义(P>0.05);AD患者对多奈哌齐的耐受性高于卡巴拉汀和加兰他敏(P<0.05);多奈哌齐的不良反应发生率与安慰剂、美金刚以及其他非安慰剂对照药物比较差异无统计学意义(P>0.05)。经济学研究显示,与卡巴拉汀、安慰剂和不使用治疗AD的相关药物比较,多奈哌齐可延长患者的质量调整生命年(QALY)和节约医疗成本,更具有成本-效益优势;与仅针对基础疾病的常规治疗和美金刚比较,多奈哌齐虽然可延长患者的QALY,但是否具有经济学优势还需要结合国家或地区的卫生资源条件确定。结论:多奈哌齐治疗轻中度AD具有相对较好的有效性、安全性和经济性。

OBJECTIVE:To evaluate the efficacy,safety and econom y of donepezil in the treatment of Alzheimer’s disease(AD),so as to provide evidence-based evidence for clinical rational drug use.METHODS:Retrieved from PubMed,Embase,the Cochrane Library,CNKI,Wanfang database,CBM and health technology assessment(HTA)organization websites,systematic review/Meta-analysis,economic evaluation and HTA reports about donepezil in the treatment of AD were collected during the inception to Feb.2021.Data extraction and quality evaluation were carried out for the literature that met the inclusion and exclusion criteria,and the research results were summarized and analyzed qualitatively.RESULTS:A total of 26 studies were included,including 15 systematic reviews/Meta-analysis,and 11 economic studies;HTA reports were not included.The results showed that in terms of effectiveness,compared with placebo,donepezil could significantly improve the cognitive function,activity of daily life,mental behavior and overall function of AD patients(P<0.05);compared with rivastigmine,donepezil could significantly improve cognitive function of AD patients(P<0.05);compared with galantamine,donepezil could significantly improve cognitive function and overall function(P<0.05),but there was no statistical significance in terms of improving mental behavioral symptoms(P>0.05);there was no statistical significance between donepezil and memantine in improving cognitive function,psychobehavioral symptoms and activities of daily living in AD patients(P>0.05),but donepezil was weaker than memantine in overall functional(P<0.05).In terms of safety,there was no significant difference in the tolerance and mortality in patients using donepezil and placebo(P>0.05);donepezil was better tolerated than rivastigmine and galantamine(P<0.05);there was no significant difference in the incidence of ADR for donepezil compared with placebo,metamine and other non-placebo mail:15201008872@163.com controlled drugs(P>0.05).Economic studies showed that#compared with rivastigmine,placebo and no AD-related drug treatment,donepezil could prolong quality adjusted life years(QALY)and saved medical costs,which was more cost-effective.Compared with conventional treatment for basic disease and memantine,although donepezil could prolong QALY,whether it had economic advantages still needed to confirmed in combination with national or regional health resource conditions.CONCLUSIONS:Donepezil is ralatively effective,safe and economical in the treatment of AD.