| 张新娟,王璇,李锦.基于第三版遴选指南的多奈单抗与仑卡奈单抗临床综合评价[J].安徽医药,待发表. |
| 基于第三版遴选指南的多奈单抗与仑卡奈单抗临床综合评价 |
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| 投稿时间：2026-08-12 录用日期：2026-10-12 |
| DOI： |
| 中文关键词: 多奈单抗 仑卡奈单抗 阿尔茨海默病 临床综合评价 β-淀粉样蛋白 |
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| 摘要点击次数: 59 |
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| 中文摘要: |
| 目的 基于《中国医疗机构药品评价与遴选快速指南（第三版）》，对首版《商业健康保险创新药品目录》收载的抗痴呆药物多奈单抗与仑卡奈单抗进行临床综合评价，为药品遴选与合理用药提供参考。方法 依据指南5维度20项核心指标赋分框架（有效性28分、安全性27分、药学特性27分、经济性10分、其他属性8分），以说明书、监管信息、权威指南与共识及核心期刊发表的原创研究为证据，经双人独立评分与专家复核完成量化评分。结果 多奈单抗68.7分，仑卡奈单抗69.8分，差异主要在药学特性、安全性与经济性。结论 两药均可延缓早期阿尔茨海默病进展，可作有条件推荐（弱推荐）；多奈单抗在低/中tau人群疗效更突出且可有限期给药，但淀粉样蛋白相关影像异常（ARIA）风险较高；仑卡奈单抗ARIA发生率较低但需持续给药。建议结合患者特征与ARIA管理能力个体化用药。 |
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| Abstract
OBJECTIVE To conduct a comprehensive clinical evaluation of donanemab and lecanemab, two anti-dementia agents included in the first Commercial Health Insurance Innovative Drug Catalogue, based on the evaluation system established in A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Third Edition), so as to provide references for drug selection and rational clinical medication in medical institutions. METHODS Quantitative scoring was completed according to the guideline’s five-dimensional framework with 20 core indicators (effectiveness 28, safety 27, pharmaceutical characteristics 27, economy 10, and other attributes 8), using drug labels, regulatory information, authoritative guidelines and consensus, and original studies published in SCIE-indexed journals or Chinese core journals (Peking University Core List, Chinese Science and Technology Core Journals) as evidence sources, through a two-stage procedure of independent double scoring and expert review. RESULTS The overall score was 68.7 for donanemab and 69.8 for lecanemab, with the discrepancy mainly reflected in pharmaceutical characteristics, safety and economy. CONCLUSION Both agents can slow the progression of early-stage Alzheimer’s disease (AD) and can be conditionally recommended (weak recommendation). Donanemab shows more pronounced efficacy in patients with low-to-moderate tau pathology and allows fixed-term treatment, but carries a higher risk of amyloid-related imaging abnormalities (ARIA); lecanemab is associated with a relatively lower incidence of ARIA but requires continuous administration. Individualized treatment is advised based on patients’ characteristics, ARIA management capacity and economic considerations. |
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