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抗淀粉样前体蛋白（Aβ）单克隆抗体（乐卡奈单抗/多奈单抗）治疗早期阿尔茨海默病的疗效与安全性再评估

Re-evaluation of the efficacy and safety of anti-Aβ monoclonal antibodies (lecanemab/donanemab) in the treatment of early Alzheimer's disease.

作者信息

Wang Haoyang, Pan Junying, Zhang Mingming, Tan Zengde

机构信息

Department of Tuina, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, China.

出版信息

Front Pharmacol. 2025 Apr 16;16:1599048. doi: 10.3389/fphar.2025.1599048. eCollection 2025.

DOI:10.3389/fphar.2025.1599048
PMID:40308765
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12040886/
Abstract

OBJECTIVE

To systematically evaluate the efficacy and safety of anti-Aβ monoclonal antibodies (Lecanemab/Donanemab) in the treatment of early Alzheimer's disease (AD) and to provide evidence for rational clinical use.

METHODS

We searched databases including PubMed, Embase, Cochrane, Web of Science, CNKI, and the Chinese Biomedical Literature Database for relevant literature on the use of anti-Aβ monoclonal antibodies in treating early AD. Two reviewers independently screened the literature, extracted data, and conducted meta-analysis using RevMan 5.4.

RESULTS

A total of five clinical studies were included. Meta-analysis results showed that in terms of clinical outcomes, Lecanemab/Donanemab outperformed the control group in ADCOMS, CDR-SB, ADAS-Cog 14, and amyloid burden on PET. Regarding safety, the relative risk of amyloid-related imaging abnormalities (ARIA) in patients treated with Lecanemab/Donanemab was 4.35 times higher than the control group, with significantly higher risks of ARIA-E and ARIA-H. Among other adverse events, the risk of superficial siderosis of the central nervous system was notably higher and statistically significant.

CONCLUSION

Lecanemab/Donanemab can improve memory, cognitive function, and daily living abilities in patients with early AD, significantly reduce the composite score of Alzheimer's disease, and inhibit the accumulation of amyloid peptides, thereby alleviating symptoms and improving the condition.

摘要

目的

系统评价抗淀粉样蛋白β（Aβ）单克隆抗体（来卡奈单抗/多奈单抗）治疗早期阿尔茨海默病（AD）的疗效和安全性，为临床合理用药提供依据。

方法

检索PubMed、Embase、Cochrane、Web of Science、中国知网（CNKI）和中国生物医学文献数据库等数据库中关于抗Aβ单克隆抗体治疗早期AD的相关文献。两名评价员独立筛选文献、提取数据，并使用RevMan 5.4进行Meta分析。

结果

共纳入5项临床研究。Meta分析结果显示，在临床结局方面，来卡奈单抗/多奈单抗在ADCOMS、CDR-SB、ADAS-Cog 14以及PET淀粉样蛋白负荷方面均优于对照组。在安全性方面，接受来卡奈单抗/多奈单抗治疗的患者发生淀粉样蛋白相关影像异常（ARIA）的相对风险是对照组的4.35倍，ARIA-E和ARIA-H的风险显著更高。在其他不良事件中，中枢神经系统表面铁沉积的风险显著更高且具有统计学意义。

结论

来卡奈单抗/多奈单抗可改善早期AD患者的记忆、认知功能和日常生活能力，显著降低阿尔茨海默病综合评分，抑制淀粉样肽的积累，从而缓解症状、改善病情。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/6febc321cb6e/fphar-16-1599048-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/4750274b9f50/fphar-16-1599048-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/eaf026f9651a/fphar-16-1599048-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/62405f2e31b0/fphar-16-1599048-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/ee53fbeed9c1/fphar-16-1599048-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/9865cac3c747/fphar-16-1599048-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/c5f3f0783b92/fphar-16-1599048-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/6febc321cb6e/fphar-16-1599048-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/4750274b9f50/fphar-16-1599048-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/eaf026f9651a/fphar-16-1599048-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/62405f2e31b0/fphar-16-1599048-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/ee53fbeed9c1/fphar-16-1599048-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/9865cac3c747/fphar-16-1599048-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/c5f3f0783b92/fphar-16-1599048-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3149/12040886/6febc321cb6e/fphar-16-1599048-g007.jpg

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