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仑卡奈单抗治疗早期阿尔茨海默病的快速卫生技术评估
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| 篇名： | 仑卡奈单抗治疗早期阿尔茨海默病的快速卫生技术评估 |
| TITLE： | Rapid health technology assessment of lecanemab in the treatment of early-stage Alzheimer’s disease |
| 摘要： | 目的 综合评估仑卡奈单抗在早期阿尔茨海默病（AD）治疗中的有效性、安全性及经济性，为临床决策提供依据。方法系统检索PubMed、CochraneLibrary、中国知网、万方数据、Embase及主要卫生技术评估（HTA）机构官网，纳入截至2025年10月发表的仑卡奈单抗随机对照试验、药物经济学研究、Meta分析/系统评价和HTA报告。依据预设标准筛选文献，经方法学评估、提取数据后进行定性综合分析。结果共纳入6项研究，包括3项随机对照试验和3项药物经济学研究。有效性方面，与安慰剂相比，仑卡奈单抗可显著延缓认知衰退27%，使日常活动能力下降幅度减缓37%，并显著降低脑内淀粉样蛋白水平。安全性方面，仑卡奈单抗组淀粉样蛋白相关影像异常（ARIA）发生率高于对照组，其中脑水肿或渗出发生率为12.6%（安慰剂组1.7%），脑微出血或含铁血黄素沉积发生率为17.3%（安慰剂组9.0%）。经济性方面，仑卡奈单抗相比标准治疗方案的增量成本-效果比高于美国常用支付意愿阈值（50000～150000美元/QALY）。结论仑卡奈单抗在早期AD治疗中具有显著的认知保护作用，但存在较高的ARIA风险和经济负担。 |
| ABSTRACT： | OBJECTIVE To comprehensively evaluate the efficacy， safety， and cost-effectiveness of lecanemab in the treatment of early-stage Alzheimer’s disease （AD）， and to provide evidence-based guidance for clinical decision-making. METHODS A systematic search of PubMed， Cochrane Library， CNKI， Wanfang， Embase， and the official websites of leading health technology assessment （HTA） agencies was conducted for randomized controlled trials， pharmacoeconomic studies， meta-analyses/systematic reviews， and HTA reports on lecanemab published up to October 2025. After screening against predefined eligibility criteria， methodological quality was appraised with validated tools， relevant data were extracted， and the findings were synthesized qualitatively. RESULTS A total of 6 studies were included， consisting of 3 randomized controlled trials and 3 pharmacoeconomic evaluations. In terms of efficacy， lecanemab significantly slowed cognitive decline by 27% compared to placebo， reduced the decline in daily activity ability by 37%， and markedly reduced intracerebral amyloid levels. Regarding safety， the incidence of amyloid-related imaging abnormalities （ARIA） was higher in the lecanemab group than in the control group， with the incidence of edema/effusion of 12.6% （vs. 1.7% in the placebo group）， and the incidence of hemorrhage/hemosiderin deposition of 17.3% （vs. 9.0% in the placebo group）. Economically， the estimated incremental cost-effectiveness ratio of lecanemab compared with standard treatment exceeded commonly used willingness-to-pay thresholds in the United States （USD 50 000-150 000 per QALY）. CONCLUSIONS Lecanemab confers significant cognitive protection in early-stage AD； however， it is associated with a relatively high risk of ARIA and economic burden. |
| 期刊： | 2026年第37卷第04期 |
| 作者： | 沙翩；王晓杰；王涛 |
| AUTHORS： | SHA Pian，WANG Xiaojie，WANG Tao |
| 关键字： | 仑卡奈单抗；早期阿尔茨海默病；淀粉样蛋白相关影像异常；经济性 |
| KEYWORDS： | lecanemab； early-stage Alzheimer’s disease； amyloid-related imaging abnormalities； cost-effectiveness |
| 阅读数： | 3 次 |
| 本月下载数： | 0 次 |
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