【摘要】 目的 观察仑卡奈单抗在中国真实世界研究中治疗早期阿尔茨海默病(Alzheimer’s disease, AD)患者的基线特征和短期安全性。方法 本研究为多中心、回顾性、观察性研究，收集2024年6月26日至2025年3月1日在全国84个医学中心就诊并接受仑卡奈单抗治疗的646例AD患者的临床资料，所有患者治疗前进行简易智能状态检查量表(Mini-mental state examination, MMSE)评分，治疗前后进行临床痴呆评定量表(clinical dementia rating, CDR)评分，分别计算CDR总评分(CDR-global score, CDR-GS)和CDR各项目总分(CDR-sum of box, CDR-SB)。观察治疗3个月内静脉滴注相关反应(infusion-related reactions, IRR)和淀粉样蛋白相关影像学异常(amyloid-related imaging abnormalities, ARIA)发生情况。ARIA包括ARIA水肿(ARIA with edema and effusion, ARIA-E)和ARIA出血(ARIA with hemosiderin deposit, ARIA-H)。454例患者进行载脂蛋白E(apolipoprotein E,ApoE)基因检测。对基线特征和短期安全性数据进行分析。结果 本研究基线CDR-GS为0.5分和1分的患者分别为301例(46.59%)和345例(53.41%);ApoEε4携带者202例(31.27%),其中ApoEε4纯合子携带患者17例(8.42%)。发生IRR 32例(4.95%),其中90.63%(29/32)发生于首次静脉滴注，轻度IRR 31例(96.88%),中度IRR 1例(3.13%),临床症状主要表现为发热、头晕、呕吐等。发生ARIA 16例(2.48%),其中ARIA-E 5例(31.25%),ARIA-H 10例(62.50%),ARIA-E伴ARIA-H 1例(6.25%)。5例ARIA-E中2例为症状性ARIA-E;影像学上，3例为轻度、2例为中度ARIA-E。10例发生ARIA-H的患者均无临床症状；影像学上，6例为轻度、4例为中度ARIA-H。17例ApoEε4纯合子患者中发生ARIA-H 1例(5.88%),其影像学严重程度为中度。年龄增长有增加ARIA发生风险的趋势，但差异无统计学意义(P=0.056)。结论 中国真实世界研究中接受仑卡奈单抗治疗的AD患者具有年龄较轻但疾病严重程度较高的特征，短期随访数据提示仑卡奈单抗具有良好的安全性。更多还原

【Abstract】 Objective To evaluate the baseline characteristics and short-term safety of lecanemab in treatment of Alzheimer’s disease(AD) in Chinese patients in a real-world study.Methods A multicenter, retrospective, observational study was conducted on 646 AD patients who were continuously recruited and receved of lecanemab therapy in 84 medical centers from June 26,2024 to March 1,2025.Their clinical data, including baseline Mini-mental state examination(MMSE) score and clinical dementia rating(CDR) score before and after treatment, were collected, and the CDR-global score(CDR-GS) and CDR-sum of box score were calculated.The incidences of infusion-related reactions(IRR) and amyloid-related imaging abnormalities(ARIA),including ARIA with edema and effusion(ARIA-E) and ARIA with hemosiderin deposit(ARIA-H) within 3 months of treatment were observed and recorded.Apolipoprotein E(ApoE) genetic test was performed on 454 patients.Baseline characteristics and short-term safety of the patients were analyzed.Results There were 301 patients(46.59%) having a baseline CDR-GS score of 0.5 and 345(53.41%) patients had a CDR score of 1.In the 454 patients receiving genetic test, the ApoEε4 carriers accounted for 31.27%(202 cases),including 17 cases of ApoEε4 homozygous carriers(8.42%).The incidence of IRR was 4.95%(32/646),which mainly occurred during the first infusion(90.63%,29/32),and there were 96.88%(31/32) of mild and 3.13%(1/32) of moderate IRR,with main manifestations of fever, dizziness, vomiting, etc.Sixteen patients(2.48%) experienced ARIA,including 5(31.25%) ARIA-E,10(62.50%) ARIA-H,and 1(6.25%) ARIA-E and ARIA-H.For the 5 patients with ARIA-E,2 were symptomatic, and in terms of radiographic severity, 3 cases were mild and 2 cases were moderate ARIA-E.In the 10 patients with ARIA-H,all of them had no clinical symptoms, and in terms of radiographic severity, 6 had mild and 4 had moderate ARIA-H.Among the 17 ApoEε4 homozygous patients, only one patient(5.88%) experienced ARIA-H with a moderate radiographic severity.Multivariate analysis showed that age increased the trend of ARIA risk, but no statistical difference was observed(P=0.056).ConclusionIn this real-world study in China, AD patients receiving lecanemab treatment have the characteristics of being younger in age but higher disease severity.Short-term follow-up data suggest that lecanemab has good safety.更多还原