中风与神经疾病杂志2026，Vol.43Issue(6)：498-504,7.DOI:10.19845/j.cnki.zfysjjbzz.2026.0086
仑卡奈单抗治疗中国阿尔茨海默病患者12个月真实世界研究:疗效、生物标志物与安全性评估
Efficacy,biomarkers,and safety assessment of Lecanemab in treatment of Chinese patients with Alzheimer disease:A 12-month real-world study
摘要
Abstract
Objective To comprehensively assess the efficacy,biomarker changes,and safety of Lecanemab in the treatment of Chinese patients with Alzheimer disease in real-world clinical practice.Methods A retrospective analysis was performed for the data of patients who received Lecanemab treatment in The First Hospital of Hebei Medical University from 2024 to 2025,including cognitive-related neuropsychological assessment scales,radiological examination,and plasma biomarkers at baseline and at 6 and 12 months of treatment,and adverse events were recorded.The linear mixed-effects model and individual change trajectory plots were used for description and comparison of the above indicators.Results The results of MoCA and CDR-SB scales deteriorated with disease progression after Lecanemab treat-ment,while there were no significant changes in the results of MMSE scale.In addition,radiological examination and plasma biomarkers showed improvements in pathology,with amyloid PET showing a reduction in CL value,in-creases in plasma Aβ42 and Aβ42/Aβ40 ratio,and reductions in the levels of p-tau217 and GFAP.Of all patients,24.1%reported adverse events,and a rare case of severe adverse drug reaction was recorded,with no events of symptom-atic ARIA.Conclusion Lecanemab shows a clear effect of pathological clearance in Chinese patients with Alzheimer's disease in a real-world setting and can effectively reduce Aβ load in the brain and regulate the levels of plasma-related bio-markers.Lecanemab has a good overall safety profile and can delay disease progression.This study provides real-world evidence-based support for the clinical application of Lecanemab in the Chinese population.关键词
阿尔茨海默病/仑卡奈单抗/真实世界研究/生物标志物/认知功能/不良反应Key words
Alzheimer disease/Lecanemab/Real-world study/Biomarkers/Cognitive function/Ad-verse reactions分类
医药卫生引用本文复制引用
何莎,刘丽,籍义涵,高雁,李漾,梁瑞景,赵舒雅,李明康,马晓伟..仑卡奈单抗治疗中国阿尔茨海默病患者12个月真实世界研究:疗效、生物标志物与安全性评估[J].中风与神经疾病杂志,2026,43(6):498-504,7.基金项目
科技创新2030-"脑科学与类脑计划"重大项目(2021ZD0201800) （2021ZD0201800）
河北医科大学2025年大学生创新性实验计划项目(USIP2025159) （USIP2025159）
