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OA
Efficacy,biomarkers,and safety assessment of Lecanemab in treatment of Chinese patients with Alzheimer disease:A 12-month real-world study
目的 旨在综合评估仑卡奈单抗(Lecanemab)在治疗中国阿尔茨海默病(AD)患者真实世界临床实践中的疗效、生物标志物变化及安全性.方法 回顾性收集2024年—2025年于河北医科大学第一医院接受Lec-anemab治疗的患者资料.采集患者在基线期、治疗6个月及12个月时的认知相关神经心理测评量表评分、影像学和血浆生物标志物指标,并记录不良事件;使用线性混合效应模型、绘制个体变化轨迹图等对比及描述上述指标.结果 Lecanemab治疗后患者MoCA和CDR-SB量表结果随疾病进展有所恶化,而MMSE量表结果变化无统计学意义.此外,影像学和血浆标志物观察到病理改善证据:amyloid PET检查显示CL值下降,血浆Aβ42及Aβ42/Aβ40比值升高,p-tau217及胶质细胞原纤维酸性蛋白(GFAP)水平降低.24.1%患者报告不良事件;记录到1例罕见严重药品不良反应;未观察到症状性淀粉样蛋白相关成像异常(ARIA)事件.结论 Lecanemab在中国真实世界AD患者中表现出明确病理清除效应,可有效降低脑内Aβ负荷并调节血浆相关标志物水平.药物总体安全性良好,可能延缓疾病进程.本研究为Lecanemab在中国人群的临床应用提供了真实世界循证医学依据和参考.
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.
何莎;刘丽;籍义涵;高雁;李漾;梁瑞景;赵舒雅;李明康;马晓伟
河北医科大学第一医院认知障碍科,河北 石家庄 050031||首都医科大学宣武医院河北医院认知障碍科,河北 石家庄 050031||河北省神经医学技术创新中心,河北 石家庄 050031河北医科大学第一医院认知障碍科,河北 石家庄 050031||河北医科大学研究生学院,河北 石家庄 050017河北医科大学第一医院认知障碍科,河北 石家庄 050031||河北医科大学研究生学院,河北 石家庄 050017河北医科大学第一医院认知障碍科,河北 石家庄 050031||首都医科大学宣武医院河北医院认知障碍科,河北 石家庄 050031||河北省神经医学技术创新中心,河北 石家庄 050031河北医科大学第一医院认知障碍科,河北 石家庄 050031||首都医科大学宣武医院河北医院认知障碍科,河北 石家庄 050031||河北省神经医学技术创新中心,河北 石家庄 050031河北医科大学第一医院认知障碍科,河北 石家庄 050031||首都医科大学宣武医院河北医院认知障碍科,河北 石家庄 050031||河北省神经医学技术创新中心,河北 石家庄 050031河北医科大学第一医院认知障碍科,河北 石家庄 050031||河北医科大学研究生学院,河北 石家庄 050017河北医科大学基础医学院,河北 石家庄 050017河北医科大学第一医院认知障碍科,河北 石家庄 050031||首都医科大学宣武医院河北医院认知障碍科,河北 石家庄 050031||河北省神经医学技术创新中心,河北 石家庄 050031
医药卫生
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
Alzheimer diseaseLecanemabReal-world studyBiomarkersCognitive functionAd-verse reactions
《中风与神经疾病杂志》 2026 (6)
498-504,7
科技创新2030-"脑科学与类脑计划"重大项目(2021ZD0201800)河北医科大学2025年大学生创新性实验计划项目(USIP2025159)
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