奥妥珠单抗治疗磷脂酶A_(2)受体相关膜性肾病的疗效与安全性:单中心回顾性分析  

A single-center retrospective analysis of efficacy and safety of obinutuzumab for treating phospholipase A_(2) receptor associated membranous nephropathy

作　　者：张启龙 柳亿 卢会丽 罗慧 李成林 王菁 王辉 Qilong Zhang;Yi Liu;Huili Lu;Hui Luo;Chenglin Li;Jing Wang;Hui Wang(Department of Nephrology,People's Hospital of Anji(Anji Branch of the First Affiliated Hospital,Zhejiang University School of Medicine),Huzhou 313300,China;Department of Pharmacy,People's Hospital of Anji(Anji Branch of the First Affiliated Hospital,Zhejiang University School of Medicine),Huzhou 313300,China)

机构地区：[1]安吉县人民医院(浙江大学医学院附属第一医院安吉分院)肾内科,浙江湖州313300 [2]安吉县人民医院(浙江大学医学院附属第一医院安吉分院)药学部,浙江湖州313300

出　　处：《中华危重症医学杂志(电子版)》2024年第5期379-384,共6页Chinese Journal of Critical Care Medicine:Electronic Edition

基　　金：湖州市科学技术局公益性应用研究项目(2023GY78)。

摘　　要：目的分析奥妥珠单抗治疗磷脂酶A_(2)受体(PLA_(2)R)相关膜性肾病(MN)的疗效及安全性。方法本研究为单中心回顾性观察研究,收集2022年4月至2023年11月在安吉县人民医院肾内科接受奥妥珠单抗治疗的12例PLA_(2)R相关MN患者的临床资料,分析缓解情况与不良反应。治疗方案为首次奥妥珠单抗1.0 g静脉滴注,根据病情追加或不追加剂量治疗,随访截止日期为2024年3月12日。结果12例患者均存在肾穿刺病理PLA_(2)R染色阳性和(或)血清抗PLA_(2)R抗体阳性,诊断为PLA_(2)R相关MN。10例患者使用第2剂奥妥珠单抗,1例外院就诊未使用第2剂奥妥珠单抗,1例治疗8个月后追加第3剂奥妥珠单抗。12例患者均未发生严重不良事件,2例发生感染,均为常用不良事件术语标准3级。首次治疗期间5例患者出现1级输液相关反应(IRR),减缓滴速或对症处理后缓解并顺利完成输注,后续输注均无IRR及不良事件发生。治疗后10例患者达到缓解,包括4例完全缓解,另2例因随访数据缺失无法评估疗效。结论奥妥珠单抗治疗PLA_(2)R相关MN肾脏反应较好,安全性良好。Objective To analyze the efficacy and safety of obinutuzumab in the treatment of patients with phospholipase A_(2) receptor(PLA_(2)R)associated membranous nephropathy(MN).Methods It was a single-center retrospective observational study.The clinical data before and after obinutuzumab treatment of 12 patients with PLA_(2)R associated MN in the Department of Nephrology of People's Hospital of Anji from April 2022 to November 2023 were retrospectively collected.The kidney relief situation and adverse reactions were analyzed.The treatment regimen was 1.0 g intravenous infusion of obinutuzumab initially,with or without additional dosage.The follow-up was up to March 12,2024.Results All 12 patients had positive renal puncture pathology PLA_(2)R staining and/or positive serum anti-PLA_(2)R antibodies and were diagnosed with PLA_(2)R associated MN.Ten patients were treated with a 2^(nd) dose of obinutuzumab,one was treated in another hospital without a 2nd dose of obinutuzumab,and one was treated with an additional 3rd dose of obinutuzumab after eight months of treatment.None of the 12 patients experienced serious adverse events,and two had infections which were grade 3 by the common terminology criteria for adverse events.Grade 1 infusion related reactions(IRR)occurred in five patients during the initial treatment,which were alleviated after slowing down the infusion rate or symptomatic treatment,and they successfully completed the infusion.No IRR or adverse events occurred in subsequent infusions.Ten patients achieved remission after treatment,including four complete remissions,and the other two could not be evaluated for efficacy due to missing followup data.Conclusion Obinutuzumab treatment is effective for PLA_(2)R associated MN in inducing kidney remission,with favorable safety.

关 键 词：奥妥珠单抗 受体 磷脂酶A_(2) 肾小球肾炎 膜性 疗效 安全性 

分 类 号：R73[医药卫生—肿瘤]