不同剂量利妥昔单抗治疗特发性膜性肾病的疗效及安全性比较  

Comparison of efficacy and safety of rituximab at different doses in the treatment of idiopathic membranous nephropathy

作　　者：王柳西 董丹[1] 许颖[1] 张立[1] 徐弘昭 刘念[2] 远航 Wang Liuxi;Dong Dan;Xu Ying;Zhang Li;Xu Hongzhao;Liu Nian;Yuan Hang(Department of Nephrology,the First Hospital of Jilin University,Changchun 130012,China;Department of Urology,the First Hospital of Jilin University,Changchun 130012,China)

机构地区：[1]吉林大学第一医院肾病科,长春130012 [2]吉林大学第一医院泌尿外科,长春130012

出　　处：《中华肾脏病杂志》2023年第8期610-615,共6页Chinese Journal of Nephrology

基　　金：吉林省教育厅科研项目(JJKH20190025KJ);吉林省科技厅科研项目(20180101109JC,20200404185YY)。

摘　　要：该研究为回顾性队列研究。选取2020年3月至2022年3月于吉林大学第一医院肾病科住院期间确诊为特发性膜性肾病(idiopathic membranous nephropathy,IMN)并单独接受利妥昔单抗(rituximab,RTX)治疗满1个疗程的患者,按照不同给药方法将其纳入1 g标准治疗组(每次1 g,每2周1次,共2次)和375 mg/m^(2)实验治疗组(每次375 mg/m^(2),每3周1次,共3次),比较不同剂量RTX治疗IMN的疗效及安全性,为优化临床治疗方案提供参考。疗程结束后均规律随访≥9个月且资料完整。最终69例患者纳入统计分析,年龄(51.7±11.8)岁,男性46例(66.7%)。1 g标准治疗组31例,375 mg/m^(2)实验治疗组38例。1 g标准治疗组中初治比例高于375 mg/m^(2)实验治疗组(87.1%比65.8%,χ^(2)=4.174,P=0.041)。两组患者一般资料、临床特征及基线实验室指标差异均无统计学意义(均P>0.05)。治疗后3个月时,共22例(31.9%)患者发生缓解,其中1 g标准治疗组9例(29.0%)、375 mg/m^(2)实验治疗组13例(34.2%)(χ^(2)=0.211,P=0.646);6个月时,共30例(43.5%)患者发生缓解,其中1 g标准治疗组12例(38.7%)、375 mg/m^(2)实验治疗组18例(47.4%)(χ^(2)=0.521,P=0.470);9个月时,共38例(55.1%)患者发生缓解,其中1 g标准治疗组18例(58.1%)、375 mg/m^(2)实验治疗组20例(52.6%)(χ^(2)=0.204,P=0.652)。9个月时1 g标准治疗组和375 mg/m^(2)实验治疗组患者24 h尿蛋白量较基线值分别下降了7.93(6.24,8.46)g和7.45(5.66,8.67)g,血清白蛋白较基线值分别升高了16.4(15.5,17.5)g/L和15.5(9.0,15.8)g/L(均P<0.05)。Kaplan-Meier生存分析结果显示,两组磷脂酶A2受体抗体滴度降至<5 RU/ml的时间差异无统计学意义(Log-rankχ^(2)=3.653,P=0.056)。1 g标准治疗组发生23起非严重不良反应事件,累及患者16例;375 mg/m^(2)实验治疗组发生10起非严重不良反应事件,累及患者10例;375 mg/m^(2)实验治疗组安全性优于1 g标准治疗组(Fisher值=8.593,P=0.015)。使用RTX 375 mg/m^(2)方案和1 g标准方案治�It was a retrospective cohort study.Patients diagnosed with idiopathic membranous nephropathy(IMN)and received rituximab(RTX)alone for one course of treatment during hospitalization in the Department of Nephrology of the First Hospital of Jilin University from March 2020 to March 2022 were enrolled.The patients were divided into 1 g standard treatment group(once 1 g every 2 weeks for twice)and 375 mg/m^(2)experimental treatment group(375 mg/m^(2)once a week for 4 weeks)according to the different methods of drug administration,and the efficacy and safety of different doses of RTX in the treatment of IMN were compared between the two groups to provide a reference for optimizing the clinical treatment protocol.The patients were followed up regularly for more than 9 months after treatment and the data were complete.A total of 69 patients were included with age of(51.7±11.8)years old,and 46 males(66.7%).There were 31 patients in the 1 g standard treatment group and 38 patients in the 375 mg/m^(2)experimental treatment group.The proportion of first-treatment patients in the 1 g standard treatment group was higher than that in the 375 mg/m^(2)experimental treatment group(87.1%vs.65.8%,χ^(2)=4.174,P=0.041).There were no statistically significant differences in the general data,clinical characteristics and baseline laboratory parameters between the two groups(all P>0.05).At the end of 3 months of treatment,22 patients(31.9%)experienced remission,including 9 patients(29.0%)in the 1 g standard treatment group and 13 patients(34.2%)in the 375 mg/m^(2)experimental treatment group(χ^(2)=0.211,P=0.646).At 6 months,30 patients(43.5%)experienced remission,including 12 patients(38.7%)in the 1 g standard treatment group and 18 patients(47.4%)in the 375 mg/m^(2)experimental treatment group(χ^(2)=0.521,P=0.470).At 9 months,38 patients(55.1%)achieved remission,including 18 patients(58.1%)in the 1 g standard treatment group and 20 patients(52.6%)in the 375 mg/m^(2)experimental treatment group(χ^(2)=0.204,P=0.652).At 9 months,the 2

关 键 词：肾小球肾炎 膜性 利妥昔单抗 治疗结果 剂量 安全性 

分 类 号：R692[医药卫生—泌尿科学]