贝利尤单抗联合标准方案治疗活动性狼疮肾炎的疗效及安全性分析  

Efficacy and safety of belimumab combined with standard regimen in the treatment of active lupus nephritis

作　　者：吴东明 艾克达 蒋昱 欧阳玉英 李彬[1] 李剑波[1] 余健文 郑勋华[1] 黄锋先[1] 陈崴[1] 刘庆华[1] Wu Dongming;Aikeda Yimamuyushan;Jiang Yu;Ouyang Yuying;Li Bin;Li Jianbo;Yu Jianwen;Zheng Xunhua;Huang Fengxian;Chen Wei;Liu Qinghua(Department of Nephrology,the First Affiliated Hospital,Sun Yat-sen University,NHC Key Laboratory of Clinical Nephrology(Sun Yat-sen University)and Guangdong Provincial Key Laboratory of Nephrology,Guangzhou 510080,China;Department of Nephrorheumatology,Hainan Traditional Chinese Medicine Hospital,Haikou 570203,China)

机构地区：[1]中山大学附属第一医院肾内科,国家卫生健康委员会肾脏病临床研究重点实验室(中山大学),广东省肾脏病重点实验室,广州510080 [2]海南省中医院肾病风湿科,海口570203

出　　处：《中华肾脏病杂志》2023年第4期245-252,共8页Chinese Journal of Nephrology

摘　　要：目的评价贝利尤单抗(belimumab)联合标准方案治疗活动性狼疮肾炎(lupus nephritis,LN)的疗效及安全性。方法本研究为单中心、前后对照的回顾性研究,通过收集2020年6月1日至2022年6月30日于中山大学附属第一医院肾内科应用贝利尤单抗联合标准方案治疗活动性LN的患者资料,分析贝利尤单抗治疗后的肾脏缓解率与不良反应。结果共纳入17例患者,女性14例(82.35%),首次用药的年龄为(26.06±2.64)岁,使用贝利尤单抗前患病中位时间为24.00(8.50,48.50)个月,使用贝利尤单抗前复发次数为(1.24±1.03)次。17例患者均行肾活检,主要本病理类型是Ⅳ型11例(11,17),Ⅲ+Ⅴ型2例(2,17),Ⅳ+Ⅴ型3例(3,17),Ⅴ型1例(1,17)。使用贝利尤单抗前1年内糖皮质激素使用量为(22.95±8.30)mg,d。12例LN患者完成24周的贝利尤单抗治疗,24 h尿蛋白呈下降趋势,24周时与基线相比差异有统计学意义[0.49(0.15,2.19)g比2.83(1.14,4.11)g,Z=-2.100,P=0.036];24周时血清白蛋白与基线相比升高了29.36%,24周时与基线相比差异有统计学意义[(34.50±3.34)g,L比(26.67±5.75)g,L,t=-3.840,P=0.030];系统性红斑狼疮疾病活动度评分持续下降,24周时与基线相比差异有统计学意义(5.00±3.02比12.00±2.82,t=6.163,P<0.001);淋巴细胞计数升高,24周时与基线相比差异有统计学意义[0.72(0.28,2.39)×10^(9),L比0.30(0.19,0.34)×10^(9),L,Z=-2.073,P=0.038];24周时糖皮质激素用量减少,与治疗前1年的糖皮质激素用量相比差异有统计学意义[(11.25±6.35)mg,d比(22.60±9.75)mg,d,t=4.225,P=0.003]。贝利尤单抗治疗观察(38.13±22.93)周后,患者完全缓解率为64.71%(11,17),部分缓解率为17.65%(3,17),总有效率达82.35%(14,17)。1例出现复发。17例患者均未发生输液相关反应。共5例患者发生不良事件,包括肺部感染2例,脓毒血症、上呼吸道感染、巨细胞病毒感染各1例,经治疗后均好转,未影响后续治疗。结论贝利尤单抗联合标准方案治�Objective To evaluate the efficacy and safety of belimumab combined with standard regimen in the treatment of active lupus nephritis(LN).Methods It was a single-center,pre-and post-control retrospective study.The Data of active LN patients treated with belimumab combined with standard regimen in the Department of Nephrology,the First Affiliated Hospital of Sun Yat-sen University from June 1,2020 to June 30,2022 were collected for analyzing the renal response rate and adverse reactions after belimumab treatment.Results A total of 17 patients were included,including 14 females(82.35%).The age of the first medication was(26.06±2.64)years old,the median time of illness before the use of belimumab was 24.00(8.50,48.50)months,and the recurrence times before the use of belimumab was(1.24±1.03)times.All the 17 patients underwent renal biopsy.The main pathological types were type Ⅳ in 11 cases(11,17),typeⅢ+Ⅴ in 2 cases(2,17),type Ⅳ+Ⅴ in 3 cases(3,17),and type Ⅴ in 1 case(1,17).The dose of glucocorticoids was(22.95±8.30)mg,d in 1 year before belimumab administration.In 12 patients with LN who completed 24 weeks of belimumab treatment plan,the 24-hour urinary protein showed a downward trend,and there was a statistically significant difference compared with the baseline at 24 week[0.49(0.15,2.19)g vs.2.83(1.14,4.11)g,Z=-2.100,P=0.036].Compared with the baseline,serum albumin at 24 week increased by 29.36%,with statistically significant difference[(34.50±3.34)g,L vs.(26.67±5.75)g,L,t=-3.840,P=0.030].The systemic lupus erythematosus disease activity index-2K score continued to decline,with statistically significant difference compared with baseline at 24 week(5.00±3.02 vs.12.00±2.82,t=6.163,P<0.001).The lymphocyte count increased,and the difference was statistically significant compared with the baseline at 24 week[0.72(0.28,2.39)×10^(9),L vs.0.30(0.19,0.34)×10^(9),L,Z=-2.073,P=0.038].There was a statistically significant difference between the glucocorticoids dosage at 24 week and the average glucocortico

关 键 词：红斑狼疮 系统性 狼疮肾炎 治疗结果 贝利尤单抗 药物相关性副作用和不良反应 

分 类 号：R593.242[医药卫生—内科学]