[1]罗兴,赵美君,李亚丹,等.贝利尤单抗联合传统治疗对初治和复发狼疮性肾炎患者的疗效和安全性分析[J].陕西医学杂志,2025,54(10):1400-1404,1409.[doi:DOI:10.3969/j.issn.1000-7377.2025.10.019]
　LUO Xing,ZHAO Meijun,LI Yadan,et al.Efficacy and safety analysis of Belimumab combined with traditional treatment in naive and recurrent lupus nephritis[J].,2025,54(10):1400-1404,1409.[doi:DOI:10.3969/j.issn.1000-7377.2025.10.019]
点击复制

贝利尤单抗联合传统治疗对初治和复发狼疮性肾炎患者的疗效和安全性分析

《陕西医学杂志》[ISSN:1000-7377/CN:61-1281/TN]

卷:
54
期数:
2025年10期
页码:
1400-1404,1409
栏目:
药物与临床
出版日期:
2025-10-05

文章信息/Info

Title:
Efficacy and safety analysis of Belimumab combined with traditional treatment in naive and recurrent lupus nephritis
作者:
罗兴; 赵美君; 李亚丹; 刘婷; 肖广智
（空军军医大学西京医院临床免疫科，陕西 西安710032）
Author(s):
LUO Xing; ZHAO Meijun; LI Yadan; LIU Ting; XIAO Guangzhi
(Department of Clinical Immunology,Xijing Hospital of Air Fource Medical University,Xi’an 710032,China)
关键词:
狼疮肾炎; 贝利尤单抗; 传统治疗; 初治; 复发; 蛋白尿
Keywords:
Lupus nephritis; Belimumab; Traditional treatment; Naive; Relapse; Proteinuria
分类号:
R 692.3
DOI:
DOI:10.3969/j.issn.1000-7377.2025.10.019
文献标志码:
A
摘要:
目的：分析贝利尤单抗联合传统治疗对初治和复发的狼疮肾炎(LN)患者的疗效和安全性。方法：研究纳入接受肾脏病理穿刺检查，并接受贝利尤单抗治疗的LN患者52例，其中初治的患者21例，复发患者31例。收集人口学资料、实验室检查并分析临床应答、激素使用量等。结果：初治LN患者平均（34.0±2.28）岁，中位病程为0.75（0.1，3）年，LN病理分型为Ⅲ/Ⅳ型±Ⅴ型（90.5%）和Ⅴ型（9.5%）；复发LN患者的平均（33.6±1.83）岁，中位病程为9（1，14）年，LN病理分为Ⅰ/Ⅱ型（9.7%），Ⅲ/Ⅳ型±Ⅴ型（77.4%）和Ⅴ型（12.9%）。初治组患者3个月蛋白尿完全缓解率为70%，6个月为80%，12、24个月时均为100%，复发组患者3个月完全缓解率为54.2%，6个月为69.6%，12个月时76.2%，24个月时达到100%，两组间比较无统计学差异（均P>0.05）。两组12个月时服用激素用量，均为相当于≤7.5 mg/d的醋酸泼尼松，24个月时≤5 mg/d，无统计学差异（P>0.05）。两组患者SLEDAI-2K评分在3个月时均明显下降，且无统计学差异（P>0.05）。两组患者均无感染发生。结论：贝利尤单抗联合传统治疗方案治疗初治和复发的LN安全有效，且有利于激素的减量。
Abstract:
Objective:To evaluate the efficacy and safety of Belimumab in combination with traditional treatment for the naive and recurrent patients with lupus nephritis (LN).Methods：This study included 52 LN patients who underwent renal biopsy and received Belimumab treatment.The cohort comprised 21 naive patients and 31 relapsed patients.Demographic data were collected,laboratory tests were conducted,and clinical responses as well as corticosteroid usage were analyzed.Results:The mean age of naive LN patients was 34.0±2.28 years,with a median disease duration of 0.75(0.1,3) years.Pathological types were predominantly Ⅲ/Ⅳ±Ⅴ (90.5%) and Ⅴ(9.5%).For relapsed LN patients,the mean age was 33.6±1.83 years,with a median disease duration of 9(1，14) years.Pathological classifications included type Ⅰ/Ⅱ (9.7%),type Ⅲ/Ⅳ±Ⅴ (77.4%),and type Ⅴ (12.9%).The complete remission rate of proteinuria in the naive group was 70% at 3 months,80% at 6 months,and 100% at both 12 and 24 months.In the relapsed group,the rates were 54.2% at 3 months,69.6% at 6 months,76.2% at 12 months,and 100% at 24 months,with no significant difference between groups (P＞0.05).There was no significant difference in prednisone acetate dosage at 12 months or 5 mg/d at 24 months between the two groups (P＞0.05).SLEDAI-2K scores decreased significantly at 3 months in both groups without significant differences.No infections occurred in either group.Conclusion:The combination of Belimumab and traditional treatment is safe and effective for treating both naive and relapsed LN,aiding in reducing corticosteroid use.

参考文献/References:

[1]刘志红.中国狼疮肾炎诊断和治疗指南[J].中华医学杂志,2019,99(44)：3441-3455.
[2]付永涛,王莉平,郭金明,等.羟氯喹通过Toll样受体4/核因子-κB信号通路对系统性红斑狼疮小鼠肺损伤的影响[J].陕西医学杂志,2023,52(11)：1483-1488.
[3]李均,杨晓娟,冉阳,等.霉酚酸酯对狼疮性肾炎小鼠肾小球系膜细胞增殖、炎性反应的影响及分子机制研究[J].陕西医学杂志,2023,52(8)：973-976,991.
[4]FIGUEROA-PARRA G,CUELLAR-GUTIERREZ M C,GONZALEZ-TREVINO M,et al.Impact of glucocorticoid dose on complete response,serious infections,and mortality during the initial therapy of lupus nephritis：A systematic review and meta-analysis of the control arms of randomized controlled trials[J].Arthritis Rheumatol,2024,76(9)：1408-1418.
[5]WANG S,CHEN D,ZUO K,et al.Long-term renal outcomes of mesangial proliferative lupus nephritis in Chinese patients[J].Clin Rheumatol,2022,41(2)：429-436.
[6]白炜,段新旺,李芹,等.中国狼疮肾炎患者的临床特征及治疗选择：基于CSTAR队列的研究[J].中华临床免疫和变态反应杂志,2021,15(3)：275-285.
[7]LIU P,PENG Z,XIANG Y,et al.Causes and predictors of mortality from lupus nephritis in Southern Hunan,China[J].Mod Rheumatol,2022,32(2)：338-344.
[8]MU L,HAO Y,FAN Y,et al.Mortality and prognostic factors in Chinese patients with systemic lupus erythematosus[J].Lupus,2018,27(10)：1742-1752.
[9]FURIE R,ROVIN B,HOUSSIAU F,et al.Two-year,randomized,controlled trial of belimumab in lupus nephritis[J].N Engl J Med,2020,383(12)：1117-1128.
[10]GATTO M,SACCON F,ANDREOLI L,et al.Durable renal response and safety with add-on belimumab in patients with lupus nephritis in real-life setting (BeRLiSS-LN).Results from a large,nationwide,multicentric cohort[J].J Autoimmun,2021,124：102729.
[11]TAN M,XU J,TAN Y,et al.Efficacy and safety of belimumab in lupus nephritis patients：A real-world observational study in china[J].Kidney Dis (Basel),2023,9(3)：218-228.
[12]LIN S,ZHANG J,YOU X,et al.Efficacy and safety of belimumab in patients with lupus nephritis：A real-world retrospective observational study[J].Rheumatology (Oxford),2025,64(2)：614-622.
[13]田新平,李梦涛,曾小峰.我国系统性红斑狼疮的诊治现状与未来发展方向：来自中国系统性红斑狼疮发展报告2020年年度报告[J].中华内科杂志,2022,61(6)：611-616.
[14]CHEN P,ZHOU Y,WU L,et al.Efficacy and safety of biologic agents for lupus nephritis：A Systematic review and meta-analysis[J].J Clin Rheumatol,2023,29(2)：95-100.
[15]FANOURIAKIS A,KOSTOPOULOU M,CHEEMA K,et al.2019 Update of the Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of lupus nephritis[J].Ann Rheum Dis,2020,79(6)：713-723.
[16]MOK C.Combination strategies for lupus nephritis：Facts and controversies[J].Expert Rev Clin Immunol,2023,19(5)：527-536.
[17]KOSTOPOULOU M,FANOURIAKIS A,BERTSIAS G,et al.Treatment of lupus：More options after a long wait[J].Ann Rheum Dis,2022,81(6)：753-756.
[18]ANDERS H,FURIE R,MALVAR A,et al.Effect of belimumab on kidney-related outcomes in patients with lupus nephritis：Post hoc subgroup analyses of the phase 3 BLISS-LN trial[J].Nephrol Dial Transplant,2023,38(12)：2733-2742.
[19]KAPSIA E,MARINAKI S,MICHELAKIS I,et al.Predictors of early response,flares,and long-term adverse renal outcomes in proliferative lupus nephritis：A 100-month median follow-up of an inception cohort[J].J Clin Med,2022,11(17)：5017.
[20]WEEDING E,FAVA A,MAGDER L,et al.One-third of patients with lupus nephritis classified as complete responders continue to accrue progressive renal damage despite resolution of proteinuria[J].Lupus Sci Med,2022,9(1)：e000684.
[21]张彦平,贺军涛,殷鉴,等.尿液免疫球蛋白轻链检测对系统性红斑狼疮肾脏损伤的诊断价值[J].陕西医学杂志,2020,49(9)：1172-1174.
[22]BANOS A,BERTSIAS G.Flares in lupus nephritis：Risk factors and strategies for their prevention[J].Curr Rheumatol Rep,2023,25(10)：183-191.
[23]RUA-FIGUEROA F D L I,LOZANO M,FERNANDEZ-CID C,et al.Preventing organ damage in systemic lupus erythematosus：The impact of early biological treatment[J].Expert Opin Biol Ther,2022,22(7)：821-829.
[24]Kidney Disease：Improving Global Outcomes (KDIGO) Lupus Nephritis Work Group.KDIGO 2024 clinical practice guideline for the management of LUPUS NEPHRITIS[J].Kidney Int,2024,105(1S)：S1-S69.
[25]SAMMARITANO L,ASKANASE A,BERMAS B,et al.2024 American College of Rheumatology (ACR) guideline for the screening,treatment,and management of lupus nephritis[J].Arthritis Rheumatol,2025,25：1-21.
[26]FANOURIAKIS A,KOSTOPOULOU M,ANDERSEN J,et al.EULAR recommendations for the management of systemic lupus erythematosus：2023 update[J].Ann Rheum Dis,2024,83(1)：15-29.
[27]UROWITZ M,ARANOW C,ASUKAI Y,et al.Impact of belimumab on organ damage in systemic lupus erythematosus[J].Arthritis Care Res (Hoboken),2022,74(11)：1822-1828.

相似文献/References:

[1]王静,李汉超,莫凌菲,等.RSAD2 mRNA表达对贝利尤单抗治疗系统性红斑狼疮应答的预测价值[J].陕西医学杂志,2025,54(6):804.[doi:DOI:10.3969/j.issn.1000-7377.2025.06.016]
　WANG Jing,LI Hanchao,MO Lingfei,et al.Predictive value of RSAD2 mRNA expression for belimumab treatment response in SLE patients[J].,2025,54(10):804.[doi:DOI:10.3969/j.issn.1000-7377.2025.06.016]

备注/Memo

备注/Memo:
国家自然科学基金资助面上项目（62272468）
更新日期/Last Update: 2025-10-09