论著

贝利尤单抗联合传统方案治疗儿童活动性狼疮性肾炎疗效分析

  • 彭倩倩 ,
  • 杨焕丹 ,
  • 袁婷婷 ,
  • 邱闪 ,
  • 李艳 ,
  • 周苏芹 ,
  • 陆倩
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  • 徐州医科大学附属徐州儿童医院肾内风湿免疫科 (江苏徐州 221000)

收稿日期: 2023-09-18

  网络出版日期: 2024-11-08

基金资助

徐州市重点研发计划(社会发展)项目-医药卫生面上(KC22199)

Efficacy of Belimumab combined with traditional regimen in the treatment of active lupus nephritis in children

  • Qianqian PENG ,
  • Huandan YANG ,
  • Tingting YUAN ,
  • Shan QIU ,
  • Yan LI ,
  • Suqin ZHOU ,
  • Qian LU
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  • Department of Nephrology and Rheumatology, Xuzhou Children's Hospital, Xuzhou Medical University, Xuzhou221000, Jiangsu, China

Received date: 2023-09-18

  Online published: 2024-11-08

摘要

目的 探讨贝利尤单抗靶向药物与传统方案相结合在早期诱导期治疗活动性儿童狼疮性肾炎的疗效,为儿童狼疮性肾炎(LN)治疗提供新的诊疗理念及依据。方法 收集2018年1月至2021年8月58例初发的儿童活动性LN,根据诱导早期有无加用贝利尤单抗联合治疗分为观察组(传统方案联合BLM治疗)32例及对照组(传统方案治疗)26例,观察两组患儿基线及第4、12、24周血清生化指标(ALB、BUN、Cr、eGRF)、免疫指标(C3、C4、IgG、CD19+B计数、抗ds-DNA抗体)、尿微量白蛋白、24 h尿蛋白定量及SLEDAI-2K评分。随访2年后两组患儿达标率、复发率及糖皮质激素的使用剂量。结果 两组患儿肾脏病理类型及传统治疗方案比较差异无统计学意义(P>0.05)。两组患儿基线、4周、12周、24周血ALB、BUN、CR、C3、C4组间比较无统计学差异(P>0.05);组内比较差异均有统计学意义(P<0.05);治疗4周、12周观察组eGRF明显高于对照组,差异有统计学意义(P<0.05),两组组内比较无统计学差异(P>0.05);治疗12周、24周尿微量白蛋白及24 h尿蛋白定量较对照组明显下降,组间差异有统计学意义(P<0.05);组内比较差异有统计学差异(P<0.05)。治疗24周观察组CD19+B细胞计数由基线653.00(438.00~933.25)cells/μL降至45(30.50~66.50)cells/μL,IgG由14.84(12.03~17.64)g/L降至5.45(5.11~5.79)g/L,抗ds-DNA抗体阳性率由100%降至46.87%,SLEDAI-2K评分达无疾病活动状态完全缓解率(87.50%)及总效率(93.75%),明显高于对照组(65.38%、84.62%),差异均有统计学意义(P<0.05)。治疗24周观察组中87.50%患儿糖皮质激素减至5 mg/d,高于对照组(76.92%,P<0.05)。2年后随访中观察组达标率(93.75%)高于对照组(61.54%),复发率(6.25%)低于对照组(30.77%),差异有统计学意义(P<0.05)。结论 贝利尤单抗联合传统治疗诱导期治疗儿童活动性LN可减轻蛋白尿、降低SLE疾病活动度,助减激素,尽快达标,且可降低患儿复发率,改善预后,疗效优于单纯传统治疗方案。

本文引用格式

彭倩倩 , 杨焕丹 , 袁婷婷 , 邱闪 , 李艳 , 周苏芹 , 陆倩 . 贝利尤单抗联合传统方案治疗儿童活动性狼疮性肾炎疗效分析[J]. 临床儿科杂志, 2024 , 42(11) : 975 -982 . DOI: 10.12372/jcp.2024.23e0911

Abstract

Objective To investigate the efficacy of combining Belimumab with traditional therapy in treating active lupus nephritis (LN) in children during the early induction period, and to provide a novel diagnostic and therapeutic framework for the future treatment of LN in children. Method Clinical data were collected from 58 children with active LN newly diagnosed from January 2018 to August 2021. Participants were divided into observation group (32 cases) and control group (26 cases) based on the use of Belimumab in the induction stage. Serum biochemical markers(ALB, BUN, Cr, eGRF), immune markers (IgG, C3, C4, CD19+B count, anti-nuclear antibody), along with urinary microalbumin, urinary protein quantity at at 24h and SLEDAI-2K score were were assessed at baseline and after 4, 12, and 24 weeks of treatment. The compliance rate, recurrence rate and glucocorticoid dosage of the two groups were also followed up. Results No significant differences were found in renal pathological type and traditional treatment between the two groups (P>0.05), there were no significant differences in blood ALB, BUN, CR, C3 and C4 between the two groups(P>0.05). However, statistically significant differences were observed among all groups (P<0.05).The eGFR was higher in the observation group at 4 and 12 weeks, but no statistically significant difference was noted between the two groups (P>0.05). After 12 and 24 weeks of treatment,urinary microalbumin and urinary protein quantity at 24h were significantly reduced compared to the control group, with statistical significance (P<0.05); intergroup comparisons also showed significant differences (P<0.05). In the observation group at 24 weeks, the CD19+B cell count decreased from 653 (438-933.25) cells/μL to 45 (30.50-66.50) cells/μL, IgG decreased from 14.84 (12.03-17.64) g/L to 5.45 (5.11-5.79) g/L. The positive rate of anti-nuclear antibodies decreased from 100% to 46.87%, SLEDAI-2K score reached disease-free activity status. The complete remission rate (87.50%) and total efficiency (93.75%) in the observation group were significantly higher than those in the control group (65.38% and 84.62%, respectively), with statistical significance (P<0.05). The glucocorticoid dosage was reduced to 5 mg/d in 87.50% of children in the observation group after 24 weeks, compared to 76.92% in the control group, with statistically significant differences (P<0.05). After 2 years follow-up, the compliance rate in the observation group (93.75%) was significantly higher than that in the control group (61.54%), while the recurrence rate (6.25%) was lower than that of the control group (30.77%), with statistical significance (P<0.05). Conclusion The combination of Belimumab and traditional therapy is effective in treating active LN in children during the induction period. This approach alleviates proteinuria, improves disease activity in systemic lupus erythematosus (SLE), facilitates early glucocorticoid reduction, and enhances overall outcomes, demonstrating superior efficacy compared to traditional therapy alone.

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