柯琳, 董蕾, 李月强, 韩敏. 贝利尤单抗治疗狼疮肾炎的临床观察[J]. 临床肾脏病杂志, 2023, 23(2): 124-128. DOI: 10.3969/j.issn.1671-2390.2023.02.007
    引用本文: 柯琳, 董蕾, 李月强, 韩敏. 贝利尤单抗治疗狼疮肾炎的临床观察[J]. 临床肾脏病杂志, 2023, 23(2): 124-128. DOI: 10.3969/j.issn.1671-2390.2023.02.007
    Ke Lin, Dong Lei, Li Yue-qiang, Han Min. Clinical efficacy and safety ofbelimumab for lupus nephritis:a clinical observational study[J]. Journal of Clinical Nephrology, 2023, 23(2): 124-128. DOI: 10.3969/j.issn.1671-2390.2023.02.007
    Citation: Ke Lin, Dong Lei, Li Yue-qiang, Han Min. Clinical efficacy and safety ofbelimumab for lupus nephritis:a clinical observational study[J]. Journal of Clinical Nephrology, 2023, 23(2): 124-128. DOI: 10.3969/j.issn.1671-2390.2023.02.007

    贝利尤单抗治疗狼疮肾炎的临床观察

    Clinical efficacy and safety ofbelimumab for lupus nephritis:a clinical observational study

    • 摘要: 目的 真实世界研究贝利尤单抗治疗狼疮肾炎(lupus nephritis,LN)的疗效与安全性。方法 选取2020年9月至2022年5月于华中科技大学同济医学院附属同济医院接受贝利尤单抗治疗并进行随访的25例LN患者为研究对象,比较治疗前后不同时期LN患者的临床指标和用药的变化情况,记录不良反应事件发生情况。结果 应用贝利尤单抗治疗后,LN患者抗dsDNA抗体水平明显下降,补体C3逐渐升高且治疗前后不同时期抗dsDNA抗体(χ2=14.000,P=0.007)和补体C3(F=3.228,P=0.0172)水平的差异均具有统计学意义。治疗后尿蛋白/肌酐比值、尿红细胞计数、SLEDAI评分、糖皮质激素用量显著下降,血白蛋白、血红蛋白水平升高,随访第52周时与基线值比较差异均具有统计学意义。此外,治疗前后不同时期SLEDAI评分(F=12.23,P<0.001)和糖皮质激素用量(F=13.57,P<0.001)的差异均具有统计学意义。在接受贝利尤单抗治疗期间,有6例LN患者报告了不良反应事件,其中感染4例,白细胞降低2例,经治疗及对症处理后均治愈,无严重不良反应事件发生。结论 贝利尤单抗治疗LN具有良好的疗效和安全性,但仍需关注治疗期间感染和白细胞降低等不良反应事件的发生。

       

      Abstract: Objective To observe the efficacy and safety of belimumab for lupus nephritis(LN) in real world.Methods For this retrospective and real-world clinical trial, 25 LN patients received belimumab from September 2020 to May 2022.Through comparing the changes in clinical parameters and observing adverse events before and after treatment, efficacy and safety of belimumab were observed.Results After a therapy of belimumab, anti-dsDNA antibody titer declined markedly(χ2=14.000, P=0.007) and complement C3 spiked sharply(F=3.228, P=0.0172) at different follow-up timepoints.After therapy, urinary protein-to-creatinine ratio(uPCR), urinary red blood cell count, SLEDAI score and dosage of oral corticosteroid dropped markedly and blood albumin and hemoglobin levels rose.And the differences were all statistically significant between baseline and values at Week 52.In addition, SLEDAI score(F=12.23, P<0.001) and dose of oral corticosteroid(F=13.57, P<0.001) were both statistically significant.During a therapy of belimumab, 6 patients reported such adverse events as infection(n=4) and leucopenia(n=2).All of them were cured and there was no onset of serious adverse events.Conclusions Belimumab is both safe and efficacious for LN.The occurrence of adverse events such as infection and leukopenia should be closely monitored during therapy.

       

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