目的 探讨泰它西普治疗IgA肾病的有效性和安全性。 方法 回顾性收集自2022年3月─2024年3月在北京大学第一医院肾内科接受泰它西普治疗的IgA肾病患者临床资料,记录患者随访过程中的临床指标以及不良反应,评价药物的有效性和安全性。 结果 共纳入106例患者,中位随访时间5.4(3.2,11.5)月,泰它西普治疗6个月的尿蛋白(Z=-2.929,P=0.003)、IgA(t=8.857,P<0.001)、IgG(t=5.305,P<0.001),IgM(t=6.732,P<0.001)水平较基线下降。泰它西普治疗前尿蛋白<3.5 g/d和估算肾小球滤过率(estimated glomerular filtration rate,eGFR)>60 ml/(min·1.73m2)与泰它西普治疗后尿蛋白降至1.0 g/d以内相关(OR=6.483、4.552,95% CI:1.259~33.389、1.043~19.860,P=0.025、0.044)。观察到不良反应有感染和注射部位反应。 结论 泰它西普治疗可以降低IgA肾病患者尿蛋白水平,早期应用可能效果更为显著。
Objective To investigate the clinical efficacy and safety of telitacicept in the treatment of IgA nephropathy. Methods The clinical data of patients with IgA nephropathy treated with telitacicept from March 2022 to March 2024 were retrospectively collected. Their laboratory indicators and adverse reactions were recorded to evaluate the efficacy and safety of telitacicept. Result A total of 106 patients were analyzed, with a median medication time of 3.2 (2.2~5.7) months and median follow-up time of 5.4 (3.2~11.5) months. The 24-hour proteinuria decreased by 38.6% (-58.9%~1.8%) (Z=-2.929, P=0.003) from baseline at the sixth month after medication. The levels of IgA, IgG and IgM decreased from baseline; IgA decreased by 30.9% (t=8.857, P<0.001), IgG 18.1% (t=5.305, P<0.001) and IgM 43.6% (t=6.732, P<0.001). Before medication, proteinuria <3.5 g/d (OR=6.483, 95% CI:1.259~33.389, P=0.025) and eGFR>60ml/(min·1.73m2) (OR=4.552, 95% CI:1.043~19.860, P=0.044) were associated with proteinuria dropping to 1.0g/d after medication. Adverse reactions were infections and injection site reactions. Conclusion Telitacicept can significantly reduce proteinuria in patients with IgA nephropathy, and early application may be more effective.