泰它西普治疗IgA肾病的有效性及安全性分析

Efficacy and safety analysis of telitacicept in treatment of IgA nephropathy

目的评估泰它西普在IgA肾病(IgAN)治疗中的有效性及安全性。方法回顾性分析9例使用泰它西普治疗的IgAN患者临床资料。比较治疗前后尿蛋白与肌酐比值(UPCR)、血清肌酐、估算肾小球滤过率(eGFR)等指标变化。记录并分析随访过程中不良事件发生情况。结果9例患者(男7例,77.78%;女2例,22.22%)均完成12周治疗。纳入患者最常见的临床表现为持续性蛋白尿,基线UPCR为0.91(0.59,1.83)g/g,血清肌酐为(120.11±39.58)μmol/L,eGFR为(67.33±25.11)mL/(min·1.73 m^(2))。治疗12周后,UPCR低于基线,差异有统计学意义(P<0.01);治疗前后,IgAN患者血清肌酐、血清尿酸、eGFR、血清白蛋白比较,差异无统计学意义(P>0.05)。治疗第4、8、12周时UPCR均数小于基线,差异有统计学意义(F=10.032,P=0.008);eGFR均数与基线比较,差异无统计学意义(F=2.046,P=0.134)。治疗12周,9例IgAN患者总体缓解率为66.67%;所有患者对泰它西普耐受性较好,共发生不良事件(皮肤感染)1例。结论9例IgAN患者使用泰它西普治疗后,其尿蛋白显著下降,肾功能维持稳定,且安全性较好。

Objective To evaluate the efficacy and safety of telitacicept in treatment of IgA nephropathy(IgAN).Methods The clinical data of 9 patients with IgAN treated with telitacicept were retrospectively analyzed.Change of urine protein to creatinine ratio(UPCR),serum creatinine,estimated glomerular filtration rate(eGFR)and other indicators were compared before and after treatment.Adverse events during follow-up were recorded and analyzed.Results Nine patients[7 males(77.78%),2 females(22.22%)]completed 12 weeks of treatment.The most common clinical manifestations of included patients were persistent albuminuria,baseline UPCR of 0.91(0.59,1.83)g/g,serum creatinine of(120.11±39.58)μmol/L and eGFR of(67.33±25.11)mL/(min·1.73 m^(2)).After 12 weeks of treatment,UPCR was significantly lower than baseline(P<0.01);before and after treatment,there was no significant difference in serum creatinine,serum uric acid,eGFR and serum albumin in IgAN patients(P>0.05).At 4,8 and 12 weeks,the mean UPCR was significantly lower than baseline(F=10.032,P=0.008);there was no significant difference in eGFR mean and baseline(F=2.046,P=0.134).After 12 weeks of treatment,the overall remission rate of 9 IgAN patients was 66.67%.All patients were well tolerated by telitacicept,and one patient with adverse event occurred(skin infection).Conclusion In 9 IgAN patients treated with telitacicept,urinary protein is decreased significantly and renal function is remained stable with good safety.