咪唑立宾联合糖皮质激素治疗儿童IgA肾病的临床研究

Clinical research of mizoribine in the treatment of children with IgA nephropathy

目的探讨咪唑立宾(MZR)治疗儿童IgA肾病(IgAN)的疗效与安全性。方法选择2016年1月至2018年12月东部战区总医院儿科收治的儿童IgAN46例,根据治疗方法不同,按照随机数字法分为强的松(PDN)与MZR联合治疗组(联合组,n=24)和PDN单药治疗组(单药组,n=22)。分析2组患儿随访3个月、6个月、12个月和24个月的实验室检查结果、预后和不良反应。结果联合组12个月和24个月ALB水平高于基线值(P<0.05);单药组24个月白蛋白(ALB)水平高于基线值(P<0.05);联合组12个月和24个月尿蛋白定量水平低于基线值(P<0.05,P<0.01);单药组24个月尿蛋白定量水平低于基线值(P<0.05,P<0.01);联合组6个月、12个月和24个月尿N-乙酰-β-D-葡萄糖苷(NAG)酶水平低于基线值(P<0.01);单药组12个月和24个月尿NAG酶水平低于基线值(P<0.05,P<0.01);联合组12个月和24个月尿视黄醇结合(RB)蛋白水平低于基线值(P<0.05,P<0.01);单药组24个月尿RB蛋白水平低于基线值(P<0.01)。主要终点预后:24个月随访结束,联合组总体预后(91.67%)高于单药组(68.18%,P<0.05),无一例达到次要终点。联合组呼吸道感染次数(54.17%)的比例高于单药组(22.73%,P<0.05),联合组病情复发次数(12.50%)低于单药组(50.00%,P<0.05)。联合组蛋白消失比例明显高于单药组(P<0.05),激素累积剂量低于单药组[(2.45±0.61)mg/d vs(3.12±0.74)mg/d,P<0.05]。结论MZR联合PDN治疗儿童IgAN有效性和安全性较高,临床效果高于单药PDN,且长期预后好于单药PDN治疗。

Objective To investigate the efficacy and safety of mizoribine(MZR)in children with IgA nephritis(IgAN).Methods From January 2016 to December 2018,46 cases of children IgAN admitted to the Department of Paediatrics of Jinling Hospital were analyzed.According to treatment,all patients were divided into prednisone(PDN)and MZR combined treatment groups(PDN+MZR group,n=24)and PDN monotherapy group(PDN group,n=22).The laboratory tests of 3month(M),6M,12M and 24M follow-up time,prognosis and adverse reactions of the two groups of children were analyzed.Results At the follow-up time of 12M and 24M,the albumin(ALB)levels in PDN+MZR group were higher than baseline(P<0.05).At 24M time,the ALB levels in PDN group were higher than baseline(P<0.05).At 12M and 24M time,urine protein level in PDN+MZR group were lower than baseline(P<0.05,P<0.01).At 24M time,urine protein level in PDN group were lower than baseline(P<0.05,P<0.01).At 6M,12M and 24M time,the urinary NAG enzyme level in PDN+MZR group were lower than baseline(P<0.01).At 12M and 24M time,the urinary NAG enzyme level in PDN group were lower than baseline(P<0.05,P<0.01).At 12M and 24M time,the urinary RB protein levels in PDN+MZR group were lower than baseline(P<0.05,P<0.01).At 24M time,the urine RB protein level in the PDN group was lower than baseline(P<0.01).Primary end-point prognosis:at the time of 24M follow-up,the overall prognosis of PDN+MZR group(91.67%)was higher than PDN group(68.18%,P<0.05).And none of the patients reached the secondary end-point.The proportion of respiratory infections in PDN+MZR group(54.17%)was higher than that of the PDN group(22.73%,P<0.05).And the number of recurrences in PDN+MZR group(12.50%)was lower than that of the PDN group(50.00%,P<0.05).The proportion of protein was significantly higher than that in the PDN group(P<0.05).And the cumulative dose of glucocorticoid in the PDN+MZR group was lower than PDN group[(2.45±0.61)mg/d vs(3.12±0.74)mg/d,P<0.05].Conclusion MZR combined with PDN shows high efficacy and safety in the treatment IgAN children,the clinical effect is higher than single-agent PDN,and the long-term prognosis is better than single-agent PDN.