咪唑立宾治疗儿童频繁复发肾病综合征的临床研究

Clinical observation of Mizoribine for treatment of frequently relapsing nephrotic syndrome in children

目的咪唑立宾(mizoribine,MZR)是一种新型的免疫抑制剂,在国内治疗儿童肾病综合征病例报道较少。研究采取病例对照的试验方法研究咪唑立宾治疗儿童频繁复发肾病综合征的疗效和不良反应。方法纳入59例频复发型肾病综合征,并按其治疗方案的不同分为2组:治疗组29例给予MZR+糖皮质激素;对照组30例给予雷公藤(tripterygium wilfordii,TW)+糖皮质激素治疗。2组总疗程12个月。观察患儿24 h尿蛋白定量、尿N-乙酰-β-葡萄糖苷(NAG)酶、血清清蛋白、血胆固醇、血肌酐、复发频次、平均泼尼松用量。结果治疗结束时治疗组血清清蛋白高于对照组[(40.95±6.12)g/L vs(30.25±9.02)g/L],血清胆固醇[(5.45±0.82)mmol/L vs(7.53±2.74)mmol/L]、尿蛋白定量[(0.89±0.52)g/24 h vs(1.63±2.02)g/24h]、尿NAG酶[(21.43±14.16)U/(g·Cr)vs(41.67±12.35)U/(g·Cr)]水平均低于对照组,组间比较差异有统计学意义(P<0.05)。随访第3、9、12个月,治疗组平均复发次数均低于对照组,组间比较差异有统计学意义(P<0.05)。在随访第3、6、9、12个月,治疗组平均激素用量均低于对照组,分别为[(0.56±0.16)mg/(kg·d)vs(0.72±0.34)mg/(kg·d)]、(0.64±0.35)mg/(kg·d)vs[(0.67±0.52)mg/(kg·d)]、[(0.53±0.41)mg/(kg·d)vs(0.83±0.37)mg/(kg·d)]、[(0.34±0.15)mg/(kg·d)vs(0.54±0.26)mg/(kg·d)],组间比较差异有统计学意义(P<0.05)。结论相对于TW联合激素治疗,MZR联合足量激素治疗频复发型NS患儿可减少复发和降低糖皮质激素用量,提高临床缓解率。

Objective Mizoribine （ MZR） is a new immunosuppressant , however , little domestic research has been done on MZR for treatment of nephrotic syndrome in children .This study was to investigate curative effect and adverse reaction of MZR in the treatment of children with frequently relapsing nephrotic syndrome , using prospective controlled trials . Methods A total of 59 pa-tients with frequency relapsing nephrotic syndrome were randomly divided into two groups .29 patients of treatment group were treated with MZR ＋glucocorticoid , while 30 patients of control group were given Tripterygium wilfordii （ TW）＋glucocorticoid treatment , and the course of treatment lasted for 12 months.24-hour urine protein, urinary N-acetyl β-glucosidase （NAG）, serum albumin, serum cholesterol, serum creatinine, recurrence frequency, and average prednisone dosage were observed . Results At the end of treat-ment, Serum albumin in treatment group was higher than that in control group [（40.95 ±6.12）g/L vs （30.25 ±9.02）g/L], and Se-rum cholesterol （[5.45 ±0.82]mmol/L vs [7.53 ±2.74]mmol/L）, urinary protein （[0.89 ±0.52]g/24 h vs [1.63 ±2.02]g/24 h）, urinary NAG enzyme （[21.43 ±14.16]U/g· Cr vs [41.67 ±12.35]U/g· Cr） levels were lower compared with control group . There was significant difference between the two groups .In terms of mean recurrence times , no significant difference was found at 6th months of follow-up between the two groups, however, treatment group had lower recurrence rate than control group at 3rd month, 9th month, 12th month of follow-up, which was of significant difference .The average amounts of hormone of treatment group were lower than those of control group （[0.56 ±0.16] mg/kg· d vs [0.72 ± 0.34]mg/kg· d）、（[0.64 ±0.35]mg/kg· d vs [0.67 ±0.52]mg/kg· d）、（[0.53 ±0.41] mg/kg· d vs [0.83 ±0.37] mg/kg· d）、（[0.34 ±0.15] mg/kg· d vs [0.54 ±0.26] mg/kg· d） at 3rd month, 6th month, 9th month, 12th month of follow-up, which was of significant difference . Conclusion Compared to Tripterygium wil-fordii combined with hormone therapy , MZR combined with prednisone therapy in children with recurrent NS frequency can reduce the relapse rate and dosage of corticosteroid to improve the clinical remission rate .