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目的比较环磷酰胺(CTX)与霉酚酸酯(MMF)治疗小儿难治性肾病综合征(RNS)的临床疗效。方法收集2004年1月至2009年1月济南军区第一五九中心医院儿科收治的小儿RNS的临床资料。按照用药将患者分为CTX组和MMF组,比较两组患儿缓解率、尿蛋白转阴时间、肾功能变化、3年内复发和不良反应发生情况。结果研究最终纳入47例,CTX组21例,MMF组26例,两组性别、年龄、病程比较差异无统计学意义。治疗结束时CTX组和MMF组的完全缓解率分别为28.57%和42.31%,差异无统计学意义(χ2=0.949,P=0.330),且两组缓解情况分布差异无统计学意义(Z=-0.538,P=0.590)。两组肾功能指标均有好转(P均<0.05),但MMF组24 h尿蛋白、白蛋白、血肌酐水平优于CTX组(P均<0.05)。MMF组尿蛋白转阴时间为(23.9±12.36)d,CTX组为(73.67±40.33)d,差异有统计学意义(P=0.002)。治疗结束3年内,CTX组复发8例,MMF组6例,差异无统计学意义(χ2=1.253,P=0.263)。治疗过程中两组均发生不良反应,多为食欲不振、恶心、呕吐,未发生严重不良反应。结论小样本临床研究中,在小儿RNS的尿蛋白转阴时间、改善肾功能方面MMF优于CTX,但两者均有较好的缓解作用,且完全缓解率、复发率、不良反应发生情况差异无统计学意义。
Objective To compare the clinical efficacy of cyclophosphamide (CTX) and mycophenolate mofetil (MMF) in the treatment of pediatric refractory nephrotic syndrome (RNS). Methods The clinical data of pediatric RNS admitted from January 2004 to January 2009 in the First Affiliated Hospital of Jinan Military Region were collected. According to the medication, the patients were divided into CTX group and MMF group. The remission rate, urinary protein negative conversion time, renal function changes, recurrence and adverse reactions within 3 years were compared between the two groups. Results The final study included 47 cases, 21 cases in CTX group and 26 cases in MMF group. There was no significant difference in gender, age and course of disease between the two groups. At the end of treatment, the complete remission rate was 28.57% in the CTX group and 42.31% in the MMF group, with no significant difference (χ2 = 0.949, P = 0.330). There was no significant difference in the remission between the two groups (Z = 0.538, P = 0.590). The indexes of renal function improved in both groups (all P <0.05). However, 24 h urinary protein, albumin and serum creatinine in MMF group were better than those in CTX group (all P <0.05). Urine proteinuria time was (23.9 ± 12.36) d in MMF group and (73.67 ± 40.33) d in CTX group, the difference was statistically significant (P = 0.002). Within 3 years after the end of treatment, 8 cases relapsed in CTX group and 6 cases in MMF group, the difference was not statistically significant (χ2 = 1.253, P = 0.263). Adverse reactions occurred in both groups during treatment, mostly as loss of appetite, nausea and vomiting, and no serious adverse reactions occurred. Conclusions In the small sample clinical study, MMF was superior to CTX in urinary protein negative time and renal function in children with RNS, but both had a good effect of relieving, and the rates of complete remission, recurrence and adverse reactions were different No statistical significance.