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目的比较来氟米特(LEF)和环磷酰胺(CTX)静脉冲击疗法治疗难治性肾病综合征的疗效,了解其不良反应发生情况及安全性。方法将120例患者在联合使用激素的基础上随机分为两组,分别给予LEF口服(LEF组60例),或者间断性给予CTX静脉滴注(CTX组60例),随访24个月,监测相关指标观察治疗2、4、6、8、12、16、20、24、28周的相关临床指标变化及其评价,同时记录不良反应。结果随访结束时LEF组治疗总有效率81.66%,CTX组治疗总有效率78.33%,两组总有效率比较差异无统计学意义(P>0.05),来氟米特组治疗后24 h尿蛋白定量显著减少(P<0.05),血清白蛋白显著升高(P<0.05),疗效与环磷酰胺组比较差异有统计学意义(P<0.05)。两组的不良反应主要发生在治疗初期,经对症处理后均缓解,无一例患者因严重不良反应而退出治疗。来氟米特组不良反应总发生率15%;而环磷酰胺组不良反应总发生率26.7%,两组不良反应发生率比较差异有统计学意义(P<0.05),提示应用LEF治疗难治性肾病综合征显著优于CTX。结论 LEF联合糖皮质激素治疗LN具有较好的疗效,耐受性较好,但长期疗效及不良反应仍需进一步观察。
Objective To compare the curative effect of leflunomide (LEF) and cyclophosphamide (CTX) intravenous pulse therapy in the treatment of refractory nephrotic syndrome and to understand its adverse reactions and safety. Methods 120 patients were randomly divided into two groups on the basis of combination of hormones: LEF (60 in LEF group) or CTX (60 in CTX group) intermittently. The patients were followed up for 24 months and monitored Related indicators observed changes in the treatment of 2,4,6,8,12,16,20,24,28 weeks of clinical indicators and evaluation, and record adverse reactions. Results The total effective rate of LEF group was 81.66% at the end of follow-up, while the total effective rate of CTX group was 78.33%. There was no significant difference between the two groups (P> 0.05) (P <0.05), serum albumin was significantly increased (P <0.05), and the difference was statistically significant (P <0.05) compared with cyclophosphamide group. Adverse reactions in both groups occurred mainly in the early stages of treatment, after symptomatic treatment were relieved, no patient exited due to serious adverse reactions. The total incidence of adverse reactions in leflunomide group was 15%, while the total incidence of adverse reactions in cyclophosphamide group was 26.7%. The incidence of adverse reactions in both groups was significantly different (P <0.05), suggesting that refractory to LEF treatment Nephrotic syndrome is significantly better than CTX. Conclusions LEF combined with glucocorticoid has a good curative effect and good tolerability. However, long-term curative effect and adverse reactions still need further observation.