2021 年第 2 期 第 16 卷

来氟米特与环孢素A治疗原发性难治性肾病综合征临床效果与安全性的对比研究

Comparative study about clinical effect and safety of leflunomide and cyclosporin A on the treatment of primary refractory nephrotic syndrome

作者：赵智敏1成艳哲1杨玉秀1杨光2周春华3

英文作者：Zhao Zhimin1 Cheng Yanzhe1 Yang Yuxiu1 Yang Guang2 Zhou Chunhua3

单位：1北京中西医结合学会肾脏疑难病会诊中心100041；2解放军总医院第二医学中心肾脏病科，北京100853；3解放军总医院第六医学中心肾脏病科，北京100037

英文单位：1Beijing Consuition Center of Chinese and Western Medicine for Compucated Kidney Disease Beijing 100041 China; 2Department of Nephrology the Second Medical Center of PLA General Hospital Beijing 100853 China; 3Department of Nephrology the Sixth Medical Center of PLA General Hospital Beijing 100037 China

关键词：原发性难治性肾病综合征；来氟米特；环孢素A；泼尼松；治疗

英文关键词：Primaryrefractorynephroticsyndrome;Leflunomide;CyclosporineA;Prednisone;Treatment 

• 摘要：

• 目的 对比来氟米特与环孢素A治疗原发性难治性肾病综合征（NS）的临床效果与安全性。方法 选取2015年1月至2017年7月在北京中西医结合学会肾脏疑难病会诊中心和解放军总医院第二及第六医学中心肾脏病科住院治疗的原发性难治性NS患者86例为研究对象。完全随机分为观察组和对照组，每组43例。2组均给予泼尼松及常规对症治疗，观察组在常规干预基础上给予来氟米特治疗，对照组在常规干预基础上给予环孢素A治疗。观察2组的临床治疗效果，治疗前、治疗3、6、12个月后的24 h尿蛋白定量、血尿素氮、血肌酐、血浆白蛋白、三酰甘油、总胆固醇水平。观察2组不良反应发生情况。结果 2组的临床治疗总有效率和复发率比较差异均无统计学意义（均P＞0.05）。治疗3、6、12个月后，2组24 h尿蛋白定量、三酰甘油、总胆固醇水平均低于治疗前，而血浆白蛋白水平高于治疗前，差异均有统计学意义（均P＜0.05）；2组血尿素氮、血肌酐水平与治疗前比较差异均无统计学意义（均P＞0.05）。治疗3、6个月后，2组效果相似，以上指标差异无统计学意义（均P>0.05）。治疗12个月后，观察组24 h尿蛋白定量低于对照组，血浆白蛋白水平高于对照组［（1.14±0.76）g比（2.87±0.93）g、（36±8）g/L比（32±8）g/L］，差异均有统计学意义（均P＜0.05）。观察组治疗期间不良反应总发生率明显低于对照组［20.9%（9/43）比46.5%（20/43）］，差异有统计学意义（P＜0.05）。结论 来氟米特和环孢素A在治疗难治性NS方面均有较好的疗效。与环孢素A相比，来氟米特治疗期间不良反应总发生率低，安全性高、效果持久稳定。

• Objective To compare the clinical effects and safety of leflunomide and cyclosporin A on the treatment of primary refractory nephrotic syndrome （NS）. Methods A total of 86 patients with primary refractory NS hospitalized in Beijing Consuition Center of Chinese and Western Medicine for Compucated Kidney Disease, the Second Medical Center of PLA General Hospital and the Sixth Medical Center of PLA General Hospital from January 2015 to July 2017 were recruited. The patients were randomly divided into observation group and control group, with 43 cases in each group. Both groups were given prednisone and conventional symptomatic treatment, the observation group was treated with leflunomide on the basis of routine intervention, and the control group was treated with cyclosporine A on the basis of routine intervention. The clinical curative effect and the levels of 24 h urine protein qualification, blood urea nitrogen(BUN), serum creatinine(Scr), plasma albumin(ALB), triglycerides(TG), total cholesterol(TC) of the two groups were observed before the treatment and 3, 6 and 12 months after treatment. The adverse reactions of the two groups were observed. Results  There were no statistical differences between the two groups in the total clinical effective rate and recurrence rate(both P>0.05). After 3, 6 and 12 months of treatment, the 24 h urine protein qualification, TG and TC levels of the two groups were lower than those before treatment, while the plasma ALB level was higher than that before treatment(all P<0.05), and there were no statistical differences in BUN and Scr levels in the two groups before and after treatment（all P＞0.05）. After 3 and 6 months of treatment, there were no differences in above indicators between the two groups(all P>0.05). After 12 months of treatment, the 24 h urine protein qualification in the observation group was lower than that in the control group, and the ALB level in the observation group was higher than that in the control group［（1.14±0.76）g vs （2.87±0.93）g, （36±8）g/L vs （32±8）g/L］(both P<0.05). The total incidence of adverse reactions in the observation group was significantly lower than that in the control group［20.9%（9/43） vs 46.5%（20/43）］(P<0.05). Conclusions Both leflunomide and cyclosporin A have good efficacy in the treatment of refractory NS. Compared with cyclosporine A, the patients treated with leflunomide have lower total incidence of adverse reactions, high safety and long-lasting effect.