他克莫司治疗老年激素抵抗型肾病综合征临床随机对照研究

RCT of Tacrolimus and Cyclophosphamide in Treating Hormone Resistant Nephrotic Syndrome

目的探讨他克莫司对激素抵抗型肾病综合征的应用价值。方法选择医院2012年4月至2014年1月收治的老年激素抵抗型肾病综合征患者70例,按随机分配原则将其分为观察组和对照组,各35例。观察组患者用他克莫司进行治疗,对照组患者给予环磷酰胺进行治疗。结果治疗4,8,12周后,观察组患者血浆白蛋白、总胆固醇及24 h尿蛋白改善情况与对照组相比有显著性差异(P<0.05),其中24 h尿蛋白的变化差异更显著(P<0.01);观察组治疗4周后,血浆白蛋白、总胆固醇及24 h尿蛋白与治疗前有明显差异(P<0.05);观察组患者总有效率为85.71%,显著高于对照组的65.71%(P<0.05),观察组有效患者中显著缓解及完全缓解比例为83.33%(25/30),对照组有效患者中显著缓解及完全缓解比例为69.57%(16/23)。结论他克莫司可纠正Th1/Th2平衡失调,治疗老年激素抵抗型肾病综合征有较好效果,可显著抑制机体自身免疫反应,减轻炎症对肾脏特别是肾小球的损伤,从而改善患者蛋白尿症状,使患者血浆白蛋白含量上升,总胆固醇及24 h尿蛋白的含量下降,肾病综合征的临床表征得以缓解,且效果显著,不良反应较基础疗法少,值得临床推广。

Objective To study the effect and application value of tacrolimus and cyclophosphamide in patients with steroid resistant nephrotic syndrome. Methods 70 patients with steroid resistant nephrotic syndrome were randomly divided into observation group and control group by random allocation principle,35 cases in each group. The observation group was treated by tacrolimus,and the control group was treated by cyclophosphamide. Results After treatment, the changes of serum albumin,total cholesterol,and urinary protein 24 h in the observation group after 4,8, 12 weeks administration of tacrolimus had statistically significant difference compared with the control group （P 〈 0.05）,and the change in 24 h urinary protein were more significantly different （P 〈 0.01）;comparison in the observation group showed that the changes of total cholesterol and 24 h urinary protein in the serum albumin steroid- resistant nephrot- ic syndrome patients with tacrolimus administered 4 weeks had statistically significant difference （P 〈 0. 05）;the total effective rate of the observation group was 85.71% ,which was significantly higher than of the control group 65.71% （P 〈 O. 05）,the rate of signifi- candy effective and complete remission in the observation group was 83.33% （25/30）,with the control group being 69.57% （16/23）. Conclusion Tacrolimus can correct the imbalance of Thl/Th2, has good effect in the treatment of elderly patients with steroid resistant nephrotie syndrome, can significantly inhibit the body＇s immune response, reduce inflammation of the kidney, especially glomerular dam- age,can improve the patient＇s protein urine symptoms,lower the level of plasma albumin,total cholesterol and 24 h urine protein con- tent,and alleviate the clinical manifestations of the nephrotie syndrome. It is simple and easy to operate, the effect is remarkable,the adverse reaction is less than the basic therapy,which is worthy of clinical promotion.