The evaluation of clinical efficacy and safety of Huangqi Dihuang decoction combined with cyclophosphamide in the treatment of refractory nephrotic syndrome
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摘要: 目的：探讨黄芪地黄汤联合环磷酰胺治疗难治性肾病综合征的临床疗效及安全性。方法：难治性肾病综合征病人96例，按照随机数字表法分为观察组和对照组，各48例。对照组给予环磷酰胺治疗，观察组在对照组基础上联合黄芪地黄汤治疗。2组疗程均为6个月。比较2组病人治疗有效率、治疗前后肾功能指标尿素氮、血肌酐和24 h尿蛋白、白介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）水平以及不良反应情况。结果：观察组总有效率95.83%，高于对照组的79.17%（P<0.05）；2组治疗后尿素氮、血肌酐、24 h尿蛋白水平和血清IL-6、TNF-α水平均较治疗前明显下降（P<0.01），且观察组相应指标的下降幅度均明显大于对照组（P<0.01）；2组病人均无明显药物不良反应。结论：黄芪地黄汤联合环磷酰胺治疗难治性肾病综合征临床疗效确切，且安全性良好，其作用可能与改善肾功能和降低24 h尿蛋白、IL-6和TNF-α水平有关。Abstract: Objective:To investigate the clinical efficacy and safety of Huangqi Dihuang decoction combined with cyclophosphamide in the treatment of refractory nephrotic syndrome.Methods:Ninety-six patients with refractory nephrotic syndrome were randomly divided into the observation group and control group(48 cases each group).The control group was treated with cyclophosphamide,and the observation group was treated with Huangqi Dihuang decoction based on the control group for 6 months.The effective rate of treatment,levels of urea nitrogen(BUN),serum creatinine(Scr),24 h urinary protein,interleukin-6(IL-6) and tumor necrosis factor-α(TNF-α) before and after treatment,and adverse reactions between the two groups were compared.Results:The total effective rate in observation group(95.83%) was higher than that in control group(79.17%)(P<0.05).Compared with before treatment,the levels of BUN and Scr,24 h urine protein,IL-6 and TNF-α in two groups significantly decreased after treatment (P<0.01),and the decreasing levels of BUN and Scr,24 h urine protein,IL-6 and TNF-α in observation group were significantly lower than those in control group(P<0.01).No obvious adverse drug reactions in two groups were found.Conclusions:Huangqi Dihuang decoction combined with cyclophosphamide in the treatment of refractory nephrotic syndrome is effective and safe,which may be related to the improvement of renal function and decreasing levels of 24 h urinary protein,IL-6 and TNF-α.
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