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目的探讨多靶点免疫抑制剂治疗儿童激素耐药型肾病综合征(SRNS)疗效及安全性。方法选择2013年9月至2015年10月安徽省儿童医院等5家医疗机构的SRNS患儿48例,在综合治疗基础上随机分为两组:(1)观察组:给予环孢素(CSA)[3~4 mg/(kg·d)]联合霉酚酸酯(MMF)[20 mg/(kg·d)]多靶点治疗;(2)对照组:给予CSA[4~6 mg/(kg·d)]。治疗期间严密监测各组不良反应,分别于治疗后2周、1个月、3个月、6个月测定患儿CSA浓度、尿蛋白/尿肌酐、肝肾功能、血常规、尿常规等。结果治疗期间观察组CSA平均血药浓度为(88.76±16.94)μg/L,对照组为(152.96±19.20)μg/L(P<0.001)。治疗1、3个月,观察组尿蛋白/尿肌酐与对照组同时间尿蛋白/尿肌酐相比下降(P<0.05)。治疗1、3个月,观察组血浆白蛋白与对照组同时间血浆白蛋白相比升高(P<0.05)。治疗期间两组尿β2-微球蛋白相比差异无统计学意义(P>0.05)。观察组总缓解率为88%,对照组总缓解率为87%。观察组在治疗2周、1个月时缓解率优于对照组(P<0.05)。治疗期间主要的副反应有感染、胃肠道反应、多毛、高血压、白细胞下降。观察组在治疗期间不良反应发生率明显低于对照组(P<0.05)。结论 CSA联合MMF可以使SRNS患儿早期即可得到缓解,也可与单用CSA一样维持长期缓解,但副反应更小。
Objective To investigate the efficacy and safety of multi-targeted immunosuppressants in the treatment of steroid-resistant nephrotic syndrome (SRNS) in children. Methods Forty-eight children with SRNS were selected from 5 medical institutions in Anhui Provincial Children’s Hospital from September 2013 to October 2015. The patients were randomly divided into two groups on the basis of comprehensive treatment: (1) Observation group: CsA (3 ~ 4 mg / (kg · d)] combined with mycophenolate mofetil (MMF) [20 mg / (kg · d) (kg · d)]. During treatment, adverse reactions in each group were closely monitored. Concentrations of CSA, urinary protein / creatinine, liver and kidney function, blood routine and urine routine in children were measured at 2 weeks, 1 month, 3 months and 6 months after treatment. Results The average CSA concentration of observation group was (88.76 ± 16.94) μg / L during the treatment period and (152.96 ± 19.20) μg / L in the control group (P <0.001). At 1 and 3 months after treatment, urinary protein / creatinine in the observation group was lower than that in the control group at the same time (P <0.05). After 1 and 3 months of treatment, plasma albumin in the observation group was higher than that in the control group at the same time (P <0.05). There was no significant difference in urine β2-microglobulin between two groups during treatment (P> 0.05). The observation group, the total remission rate was 88%, the control group, the overall response rate was 87%. The observation group was better than the control group in the treatment of 2 weeks and 1 month (P <0.05). During the treatment of the main side effects of infection, gastrointestinal reactions, hirsutism, high blood pressure, leukopenia. The incidence of adverse reactions in observation group during treatment was significantly lower than that in control group (P <0.05). Conclusions CSA combined with MMF can relieve the early stage of SRNS in children. It can also maintain the long-term remission as with CSA alone, but with less side effects.