黄芪当归合剂联合他克莫司对难治性肾病综合征患者免疫功能及肾功能的影响

Effects of Astragalus Angelica Mixture combined with tacrolimus on immune and renal functions in patients with refractory nephrotic syndrome

目的观察黄芪当归合剂联合他克莫司对难治性肾病综合征患者免疫功能及肾功能的影响。方法将126例难治性肾病综合征患者随机分为治疗组和对照组,每组63例。对照组予他克莫司及对症治疗,治疗组在对照组基础上加用黄芪当归合剂。两组疗程均为6个月,观察临床疗效、T淋巴细胞亚群(CD4^+、CD8^+、CD4^+/CD8^+)、血肌酐(SCr)、尿素氮(BUN)、肾小球滤过率(GER)、24 h尿蛋白定量、血清白蛋白水平变化情况,以及不良反应发生情况。结果①治疗组、对照组总有效率分别为98.4%、88.9%;组间临床疗效比较,差异有统计学意义(P<0.05)。②治疗前后组内比较,两组CD4^+、CD8^+、CD4^+/CD8^+水平差异均有统计学意义(P<0.05);组间治疗后比较,治疗组CD8^+水平低于对照组,CD4^+、CD4^+/CD8^+水平高于对照组,差异有统计学意义(P<0.05)。③治疗前后组内比较,两组SCr、BUN、24 h尿蛋白定量及血清白蛋白水平均有改善(P<0.05);组间治疗后比较,治疗组SCr、BUN、24 h尿蛋白定量水平低于对照组,血清白蛋白、GFR水平高于对照组,差异有统计学意义(P<0.05)。④试验期间,两组不良反应发生率分别为11.11%、31.74%,治疗组明显低于对照组(P<0.05)。结论黄芪当归合剂联合他克莫司治疗难治性肾病综合征的临床疗效优于单用他克莫司,能显著改善患者的免疫功能、肾功能,并且安全性高。

Objective To study the effects of Astragalus Angelica Mixture combined with tacrolimus on immune and renal functions in patients with refractory nephrotic syndrome.Methods 126 patients with refractory nephrotic syndrome were assigned into treatment group and control group,63 patients in each group.Patients in both groups were given tacrolimus and symptomatic treatment,and those in the treatment group were treated with Astragalus Angelica Mixture in addition.The treatment course was 6 months.Clinical efficacy,changes in T lymphocyte subsets(CD4^+,CD8^+,CD4^+/CD8^+),serum creatinine(SCr),urea nitrogen(BUN),glomerular filtration rate(GFR),24 h urine protein quantitation and serum albumin level,as well as the occurrence of adverse reactions were observed.Results(1)The total effective rate was 98.4%and 88.9%in the treatment group and the control group respectively;there were statistically significant differences in clinical efficacy between the groups(P<0.05).(2)There were statistically significant differences in the levels of CD4^+,CD8^+and CD4^+/CD8^+in both groups after treatment compared to those before treatment(P<0.05);after treatment,the level of CD8^+was lower in the treatment group than in the control group,and the levels of CD4^+and CD4^+/CD8^+were higher in the treatment group than in the control group,with statistically significant differences(P<0.05).(3)The levels of SCr,BUN,24 h urinary protein quantitation and serum albumin improved in both groups after treatment compared to those before treatment(P<0.05);after treatment,the levels of SCr,BUN and 24 h urinary protein quantitation were lower in the treatment group than in the control group,and the levels of serum albumin and GFR were higher in the treatment group than in the control group,with statistically significant differences(P<0.05).(4)During the trial,the incidence of adverse reactions in the treatment group(11.11%)was significantly lower than that in the control group(31.74%)(P<0.05).Conclusion Astragalus Angelica Mixture combined with tacrolimus has superior clinical efficacy to tacrolimus alone in the treatment of refractory nephrotic syndrome,which significantly improves immune and renal functions and is safe.