肾炎康复片联合来氟米特治疗系膜增生性肾炎的临床研究

Clinical study on Shenyan Kangfu Tablets combined with leflunomide in treatment of mesangial proliferative nephritis

目的探讨肾炎康复片联合来氟米特治疗系膜增生性肾炎的临床效果。方法选取2015年9月-2018年9月中国人民解放军成都军区总医院收治的80例系膜增生性肾炎患者,随机分成对照组(n=40)和治疗组((n=40)。对照组口服来氟米特片,50 mg/次,1次/d,连服3 d,之后以负荷剂量20 mg/d(20 mg/次,1次/d)维持。治疗组在对照组基础上口服肾炎康复片,5片/次,3次/d。两组均连续治疗6个月。观察两组的临床疗效,比较两组治疗前后肾功能指标、血清学指标、欧洲五维健康量表(EQ-5D)评分的变化情况。结果治疗后,对照组和治疗组的总有效率分别是80.0%、95.0%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组尿红细胞(RBC)计数、24 h尿蛋白定量(24 h-UTP)、肌酐(Cr)、尿素氮(BUN)均显著低于治疗前,同组治疗前后比较差异有统计学意义(P<0.05);治疗后,治疗组这些肾功能相关参数显著低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组血清干扰素γ(IFN-γ)、Ⅳ型胶原(ⅣC)、层粘连蛋白(LN)水平均显著降低,而白介素(IL)-10则均显著增高,同组治疗前后比较差异有统计学意义(P<0.05);治疗后,治疗组血清IFN-γ、ⅣC、LN水平显著低于对照组,而IL-10水平显著高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组EQ-5D健康效用值和EQ-VAS评分均较治疗前显著升高,同组治疗前后比较差异有统计学意义(P<0.05);治疗后,治疗组EQ-5D健康效用值和EQ-VAS评分均显著高于对照组,两组比较差异具有统计学意义(P<0.05)。结论肾炎康复片联合来氟米特治疗系膜增生性肾炎的整体疗效确切,可有效改善患者肾功能,纠正Th1/Th2免疫失衡,提高患者生命质量,具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Shenyan Kangfu Tablets combined with leflunomide in treatment of mesangial proliferative nephritis.Methods 80 Patients with mesangial proliferative nephritis from September 2015 to September 2018 were randomly divided into control group(n=40)and treatment group(n=40).Patients in the control group were po administered with Leflunomide Tablets,50 mg/time,once daily,for 3 d.The load dosage was then maintained at 20 mg/d(20 mg/time,once daily).Patients in the treatment group were po administered with Shenyan Kangfu Tablets,5 tablets/time,three times daily.Patients in two groups were treated for 6 months.After treatment,the clinical efficacy was evaluated,and the changes of renal function indexes,serological indexes and EQ-5 D scores in two groups were compared.Results After treatment,the clinical efficacy in the control and treatment groups were 80.0%and 95.0%,respectively,and there were differences between two groups(P<0.05).After treatment,RBC,24 h-UTP,Cr,and BUN in two groups were significantly decreased,and there were differences in the same group(P<0.05).After treatment,those renal function indexes in the treatment group were significantly lower than those in the control group,and there were differences between two groups(P<0.05).After treatment,IFN-γ,ⅣC,and LN in two groups were significantly decreased,but IL-10 were significantly increased,and there were differences in the same group(P<0.05).After treatment,IFN-γ,ⅣC,and LN in the treatment group were lower than those in the control group,but IL-10 were higher than those in the control group,and there were differences between two groups(P<0.05).After treatment,EQ-5 D health utility value and EQ-VAS score in both groups were significantly higher than those before treatment,and there were differences in the same group(P<0.05).After treatment,EQ-5 D health utility value and EQ-VAS score in the treatment group were significantly higher than those in the control group,and there were differences between two groups(P<0.05).Conclusion Shenyan Kangfu Tablets combined with leflunomide has overall accurate efficacy in treatment of mesangial proliferative nephritis,and can effectively improve the renal function of patients,and can correct Th1/Th2 immune imbalance,and also can improve the life quality,which has a certain clinical application value.