四君子合温胆汤加减方治疗痛风性肾病的临床疗效观察

Clinical Observation of Gouty Nephropathy Treated by Modified Sijunzi Plus Wendan Decoction

【目的】评价四君子合温胆汤加减方治疗脾肾气虚夹痰瘀型早期痛风性肾病[肾小球滤过率(GFR)≥30 mL(/min·1.73 m^(2))]的有效性及安全性。【方法】将74例脾肾气虚夹痰瘀型早期痛风性肾病患者随机分为治疗组和对照组,每组各37例。2组患者均给予常规治疗(包括饮食治疗、碱化尿液和对症治疗等),在此基础上,对照组给予口服非布司他片治疗,治疗组给予非布司他片联合四君子合温胆汤加减方治疗,疗程为8周。观察2组患者治疗前后中医证候积分及血尿酸(SUA)、血肌酐(SCr)、尿素氮(BUN)、胱抑素C(Cys-C)、总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)等指标的变化情况,并评价2组患者的西医临床疗效、中医证候疗效及安全性。【结果】(1)治疗8周后,治疗组的西医临床疗效和中医证候疗效的总有效率分别为97.30%(36/37)、94.59%(35/37),对照组分别为75.68%(28/37)、43.24%(16/37),组间比较,治疗组的西医临床疗效和中医证候疗效均明显优于对照组(P<0.05)。(2)治疗后,2组患者的中医证候积分均较治疗前明显降低(P<0.05),且治疗组的降低作用明显优于对照组(P<0.05)。(3)治疗后,治疗组患者的SUA、Cys-C、BUN、SCr水平及对照组的SUA、BUN、SCr水平均较治疗前明显降低(P<0.05),且治疗组对SUA、Cys-C、BUN、SCr水平的降低作用均明显优于对照组(P<0.05)。(4)治疗后,对照组的TC、TG、LDL-C水平均无明显变化(P>0.05),而治疗组的TC、TG、LDL-C水平均较治疗前明显降低(P<0.05);组间比较,治疗组对TC、TG、LDL-C水平的降低作用均明显优于对照组(P<0.05)。(5)治疗过程中,2组患者均无明显的不良反应情况发生。【结论】在非布司他片基础上联合四君子合温胆汤加减方,能有效改善脾肾气虚夹痰瘀型早期痛风性肾病患者的肾功能、血脂情况及临床症状,其疗效优于单纯非布司他片治疗。

Objective To investigate the clinical efficacy and safety of the modified Sijunzi plus Wendan Decoction in the treatment of early gouty nephropathy with the estimated glomerular filtration rate≥30 mL(/min·1.73 m^(2))and differentiated as spleen and kidney qi deficiency mingling with phlegm and blood stasis.Methods A total of 74 qualified patients with early gouty nephropathy were randomly divided into treatment group and control group,and each group had 37 cases.The two groups were given conventional treatment such as dietary therapy,alkalization of urine and symptomatic treatment.And additionally,the control group was given oral use of Febuxostat Tablets,and the treatment group was given oral use of Febuxostat Tablets combined with the decoction of modified Sijunzi Decoction and Wendan Decoction.The treatment for the two groups covered a course of 8 weeks.Before and after treatment,the scores of traditional Chinese medicine(TCM)syndrome,and the levels of laboratory indexes of serum uric acid(SUA),serum creatinine(SCr),blood urea nitrogen(BUN),cystatin-C(Cys-C),total cholesterol(TC),triglyceride(TG),low-density lipoprotein cholesterol(LDL-C)in the two groups were observed.After treatment,the western medicine clinical efficacy,efficacy for TCM syndrome,and the clinical safety between the two groups were evaluated.Results(1)After treatment for 8 weeks,the total effective rate of western medicine clinical efficacy and efficacy for TCM syndrome in the treatment group were 97.30%(36/37)and 94.59%(35/37)respectively,and those in the control group were 75.68%(28/37)and 43.24%(16/37)respectively.The intergroup comparison showed that western medicine clinical efficacy and efficacy for TCM syndrome in the treatment group were superior to those in the control group,and the difference was statistically significant(P<0.05).(2)After treatment,the scores of TCM syndrome in the two groups were obviously decreased in comparison with those before treatment(P<0.05),and the decrease in the treatment group was superior to that in the control group(P<0.05).(3)After treatment,the levels of SUA,Cys-C,BUN and SCr in the treatment group and the levels of SUA,BUN and SCr in the control group were lowered in comparison with those before treatment(P<0.05),and the effect on decreasing the levels of SUA,Cys-C,BUN and SCr in the treatment group was superior to that in the control group(P<0.05).(4)After treatment,the levels of TC,TG and LDL-C in the control group showed no obvious changes(P>0.05),but the levels of TC,TG and LDL-C in the treatment group were significantly decreased in comparison with those before treatment(P<0.05).The intergroup comparison showed that the treatment group had stronger effect on decreasing the levels of TC,TG and LDL-C than the control group(P<0.05).(5)During the treatment,no obvious adverse reactions were found in both groups.Conclusion Oral use of Febuxostat Tablets combined with the modified Sijunzi plus Wendan Decoction exerts certain effect on improving the renal function,blood lipid and clinical symptoms in the treatment of early gouty nephropathy with the syndrome of spleen and kidney qi deficiency mingling with phlegm and blood stasis.And the efficacy of the combined therapy is superior to that of oral use of Febuxostat Tablets alone.