降尿酸中药方对慢性肾脏病3~5期合并高尿酸血症患者的作用

目的:观察改良四妙散方联合非布司他降低尿酸对慢性肾脏病(chronic kidney disease,CKD)3~5期合并高尿酸血症患者的作用,评估中药方联合非布司他降尿酸的安全性及有效性。方法:选择2018年4月至2019年4月在上海市静安区闸北中心医院治疗、年龄18~75岁、CKD 3~5期合并高尿酸血症的患者120例,随机分为两组,每组60例。观察组用降尿酸中药方联合半剂量非布司他(20 mg,qd),对照组单用非布司他(40 mg,qd)降尿酸治疗。分别检测治疗0、3、6个月患者的血清肌酐、血尿素氮、血尿酸、尿蛋白等指标,记录治疗前后的中医症候积分,以估算肾小球滤过率(estimated glomerular filtration rate,eGFR)的降幅>10%、进行透析、发生心脑血管事件为观察终点事件。结果:与治疗前相比,观察组患者治疗6个月的eGFR升高[(28.01±13.37)ml/(min·1.73 m²)vs(23.36±10.80)ml/(min·1.73 m²)]、血尿素氮下降[(12.52±4.58)mmol/L vs(14.62±4.99)mmol/L],血尿酸下降[(325.32±43.45)μmol/L vs(543.53±54.75)μmol/L],24 h尿蛋白下降[(1624.32±1153.00)mg/d vs(2156.01±1322.43)mg/d],差异均有统计学意义(P<0.05)。观察组患者的中医症候积分明显降低,与对照组比较,差异有统计学意义(P<0.05)。观察组有1例患者到达终点事件;对照组有3例患者到达终点事件,其中1例进行血液透析治疗。观察组和对照组的降尿酸治疗有效率分别为98.3%和91.7%,差异无统计学意义(P=0.173)。结论:降尿酸中药方联合半剂量非布司他降尿酸治疗,能够明显降低尿酸,提高eGFR,明显改善CKD 3~5期合并高尿酸血症患者的临床症状,表明治疗安全、有效。

Effect of traditional Chinese medicine formula for lowering uric acid in the patients with stage 3-5 chronic kidney disease complicated with hyperuricemia

Objective:To observe the effects of modified Simiao San combined with febuxostat to reduce uric acid in the patients with stage 3-5 chronic kidney disease(CKD)complicated with hyperuricemia,so as to evaluate the safety and combined effects of traditional Chinese medicine(TCM)formula and febuxostat.Methods:One hundred and twenty patients complicated with hyperuricemia with an age range of 18-75 years and stage 3-5 chronic kidney disease(CKD),who received treatment in Zhabei Central Hospital,Jing’an District of Shanghai from April 2018 to April 2019 were recruited for the study.They were randomly divided into 2 groups,each consisting of 60 patients.The observation group was treated with uric acid-lowering TCM formula and half-dose febuxostat(20 mg,qd),while the control group was treated with febuxostat(40 mg,qd)alone.The levels of serum creatinine,blood urea nitrogen,blood uric acid,urine protein and other indicators as well as TCM syndrome scores were detected before treatment and 3 and 6 months after treatment.Over 10%decrease of estimated glomerular filtration rate(eGFR),dialysis and occurrence of cardiovascular and cerebrovascular events were set as observation endpoints.Results:As compared with those before treatment,the level of eGFR in the observation group increased[(28.01±13.37)ml/(min·1.73 m²)vs(23.36±10.80)ml/(min·1.73 m²)],blood urea nitrogen decreased[(12.52±4.58)mmol/L vs(14.62±4.99)mmol/L],blood uric acid decreased[(325.32±43.45)μmol/L vs(543.53±54.75)μmol/L]and 24 h urine protein decreased[(1624.32±1153.00)mg/d vs(2156.01±1322.43)mg/d].Statistical significance could be noted when comparisons were made between the 2 groups(P<0.05).TCM syndrome scores of the observation group obviously deceased,and statistical significance could also be seen when compared with those of the control group(P<0.05).There was one patient in the observation group who reached the end point,but there were 3 patients in the control group who reached the end point,in which 1 patient underwent hemodialysis.The effective rates of uric acid-lowering treatment in the observation group and control group were 98.3%and 91.7%respectively,without statistical significance(P=0.173).Conclusion:Uric acid-lowering TCM combined with half-dose febuxostat could significantly reduce uric acid,increase eGFR,and significantly alleviate clinical symptoms of stage 3-5 CKD complicated with hyperuricemia,indicating that the treatment is safe and effective.