在慢性肾病管理平台架构下探讨“益肾清利泄浊方”治疗慢性肾脏病5期的疗效及安全性

Efficacy and Safety of Yishen Qingli Xiezhuo Recipe for Treating Patients with Chronic Kidney Disease Stage 5 Under the Framework of Chronic Kidney Disease Management Platform

目的利用江苏省中医院肾内科临床-科研-慢病管理数据平台提取真实世界数据观察益肾清利泄浊方对慢性肾脏病(Chronic kidney disease,CKD)5期非透析患者的治疗作用。方法2010年10月1日至2019年1月31日在南京中医药大学附属医院肾内科CKD管理系统内的有随访记录的CKD5期患者共203例,其中随访超过6个月患者共126例(62%)纳入数据分析,比较6个月治疗过程前后血清肌酐(serum creatinine,SCr)、尿素氮(blood urea nitrogen,BUN)、估算肾小球滤过率(estimated glomerular filtration rate,eGFR)、24小时尿蛋白定量,血红蛋白(hemoglobin,Hb)、白蛋白(albumin,ALB),血钙(calcium,Ca),血磷(phosphorus,P),血压变化情况以及安全性指标。结果与基线数据比较,在观察期内肾功能改善显著,eGFR从基线10.7 mL/min/(1.73 m^2)在第1月末上升为13.2 mL/min/(1.73 m^2)(P<0.05),第2月末上升为15.0 mL/min/(1.73 m^2)(P<0.05),在6个月观察期末上升为17.2 mL/min/(1.73 m^2),在6个月观察期末SCr、BUN、eGFR、Hb、ALB、Ca、P、尿蛋白定量、血压水平与基线比较,差异无统计学意义(P>0.05)。观察期间无严重不良事件发生。结论在CKD一体化基础治疗基础上加用益肾清利泄浊方能有效保护CKD5期非透析患者残余肾功能,延缓甚至在一定时期内逆转肾功能减退并具有良好的安全性。

Objective To evaluate the effect of Yishen Qingli Xiezhuo Recipe for treating patients with CKD stage 5(predialysis)by using the chronic disease management data platform of Department of Nephrology,Jiangsu Provincial Hospital of Traditional Chinese Medicine.Methods From October 2010 to January 2019,there were a total of 203 patients with CKD stage 5 who had follow-up records in the chronic disease management data platform,therein 126 patients who were followed up for more than 6 months(62%).Serum creatinine(Scr),blood urea nitrogen(BUN),evaluated glomerular filtration rate(eGFR),24-hour urine protein quantitation,hemoglobin(Hb),albumin(ALB),serum calcium(Ca),serum phosphorus(P)and blood pressure were compared before and after 6 months of treatment.Results Compared with baseline,renal function was improved significantly during the 6-month observation period.eGFR increased from 10.7 mL·min^-1 to 13.2 mL·min^-1,15 mL·min^-1 17.2 mL/min/1.73 m^2 at the end of first month,second month and the end of 6 months(P<0.05).There was no significant difference in Scr,BUN,Hb,ALB,Ca,P,urinary protein quantification and blood pressure at the end of 6 months(P>0.05).There were no serious adverse events during the observation period.Conclusion Yishen Qingli Xiezhuo Recipe with basis treatment can effectively protect residual renal function and delay and even reverse the progression of renal dysfunction in patients with CKD stage 5(pre-dialysis)and have favorable safety.