非布司他治疗CKD3-4期糖尿病肾病合并高尿酸血症的疗效

doi:10.3969/j.issn.2095-9400.2020.05.006

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摘要目的：通过前瞻性随机对照试验研究非布司他治疗CKD3期和CKD4期糖尿病肾病（DN）伴高尿酸血症（HUA）患者的疗效及安全性。方法：收集2017年1月至2019年6月温州医科大学附属第二医院门诊及住院的DN[肾小球滤过率（eGFR）为15～59 mL/（min·1.73 m-2）]合并HUA患者作为研究对象，根据eGFR值分为CKD3期组[eGFR为30～59 mL/（min·1.73 m-2）]和CKD4期组[eGFR为15～29 mL/（min·1.73 m-2）]，随机数字表法将CKD3期组分为治疗组1和对照组1，CKD4期组分为治疗组2和对照组2，4组均控制血糖、血压、血脂及经过肾素血管紧张素抑制剂（RASI）治疗，治疗组在此基础上给予非布司他治疗，观察各组治疗24周后血尿酸（UA）、血肌酐（SCr）、血清胱抑素C（Cys-C）、eGFR、24小时尿蛋白定量、尿白蛋白与肌酐比值（ACR）、血尿中性粒细胞明胶酶相关脂质运载蛋白（NGAL）、血肾素-血管紧张素-醛固酮（RAAS）变化，并统计不良反应。结果：符合入选条件并完成试验的患者共95例，治疗组1为26例，对照组1为24例，治疗组2为23例，对照组2为22例，CKD3期治疗24周后2组间SCr、eGFR、尿蛋白定量、UA、Cys-C、ACR、血尿NGAL、血RAAS差异有统计学意义（ P ＜0.05）；CKD4期治疗24周后2组间血UA、SCr、eGFR、Cys-C、ACR、血尿NGAL、血RAAS差异有统计学意义（ P ＜0.05），而尿蛋白定量差异无统计学意义（ P ＞0.05）。治疗组1和治疗组2均无严重不良反应发生。治疗组1治疗24周后血UA达标率为95%；治疗组2治疗24周后血UA达标率为85%。结论：非布司他治疗能够改善CKD3、CKD4期DN合并HUA患者肾功能且较安全。

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关键词 ：非布司他, 糖尿病肾病, 高尿酸血症, 肾功能, 治疗

Abstract：Objective: To evaluate the effect of febuxostat on patients with CKD3 and CKD4 stage diabetic nephropathy (DN) with hyperuricemia (HUA) through prospective randomized controlled clinical studies. Methods: Diabetic nephropathy patients [glomerular leachate (eGFR) 15-59 mL/(min·1.73 m-2)] combined HUA, who were treated in the Second Affiliated Hospital of Wenzhou Medical University from January 2017 to June 2019, were recruited as subjects. According to the eGFR value, patients were divided into CKD3 group [eGFR is 30-59 mL/(min·1.73 m-2)] and CKD4 [eGFR is 15-29 mL/(min·1.73 m-2)]. CKD3 group was further divided randomly as treatment group 1 and control group 1. CKD4 group was further divided randomly as treatment group 2 and control group 2. Blood glucose, blood pressure, lipids controlling and renin angiotensin inhibitors (RASI) treatment were performed on all groups in the meantime. Febuxostat was given to patients in treatment group 1 and treatment group 2. Serum uric acid (UA), serum creatinine (SCr), serum cystayl C (Cys-C), eGFR, 24 hours of urine protein quantification, albumin creatinine Ratio (ACR), neutrophi gelatinase-associated lipocalin (NGAL) and renin-angiotensin- aldosterone system (RASS) were observed after 24 weeks. Results: A total of 95 patients completed the study and were qualified for selection, among whom 26 were in the treatment group 1, 24 in the control group 1, 23 in the treatment group 2 and 22 in the control group 2. Significant differences were observed in the distribution of UA, SCr, Cys-C, eGFR, 24 hours of urinary protein quantification, ACR, NGAL and RASS at 24 weeks between CKD 3 treatment group1 and control group 1. There were significant differences in the distribution of UA, SCr, Cys-C, eGFR, ACR, NGAL and RASS between CKD4 treatment group 2 and control group 2 (P<0.05), but no significant difference in urine protein quantification (P>0.05). In treatment group 1, the UA standard rate was 95% after 24 weeks of treatment. In treatment group 2, the UA standard rate was 85% after 24 weeks of treatment. Conclusion: Febustat can improve renal function in patients with CKD3 and CKD4 stage DN with HUA and has proved to be safe.

Key words： febuxostat diabetic nephropathy hyperuricemia kidney function treatment

收稿日期: 2019-11-09

基金资助:温州医科大学附属第二医院首届临床研究基金暨双五研究计划。

通讯作者: 朱永林，副主任医师，Email：1075540976@qq.com。

作者简介: 赵艳玲（1971-），辽宁彰武人，副主任医师，硕士。

链接本文:

https://xb.wmu.edu.cn/CN/ 10.3969/j.issn.2095-9400.2020.05.006 或 https://xb.wmu.edu.cn/CN/Y2020/V50/I5/382

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