Mei Mei, Zeng Jun, Fang Li, Xiang Sha, Sun Haili, Wen Chaolin, Chai Liyin, Chen Xinqing, Li Zhuhong, Li Ning, Shen Bingbing
Department of Nephrology, People's Hospital of Shapingba District, Chongqing University Shapingba Hospital, School of Medicine, Chongqing University, Chongqing, China.
Department of Nephrology, The First Hospital Affiliated to Army Medical University, Chongqing, China.
Int Urol Nephrol. 2025 Jan;57(1):187-196. doi: 10.1007/s11255-024-04156-9. Epub 2024 Jul 17.
Although sodium glucose cotransporter2 inhibitor (SGLT-2I) is widely used in clinical practice, sufficient renin-angiotensin system (RAS) inhibition remains the cornerstone of diabetic kidney disease (DKD) treatment. The aim of this single-center study was to evaluate the efficacy and safety of dual RAS blockade compared with angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB) monotherapy in non-elderly DKD patients with preserved eGFR (WHO Standard, < 60y).
This single-center study was registered in Chinese Clinical Trial Registry (ChiCTR1900024752), and approved by the ethical committee (KY201994). In this study, we recruited non-elderly type 2 diabetes volunteers with initial diagnosis of DKD to receive dual RAS blockade or monotherapy. 150 non-elderly DKD patients with preserved eGFR were recruited. The patients were randomly divided into dual RAS blockade group and monotherapy group. The dual RAS blockade group treatment regimen was an 80 mg valsartan plus a 4 mg perindopril tert-butylamine per day. At the same time, monotherapy group patients who received the 8 mg perindopril tert-butylamine or 160 mg valsartan monotherapy. The clinical data of the three groups were compared at baseline and collected during the follow-up period of 12 months.
The baseline of patients who received dual RAS blockade was similar to that of monotherapy group. After 12 months of treatment, the median level of proteinuria in the dual RAS blockade group was significantly lower than that in the monotherapy group. There was no significant difference in the estimated glomerular filtration rate (eGFR) level, potassium, blood pressure and no serious adverse reactions.
In non-elderly DKD patients with preserved eGFR, dual RAS blockade is superior to control proteinuria, and does not increase the probability of adverse reactions such as hyperkalemia, hypotension and acute kidney injury in 12 months.
尽管钠-葡萄糖协同转运蛋白2抑制剂(SGLT-2I)在临床实践中被广泛应用,但充分抑制肾素-血管紧张素系统(RAS)仍是糖尿病肾病(DKD)治疗的基石。本单中心研究的目的是评估在估算肾小球滤过率(eGFR)保留的非老年DKD患者(世界卫生组织标准,<60岁)中,与血管紧张素转换酶抑制剂(ACEI)/血管紧张素II受体阻滞剂(ARB)单药治疗相比,双重RAS阻断的疗效和安全性。
本单中心研究已在中国临床试验注册中心注册(ChiCTR1900024752),并获得伦理委员会批准(KY201994)。在本研究中,我们招募了初诊为DKD的非老年2型糖尿病志愿者接受双重RAS阻断或单药治疗。招募了150例eGFR保留的非老年DKD患者。患者被随机分为双重RAS阻断组和单药治疗组。双重RAS阻断组的治疗方案是每天服用80毫克缬沙坦加4毫克培哚普利叔丁胺。同时,单药治疗组患者接受8毫克培哚普利叔丁胺或160毫克缬沙坦单药治疗。在基线时比较三组的临床数据,并在12个月的随访期内收集。
接受双重RAS阻断的患者基线与单药治疗组相似。治疗12个月后,双重RAS阻断组的蛋白尿中位数水平显著低于单药治疗组。估算肾小球滤过率(eGFR)水平、血钾、血压无显著差异,且无严重不良反应。
在eGFR保留的非老年DKD患者中,双重RAS阻断在控制蛋白尿方面优于单药治疗,且在12个月内不会增加高钾血症、低血压和急性肾损伤等不良反应的发生概率。