钠-葡萄糖协同转运蛋白2抑制剂联合金匮肾气丸对Ⅲ、Ⅳ期糖尿病肾病的应用效果研究

Study on the efficacy of SGLT-2 inhibitors combined with Jinkui Shenqi Pill in patients with stage Ⅲ-Ⅳ diabetic kidney disease

摘要:

目的 评估在标准降糖及肾脏保护方案基础上加用金匮肾气丸，对Ⅲ、Ⅳ期糖尿病肾病患者肾功能、氧化-炎症状态及生活质量的影响和安全性。方法 回顾性选取2022年2月—2025年2月大庆市龙南医院126例Ⅲ、Ⅳ期糖尿病肾病患者为研究对象，均接受常规标准降糖治疗，对照组（63例）接受钠-葡萄糖协同转运蛋白2抑制剂（SGLT-2I），观察组（63例）在对照组基础上加用金匮肾气丸。比较两组患者治疗前后的肾小球滤过率（eGFR）、尿白蛋白/肌酐比值（UACR）、24h尿白蛋白排泄率（AER）、肾小球-肾小管功能指标［尿总蛋白/肌酐比（uTP/Cr）、肾损伤分子-1（KIM-1）、中性粒细胞明胶酶相关脂质运载蛋白（NGAL）、N-乙酰-β-D-葡萄糖苷酶（NAG）］、氧化应激与炎症指标［超氧化物歧化酶（SOD）、谷胱甘肽过氧化物酶（GSH-Px）、丙二醛（MDA）］、血糖指标［糖化血红蛋白（HbA1c）、空腹血糖（FPG）］、肾脏疾病生活质量（KDQOL-36）评分，以及不良事件。结果 两组治疗第8周，观察组eGFR高于对照组，UACR、24h AER均低于对照组（P <0.05）；观察组uTP/Cr、尿KIM-1、尿NGAL、尿NAG均低于对照组（P <0.05）；观察组SOD、GSH-Px均高于对照组，血浆MDA、尿MDA均低于对照组（P <0.05）。观察组治疗前后HbA1c、FPG差值均高于对照组（P <0.05）。观察组KDQOL-36评分各维度均高于对照组（P <0.05）。观察组患者不良事件总发生率低于对照组（P <0.05）。结论 在SGLT-2I基础上联合金匮肾气丸，能显著减缓Ⅲ、Ⅳ期糖尿病肾病患者肾功能衰退，降低蛋白尿与肾小管损伤，改善氧化-炎症状态与生活质量，减少总体不良反应。

Abstract:

Objective To evaluate the effects and safety of adding Jinkui Shenqi Pill to standard hypoglycemic and renal protection regimens on renal function, oxidative-inflammatory status, and quality of life in patients with stage Ⅲ-Ⅳ diabetic kidney disease (DKD).Methods A total of 126 patients with stage Ⅲ–Ⅳ DKD treated in Longnan Hospital of Daqing from February 2022 to February 2025 were retrospectively enrolled. All patients received routine standard hypoglycemic treatment. The control group (63 cases) received sodium-glucose cotransporter 2 inhibitors (SGLT-2I), and the observation group (63 cases) received additional Jinkui Shenqi Pill on the basis of the control group. The estimated glomerular filtration rate (eGFR), urine albumin-creatinine ratio (UACR), 24-hour urinary albumin excretion rate (AER), glomerular-tubular function indexes (urine total protein/creatinine ratio, kidney injury molecule-1 [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL], N-acetyl-β-D-glucosaminidase [NAG] ), oxidative stress indicators (superoxide dismutase [SOD], glutathione peroxidase [GSH-Px], malondialdehyde [MDA] ), Kidney Disease Quality of Life (KDQOL-36) scores, glycemic indicators (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG] ), and adverse events were compared between the two groups before and after treatment.Results After 8 weeks of treatment, the observation group had higher eGFR, and lower UACR and 24h AER than the control group (P < 0.05). Urine total protein/creatinine ratio, urinary KIM-1, NGAL and NAG were lower in the observation group (P < 0.05). SOD and GSH-Px were higher, while plasma MDA and urinary MDA were lower in the observation group (P < 0.05). The pre-to-post-treatment reductions in HbA1c and FPG were greater in the observation group than in the control group (P < 0.05). All dimensions of KDQOL-36 scores were higher in the observation group (P < 0.05). The total incidence of adverse events was lower in the observation group (P < 0.05).Conclusion Combining Jinkui Shenqi Pill with SGLT-2 inhibitors significantly slows renal function decline, reduces proteinuria and tubular injury, improves oxidative-inflammatory status and quality of life, and lowers overall adverse events in stage Ⅲ-Ⅳ DKD patients.