Abstract:

Objective　To explore the effect of fineridone combined with sodium-dependent glucose transporters 2 (SGLT2) inhibitor on cardiorenal outcomes in diabetes mellitus complicated with chronic kidney disease (CKD) patients. Methods　This study was a prospective study. A total of 82 patients with diabetes and CKD who were treated at the Second Affiliated Hospital of Xi'an Medical University from March 2022 to March 2024 were selected for this study. They were randomly divided into a control group and a study group, with 41 cases in each group, using the envelope method. The control group consisted of 24 males and 17 females, with an average age of (58.22±6.55) years. The study group included 22 males and 19 females, with an average age of (59.02±6.44) years. The control group received SGLT2 inhibitor (dapagliflozin) plus placebo (starch tablets simulating Finerenone), while the study group received SGLT2 inhibitor (dapagliflozin) combined with Finerenone. Both groups were treated continuously for 3 months. Clinical efficacy, laboratory indicators of cardiovascular and renal function before and after treatment, and cardiovascular and renal outcomes were compared. Statistical analysis was performed using t tests, χ² tests, and Fisher's exact probability method. Results　The overall clinical effective rate in the study group was higher than that in the control group [95.12% (39/41) vs. 80.49% (33/41)], with a statistically significant difference (χ²=4.100, P=0.043). After treatment, levels of brain natriuretic peptide, urinary albumin excretion rate, and blood urea nitrogen in the study group were lower than those in the control group [(142.63±28.74) ng/L vs. (210.26±38.78) ng/L; (98.52±18.63) mg/24 h vs. (130.85±25.63) mg/24 h; (7.22±2.01) mmol/L vs. (9.18±2.37) mmol/L], with all differences being statistically significant (t=8.971, 6.533, 4.039; all P<0.001). The incidence of the primary endpoint in the study group was lower than that in the control group [9.76% (4/41) vs. 26.83% (11/41)] (χ²=3.998, P=0.046), with 2 cardiovascular events and 2 renal events in the study group, compared to 7 cardiovascular events and 4 renal events in the control group. The incidence of newly developed proteinuria in the study group was lower than that in the control group [4.88% (2/41) vs. 19.51% (8/41)] (χ²=4.100, P=0.043). There were no statistically significant differences in all-cause mortality, hyperkalemia incidence, and drug safety between the two groups (all P>0.05). Conclusion　The combination of finerenone and SGLT2 inhibitor in patients with diabetes and CKD can enhance clinical efficacy, improve cardiac and renal functions, and optimize cardiac and renal outcomes, making it worthy of promotion and application.

Key words:

Diabetes mellitus, Chronic kidney disease, Finerenone, SGLT2 inhibitor, Cardiorenal outcomes

摘要：

目的　探讨非奈利酮联合钠-葡萄糖协同转运蛋白2（sodium-dependent glucose transporters 2，SGLT2）抑制剂对糖尿病合并慢性肾脏病（chronic kidney disease，CKD）患者心肾结局的影响。方法　本研究为前瞻性研究。选择2022年3月至2024年3月西安医学院第二附属医院接诊的糖尿病合并CKD患者82例为研究对象，信封法随机分为对照组和研究组，各41例。对照组男24例、女17例，年龄（58.22±6.55）岁。研究组男22例、女19例，年龄（59.02±6.44）岁。对照组采用SGLT2抑制剂（达格列净）+安慰剂（模拟非奈利酮，淀粉片）治疗，研究组采用SGLT2抑制剂（达格列净）联合非奈利酮治疗。两组均连续治疗3个月。比较两组临床疗效、治疗前后心肾功能实验室指标水平、心肾结局。采用t、χ²检验和Fisher确切概率法进行统计分析。结果　研究组患者的总有效率高于对照组［95.12%（39/41）比80.49%（33/41）］，差异有统计学意义（χ²=4.100，P=0.043）。治疗后，研究组的脑钠肽、尿白蛋白排泄率、尿素氮均低于对照组［（142.63±28.74）ng/L比（210.26±38.78）ng/L、（98.52±18.63）mg/24 h比（130.85±25.63）mg/24 h、（7.22±2.01）mmol/L比（9.18±2.37）mmol/L］，差异均有统计学意义（t=8.971、6.533、4.039，均P<0.001）。研究组的主要终点总发生率低于对照组［9.76%（4/41）比26.83%（11/41）］（χ²=3.998，P=0.046），其中研究组发生心血管事件2例、肾脏事件2例，对照组发生心血管事件7例、肾脏事件4例；研究组次要终点中的新发蛋白尿发生率低于对照组［4.88%（2/41）比19.51%（8/41）］（χ²=4.100，P=0.043）；两组全因死亡率、高钾血症发生率和药物安全性比较，差异均无统计学意义（均P>0.05）。结论　非奈利酮联合SGLT2抑制剂应用于糖尿病合并CKD患者，可提高临床疗效、改善心肾功能、优化心肾结局，值得推广应用。

关键词:

糖尿病, 慢性肾脏病, 非奈利酮, SGLT2抑制剂, 心肾结局