To observe clinical effect and safety of dapagliflozin tablets combined with metformin tablets in the treatment of patients with diabetic kidney disease (DKD).

According to cohort method, DKD patients were divided into control group and treatment group. The control group was given oral metformin tablets (0.5 g per time, twice a day), while treatment group was given oral dapagliflozin tablets (10 mg per time, once a day) on basis of control group. All patients were treated for 12 weeks. The clinical curative effect, glucose metabolism indexes [glycated hemoglobin (HbA1c), fasting blood glucose (FPG), 2 h postprandial blood glucose (2 h PG)], renal function [urine albumin/creatinine (UACR), serum creatinine (SCr), estimated glomerular filtration rate (eGFR)], renal vascular function [resistance index (RI), pulsatility index (PI), peak systolic velocity (PSV), end-diastolic velocity (EDV)], urine α-smooth muscle actin (SMA), membrane protein, transforming growth factor (TGF)-β1 and inflammatory factors [interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α] in the two groups were compared, and the safety was evaluated.

There were 40 cases in control group and 40 cases in treatment group. After treatment, difference in total response rate between treatment group and control group was statistically significant [92.50% (37 cases/40 cases) vs 72.50% (29 cases/40 cases), P<0.05]. After treatment, HbA1c levels in treatment group and control group were (6.52±0.76)% and (7.44±0.98)%; FPG levels were (7.11±1.05) and (8.05±1.21)mmol·L^-1; 2 h PG levels were (9.32±1.08) and (10.57±1.35) mmol·L^-1; UACR levels were (104.76±13.85) and (138.41±16.07)mg·g^-1; SCr levels were (82.27±10.38) and (101.68±13.54) μmol·L^-1; eGFR levels were (88.06±8.37) and (80.52±7.64) mL·min^-1·1.73 m^-2; RI levels were 0.51±0.10 and 0.65±0.13; PI were 1.15±0.24 and 1.49±0.31; PSV were (38.30±5.29) and (34.59±4.71) cm·s^-1; EDV were (15.73±2.49) and (13.41±2.02) cm·s^-1; levels of urine SMA were (26.31±2.39) and (30.47±2.86)kU·L^-1; levels of urine membrane protein were (528.41±50.78) and (581.65±57.22) μg·L^-1; levels of urine TGF-β1 were (85.01±9.82) and (102.94±13.57) μg·L^-1; levels of serum IL-1β were (26.93±3.36) and (40.14±4.57)ng·L^-1; levels of serum IL-6 were (14.36±1.59) and (17.94±2.01) ng·L^-1; levels of serum TNF-α were (30.22±3.37) and (43.81±4.06) ng·L^-1, and differences of all the above indexes between the two groups were statistically significant (all P<0.05). The adverse drug reactions were mainly on loss of appetite, diarrhea, fatigue and nausea in treatment group, while which were mainly on loss of appetite, headache and nausea in control group. There was no significant difference in total incidence of adverse drug reactions between treatment group and control group [12.50% (5 cases/40 cases) vs 7.50% (3 cases/40 cases), P>0.05].

Dapagliflozin combined with metformin can improve glucose metabolism, promote recovery of renal function and renal vascular function, regulate levels of SMA, membrane protein and TGF-β1, relieve inflammatory response and improve clinical curative effect in DKD patients.