中国药物应用与监测

目的 探讨大柴胡汤化裁联合达格列净治疗气虚血瘀证早期糖尿病肾病(DKD)的临床疗效。方法 选取2023年1月至2024年9月就诊于如皋博爱医院的气虚血瘀证早期DKD患者90例，按照随机数字表法分为观察组和对照组。对照组45例患者给予常规治疗联合达格列净片，观察组在对照组患者的基础上加用大柴胡汤化裁，两组患者的疗程均为12周。分析对照组和观察组患者治疗前与治疗12周后血糖、氧化应激、肾功能水平。比较对照组和观察组患者的临床疗效及不良反应发生率。结果 治疗12周后观察组患者的空腹血糖、糖化血红蛋白、丙二醛、尿微量白蛋白、血肌酐、尿白蛋白排泄率水平[分别为(5.82±0.76)mmol·L^-1、(6.58±0.47)%、(4.12±0.81)mmol·L^-1、(45.79±5.41)mg·L^-1、(92.58±9.37)μmol·L^-1、(75.26±10.56)μg·min^-1]均低于对照组[分别为(6.85±0.87)mmol·L^-1、(7.25±0.51)%、(5.76±1.03)mmol·L^-1、(56.14±7.38)mg·L^-1、(107.26±11.19)μmol·L^-1、(97.63±13.25)μg·min^-1]，差异有统计学意义(t=5.981、6.481、8.396、7.588、6.747、8.857,P<0.05)。治疗12周后观察组患者的超氧化物歧化酶水平[(35.32±4.39)μmol·L^-1]高于对照组[(27.56±4.18)μmol·L^-1]，差异有统计学意义(t=8.588,P<0.05)。观察组患者的总有效率(91.11%,41/45)高于对照组(73.33%,33/45)，差异有统计学意义(χ²=4.865,P<0.05)。观察组与对照组患者的不良反应发生率[15.56%(7/45) vs 11.11%(5/45)]比较，差异无统计学意义(χ²=0.385,P=0.535)。结论 大柴胡汤化裁联合达格列净能够有效降低气虚血瘀证早期DKD患者的血糖水平，改善氧化应激水平和肾功能，具有较好的临床疗效，且安全性良好。

Objective To explore the clinical efficacy of Modified Dachaihu Decoction combined with dapagliflozin in treating early diabetic kidney disease(DKD) with qi deficiency and blood stasis syndrome. Methods A total of 90 patients with early DKD who were treated at Rugao Bo'ai Hospital from January 2023 to September 2024 were selected and divided into the control group and the observation group according to a random number table method. The control group(45 cases) received conventional treatment combined with dapagliflozin tablets, and the observation group(45 cases) was additionally administered Dachaihu Decoction on the basis of the control group's treatment regimen. The treatment course for both groups was 12 weeks. The levels of blood glucose, oxidative stress and renal function were analyzed before treatment and after 12 weeks of treatment in both groups. The clinical efficacy and the incidence of adverse reactions were compared between the control group and the observation group. Results After 12 weeks of treatment, the levels of fasting blood glucose, glycated hemoglobin, malondialdehyde, urinary microalbumin, serum creatinine and urinary albumin excretion rate in the observation group((5.82±0.76) mmol·L^-1,(6.58±0.47)%,(4.12±0.81) mmol·L^-1,(45.79±5.41) mg·L^-1,(92.58±9.37) μmol·L^-1,(75.26±10.56) μg·min^-1, respectively) were lower than those in the control group((6.85±0.87) mmol·L^-1,(7.25±0.51)%,(5.76±1.03) mmol·L^-1,(56.14±7.38) mg·L^-1,(107.26±11.19) μmol·L^-1,(97.63±13.25) μg·min^-1, respectively), and the differences were statistically significant(t=5.981, 6.481, 8.396, 7.588, 6.747, 8.857, all P<0.05). After 12 weeks of treatment, the superoxide dismutase level in the observation group((35.32±4.39) μmol·L^-1) was higher than that in the control group((27.56±4.18) μmol·L^-1), and the difference was statistically significant(t=8.588, P<0.05). The total effective rate in the control group(91.11%(41/45)) was higher than that in the observation group(73.33%(33/45)), and the difference was statistically significant((χ²=4.865, P<0.05). No significant difference was observed in the incidence of adverse reactions between the two groups(15.56%(7/45) vs 11.11%(5/45))(χ²=0.385, P=0.535). Conclusion The Modified Dachaihu Decoction combined with dapagliflozin can effectively reduce blood glucose level in patients with early DKD with qi deficiency and blood stasis syndrome, improve oxidative stress levels and renal function, and have favorable clinical efficacy with good safety.