Abstract:

Objective　To explore the effect of modified Shenling Baishu Powder combined with dapagliflozin for patients with type 2 diabetes. Methods　A total of 120 patients with type 2 diabetes treated at Xi 'an Hospital of Traditional Chinese Medicine from January 2021 to January 2024 were selected for the randomized controlled trial, and were divided into a monotherapy group and a combination group by lottery, with 60 cases in each group. There were 34 males and 26 females in the monotherapy group; they were (65.58±7.71) years old; there were 28 cases of hypertension and 21 cases of coronary heart disease. There were 35 males and 25 females in the combination group; they were (65.64±7.87) years old; there were 26 cases of hypertension and 23 cases of coronary heart disease. The monotherapy group were treated with dapagliflozin, and the combination group with dapagliflozin and modified Shenling Baishu Powder, for 10 weeks. The metabolic and cognitive functions, cerebrovascular hemodynamics, and traditional Chinese medicine (TCM) syndrome scores before and after the treatment and adverse reactions were compared between the two groups by χ² and t tests. Results　After the treatment, the fasting blood glucose (FBG), glycated hemoglobin (HbA1c), homeostatic model assessment of beta-cell function (HOMA-β), and homeostatic model assessment of insulin resistance (HOMA-IR) in the combination group were lower than those in the monotherapy group [(6.04±0.51) mmol/L vs. (7.51±0.68) mmol/L, (5.85±0.51)% vs. (7.12±0.73)%, (18.44±1.82) vs. (29.03±3.21), and (1.04±0.17) vs. (1.43±0.24); t=13.396, 11.047, 22.230, and 10.271; all P<0.05]; the scores of Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE), peak velocity (Vp), and mean velocity (Vm) in the combination group were higher than those in the monotherapy group [(25.72±4.08) vs. (21.88±3.17), (25.38±3.37) vs. (22.55±2.72), (72.22±8.87) cm/s vs. (63.41±7.70) cm/s, and (36.33±4.46c) m/s vs. (33.41±3.77) cm/s; t=5.757, 5.062, 5.810, and 3.873; all P<0.05]; the pulsatility index (PI), resistance index (RI), and scores of TCM syndromes in the combination group were lower than those in the monotherapy group [(0.77±0.26) vs. (0.90±0.42), (0.45±0.15) vs. (0.60±0.37), (1.14±0.27) vs. (2.45±0.85), (1.08±0.11) vs. (2.15±0.26), (0.81±0.27) vs. (1.86±0.42), and (0.86±0.13) vs. (1.57±0.44); t=2.039, 2.910, 11.378, 29.358, 16.289, and 11.987; all P<0.05]. There was no statistical difference in the incidence of adverse reactions between the monotherapy group and the combination group [6.7% (4/60) vs. 8.3% (5/60); χ²=0.120; P=0.729]. Conclusion　Modified Shenling Baishu Powder combined with dapagliflozin for patients with type 2 diabetes can improve their metabolic function, cognitive function, cerebrovascular hemodynamics, and TCM syndrome scores.

Key words:

Type 2 diabetes, Modified Shenling Baishu Powder, Dapagliflozin, Cognitive function, Cerebral hemodynamics

摘要：

目的　探究参苓白术散加减联合达格列净片治疗2型糖尿病患者的效果。方法　选取2021年1月至2024年1月西安市中医医院收治的120例2型糖尿病患者进行随机对照试验。采用抽签法将其分为单一组和联合组，各60例。单一组男34例，女26例，年龄（60.58±7.71）岁，高血压28例，冠心病21例。联合组男35例，女25例，年龄（60.64±7.87）岁，高血压26例，冠心病23例。单一组给予达格列净片治疗，联合组在单一组的基础上给予参苓白术散加减治疗；两组均治疗10周。比较两组治疗前后糖代谢功能、认知功能、脑血流动力学、中医证候积分及不良反应。采用χ²和t检验。结果　治疗后，联合组空腹血糖（fasting blood glucose，FBG）、糖化血红蛋白（glycated hemoglobin，HbA1c）、胰岛β细胞功能指数（homeostatic model assessment of beta-cell function，HOMA-β）、胰岛素抵抗指数（homeostatic model assessment of insulin resistance，HOMA-IR）均低于单一组［（6.04±0.51）mmol/L比（7.51±0.68）mmol/L、（5.85±0.51）%比（7.12±0.73）%、（18.44±1.82）比（29.03±3.21）、（1.04±0.17）比（1.43±0.24）；t=13.396、11.047、22.230、10.271，均P<0.05］；联合组蒙特利尔认知评估量表（Montreal Cognitive Assessment，MoCA）和简易智能状态检查量表（Mini-Mental State Examination，MMSE）评分均高于单一组［（25.72±4.08）分比（21.88±3.17）分、（25.38±3.37）分比（22.55±2.72）分；t=5.757、5.062，均P<0.05］；联合组峰流速（peak velocity，Vp）、平均流速（mean velocity，Vm）均高于单一组［（72.22±8.87）cm/s比（63.41±7.70）cm/s、（36.33±4.46 ）cm/s比（33.41±3.77）cm/s］，搏动指数（pulsatility index，PI）、阻力指数（resistance index，RI）均低于单一组［（0.77±0.26）比（0.90±0.42）、（0.45±0.15）比（0.60±0.37）］（t=5.810、3.873、2.039、2.910，均P< 0.05）；联合组中医证候各项积分均低于单一组［（1.14±0.27）分比（2.45±0.85）分、（1.08±0.11）分比（2.15±0.26）分、（0.81±0.27）分比（1.86±0.42）分、（0.86±0.13）分比（1.57±0.44）分；t=11.378、29.358、16.289、11.987，均P<0.05］。单一组和联合组不良反应发生率比较，差异无统计学意义［6.7%（4/60）比8.3%（5/60）；χ²=0.120，P=0.729］。结论　参苓白术散加减联合达格列净片可改善2型糖尿病患者糖代谢功能、认知功能、脑血流动力学及中医证候积分。

关键词:

2型糖尿病, 参苓白术散加减, 达格列净, 认知功能, 脑血流动力学