[关键词]
[摘要]
【目的】 探讨益气养阴通络方联合达格列净对气阴两虚血瘀型糖尿病肾病(DN)的治疗效果及其对肾功能、血液流变学 等的影响。【方法】 选取 2022 年 12 月至 2024 年 6 月在江苏省高邮市中医医院肾病科接受治疗的气阴两虚血瘀型糖尿病肾病 (DN)患者104例,采用随机数字表法将患者随机分为复合组和西医组,每组各52例。在糖尿病常规治疗基础上,西医组给 予达格列净治疗,复合组给予益气养阴通络方联合达格列净治疗,疗程均为 12周。观察 2组患者治疗前后中医证候积分、 血糖指标、肾功能指标、血液流变学指标的变化情况,并评价2组患者的临床疗效和用药安全性。【结果】(1)疗效方面,治 疗 12周后,复合组的总有效率为 88.46%(46/52),西医组为 71.15%(37/52),组间比较(χ2检验),复合组的疗效明显优于西 医组(P<0.05)。(2)中医证候积分方面,治疗后,2组患者的中医证候积分均较治疗前降低(P<0.01),且复合组的降低幅度 明显优于西医组(P<0.01)。(3)血糖指标方面,治疗后,2组患者的糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后 2 h血糖 (2hPG)水平均较治疗前降低(P<0.05),且复合组的降低幅度均明显优于西医组(P<0.01)。(4)肾功能指标方面,治疗后, 2 组患者的血清胱抑素C(CysC)、尿素氮(BUN)、肌酐(Cr)水平均较治疗前降低(P<0.05),且复合组的降低幅度均明显优于 西医组(P<0.01)。(5)血液流变学指标方面,治疗后,2 组患者的血浆黏度(PV)、全血高切黏度(HBV)、全血低切黏度 (LBV)、纤维蛋白原(FIB)水平均较治疗前降低(P<0.05),且复合组的降低幅度均明显优于西医组(P<0.01)。(6)安全性方 面,治疗期间,复合组的不良反应总发生率为 5.77%(3/52),西医组为 11.54%(6/52),组间比较,差异无统计学意义(P> 0.05)。【结论】 益气养阴通络方联合达格列净治疗气阴两虚血瘀型DN患者疗效确切,可有效降低血液黏度,调节血糖水平, 改善肾功能,临床应用价值较高。
[Key word]
[Abstract]
Objective To investigate the therapeutic efficacy of Yiqi Yangyin Tongluo Formula combined with dapagliflozin in diabetic nephropathy (DN) patients with deficiency of both qi and yin and blood stasis syndrome and to observe its effects on renal function and hemorheological parameters. Methods A total of 104 DN patients with deficiency of both qi and yin and blood stasis syndrome treated in the Nephrology Department of Gaoyou Hospital of Traditional Chinese Medicine, Jiangsu Province, between December 2022 and June 2024 were selected and randomly divided into a combination group and a western medicine group using a random number table method, with 52 patients in each group. Based on conventional diabetes treatment,the western medicine group received dapagliflozin,while the combination group received Yiqi Yangyin Tongluo Formula combined with dapagliflozin. The treatment course for both groups was 12 weeks. Traditional Chinese medicine (TCM) syndrome scores, glycemic parameters, renal function indicators, and hemorheological parameters were observed before and after treatment. Clinical efficacy and medication safety were evaluated in both groups. Results (1) Therapeutic effect:After 12 weeks of treatment,the total effective rate was 88.46% (46/52) in the combination group and 71.15% (37/52) in the western medicine group. Intergroup comparison (by chi-square test) showed that the combination group demonstrated significantly superior therapeutic efficacy compared to the western medicine group (P<0.05). (2) TCM syndrome scores: After treatment, both groups showed significant reduction in TCM syndrome scores compared to before treatment (P<0.01), and the combination group exhibited a significantly greater reduction than the western medicine group (P<0.01). (3) Glycemic parameters: After treatment, hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and 2-hour postprandial glucose (2hPG) levels decreased significantly in both groups compared to before treatment (P<0.05), and the combination group showed significantly greater reductions than the western medicine group (P<0.01). (4) Renal function parameters:After treatment,serum cystatin C (CysC),blood urea nitrogen (BUN),and serum creatinine (Cr) levels decreased significantly in both groups compared to before treatment (P<0.05),and the combination group demonstrated significantly greater reductions than the western medicine group (P<0.01).(5) Hemorheological parameters: After treatment, plasma viscosity (PV), high-shear blood viscosity (HBV), low-shear blood viscosity (LBV),and fibrinogen (FIB) levels significantly decreased in both groups compared to before treatment (P<0.05),and the combination group showed significantly greater reductions than the western medicine group (P<0.01).(6) Safety:During the treatment period,the total incidence of adverse reactions was 5.77% (3/52) in the combination group and 11.54% (6/52) in the western medicine group, with no statistically significant difference between the groups (P>0.05). Conclusion Yiqi Yangyin Tongluo Formula combined with dapagliflozin in exerts certain effects on DN patients with deficiency of both qi and yin and blood stasis syndrome,effectively reducing blood viscosity, regulating glycemic levels, and improving renal function, indicating high clinical application value.
[中图分类号]
R259.872
[基金项目]
江苏省自然科学基金基础研究计划专项资金项目(编号:BK20210266);高邮市卫生健康委员会医学科研立项项目(编号: GY20221219)