目的 探讨雷公藤多苷片与恩格列净联用治疗Ⅳ期糖尿病肾病的临床疗效。方法 纳入衡水市中医医院2022年5月—2025年5月收治的216例Ⅳ期糖尿病肾病患者，采用随机数字表法分为对照组（106例）和治疗组（105例）。对照组口服恩格列净片，10 mg/次，1次/d，治疗组在对照组基础上口服雷公藤多苷片，20 mg/次，3次d。两组均治疗3个月。观察两组总有效率，比较治疗前后两组中医证候评分、血糖指标、肾功能指标、肾间质纤维化指标和炎性因子水平。结果 治疗后，治疗组与对照组的总有效率分别为86.67%、75.47%，两组比较差异有统计学意义（P＜0.05）。治疗后，两组中医证候评分显著下降（P＜0.05），且与对照组比较，治疗后治疗组中医证候积分更低（P＜0.05）。治疗后，两组空腹血糖（FBG）、餐后2 h血糖（2 hPG）和糖化血红蛋白（HbA1c）较治疗前显著下降（P＜0.05），且治疗后治疗组FGB、2 hPG和HbA1c显著小于对照组（P＜0.05）。治疗后，两组肌酐（Scr）、尿素氮（BUN）和24 h尿蛋白定量较治疗前均显著下降（P＜0.05），且治疗组Scr、BUN和24 h尿蛋白定量均显著小于对照组（P＜0.05）。治疗后，两组同型半胱氨酸（Hcy）、血管内皮生长因子（VEGF）、转化生长因子-β1（TGF-β1）较治疗前均显著下降（P＜0.05），且治疗组Hcy、VEGF和TGF-β1均显著小于对照组（P＜0.05）。治疗后，两组白细胞介素-6（IL-6）、C-反应蛋白（CRP）、肿瘤坏死因子-α（TNF-α）较治疗前均显著下降（P＜0.05），且治疗组IL-6、CRP和TNF-α均显著小于对照组（P＜0.05）。结论 雷公藤多苷片与恩格列净联用能显著提高Ⅳ期糖尿病肾病的临床疗效，改善血糖水平和肾功能水平、抑制肾间质纤维化和炎性因子释放及改善中医证候，且未显著增加ADR发生风险。

Objective To explore the clinical efficacy of tripterygium glycoside tablets combined with empagliflozin in the treatment of stage IV diabetic nephropathy. Methods A total of 216 patients diagnosed with stage Ⅳ diabetic nephropathy admitted to Hengshui Hospital of Traditional Chinese Medicine from May 2022 to May 2025 were divided into control group (106 cases) and treatment group (105 cases) using random number table method. The control group received oral Empagliflozin Tablets at a dose of 10 mg once daily. On the basis of the conventional treatment, the treatment group was additionally administered oral Tripterygium Glycosides Tablets 20 mg three times daily. Both groups received a 3-month continuous treatment course. The overall clinical response rate was evaluated. Traditional Chinese medicine (TCM) syndrome scores, fasting blood glucose (FGB), 2 h postprandial blood glucose (2 h PG), glycosylated hemoglobin (HbA1c), renal function indicators serum creatinine (Scr), blood urea nitrogen (BUN), 24 h urinary total protein, renal interstitial fibrosis markers homocysteine (Hcy), vascular endothelial growth factor (VEGF), transforming growth factor-β1 (TGF-β1), inflammatory cytokines interleukin-6 (IL-6), C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were compared between the two groups before and after treatment. Results After treatment, the overall effective rate was 86.67% in the treatment group and 75.47% in the control group, with a statistically significant difference between the two groups (P < 0.05). After treatment, the TCM syndrome scores decreased significantly in both groups (P < 0.05), and compared with the control group, the TCM syndrome score in the treatment group was lower after treatment (P < 0.05). After treatment, FGB, 2 hPG, and HbA1c decreased significantly compared with those before treatment in both groups (P < 0.05), and after treatment, FGB, 2 hPG, and HbA1c in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, Scr, BUN, and 24 h urinary protein quantification decreased significantly compared with those before treatment in both groups (P < 0.05), and Scr, BUN, and 24 h urinary protein quantification in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, Hcy, VEGF, and TGF-β1 decreased significantly compared with those before treatment in both groups (P< 0.05), and Hcy, VEGF, and TGF-β1 in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, IL-6, CRP, and TNF-α decreased significantly compared with those before treatment in both groups (P < 0.05), and IL-6, CRP, and TNF-α in the treatment group were significantly lower than those in the control group (P < 0.05). Conclusion The combination of Tripterygium Glycosides Tablets and empagliflozin can significantly improve the clinical efficacy for stage IV diabetic nephropathy. This synergistic therapy effectively optimizes blood glucose levels, ameliorates renal function, inhibits renal interstitial fibrosis and inflammatory response, and alleviates TCM syndromes, without substantially increasing the risk of adverse drug reactions.

R977

河北省中医药类科学研究课题计划项目（2026178）