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投稿时间：2025-03-12 网络发布日期：2025-09-19
投稿时间：2025-03-12 网络发布日期：2025-09-19
中文摘要: 目的 探讨在Ⅲ~Ⅳ期2型糖尿病合并糖尿病肾病患者中使用肾衰宁片联合达格列净治疗的疗效及安全性。方法 前瞻性选取2022年8月至2024年1月在安徽医科大学附属安庆 第一人民医院就诊的81例Ⅲ~Ⅳ期2型糖尿病合并糖尿病肾病患者为研究对象，随机分为对照组（n=40）和联合组（n=41），对照组采用达格列净（10mg/d）治疗，联合组采用肾衰宁片（4片/次，3次/d）联合达格列净（10mg/d）治疗。两组疗程均为12周。比较两组患者治疗效果。对两组治疗前后肾功能指标（血肌酐、胱抑素C、尿素氮）、血脂（总胆固醇、三酰甘油）、炎症指标（白细胞介素-6、C-反应蛋白、肿瘤坏死因子-α）水平的变化进行比较，并评估治疗期间的用药安全性。结果 治疗后，联合组总有效率高于对照组（92.68% vs 72.50%，χ2=5.769，P= 0.016）；治疗后，肾功能指标、血脂指标、炎症指标两组均降低，且与对照组比较，联合组改善更明显（P＜0.05）；治疗期间，联合组与对照组副作用发生率差异无统计学意义（14.63% vs 10.00%，χ2=0.402，P= 0.526）。结论 相较于单独使用达格列净，肾衰宁片联合达格列净治疗对Ⅲ~Ⅳ期2型糖尿病合并糖尿病肾病患者的临床疗效更显著，改善肾功能、血脂和炎症因子水平的效果更好。
Abstract:Objective To explore the effect and safety of Shenshuaining Tablet combined with dapagliflozin in the treatment of patients with stage Ⅲ-Ⅳ type 2 diabetes mellitus (T2DM) complicated with diabetic kidney disease (DKD). Methods A total of 81 patients with stage Ⅲ-Ⅳ T2DM complicated with DKD who were treated at Anqing First People’s Hospital of Anhui Medical University from August 2022 to January 2024 were prospectively selected as the research subjects and randomly divided into the control group (n=40) and the combination group (n=41). The control group was treated with dapagliflozin (10 mg/d). The combined group was treated with Shenshuaining Tablets (4 tablets each time, 3 times a day) combined with dapagliflozin (10 mg/d). The treatment course for both groups was 12 weeks. The effects of the two groups of patients after treatment were compared. The changes in renal function indicators (serum creatinine, cystatin C, blood urea nitrogen), blood lipids (total cholesterol, triglycerides), inflammatory indicators (interleukin-6, C-reactive protein, tumor necrosis factor-α) levels before and after treatment were compared, and the safety of medication during the treatment period was evaluated between the two groups. Results After treatment, the total effective rate of the combination group was higher than that of the control group (92.68% vs 72.50%, χ2=5.769, P= 0.016). After treatment, renal function indicators, blood lipid indicators, and inflammatory indicators in both groups decreased, and compared with the control group, the combination group showed more significant improvement (P＜0.05). During the treatment period, there was no statistically significant difference in the incidence of side effects between the combination group and the control group (14.63% vs 10.00%, χ2=0.402, P= 0.526). Conclusion The combination of Shenshuaining Tablets and dapagliflozin has a good clinical efficacy in the treatment of stage Ⅲ - Ⅳ T2DM patients with DKD, and can further improve renal function, blood lipids, and inflammatory factor levels.
keywords: Shenshuaining Tablet Dapagliflozin Diabetic kidney disease Renal function Blood lipid Inflammatory indicator Side effect Type 2 diabetes mellitus
文章编号： 中图分类号：R587.2 R692.9 文献标志码：A
基金项目:安徽省中医药传承创新科研项目（2022CCYB12）；安徽医科大学教学医院科研专项立项项目（WK2023JXYY013）
附件
| 作者 | 单位 |
| 王天义 | 安徽医科大学附属安庆 第一人民医院肾内科,安徽 安庆 246000 |
| 吴军 | 安徽医科大学附属安庆 第一人民医院肾内科,安徽 安庆 246000 |
| 宣建宗 | 天长市中医院肾内科,安徽 滁州 239300 |
| 王昱 | 皖南医学院,安徽 芜湖 241002 |
引用文本：
王天义,吴军,宣建宗,等.肾衰宁片联合达格列净治疗Ⅲ~Ⅳ期糖尿病肾病[J].中国临床研究,2025,38(9):1346-1349.
王天义,吴军,宣建宗,等.肾衰宁片联合达格列净治疗Ⅲ~Ⅳ期糖尿病肾病[J].中国临床研究,2025,38(9):1346-1349.