参苓白术散联合桂枝茯苓丸、达格列净治疗2型糖尿病肾病IV期的蛋白尿的随机对照研究

A Randomised Controlled Study of Can Ling Bai Shu San Combined with Guizhi Fuling Pills and Dagliflozin in the Treatment of Proteinuria in Type 2 Diabetic Nephropathy Stage IV

摘要: 目的：观察参苓白术散联合桂枝茯苓丸、达格列净治疗2型糖尿病肾病IV期患者蛋白尿的临床疗效。方法：收集于2021年9月~2022年9月潍坊市益都中心医院就诊的诊断为2型糖尿病肾病IV期患者60例。采用随机、对照的临床研究设计分为治疗组和对照组，观察患者症状评分、实验室指标、疾病疗效等指标变化。结果：本研究最终纳入统计分析的治疗组29例、对照组28例。治疗后，治疗组的中医证候、蛋白尿、肾小球滤过率(eGFR)、糖化血红蛋白(HbA1c)、D-二聚体、尿NGAL、低密度脂蛋白疗效优于对照组(P < 0.05)；治疗组24 h尿蛋白定量、HbA1c、D-二聚体、尿NGAL较治疗前明显下降(P < 0.05)，肾小球滤过率较治疗前略有下降，无差异(P > 0.05)。对照组经治后，尿NGAL较治疗前明显下降(P < 0.05)，其余指标与治疗前均无差异(P < 0.05)。两组均未见不良反应。结论：参苓白术散联合桂枝茯苓丸、达格列净治疗可减轻DKD IV期患者临床症状，降低蛋白尿、NGAL、糖化血红蛋白、D-二聚体、低密度脂蛋白，保护肾小管及肾小球、改善机体高凝状态及血糖，延缓肾功能下降，提高临床疗效。

Abstract: Objective: To observe the clinical efficacy of Can Ling Bai Shu San combined with Guizhi Fuling pills and Dagliflozin in the treatment of proteinuria in patients with type 2 diabetic nephropathy stage IV. Methods: 60 patients diagnosed with type 2 diabetes mellitus nephropathy stage IV were col-lected from September 2021 to September 2022 in Yidu Central Hospital of Weifang City. A ran-domised, controlled clinical study design was used to divide them into treatment and control group, and changes in patients’ symptom scores, laboratory indicators, disease efficacy and other indica-tors were observed. Results: 29 cases in the treatment group and 28 cases in the control group were finally included in the statistical analysis of this study. After treatment, the efficacy of Chinese med-icine symptoms, proteinuria, glomerular filtration rate (eGFR), glycated haemoglobin (HbA1c), D-dimer, urinary NGAL, and LDL in the treatment group was better than that of the control group (P < 0.05); 24 h urinary protein quantification, HbA1c, D-dimer, and urinary NGAL of the treatment group were significantly decreased compared with that before treatment (P < 0.05), glomerular fil-tration rate decreased slightly compared with that before treatment, with no difference (P > 0.05). In the control group, after treatment, urinary NGAL decreased significantly (P < 0.05), and the rest of the indicators did not differ from those before treatment (P < 0.05). No adverse reactions were seen in both groups. Conclusion: The treatment of Can Ling Bai Shu San combined with Guizhi Fuling pills and Dagliflozin can reduce the clinical symptoms of DKD IV patients, lower proteinuria, NGAL, glycosylated haemoglobin, D-dimer and low-density lipoprotein, protect renal tubules and glomeru-li, improve the hypercoagulable state of the body and blood glucose, delay the decline of renal func-tion, and improve the clinical efficacy.