糖尿病肾病患者生活质量和临床疗效的中西医结合治疗新模式的临床试验：构建中西医结合治疗糖尿病肾病新模式的临床试验

Advanced Chinese Medicine Pub Date : 2024-06-20 DOI:10.1002/acm4.19

Xian Jin, Yanmei Wang, Ping Li, Lili Wu, Na Wang, Jun Duan, Qinyu Jiang, Yangxi Li, Zhuo Yin, Xi'ai Wu, Xiaoping Chen

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摘要

背景糖尿病肾病（DKD）是糖尿病最常见的微血管并发症之一，已成为中国终末期肾病的主要病因。对于严重肾功能不全的患者，西医治疗往往效果不理想。初步研究表明，中药配方丹参方可改善糖尿病患者的肾小球滤过率（eGFR）。方法/设计这是一项多中心、随机、开放标签、对照临床试验。eGFR水平在25-75 mL/min (1.73 m2)之间且尿白蛋白与肌酐比值（UACR）≥ 30 mg/g，或eGFR水平在25-60 mL/min (1.73 m2)之间且UACR <30 mg的DKD患者将被纳入其中。总共 144 名参与者将按 1:1 的比例随机分配到治疗组（丹参方加标准西药，加或不加其他传统中药[TCM]）和对照组（标准西药，加或不加其他传统中药）。研究持续时间为 24 周，随访期延长至 96 周。主要终点为 eGFR 从基线到第 24 周的变化。次要终点包括 UACR、体重、腰围、血压、血脂水平、空腹血浆葡萄糖、糖化血红蛋白 A1c (HbA1c) 的变化，以及中医症状和生活质量的改善。此外，还将对不良反应进行评估。讨论本研究将为丹参方治疗 DKD 患者的有效性和安全性提供证据。该研究还将形成中西医结合治疗DKD的临床路径和专家共识，为合理使用汤臣倍健医院制剂提供临床证据。试验注册中国临床试验注册中心，ChiCTR2300069269。注册日期：2023年3月10日。

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Study to evaluate the effect of Tangshen Fang combined with guideline-directed medical treatment on the quality of life and clinical outcomes in patients with diabetic nephropathy: A clinical trial on constructing a novel paradigm of integrated traditional Chinese and Western medicine in the treatment of diabetic nephropathy

Background

Diabetic kidney disease (DKD) is one of the most common microvascular complications of diabetes mellitus and has become the primary cause of end-stage renal disease in China. In patients with severe renal insufficiency, Western medical treatments often yield unsatisfactory results. Preliminary studies have indicated that the Chinese herbal formula Tangshen Fang improves estimated glomerular filtration rate (eGFR) in patients with DKD.

Methods/design

This is a multicenter, randomized, open-label, controlled clinical trial. DKD patients with eGFR levels between 25 and 75 mL/min (1.73 m²) and urinary albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, or eGFR level between 25 and 60 mL/min (1.73 m²) and UACR <30 mg will be included. A total of 144 participants will be randomly allocated to the treatment group (Tangshen Fang plus standard Western medicine with or without other traditional Chinese medicine [TCM]) and the control group (standard Western medicine with or without other TCM) at a 1:1 ration. The study duration will be 24 weeks and the follow-up period will be extended to 96 weeks. The primary endpoint will be the change in eGFR from baseline to week 24. Secondary endpoints will include changes in UACR, body weight, waist circumference, blood pressure, lipid levels, fasting plasma glucose, glycosylated hemoglobin A₁c (HbA₁c), and improvement in TCM symptoms and quality of life. Adverse events will also be evaluated.

Discussion

This study will provide evidence of the effectiveness and safety of Tangshen Fang in treating patients with DKD. It will also form the clinical pathway and expert consensus on integrating traditional Chinese and Western medicine for DKD and provide clinical evidence for the rational use of hospital preparations of Tangshen Fang.

Trial registration

Chinese Clinical Trials Registry, ChiCTR2300069269. Registered March 10, 2023.

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