Wang Yu, Guo Yilei, Lei Ye, Huang Shuwei, Dou Liping, Li Chang, Zhao Buchang, Fu Wei, Zhou Peng, Wan Haitong, Zhao Mingjun, Yang Jiehong
School of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, China.
School of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou, China.
Front Pharmacol. 2021 Jun 3;12:625785. doi: 10.3389/fphar.2021.625785. eCollection 2021.
Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of diabetic vascular complications. However, the evidence supporting the efficacy of Tongmai Jiangtang capsules in type 2 diabetic coronary heart disease (T2DM-CHD) remains unclear. Herein, we designed a randomized, parallel-controlled clinical trial to investigate a new complementary therapy for T2DM-CHD patients. A total of 360 T2DM-CHD subjects (aged 18-75 years) will be randomly assigned to the TJC group or the placebo group at a 2:1 ratio. On the basis of western medicine therapy, all the participants will receive TJC or placebo, orally, three capsules/treatment, three per day for 12 weeks. The primary outcomes will be assessed according to the Canadian Cardiovascular Society (CCS) classification. All statistical analyses will be performed setting a two-sided 0.05 significance level, using SAS 9.4 statistical software. The efficacy of TJC for the treatment of T2DM-CHD patients will be evaluated. The study will provide reliable clinical research evidence for application of TJC in treating T2DM-CHD patients. https://www.chictr.org.cn/enIndex.aspx, Chinese Clinical Trial Registry ChiCTR2000037491.
基于人群的研究一致表明，2型糖尿病（T2DM）患者的冠心病发病率和心脏死亡率有所增加。通脉降糖胶囊（TJC）是在中国已获批准用于治疗糖尿病血管并发症的中成药。然而，支持通脉降糖胶囊治疗2型糖尿病合并冠心病（T2DM-CHD）疗效的证据仍不明确。在此，我们设计了一项随机、平行对照临床试验，以研究一种针对T2DM-CHD患者的新辅助治疗方法。总共360名T2DM-CHD受试者（年龄在18至75岁之间）将按2:1的比例随机分配至TJC组或安慰剂组。在西医治疗的基础上，所有参与者将口服TJC或安慰剂，每次三粒，每日三次，共12周。主要结局将根据加拿大心血管学会（CCS）分类进行评估。所有统计分析将使用SAS 9.4统计软件，设定双侧0.05的显著性水平。将评估TJC治疗T2DM-CHD患者的疗效。该研究将为TJC应用于治疗T2DM-CHD患者提供可靠的临床研究证据。https://www.chictr.org.cn/enIndex.aspx，中国临床试验注册中心ChiCTR2000037491。
