Kang Xiaomin, Jin De, Ji Hangyu, An Xuedong, Zhang Yuehong, Duan Liyun, Yang Cunqing, Zhou Rongrong, Duan Yingying, Zhang Yuqing, Sun Yuting, Jiang Linlin, Lian Fengmei, Tong Xiaolin
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, People's Republic of China.
Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Drug Des Devel Ther. 2024 Dec 3;18:5573-5582. doi: 10.2147/DDDT.S487315. eCollection 2024.
The results of Study 1 we have published proved that medium and high doses of Gegen Qinlian Decoction (GQD) were effective in treating type 2 diabetes (T2D) with damp-heat syndrome. However, whether the main drug of GQD in treating T2D was or has always been a hot topic of debate among many doctors. Therefore, we conducted Study 2 and Study 3 to determine the main drug of GQD for treating T2D.
Both Study 2 and Study 3 were randomized, double-blind, dose-parallel controlled, multicenter trials. In Study 2, was used as the main drug, and in Study 3, was used as the main drug. About 120 patients with newly diagnosed T2D were enrolled in each study and randomized 1:1:1 to three treatment groups. The three treatment groups were named HD, MD, and LD groups according to the high, medium, and low doses of the main drug. The course of treatment was 12 weeks. The primary outcomes were the changes in HbA1c.
In Study 2, the HbA1c decreased by 0.58 (0.87), 0.28 (1.17), and 0.55 (0.85) in the HD, MD, and LD groups, respectively, with no significant difference between treatment groups according to covariance analysis (F=0.66, P=0.5206). In Study 3, the HbA1c decreased by 0.75 (0.82), 0.34 (0.71), and 0.26 (0.79) in the HD, MD, and LD groups respectively. By analysis of covariance, the change values of HbA1c were significantly different among the three groups (F=3.11, P=0.0492).
The changes in HbA1c were positively correlated with the dose of , but not significantly with the dose of . It demonstrated that the main drug of GQD in treating T2D patients is .
我们已发表的研究1结果证明,中高剂量的葛根芩连汤(GQD)对治疗湿热证2型糖尿病(T2D)有效。然而,GQD治疗T2D的主要药物究竟是[此处原文缺失相关药物名称]还是[此处原文缺失相关药物名称]一直是众多医生争论的热点话题。因此,我们开展了研究2和研究3以确定GQD治疗T2D的主要药物。
研究2和研究3均为随机、双盲、剂量平行对照、多中心试验。在研究2中,[此处原文缺失相关药物名称]被用作主要药物,在研究3中,[此处原文缺失相关药物名称]被用作主要药物。每项研究纳入约120例新诊断的T2D患者,并按1:1:1随机分为三个治疗组。根据主要药物的高、中、低剂量,三个治疗组分别命名为HD组、MD组和LD组。疗程为12周。主要结局指标为糖化血红蛋白(HbA1c)的变化。
在研究2中,HD组、MD组和LD组的HbA1c分别下降了0.58(0.87)、0.28(1.17)和0.55(0.85),根据协方差分析,各治疗组之间无显著差异(F = 0.66,P = 0.5206)。在研究3中,HD组、MD组和LD组的HbA1c分别下降了0.75(0.82)、0.34(0.71)和0.26(0.79)。通过协方差分析,三组之间HbA1c的变化值有显著差异(F = 3.11,P = 0.0492)。
HbA1c的变化与[此处原文缺失相关药物名称]的剂量呈正相关,但与[此处原文缺失相关药物名称]的剂量无显著相关性。这表明GQD治疗T2D患者的主要药物是[此处原文缺失相关药物名称]。