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Metabolomics-Based Clinical Efficacy and Effect on the Endogenous Metabolites of Tangzhiqing Tablet a Chinese Patent Medicine for Type 2 Diabetes Mellitus with Hypertriglyceridemia

机译:基于代谢组学的临床功效及其对糖脂清片的内源性代谢产物的影响糖脂清片是中二型糖尿病伴高甘油三酯血症的中成药

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摘要

Tangzhiqing tablet (TZQ) is derived from Tangzhiqing formula, which has been used to regulate glucose and lipid metabolism in China for hundreds of years. However, as a new Chinese patent medicine, its clinical indication is not clear. To explore the clinical indication and effect on the patients with type 2 diabetes mellitus (T2DM), a pilot clinical trial and metabolomics study were carried out. In the clinical study, T2DM patients were divided into three groups and treated with TZQ, placebo, or acarbose for 12 weeks, respectively. The metabolomic study based on UPLC Q-TOF MS was performed including patients with hypertriglyceridemia in TZQ and placebo groups and healthy volunteers. The clinical results showed that TZQ could reduce glycosylated hemoglobin (HbA1c) and fasting insulin. For patients with hypertriglyceridemia in TZQ group, the levels of HbA1c all decreased and were correlated with the baseline level of triglyceride. Metabonomics data showed a significant difference between patients and healthy volunteers, and 17 biomarkers were identified. After 12-week treatment with TZQ, 11 biomarkers decreased significantly (p<0.05), suggesting that TZQ could improve the metabolomic abnormalities in these participants. In conclusion, the clinical indication of TZQ was T2DM with hypertriglyceridemia, and its target was related to glycerophospholipid metabolism.
机译:糖脂清片(TZQ)源于糖脂清配方,在中国数百年来一直被用于调节葡萄糖和脂质的代谢。但是,作为一种新的中成药,其临床适应症尚不清楚。为了探讨2型糖尿病(T2DM)患者的临床适应症和效果,进行了一项初步的临床试验和代谢组学研究。在临床研究中,T2DM患者分为三组,分别接受TZQ,安慰剂或阿卡波糖治疗12周。基于UPLC Q-TOF MS的代谢组学研究包括TZQ高甘油三酯血症患者和安慰剂组以及健康志愿者。临床结果表明TZQ可以减少糖基化血红蛋白(HbA1c)和空腹胰岛素。对于TZQ组的高甘油三酯血症患者,HbA1c的水平均下降,并且与甘油三酯的基线水平相关。代谢组学数据显示,患者与健康志愿者之间存在显着差异,并鉴定了17种生物标记。 TZQ治疗12周后,有11种生物标志物显着降低(p <0.05),表明TZQ可以改善这些参与者的代谢组异常。总之,TZQ的临床指征是伴有高甘油三酯血症的T2DM,其靶标与甘油磷脂代谢有关。

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