一项基于真实世界数据的观察性研究，旨在使用连续血糖监测评估清热利湿方对肥胖 2 型糖尿病患者血糖谱的影响。
A real-world observational study on the effect of Qingre Lishi decoction on glycemic profile using continuous glucose monitoring in obese type 2 diabetes adults.
机构信息
The First Clinical College, Liaoning University of Traditional Chinese Medicine, Shenyang, China.
Endocrinology Department, the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China.
出版信息
Front Endocrinol (Lausanne). 2024 Jul 23;15:1372593. doi: 10.3389/fendo.2024.1372593. eCollection 2024.
OBJECTIVE
To observe the clinical efficacy and safety of the Qingre Lishi decoction in treating of newly diagnosed overweight and obese patients with type 2 diabetes mellitus (T2DM) from an evidence-based medical perspective.
METHODS
70 cases of overweight and obese patients with newly diagnosed T2DM treated in the outpatient clinic of the Department of Endocrinology of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from December 2021 to November 2022 were selected, of which 35 cases were in the observation group and 35 cases were in the control group. The observation group was treated with the Qingre Lishi decoction add lifestyle intervention, and the control group was treated with lifestyle intervention only. We compared and analyzed the fasting blood glucose (FPG), 2-hour postprandial glucose (2hPG), the occurrence of adverse reactions, and the related indexes provided by wearing the CGM device during the observation period of the patients in the two groups.
RESULTS
53 participants completed the clinical trial. In relation of glycemic control, a decreasing trend has shown in both groups, with the decreases in FPG, 2hPG, eHbA1c, and MG in the observation group being higher than those in the control group (<0.05). In regard to blood glucose attainment, at the 28d, the attainment rate of patients in the observation group with TIR>80% was 87.10%, and the magnitude of changes in the rise of TIR and the fall of TAR was significantly better than that in the control group (<0.01). In terms of blood glucose fluctuation, CV and SD of the patients in the observation group decreased compared with the 0d; the magnitude of daytime blood glucose fluctuation was significantly alleviated compared with that of the control group. The degree of decrease in LAGE, MAGE, and MODD was significantly lower than that of the control group (<0.01).
CONCLUSION
The Qingre Lishi decoction can effectively improve the hyperglycemic condition of overweight and obese patients with newly diagnosed T2DM. It can reduce blood glucose, alleviate blood glucose fluctuations, reduce the incidence of hypoglycemia, and improve patients' adherence and self-confidence in controlling blood glucose.
CLINICAL TRIAL REGISTRATION
https://itmctr.ccebtcm.org.cn/, identifier ITMCTR2024000006.
目的
从循证医学角度观察清热利湿方治疗新诊断超重和肥胖 2 型糖尿病（T2DM）患者的临床疗效和安全性。
方法
选取 2021 年 12 月至 2022 年 11 月辽宁中医药大学附属医院内分泌科门诊治疗的超重和肥胖新诊断 T2DM 患者 70 例，其中观察组 35 例，对照组 35 例。观察组采用清热利湿方加生活方式干预治疗，对照组仅采用生活方式干预。比较分析两组患者在观察期间的空腹血糖（FPG）、餐后 2 小时血糖（2hPG）、不良反应发生情况及佩戴 CGM 设备提供的相关指标。
结果
53 名参与者完成了临床试验。在血糖控制方面，两组均呈现下降趋势，观察组 FPG、2hPG、eHbA1c、MG 下降幅度均高于对照组（<0.05）。在血糖达标方面，观察组患者 TIR>80%的达标率为 87.10%，TIR 升高和 TAR 降低的变化幅度明显优于对照组（<0.01）。在血糖波动方面，观察组患者 28d 时的 CV 和 SD 较 0d 降低；与对照组相比，日间血糖波动明显减轻。LAGE、MAGE、MODD 下降幅度明显低于对照组（<0.01）。
结论
清热利湿方可有效改善超重肥胖新诊断 T2DM 患者的高血糖状态，可降低血糖，缓解血糖波动，减少低血糖发生，提高患者对血糖控制的依从性和自信心。
临床试验注册
https://itmctr.ccebtcm.org.cn/，标识符 ITMCTR2024000006。
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