氢气吸入疗法对二甲双胍疗效不佳的2型糖尿病患者的有效性和安全性

Efficacy and Safety of Hydrogen Inhalation Therapy in Type 2 Diabetes Mellitus Patients Inadequately Controlled by Metformin Alone

摘要: 目的：探索氢气吸入疗法联合二甲双胍对二甲双胍单药控制不佳患者的治疗效果和安全性。方法：将110例2型糖尿病(T2DM)患者随机分为治疗组(n = 55)和对照组(n = 55)，治疗组患者服用二甲双胍并且接受氢气吸入疗法，对照组患者使用二甲双胍和安慰剂气体，疗程12周，观察治疗前后两组患者的糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后2 h血糖(2hPG)、一日七次的血糖自测、甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL)、低密度脂蛋白胆固醇(LDL)、胰岛素抵抗指数(HOMA-IR)、胰岛细胞功能指数(HOMA-)和体重等指标变化，并且比较两组患者不良反应的发生率。结果：在基线状态下，两组患者的各项指标均无显著差异(P > 0.05)，经过12周治疗后，治疗组患者的HbA1c、FPG、2hPG、TG、TC、HDL、LDL、HOMA-IR、HOMA-和体重均显著得到改善(P < 0.05)。对照组患者FPG、2hPG、TC、HDL、HOMA-IR和体重显著升高，LDL显著降低(P < 0.05)。组间对比显示，接受氢气吸入疗法的患者更为显著地改善了HbA1c、FPG、2hPG、一日七次的血糖自测水平、TG、TC、LDL、HOMA-IR、HOMA-和体重(全部P < 0.05)，同时不良反应发生率也显著低于对照组(3.6% vs 32.7%, P = 0.009)。结论：氢气吸入疗法联合二甲双胍进行长达12周的治疗能够显著降低T2DM患者的血糖水平，改善脂质代谢，促使体重下降，调节胰岛素抵抗并恢复胰岛功能，同时减少治疗期间不良反应的发生频率，提高安全性。

Abstract: Objective: To explore the efficacy and safety of hydrogen inhalation therapy combined with met-formin in patients with inadequately controlled by metformin alone. Methods: 110 patients with type 2 diabetes mellitus (T2DM) were randomly divided into treatment group (n = 55) and control group (n = 55). The patients in the treatment group received metformin and hydrogen inhalation therapy, and the patients in the control group received metformin and placebo gas for 12 weeks. The changes of glycated hemoglobin (HbA1c), fasting blood glucose (FPG), 2-hour postprandial blood glucose (2hPG), self-monitoring of blood glucose seven times a day, triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), insulin resistance index (HOMA-IR), pancreatic islet β cell function index (HOMA-β), body weight and the incidence of adverse events in the two groups were compared. Results: At baseline, there was no significant difference between the two groups in all indicators (P > 0.05). After 12 weeks of treatment, HbA1c, FPG, 2hPG, TG, TC, HDL, LDL, HOMA-IR, HOMA-β and body weight of pa-tients in the treatment group were significantly improved (P < 0.05). FPG, 2hPG, TC, HDL, HOMA-IR and body weight of patients in the control group were significantly increased, while LDL was signifi-cantly decreased (P < 0.05). Patients receiving hydrogen inhalation therapy significantly improved HbA1c, FPG, 2hPG, self-monitoring of blood glucose level seven times a day, TG, TC, LDL, HOMA-IR, HOMA-β and body weight (all P < 0.05), and the incidence of adverse reactions was also significantly lower than that of the control group (3.6% vs 32.7%, P = 0.009). Conclusion: Hydrogen inhalation therapy combined with metformin for 12 weeks can significantly reduce the blood glucose level, improve lipid metabolism, promote weight loss, regulate insulin resistance and restore islet func-tion in T2DM patients, reduce the frequency of adverse reactions during treatment, and improve safety.