Ji Hongxiang, Zhao Ziyi, Liu Zeyu, Sun Ruitao, Li Yuquan, Ding Xiaoheng, Ni Tongshang
College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, People's Republic of China.
Department of Hand and Foot, Microsurgery, The Affiliated Hospital of Qingdao University, Qingdao, People's Republic of China.
Diabetes Metab Syndr Obes. 2023 Jul 5;16:2039-2050. doi: 10.2147/DMSO.S412898. eCollection 2023.
To evaluate the real-life effectiveness and safety of Chinese patients with type 2 diabetes mellitus (T2DM) receiving hydrogen inhalation (HI) treatment as a supplementary treatment.
This retrospective, multicenter, observational 6-months clinical study included T2DM patients maintaining HI, visited at 4 time points. The primary outcome is the mean change in glycated hemoglobin (HbA1c) at the end of the study compared to baseline. The secondary outcome is analyzing the mean change of fasting plasma glucose (FPG), weight, lipid profile, insulin dose and homeostasis model assessment. Linear regression and logistics regression are applied to evaluate the effect of HI after the treatment.
Of the 431 patients comprised, it is observed a significant decrease in HbA1c level (9.04±0.82% at baseline to 8.30±0.99% and 8.00±0.80% at the end, p<0.001), FPG (165.6±40.2 mg/dL at baseline to 157.1±36.3mg/dL and 143.6±32.3mg/dL at the end, p<0.001), weight (74.7±7.1kg at baseline to 74.8±10.0kg and 73.6±8.1kg at the end, p<0.001), insulin dose (49.3±10.8U/d at baseline to 46.7±8.0U/d and 45.2±8.7U/d, p<0.001). The individuals in subgroup with higher baseline HbA1c and longer daily HI time duration gain greater HbA1c decrease after 6 months. Linear regression shows that higher baseline HbA1c level and shorter diabetes duration are significantly in relation to greater HbA1c reduction. Logistics regression reveals that lower weight is associated with a higher possibility of reaching HbA1c<7%. The most common adverse event is hypoglycemia.
HI therapy significantly improves glycemic control, weight, insulin dose, lipid metabolism, β-cell function and insulin resistance of patients with type 2 diabetes after 6 months. Higher baseline HbA1c level and shorter diabetes duration is related to greater clinical response to HI.
评估2型糖尿病（T2DM）中国患者接受氢气吸入（HI）治疗作为辅助治疗的实际疗效和安全性。
这项回顾性、多中心、为期6个月的观察性临床研究纳入了持续接受HI治疗的T2DM患者，在4个时间点进行访视。主要结局是研究结束时糖化血红蛋白（HbA1c）相较于基线的平均变化。次要结局是分析空腹血糖（FPG）、体重、血脂谱、胰岛素剂量和稳态模型评估的平均变化。应用线性回归和逻辑回归来评估治疗后HI的效果。
在纳入的431例患者中，观察到HbA1c水平显著降低（基线时为9.04±0.82%，结束时为8.30±0.99%和8.00±0.80%，p<0.001），FPG（基线时为165.6±40.2mg/dL，结束时为157.1±36.3mg/dL和143.6±32.3mg/dL，p<0.001），体重（基线时为74.7±7.1kg，结束时为74.8±10.0kg和73.6±8.1kg，p<0.001），胰岛素剂量（基线时为49.3±10.8U/d，结束时为46.7±8.0U/d和45.2±8.7U/d，p<0.001）。基线HbA1c较高且每日HI持续时间较长的亚组患者在6个月后HbA1c降低幅度更大。线性回归显示，较高的基线HbA1c水平和较短的糖尿病病程与更大的HbA1c降低显著相关。逻辑回归显示，较低的体重与HbA1c<7%的可能性较高相关。最常见的不良事件是低血糖。
HI治疗6个月后可显著改善2型糖尿病患者的血糖控制、体重、胰岛素剂量、脂质代谢、β细胞功能和胰岛素抵抗。较高的基线HbA1c水平和较短的糖尿病病程与对HI的更大临床反应相关。
