氫氣吸入作為中國2型糖尿病患者的輔助治療的有效性和安全性：一項回顧性、觀察性、雙臂、實際臨床研究
赵子翼1，季红香2，赵云生3，刘泽宇1，孙瑞涛1，李玉泉2，倪同尚4
目的：分析氫氣吸入治療作為中國2型糖尿病（T2DM）患者的輔助治療在實際臨床環境中的有效性和安全性。
方法：這項觀察性、非干預性、回顧性、雙臂、為期6個月的臨床研究納入了從2018年到2021年接受傳統抗糖尿病藥物治療的T2DM患者，有些患者開始接受氫氣吸入治療，有些不接受，經過1:1傾向得分匹配（PSM）後分配到氫氣組或非氫氣組（對照組）。主要評估不同組的6個月後糖化血紅蛋白（HbA1c）平均變化。次要結果由空腹血漿葡萄糖（FPG）平均變化、體重、脂質代謝和家庭ostasis模型評估組成。進行邏輯回歸，評估不同HbA1c水平的患者在6個月治療後達到的可能性。同時評估兩組患者的不良事件（AE）。
總共選擇了1088名患者進行分析。與對照組相比，接受氫氣吸入治療的患者在治療後的6個月中HbA1c水平的改善程度（-0.94％ vs -0.46％）、空腹血糖（-22.7毫克/分升 vs -11.7毫克/分升）、總膽固醇（-12.9毫克/分升 vs -4.4毫克/分升）、HOMA-IR（-0.76 vs -0.17）和HOMA-β（8.2％ vs 1.98％）方面有更大的改善，所有p值均小於0.001。邏輯回歸分析表明，在隨訪期內達到HbA1c＜7％、≥7％至＜8％和大於1％的降低概率在HI組中更高，而控制組的患者更有可能達到HbA1c≥9％。相比對照組，HI組的患者觀察到較低的幾種不良事件發生率，包括低血糖（2.0％ vs 6.8％）、嘔吐（2.6％ vs 7.4％）、便秘（1.7％ vs 4.4％）和頭暈（3.3％ vs 6.3％）。
結論：氫氣吸入作為輔助療法可以改善T2DM患者的血糖控制、脂代謝、胰島素抵抗和不良事件的發生率，在現有的糖尿病臨床治療中提供了一個值得注意的啟示。
The study aimed to investigate the effectiveness and safety of hydrogen inhalation therapy (HI) as an adjunct treatment for Chinese patients with type 2 diabetes mellitus (T2DM) in a real-life clinical setting. The research was conducted retrospectively and non-interventionally over a period of 6 months.
The study included T2DM patients who were receiving conventional anti-diabetes medication with or without HI from 2018 to 2021. Patients were assigned to either the HI group or the control group after propensity score matching. The mean change in glycated hemoglobin (HbA1c) after 6 months was evaluated as the primary outcome, while the secondary outcome included the mean change of fasting plasma glucose (FPG), weight, lipid profile, and homeostasis model assessment.
In total, 1088 patients were included in the analysis, and the results showed that patients in the HI group maintained greater improvement in HbA1c, FPG, total cholesterol, HOMA-IR, and HOMA-β compared to the control group. Furthermore, the likelihood of reaching different HbA1c levels after 6 months of treatment was higher in the HI group.
In terms of safety, patients in the HI group had a lower incidence of adverse events such as hypoglycemia, vomiting, constipation, and giddiness compared to the control group.
Overall, the study concluded that HI therapy as an adjunct treatment can effectively improve glycemic control, lipid metabolism, insulin resistance, and reduce adverse events in Chinese patients with T2DM after 6 months of treatment. These findings may inspire new approaches to the clinical treatment of diabetes.
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