聚乙二醇洛塞那肽治疗肥胖型2型糖尿病患者轴状胃切除术患者的临床研究

Clinical trial of pegylated losenatide in the treatment of obese patients with type 2diabetes mellitus undergoing axial gastrectomy

目的 观察聚乙二醇洛塞那肽注射液联合二甲双胍片对肥胖型2型糖尿病(T2DM)患者轴状胃切除术后血清代谢、血脂水平及肠道菌群的影响。方法 将接受轴状胃切除术的肥胖型T2DM患者按队列法分为试验组和对照组。对照组口服盐酸二甲双胍片0.5 g,tid。试验组在对照组治疗的基础上,联合聚乙二醇洛塞那肽注射液0.2 mg皮下注射,每周1次。2组患者均连续治疗3个月。比较2组患者的体质量指数(BMI)、血清代谢指标、血脂水平、血糖水平、肠道菌群及药物不良反应发生情况。结果 本研究试验组共纳入70例,对照组共纳入50例。治疗3个月后,试验组与对照组的BMI分别为(26.35±2.36)和(29.34±3.59)kg·m^(-2),谷胱甘肽过氧化物酶分别为(192.42±13.18)和(134.27±12.86)U,白细胞介素-6分别为(6.14±1.78)和(7.65±2.09)μg·L^(-1),空腹血糖分别为(5.36±0.41)和(7.43±0.78)mmol·L^(-1),血浆总胆固醇分别为(2.55±0.67)和(3.47±0.79)mmol·L^(-1);试验组的双歧杆菌、拟杆菌、乳酸杆菌、肠杆菌、肠球菌分别为(8.79±1.36)、(9.62±1.37)、(6.74±2.15)、(7.98±0.61)和(7.23±1.29)logN·g^(-1),对照组的分别为(7.98±1.79)、(8.13±1.45)、(5.71±2.41)、(9.21±0.88)和(8.15±1.54)logN·g^(-1),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有恶心、头痛、头晕、血压升高、消化不良;对照组的药物不良反应主要有恶心、头痛、消化不良,试验组和对照组的总药物不良反应发生率分别为8.57%和6.00%,在统计学上差异无统计学意义(P>0.05)。结论 聚乙二醇洛塞那肽注射液联合二甲双胍片对肥胖型2型糖尿病患者轴状胃切除术后有显著效果。

Objective To observe the effects of pegylated losenatide injection combined with metformin tablets on serum metabolism,lipid levels and intestinal flora in obese type 2 diabetes mellitus (T2DM)patients after axial gastrectomy.Methods Obese T2DM patients who underwent axial gastrectomy were divided into treatment group and control group by cohort methods.The control group was treated with metformin hydrochloride tablet 0.5 g orally,tid.The treatment group was treated by subcutaneous injection of pegylated losenatide injection 0.2 mg once a week on the basis of control group.Both groups were treated continuously for 3 months.Body mass index (BMI),serum metabolic indexes,blood lipid levels,blood glucose levels,intestinal flora and adverse drug reactions were compared between the two groups.Results In this study,a total of 70 subjects were included in the treatment group,and 50 subjects were included in the control group.After three months of treatment,the BMI indices of the treatment and control groups were (26.35±2.36)and (29.34±3.59) kg·m^(-2),respectively;the glutathione peroxidase levels were (192.42±13.18) and(134.27±12.86) U;interleukin-6 levels were (6.14±1.78) and (7.65±2.09)μg·L^(-1);fasting blood glucose levels were (5.36±0.41) and (7.43±0.78) mmol·L^(-1);total cholesterol levels were (2.55±0.67) and(3.47±0.79) mmol·L^(-1)for the treatment and control groups,respectively.The levels of Bifidobacteria,Bacteroides,Lactobacilli,Enterobacteria,and Enterococci in the treatment group were (8.79±1.36),(9.62±1.37),(6.74±2.15),(7.98±0.61),and (7.23±1.29) log N·g^(-1),respectively;in the control group,these levels were(7.98±1.79),(8.13±1.45),(5.71±2.41),(9.21±0.88),and (8.15±1.54) log N·g^(-1.)The differences in the above indicators between the treatment and control groups were statistically significant (all P<0.05).The main adverse drug reactions in the treatment group included nausea,headache,dizziness,elevated blood pressure,and indigestion.In the control group,the main adverse drug reactions were nausea,headache,and indigestion.The total incidence of adverse drug reactions in the treatment and control groups was 8.57%and 6.00%,respectively,with no statistically significant difference (P>0.05).Conclusion Pegylated losenatide injection combined with metformin tablets has a significant effect on axial gastrectomy in obese type 2 diabetes patients.