聚乙二醇洛塞那肽与司美格鲁肽在2型糖尿病治疗中疗效和安全性对比的真实世界队列研究OA
Real-world cohort study on the efficacy and safety of polyethylene glycol loxenatide versus semaglutide in the treatment of type 2 diabetes mellitus
目的:在真实世界临床实践中,比较胰高血糖素样肽-1受体激动剂周制剂聚乙二醇洛塞那肽与司美格鲁肽在血糖控制欠佳的2型糖尿病患者中的长期疗效与安全性.方法:采用回顾性队列研究设计,纳入汕头大学医学院第一附属医院2021年1月至2022年10月期间起始使用聚乙二醇洛塞那肽(200 μg/周)或司美格鲁肽(1.0 mg/周)的2型糖尿病患者.通过1∶1倾向评分匹配平衡基线特征后,对最终每组410例患者进行分析.主要终点为治疗24个月时糖化血红蛋白自基线的变化.采用线性混合模型比较两组在3、6、12、24个月时糖化血红蛋白、体重、体重指数、低密度脂蛋白胆固醇及收缩压的变化,并记录药物不良反应.结果:治疗24个月时,聚乙二醇洛塞那肽组与司美格鲁肽组糖化血红蛋白分别下降2.00%与2.21%,组间差异无统计学意义(-0.20%,95%CI:-0.34～0.06,P=0.114).然而,司美格鲁肽在减轻体重(24个月组间差异:-5.09 kg,P<0.001)、降低低密度脂蛋白胆固醇(-0.48 mmol/L,P<0.001)和收缩压(-2.25 mmHg,P<0.001)方面均持续优于聚乙二醇洛塞那肽.安全性方面,两组严重低血糖发生率均极低.治疗前3个月,司美格鲁肽组恶心、呕吐及腹泻的发生率高于聚乙二醇洛塞那肽组(P<0.05).结论:在真实世界中,聚乙二醇洛塞那肽与司美格鲁肽在为期2年的治疗中降糖疗效相当.司美格鲁肽在减重及改善部分心血管代谢危险因素方面优势明显,而聚乙二醇洛塞那肽在治疗初期的胃肠道耐受性更佳.临床决策需依据个体化治疗目标进行权衡.
Objective:To compare the long-term efficacy and safety of the once-weekly glucagon-like peptide-1 receptor agonists,polyethylene glycol loxenatide and semaglutide,in patients with suboptimally controlled type 2 diabetes mellitus in real-world clinical practice.Methods:This retrospective cohort study included patients with type 2 diabetes mellitus who initiated treatment with polyethylene glycol loxenatide(200 μg/week)or semaglutide(1.0 mg/week)at The First Affiliated Hospital of Shantou University Medical College between January 2021 and October 2022.After balancing baseline characteristics via 1∶1 propensity score matching,410 patients in each group were analyzed.The primary endpoint was the change from baseline in glycated hemoglobin(HbA1c)at 24 months.Changes in HbA1c,body weight,body mass index,low-density lipoprotein cholesterol,and systolic blood pressure at 3,6,12,and 24 months were compared between groups using a linear mixed model,and adverse drug reactions were recorded.Results:At 24 months,HbA1c decreased by 2.00%and 2.21%in the polyethylene glycol loxenatide and semaglutide groups,respectively,with no statistically significant between-group difference(-0.20%,95%CI:-0.34 to 0.06,P=0.114).However,semaglutide demonstrated consistently superior effects in reducing body weight(between-group difference at 24 months:-5.09 kg,P<0.001),low-density lipoprotein cholesterol(-0.48 mmol/L,P<0.001),and systolic blood pressure(-2.25 mmHg,P<0.001)compared to polyethylene glycol loxenatide.Regarding safety,the incidence of severe hypoglycemia was very low in both groups.During the first 3 months of treatment,the incidence of nausea,vomiting,and diarrhea was higher in the semaglutide group than in the polyethylene glycol loxenatide group(P<0.05).Conclusion:In this real-world study,polyethylene glycol loxenatide and semaglutide showed equivalent glucose-lowering efficacy over a 2-year treatment period.Semaglutide demonstrated clearer advantages in weight reduction and improvement of some cardiovascular metabolic risk factors,while polyethylene glycol loxenatide showed better gastrointestinal tolerability during the initial treatment phase.Clinical decisions should be based on individualized treatment goals.
卓烨烨;余泽林;王亚力;蔡德
汕头大学医学院第一附属医院药学部,广东 汕头 515041汕头大学医学院第二附属医院药学部,广东 汕头 515041汕头大学医学院第一附属医院药学部,广东 汕头 515041汕头大学医学院第一附属医院药学部,广东 汕头 515041
医药卫生
聚乙二醇洛塞那肽司美格鲁肽2型糖尿病胰高血糖素样肽-1受体激动剂真实世界研究
polyethylene glycol loxenatidesemaglutidetype 2 diabetes mellitusglucagon-like peptide-1 receptor agonistreal-world study
《汕头大学医学院学报》 2026 (1)
7-13,18,8
中国医药教育协会临床用药卫生技术评估专项课题(2023WSJSPGZXKT-42)
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