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司美格鲁肽和度拉糖肽治疗2型糖尿病的疗效与安全性比较:基于倾向性评分匹配的回顾性队列研究

Comparison of the effectiveness and safety of semaglutide versus dulaglutide for treating type 2 diabetes: a retrospective cohort study utilizing propensity score matching

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【作者】 贺兰芝周鹏翔黄淑琳林春燕罗海坤戚健英张宏亮陈晓宇周甘平

【Author】 HE Lanzhi;ZHOU Pengxiang;HUANG Shulin;LIN Chunyan;LUO Haikun;QI Jianying;ZHANG Hongliang;CHEN Xiaoyu;ZHOU Ganping;Department of Pharmacy,Jiangbin Hospital of Guangxi Zhuang Autonomous Region;Department of Pharmacy,Peking University Third Hospital;Institute for Drug Evaluation,Peking University Health Science Center;Department of Pharmacy,the First Affiliated Hospital of Guangxi Medical University;The People’s Hospital of Guangxi Zhuang Autonomous Region;

【通讯作者】 周甘平;

【机构】 广西壮族自治区江滨医院药学部北京大学第三医院药学部北京大学医学部药物评价中心广西医科大学第一附属医院药学部广西壮族自治区人民医院药学部

【摘要】 目的 探究司美格鲁肽对比度拉糖肽治疗2型糖尿病的疗效和安全性。方法 采用多中心、回顾性队列研究设计,选择2021年4月—2023年7月在3家医院就诊的2型糖尿病患者为研究对象。根据用药情况分为司美格鲁肽组(以下简∶称“SEMA组”)、度拉糖肽组(以下简称“DULA组”),并根据基线性别、年龄、身体质量指数、血糖水平、糖尿病病程及并发症等,采用倾向性评分匹配法对2组患者进行1观察治疗后3、6、9、12个月的空腹血糖、餐后2 h血糖、糖化血红蛋白(HbA1c)、血肌酐、尿素氮、估算肾小球滤过率(eGFR)、尿白蛋白/肌酐比值(UACR)及不良反应的发生情况。结果 倾向性评分匹配后,SEMA组和DULA组各纳入98例患者,2组患者的基线特征差异无统计学意义(P> 0.05)。2组各随访时点的空腹血糖、餐后2 h血糖、HbA1c均较基线明显降低(P≤0.05)。2组各随访时点空腹血糖、餐后2 h血糖、HbA1c变化(各随访时点与基线差值)差异无统计学意义(P> 0.05);第6个月时,SEMA组HbA1c <7%的比例高于DULA组(P <0.05)。相较于基线,SEMA组第6个月时血肌酐和尿素氮下降,第3、6个月时eGFR升高、UACR降低,差异均有统计学意义(P <0.05);DULA组第3、6个月时血肌酐升高、eGFR下降,第9个月时尿素氮下降,差异均有统计学意义(P <0.05)。第3、6个月时,SEMA组血肌酐较基线的降幅大于DULA组,SEMA组eGFR较基线的升幅大于DULA组,差异均有统计学意义(P <0.05);第6个月时,SEMA组UACR较基线的降幅大于DULA组,SEMA组肾功能不全比例低于DULA组,差异均有统计学意义(P <0.05)。2组不良反应发生率差异无统计学意义(P> 0.05)。结论 司美格鲁肽和度拉糖肽均可显著改善血糖控制效果,总体降糖效果相似,安全性相当,而司美格鲁肽有潜在的肾功能保护作用。

【Abstract】 Objective To compare the effectiveness and safety of semaglutide with dulaglutide in patients diagnosed with type 2 diabetes. Methods A multicenter retrospective cohort study was conducted to include patients with type 2 diabetes who received semaglutide or dulaglutide treatment at three hospitals between April 2021 and July 2023 in the study. The patients were divided into the semaglutide group(SEMA group) and the dulaglutide group(DULA group) based on their treatment. Propensity score matching was used to pair the two groups in a 1 ∶ 1 ratio, aligning them based on baseline characteristics such as gender, age, body mass index, blood glucose levels, duration of diabetes, and complications. Various parameters including fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin(HbA1c), serum creatinine, urea nitrogen levels, estimated glomerular filtration rate(eGFR), urinary albumin/creatinine ratio(UACR), and occurrences of adverse reactions were assessed at 3, 6, 9, and 12 months after the treatment. Results After propensity score matching, 98 patients were included in both the SEMA and DULA groups, showing no statistically significant differences in baseline characteristics between the groups(P>0.05). At each follow-up point, the fasting blood glucose, 2-hour postprandial blood glucose, and HbA1c levels of both groups showed a significant decrease compared to the baseline(P≤0.05). The inter-group comparison revealed no statistically significant differences in the changes in fasting blood glucose, 2-hour postprandial blood glucose, and HbA1c levels between the two groups(P>0.05). At the 6th month, the SEMA group exhibited a statistically significant higher rate of HbA1c<7% compared to the DULA group(P<0.05). In the SEMA group, serum creatinine and urea nitrogen decreased significantly at the 6th month compared to baseline, while eGFR showed an increase at the 3rd and 6th month, and UACR decreased, all with statistical significance(P<0.05). In the DULA group, there was a statistically significant increase in serum creatinine and decrease at the 3rd and 6th months in eGFR, respectively. Additionally, urea nitrogen levels decreased significantly at the 9th month, all differences were statistically significant(P<0.05). The inter-group comparison revealed that at the 3rd and 6th month, the SEMA group exhibited a greater reduction in serum creatinine levels compared to the DULA group. Additionally, the SEMA group demonstrated a more pronounced increase in eGFR levels than the DULA group, with statistical significance(P<0.05). At the 6th month, the SEMA group exhibited a significantly greater decrease in UACR and a significantly lower incidence of renal insufficiency compared to the DULA group(P<0.05). There were no significant difference in the incidence of adverse reactions between the two groups(P>0.05). Conclusion Semaglutide and dulaglutide can significantly improve blood glucose control, exhibit comparable effectiveness and safety in lowering blood glucose levels, and semaglutide has a potentially protective effect on renal function.

【基金】 2022—2023年度广西壮族自治区卫生健康委药品临床综合评价课题(YPPJ003);广西壮族自治区卫生健康委自筹经费科研课题(Z-A20220246)
  • 【文献出处】 药物流行病学杂志 ,Chinese Journal of Pharmacoepidemiology , 编辑部邮箱 ,2024年06期
  • 【分类号】R587.1;R969
  • 【下载频次】126
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