机构地区:[1]复旦大学附属华东医院药剂科,上海200040 [2]上海健康医学院药学院,上海201318 [3]复旦大学附属华东医院消化内科,上海200040
出 处:《中国医院药学杂志》2024年第8期911-915,共5页Chinese Journal of Hospital Pharmacy
基 金:国家重点研发计划项目(编号:2020YFC2009001)。
摘 要:目的:评估度拉糖肽对2型糖尿病(type 2 diabetic mellitus,T2DM)患者的降糖等疗效,并分析降糖疗效的影响因素,为促进度拉糖肽临床应用提供依据。方法:以复旦大学附属华东医院2020年6月至2022年6月间首次使用度拉糖肽的T2DM患者为研究对象,采用回顾性分析方法,观察和比较患者首次使用度拉糖肽6个月及以上前后的降糖疗效,及体质量疗效指标的变化。另将患者分成降糖疗效达标[治疗后糖化血红蛋白(glycated hemoglobin,HbA1c)<7%或下降幅度>1%]和疗效未达标组,对基线数据进行单因素分析,包括基本信息、检验指标、合并用药情况等,并随访比较2组间的不良事件,logistic回归法筛选出降糖疗效的影响因素。结果:159例T2DM患者首次使用度拉糖肽6个月及以上后,HbA1c、空腹血糖、体质量、体重指数(body mass index,BMI)分别下降(0.91±1.60)%、(0.61±2.60)mmol·L^(–1)、(1.41±3.02)kg、(0.45±1.02)kg·m^(–2),差异均具有统计学意义(P<0.05)。62.89%(100/159)患者达到预期降糖目标,37.11%(59/159)未达标。研究发现2组患者的糖尿病病程、基线HbA1c水平、首次使用前的降糖药种类数差异具有统计学意义(P<0.05),logistic回归分析显示基线HbA1c水平对度拉糖肽降糖疗效有显著意义[P=0.017,OR=1.285,95%CI(1.045,1.579)]。结论:T2DM患者首次使用度拉糖肽治疗6个月及以上,HbA1c、空腹血糖、体质量、BMI显著下降。患者的糖尿病病程、基线HbA1c水平、首次使用前的降糖药种类数在度拉糖肽降糖疗效分组间存在差异,基线HbA1c水平是影响度拉糖肽疗效的主要因素,基线HbA1c较高的患者用药后的疗效更佳。OBJECTIVE To evaluate the hypoglycemic efficacy of dulaglutide in type 2 diabetic mellitus(T2DM)patients and analyze the influencing factors of hypoglycemic efficacy to provide rationales for clinical application of dulaglutide.METHODS From June 2020 to June 2022,159 T2DM patients treated initially with dulaglutide at Affiliated Huadong Hospital were selected as research subjects.Hypoglycemic efficacy of dulaglutide for 6 months or more and changes of body weight were compared.They were assigned into the group of reaching the standard of hypoglycemic efficacy(HbA1c<7%or a decline of>1%post-treatment)and that of failing to reach the standard.Baseline profiles were examined by univariate analysis,including basic demographics,test parameters and combined medications.Adverse events of two groups were recorded.Logistic regression was utilized for screening for the influencing factors of hypoglycemic efficacy.RESULTS Glycated hemoglobin(HbA1c),fasting blood glucose(FBG),body weight(BW)and body mass index(BMI)declined by(0.91±1.60)%,(0.61±2.60)mmol·L^(-1),(1.41±3.02)kg and(0.45±1.02)kg·m^(-2)respectively.Significant differences existed in HbA1c,FBG,BW and BMI(P<0.05).And 62.89%patients(100/159)achieved the expected hypoglycemic goal while 37.11%patients(59/159)failed.Statistically significant inter-group differences existed in diabetic duration,baseline level of HbA1c and number of hypoglycemic agents before an initial use(P<0.05).Logistic regression analysis revealed that baseline HbA1c level was significantly associated with hypoglycemic efficacy of dulaglutide[P=0.017,OR=1.285,95%CI(1.045,1.579)].CONCLUSION The levels of HbA1c,FBG,BW and BMI decline markedly in T2DM patients on dulaglutide initially for 6 months or more.Inter-group differences exist in diabetic duration,baseline level of HbA1c and number of hypoglycemic agents before an initial use of dulaglutide.Baseline level of HbA1c is a major factor affecting the efficacy of dulaglutide.Patients with higher baseline level of HbA1C have a better efficacy af
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