首页> 美国卫生研究院文献>Journal of Drug Assessment >A comparison of the clinical courses of type 2 diabetic patients whose basal insulin preparation was replaced from insulin glargine 100 units/mL to insulin glargine biosimilar or 300 units/mL: a propensity score-matched observation study
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A comparison of the clinical courses of type 2 diabetic patients whose basal insulin preparation was replaced from insulin glargine 100 units/mL to insulin glargine biosimilar or 300 units/mL: a propensity score-matched observation study

机译:将基础胰岛素制剂从甘精胰岛素100单位/ mL替换为甘精胰岛素生物仿制药或300单位/ mL的2型糖尿病患者的临床历程比较:倾向评分匹配观察研究

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摘要

>Objective: We compared the clinical course of type 2 diabetic patients whose basal insulin preparations were replaced from insulin glargine (IGlar) 100 units/mL (U100) to IGlar biosimilar or IGlar 300 units/mL (U300).>Methods: After propensity score matching, 34 patients whose basal insulin preparation was switched from IGlar U100 to IGlar biosimilar and 102 switched to IGlar U300 were observed for 6 months.>Results: The HbA1c level and body weight did not change significantly after the replacement in the IGlar biosimilar or IGlar U300 groups. In the IGlar biosimilar group, the frequency of subjects who experienced hypoglycemia after the replacement (12%) was not different from before (12%). However, the frequency was significantly lower after the replacement (2%) than before (13%) in the IGlar U300 group. The change in the HbA1c level after the replacement showed a significant association with the HbA1c level at the baseline but not with the kind of IGlar. Hypoglycemia was frequently observed in subjects who had experienced hypoglycemia before the replacement.>Conclusions: IGlar biosimilar and IGlar U300 induced similar HbA1c and body weight changes among type 2 diabetic patients. IGlar biosimilar is a suitable option for patients with a low risk for hypoglycemia.
机译:>目的:我们比较了将基础胰岛素制剂从甘精胰岛素(IGlar)100单位/ mL(U100)替换为IGlar生物仿制药或IGlar 300单位/ mL(U300)的2型糖尿病患者的临床过程>方法:在倾向评分匹配后,观察了34例患者,他们的基础胰岛素制剂从IGlar U100切换到IGlar生物仿制药,而102例患者切换到IGlar U300,持续6个月。>结果:更换IGlar生物仿制药或IGlar U300组后,HbA1c水平和体重无明显变化。在IGlar生物仿制药组中,更换后经历低血糖的受试者的频率(12%)与之前没有差异(12%)。但是,IGlar U300组中更换后的频率(2%)显着低于之前(13%)。更换后HbA1c水平的变化与基线时的HbA1c水平显着相关,但与IGlar类型无关。在更换前发生低血糖的受试者中经常观察到低血糖。>结论: IGlar生物仿制药和IGlar U300在2型糖尿病患者中诱发相似的HbA1c和体重变化。 IGlar生物仿制药是低血糖风险低的患者的合适选择。

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