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2021美国内分泌年会速递:胰岛素每周一次或将成为可能

2021-03-22 Oranhgy MedSci原创

BIF作为每周一次的基础胰岛素有希望,可能是胰岛素治疗的重大进步。

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据一项2期临床试验显示,与每日基础胰岛素相比,一种新型每周一次的基础胰岛素注射液表现出相似的疗效和安全性,且低血糖发作率更低。该研究结果将在2021年内分泌学会年会ENDO 2021上发表,该研究比较了一种名为基础胰岛素Fc(BIF)的研究药物与市售长效日用胰岛素degludec在2型糖尿病患者中的作用。

这项为期32周的临床试验在399名患者中进行。所有患者都有2型糖尿病,并且是基础胰岛素与口服抗糖尿病药物相结合的用户。

患者被随机分配到三个治疗组中的一个组:以两种不同的给药算法(空腹血糖水平的目标不同),即每周注射一次BIF,或每天注射一次标准的胰岛素degludec。接受BIF的患者的空腹血糖目标一个是低于140毫克/分升(mg/dL),另一个是在或低于120毫克/分升。胰岛素degludec的空腹血糖目标为100毫克/分升或更低。

该研究的主要研究者、加州洛杉矶国家研究所的医学主任Juan Frias博士指出,与胰岛素降糖药相比,服用BIF的患者实现了类似的长期血糖控制。数据显示,研究参与者在研究开始时的平均血红蛋白A1c为8.1%,在研究结束时,BIF的A1c平均改善0.6%,胰岛素降糖灵改善0.7%。

此外,BIF的使用使低血糖,或低血糖(小于70mg/dL)的发生率显著降低。严重的未经治疗的低血糖症是一种危险的并发症,可导致癫痫发作、意识丧失和死亡。

Frias称,研究结果表明,BIF作为每周一次的基础胰岛素有希望,可能是胰岛素治疗的重大进步。BIF 与目前的每日基础胰岛素相比,具有更平坦、更可预测的作用潜力,这可能是导致低血糖发生率降低的原因。同时补充说道,每周注射胰岛素的次数减少可能会改善胰岛素治疗的依从性,这可能会导致比每日基础胰岛素更好的患者结果,当单独口服药物不再给予足够的血糖控制时,每周一次的剂量也可能会增加2型糖尿病患者开始胰岛素治疗的意愿。

此外,关于安全性,Frias表示,BIF的不良事件谱与胰岛素降糖药的不良事件谱一般相当。

基于目前数据,该研究已经开始在1型糖尿病患者和其他2型糖尿病患者人群中进一步进行。

 

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    2021-05-01 baoya
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    2021-08-12 熊彼特

    学习了

    0

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    2021-06-01 学习啊学习

    学习

    0

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    2021-03-22 小医精/诚

    基础胰岛素是如何释放入血液中的呢?

    0

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    2021-03-22 ms3000000110189438

    学习打卡,老人们应该会很喜欢

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