NEJM:C型利钠肽类似物治疗儿童软骨发育不全

2019-07-04 xing.T MedSci原创

由此可见,在软骨发育不全的儿童中,每日一次皮下注射Vosoritide与副作用相关,其通常看起来是轻微的。治疗导致年度生长速度持续增加长达42个月。

软骨发育不全是一种遗传性疾病,可抑制软骨内骨化,导致不成比例的身材矮小和临床上显著的医学并发症。Vosoritide是C型利尿钠肽的生物类似物,一种有效的软骨内骨化刺激物。

近日,顶级医学期刊NEJM上发表了一篇研究文章,在一项多国、2期、剂量研究和推广研究中,研究人员评估了软骨发育不全的儿童(5至14岁)中Vosoritide的安全性和副作用。共有35名儿童参加了4个连续队列接受Vosoritide,每日一次皮下注射2.5μg/kg体重(队列1中有8名患者);7.5μg/kg(队列2中有8名患者);15.0 μg/kg(队列3中有10名患者)或30.0μg/kg(队列4中有9名患者)。6个月后,队列1中的剂量增加至7.5μg/kg,然后增加至15.0μg/kg,而在队列2中,剂量增加至15.0μg/kg; 队列3和4中的患者继续接受其初始剂量治疗。在数据截止时,24个月的剂量研究已经完成,30名患者参加了正在进行的长期延伸研究;两项研究的中位随访时间为42个月。

在剂量研究和延伸研究的治疗期间,35名患者中的35名(100%)发生不良事件,35名患者中有4名(11%)发生严重不良事件。6名患者停止了治疗(1例因不良事件)。在治疗的前6个月,使用Vosoritide可观察到剂量依赖性的年度增长速度,剂量为15.0μg/kg,并且在15.0和30.0μg/kg剂量下观察到年度生长速度持续增加直至42个月。

由此可见,在软骨发育不全的儿童中,每日一次皮下注射Vosoritide与副作用相关,其通常看起来是轻微的。治疗导致年度生长速度持续增加长达42个月。 

原始出处:

Ravi Savarirayan,et al.C-Type Natriuretic Peptide Analogue Therapy in Children with Achondroplasia.NEJM.2019.https://www.nejm.org/doi/full/10.1056/NEJMoa1813446

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    2019-07-05 neurowu
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    2019-07-04 SAS

    学习

    0

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    2019-07-04 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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