资讯中心

FDA批准甲状旁腺激素用于治疗低钙血症

FDA approves use of parathyroid hormone to manage hypocalcemia
来源:爱思唯尔 2015-01-28 08:00点击次数:529发表评论

根据FDA发布的公告,甲状旁腺激素Natpara已被批准用于治疗甲状旁腺功能减退症患者的低钙血症。


在REPLACE Ⅲ期临床试验中,124例受试者被随机分到Natpara组和安慰剂组,旨在明确Natpara是否能够作为活性维生素D和口服钙剂的一种替代治疗药物,或者Natpara是否有助于降低甲状旁腺功能减退症患者活性维生素D和口服钙剂补充治疗剂量。FDA透露道,在接受Natpara治疗的患者中,有42%患者血钙水平恢复正常;而安慰剂组中仅有3%患者血钙水平恢复正常。



FDA药品评估和研究中心内分泌和代谢药物产品部门主任Jean-Marc Guettier博士在新闻稿中指出,“当前甲状旁腺功能减退症患者的治疗选择非常有限,且在面对各种可严重影响患者生活质量的症状时常束手无策。对于那些通过钙剂和活性维生素D补充治疗,但血钙水平不能得到有效控制的患者而言,这种药物提供了另外一种解决方案。


由于在大鼠试验研究中曾观察到骨癌病例,Natpara被加上一项黑框警告,且仅被推荐用于通过其他治疗手段低钙血症无法得到有效控制的患者。Natpara常见不良反应包括刺痛感、低血钙、头痛、高血钙和恶心。


依据FDA的说法,甲状旁腺功能减退症是一种少见病,在美国,仅有约6万例甲状旁腺功能减退症患者。甲状旁腺激素有助于调节机体的钙磷水平,当甲状旁腺功能减退,导致机体分泌的甲状旁腺激素水平显著降低时,就会发生甲状旁腺功能减退症;手术切除甲状旁腺是另外一种常见的甲状旁腺功能减退病因;此外,更少见的病因还包括自身免疫性甲状旁腺功能减退和先天性甲状旁腺功能减退。


Natpara是由美国NPS制药公司生产。


爱思唯尔版权所有 未经授权请勿转载!


The parathyroid hormone Natpara has been approved to manage hypocalcemia in patients with hypoparathyroidism, according to a press release from the Food and Drug Administration.


In the phase III REPLACE study, 124 participants were randomly assigned Natpara or a placebo to determine whether Natpara can be used as a substitute for or help reduce the amount of active forms of vitamin D or oral calcium taken by participants. Of patients treated with Natpara, 42% achieved normal blood calcium levels, while 3% of patients achieved normal blood calcium levels on the placebo, the FDA said.


“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life. This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D,” Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in the press release.


Because of instances of bone cancer in rat studies, Natpara carries a warning and is only recommended for patients whose hypocalcemia cannot be controlled by other means. Common side effects include sensations of tingling, low blood calcium, headache, high blood calcium, and nausea.


Hypoparathyroidism is a rare disease, only affecting about 60,000 people in the United States. It occurs when loss of function of the parathyroid glands causes the body to secrete abnormally low levels of parathyroid hormone, which helps regulate calcium and phosphorus levels in the body; surgical removal of the parathyroid glands is another cause as is, and more rarely, autoimmune or congenital diseases, according to the FDA.


Natpara is manufactured by NPS Pharmaceuticals, Inc.



Copyright © 2015 Frontline Medical News, a Frontline Medical Communications, Inc. company. All rights reserved. This material may not be published, broadcast, copied or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications, Inc.


---------------------------------------------------------------------------------------------------------------------------------------------
欢迎关注爱唯医学网糖尿病及内分泌官方微信
学科代码:内分泌学与糖尿病   关键词:FDA;甲状旁腺激素;低钙血症;
来源: 爱思唯尔
爱思唯尔介绍:全球最大的科技医学出版商――爱思唯尔以出版发行高品质的、前沿的科学、技术和医学信息,并保证其满足全世界科技和医学工作者对于信息的需求而著称。现在,公司建立起全球的学术体系,拥有7,000名期刊编辑、70,000名编辑委员会成员、200,000专家审稿人以及500,000名作者,每年出版2,000本期刊和2,200种新书,并拥有17,000种在库图书。 马上访问爱思唯尔网站http://www.elseviermed.cn
顶一下(0
您可能感兴趣的文章
    发表评论网友评论(0)
      发表评论
      登录后方可发表评论,点击此处登录
      他们推荐了的文章