主页 > 医药生命 >
【drug-news】FDA正在调查重组人生长激素与增加死
[Posted 12/22/2010]
AUDIENCE: Pediatrics, Endocrinology
ISSUE: FDA is informing the public that results from a study conducted in France — the Santé Adulte GH Enfant (SAGhE) study — found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
BACKGROUND: Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. In the United States, recombinant human growth hormone is used in the pediatric population to treat short stature due to growth hormone deficiency (including idiopathic [of unknown cause] growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic short stature and children small for gestational age. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.
RECOMMENDATION: Do not stop taking recombinant human growth hormone without talking to your healthcare professional. At this time, FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks.
source:www.fda.gov 初译：
Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death
重组人生长激素（somatropin）：正在进行的药物安全性回顾性分析显示可能增加死亡风险
[Posted 12/22/2010]
发布日期：2010年12月20日
AUDIENCE: Pediatrics, Endocrinology
发布对象：儿科，内分泌学
ISSUE: FDA is informing the public that results from a study conducted in France — the Santé Adulte GH Enfant (SAGhE) study — found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
事件：FDA正在告知公众，来自在法国进行的一项名为SAGhE的研究发现，在患有某种类型的身材矮小（特发性生长激素缺乏和特发性或妊娠期生长迟缓）并在儿童时期曾接受过重组人生长激素（recombinant human growth hormone）治疗的的人群中，通过长期随访显示，当与普通人群中的个体患者相比时，前者的死亡风险会有小幅度地增加。FDA正在回顾性分析所有有关这一潜在风险的已有信息，并且一旦其调查完成，便会将所有新的建议与公众沟通。
BACKGROUND: Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. In the United States, recombinant human growth hormone is used in the pediatric population to treat short stature due to growth hormone deficiency (including idiopathic [of unknown cause] growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic short stature and children small for gestational age. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.
背景：重组人生长激素是一种经合成的与自然生成的人生长激素的主要形式几乎完全相同的蛋白质。这种激素可刺激组织生长、长度生长（高度）以及蛋白质、碳水化合物、脂类和矿物质代谢。该药已获批适用于成人和儿童人群。在美国，重组人生长激素常被用于儿童人群以治疗因生长激素缺乏（包括特发性（未明原因的）生长激素缺乏）而引起的身材矮小、特纳综合征（Turner syndrome）、努南综合征（Noonan syndrome）、普-威综合征（Prader-Willi syndrome）、矮小同源盒基因（SHOX）缺乏、慢性肾功能不全、特发性身材矮小和小于胎龄儿。重组人生长激素又名生长激素[重组DNA源]注射剂（somatropin [rDNA origin] injection），在美国上市的商品名有以下几种：Genotropin、Humatrope、Norditropin、Nutropin、 Nutropin AQ、Omnitrope、Saizen、和Tev-Tropin。
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-01-10 20:01
医学,生命科学网