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**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**（recombinant human growthhormone）**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。重组人生长**是一种经合成的与自然生成的人生长**的主要形式几乎完全相同的蛋白质。这种**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**和儿童人群。在美国，重组人生长**常被用于儿童人群以**因生长**缺乏（包括特发性（未明原因的）生长**缺乏）而引起的身材矮小、特纳综合征（Turnersyndrome）、努南综合征（Noonan syndrome）、普-威综合征（Prader-Willisyndrome）、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**又名生长**[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。FDA建议：在未告知医护专业人士的情况下，勿停止使用重组人生长**。到目前为止，其认为重组人生长**的**益处仍大于其潜在的风险。
AUDIENCE: Pediatrics, EndocrinologyISSUE: FDA is informing the public that results from a studyconducted in France — the Santé Adulte GH Enfant (SAGhE) study —found that persons with certain kinds of short stature (idiopathicgrowth hormone deficiency and idiopathic or gestational shortstature) treated with recombinant human growth hormone duringchildhood and who were followed over a long period of time, were ata small increased risk of death when compared to individuals in thegeneral population of France. FDA is currently reviewing allavailable information on this potential risk and will communicateany new recommendations once it has completed its review.BACKGROUND: Recombinant human growth hormone is a protein that ismanufactured to be nearly identical to the main form of thenaturally occurring human growth hormone. This hormone canstimulate tissue growth, linear growth (height), and protein,carbohydrate, lipid, and mineral metabolism. It has approvedindications in both the ***** and pediatric populations. In theUnited States, recombinant human growth hormone is used in thepediatric population to treat short stature due to growth hormonedeficiency (including idiopathic [of unknown cause] growth hormonedeficiency), Turner syndrome, Noonan syndrome, Prader-Willisyndrome, short stature homeobox-containing gene (SHOX) deficiency,chronic renal insufficiency, idiopathic short stature and childrensmall for gestational age. Recombinant human growth hormone, alsoknown as somatropin [rDNA origin] injection, is marketed under thefollowing brand names in the United States: Genotropin, Humatrope,Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, andTev-Tropin.RECOMMENDATION: Do not stop taking recombinant human growth hormonewithout talking to your healthcare professional. At this time, FDAbelieves the benefits of recombinant growth hormone continue tooutweigh its potential risks.本文章转载:http://www.rryangsheng.com/Frontiers/121080_01.html本文章转摘:http://www.rryangsheng.com/Frontiers/121080_01.html