药品信息: 新的Humatrope产品在日本推出 继WHO决定取消IU(国际单位)后，Eli Eilly公司在日本推出其重组人过长激素somatropin(Humatrope)毫克剂型。新的剂型包括一种6mg的(以前为18IU)针筒，一种1.33mg的(4IU)小瓶和一种新的12mg针筒。其分公司还推出Humatro-Pen注射系统，该系统可以在很广的剂量范围内快速给药。 ------------------------------------------------------------ FDA批准激素正常的无病儿童可使用Humatrope 美国政府今天批准身材矮小但健康良好的儿童可用礼来公司的一种生长激素来增加身高。 该激素名为Humatrope，1987年已开始在美国销售，用于治疗儿童生长激素缺陷症。这次新批准使用得礼来公司可让它用于激素水平正常且没有疾病的矮小儿童。 FDA说，它们批准该药用于1.2%最矮的那些孩子(即对10岁的男孩和女孩而言，不应低于4英尺1英寸，如果不用药治疗，男孩预计到成人时的身高不到5英尺3英寸，女孩不到4英尺11英寸)，Humatrope“可使其中大多数人到成年时达到医学上的正常身高”，礼来公司的女发言人摩尔(JudyKayMoore)说。 顾问委员会6月在辩论了其它各方面正常的儿童是否要在数年里每周需多次注射Humatrope来增加几英寸身高后最终以8﹕2通过了该药。在那次会议上，礼来公司争论说，矮小儿童通常遭到嘲笑和欺负，以及成人时有社会孤立，因此需要有治疗选择。 在它们的一项大型试验中，用Humatrope治疗(每周三次)的儿童平均比用安慰剂的儿童高1.5英寸。另一个研究还比较了不同用量的Humatrope(每周六次)，大剂量组儿童平均超过预计身高近3英寸，有些甚至超过预计的4英寸。“有些儿童得到的好处确实更大”，FDA新陈代谢和内分泌药物部的主任奥罗夫(DavidOrloff)说，但医生现在尚不知道哪些儿童可能反应更好。 摩尔说，礼来公司将只在一定范围内向儿童内分泌科大夫销售该药，而且不会直接向消费者宣传。另外，该药最常见的副作用通常很轻，包括关节痛等。 --------------------------------------------------------- Humatrope indications 适应症 Humatrope has FDA approval for the following three indications: Growth hormone deficiency (GHD) Humatrope is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Humatrope therapy should not be used for growth promotion in pediatric patients with closed epiphyses. Lilly's Humatrope was approved by the FDA in 1987 for the treatment of growth failure in children with GHD. For children diagnosed with GHD, growth hormone may be given. For potential growth benefit, this therapy must begin before the growth plates (epiphyses) at the ends of the long bones have closed, or fused (reached maturity). Turner syndrome Humatrope is indicated for the treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed. Turner syndrome is a genetic condition due to partial or complete absence of one of the two X chromosomes usually present in females. It affects one in every 2,000 to 2,500 females and does not affect males. Short stature is the most common feature affecting about 95 percent of individuals with Turner syndrome. The average height of affected adult woman without treatment is about 4 feet, 8 inches The other main characteristic is poor development of the ovaries resulting in failure to experience puberty in many girls, and causing infertility in most. Other physical features present in some individuals include: Broad chest with widely spaced nipples that may be inverted Stocky appearance Narrow, high-arched palate (roof of mouth) and crowded teeth Receding jaw Thick, shorter neck (in some cases, may have a "webbed" appearance) Low hairline at the back of the neck Prominent ears Arms that turn out at the elbow Soft, narrow fingernails and toenails that point upward Individuals with Turner syndrome may also have increased problems with nonverbal learning. This may result in a learning style that makes verbal learning come more easily, and math or spatial problems more difficult. Characteristics of this type of learning problem include: Difficulty imagining objects in relation to each other (visual-spatial processing), difficulty driving, poor sense of direction, difficulty reading a map Trouble appreciating subtle social cues, such as facial expressions (social cognition) Problems with nonverbal problem-solving, such as math problems Clumsiness (psychomotor problems and poor manual dexterity) Idiopathic short stature (ISS) Humatrope is indicated for the long-term treatment of idiopathic short stature, also called non-growth-hormone-deficient short stature, defined by height SDS less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. Between 1988 and 2001, Lilly conducted two studies of Humatrope treatment in approximately 300 children with ISS. One study showed that children who received Humatrope injections were on average 1.5 inches taller at final adult height than children who did not receive therapy. The other study showed that children grew significantly faster while receiving Humatrope than before they started taking the medication. For the patients in this study whose final adult height could be measured, Humatrope patients were on average 2 to 3 inches taller than they were predicted to be without Humatrope. Humatrope can help you successfully treat your patients with GHD, Turner syndrome and ISS. Where you and your patients may find more information about GHD, Turner syndrome and ISS: The Human Growth Foundation — The Human Growth Foundation helps children and adults with disorders related to growth or growth hormone through education, research, support and advocacy. This non-profit organization functions as a resource for individuals with questions about their child's development, or adults with inquiries regarding adult growth hormone deficiency. The Human Growth Foundation has more than 20 educational publications. The foundation's website also provides a list of support groups for parents, teens and adults. The MAGIC Foundation — The MAGIC Foundation for Children's Growth offers services to families of children with growth problems. These services include parent-to-parent networking opportunities, kids' clubs, medical literature in easy-to-understand terms, and more. The Turner Syndrome Society of the United States — The Turner Syndrome Society of the United States assists girls and women with TS and their families. Toll free number: (800) 365-9944 Internet: www.turner-syndrome-us.org E-mail: tssus@turner-syndrome-us.org SHOX (short stature homeobox-containing gene) deficiency ------------------------------------------------------------ 基因重组人生长激素 [药品名] 基因重组人生长激素 [英文名] Recombinant SomatroPin [别名] 健高灵，Humatrope，Genotropin，Norditropin，DNA—rhGH。 [作用与用途] 本品具有与人体生长激素同等的作用，即能促进骨骼、内脏和全身生长，促进蛋白质合成，影响脂肪和矿物质代谢，在人体生长发育中起着关键性作用。皮下注射约80％被吸收，5小时后达高峰血浓度，t1/2约4小时。主要用于内源性脑垂体生长激素分泌不足而引起的生长障碍、躯体矮小的侏儒症、短小病患儿。此外，尚可用于治疗烧伤、骨折、创伤、出血性溃疡、组织坏死、肌肉萎缩症、骨质疏松等疾病。 [用法与用量] 本品给药剂量个体差异很大，采用肌内注射或皮下注射，一般用量为每周0．5—0．7单位／kg或每周12单位／m2，分6—7次给药。 [注意事项] 偶可引进皮肤过敏、注射部位发红和皮下脂肪萎缩、氨基转移酶升高、呕吐及腹痛等。 1．肿瘤患者、糖尿病患者、颅内进行性损伤者禁用。 2，对脑肿瘤的垂体抹儒病者、心脏或肾脏病者、孕妇和哺乳妇女等慎用。 3．使用前，需对脑垂体功能作详细检查，准确诊断后才能应用。 4．应临用时配制，用注射用水溶解，轻轻摇动，切勿振荡，以免变性。 [贮藏] 2℃-8℃保存。有效期为1．5年。 [制剂] 注射用基因重组人生长激素：每瓶4单位；12单位。 肾上腺皮质激素及促肾上腺皮质激素 肾上腺皮质分泌有多种激素，在化学构造上都属于甾醇类，为环戊烷多氢菲的衍生物。其构造上的共同点是：在C3上有酮基，C4或C5之间为双键，在C17上有还原性的酮醇基侧链。 肾上腺皮质分泌的激素根据其生理功能可分为三类： 1．糖皮质素类在C11上有氧原子，包括皮质酮、可的松和氢化可的松等。它们对糖的代谢作用强而对钠及钾的作用相对地较弱。由肾上腺皮质束状带细胞所合成和分泌。 2．盐皮质素类在C11上无氧原子，包括11-去氧皮质酮及17-羟基11-去氧皮质酮。它们对于矿物质的代谢特别是促进钠的潴留及钾的排泄的作用很强。醛固酮在C11上虽有氧，但因在体内呈半缩醛式，氧原了被包围在内酯环中，故不呈糖皮质素类作用而呈现较强的盐皮质素类的作用。 盐皮质激素都是由肾上腺皮质的球状带分泌。 3．氮皮质素类包括雄激素(如去氢异雄酮)和雌激素(黄体酮、雌二醉)。性激素不仅由性腺分泌，肾上腺皮质的网状带亦为其制造场所。但雌激素主要由卵巢分泌，皮质分泌的量极少；而雄激素则皮质分泌的量较大(特别是女性体内的雄激素几全部由此处产生)。 ------------------------------------------------------------ Adult Growth Hormone Deficiency 成人生长激素缺乏症 The role of human growth hormone Growth hormone (GH) plays a central role in the growth process and maturation from childhood to adulthood. It also regulates a number of metabolic and physiological processes throughout life. GH deficiency occurs when the pituitary gland in the brain is unable to produce or release sufficient amounts of GH. Growth Hormone Deficiency (GHD) can be grouped into 3 types: Congenital: caused by a problem with the pituitary gland or hypothalamus during fetal development Acquired: caused by damage to the pituitary gland or hypothalamus from tumors, severe head injury or infections such as meningitis or encephalitis Idiopathic: unknown cause Adult GHD Growth deficiencies do not just affect children – they can be a significant problem for adults, too. Until recently, the effects of GHD in adults were unknown. Adult GHD is now recognized as a specific clinical syndrome with numerous physiological consequences including effects on: Body composition, including central obesity Lipids in the blood Muscle strength Bone composition Exercise capacity and energy Cardiovascular risk Psychological well-being GHD in adults can result from a pituitary or peri-pituitary tumor or as a direct result of surgery or radiation used to manage these conditions. Less commonly, GHD in adults arises from a deficiency acquired in childhood. In adults, the signs of GHD are more subtle than in children. These may include both psychological symptoms such as depression, anxiety, poor memory and social isolation; along with physiological problems including weakness, poor vitality, easy fatigue and weight gain. 附件: 200821108461224.pdf    ------------------------------------------------------------ 注：以下产品不同规格和不同价格，购买时请以电话咨询为准！ 原产地英文商品名: Humatrope -2x24mgCartridge 原产地英文药品名: somatropin [rDNA origin] for injection 原产地英文化合物名称: Recombinant Human Growth Hormone 中文参考商品译名: Humatrope 2x24毫克支/盒 中文参考药品译名: 注射用基因重组人类生长激素 中文参考化合物名称: 基因重组人类生长激素 生产厂家中文参考译名: 美国礼来 生产厂家英文名: Eli Lilly and Co. ------------------------------------------------------- 原产地英文商品名: Humatrope -5x6mgCartridge 原产地英文药品名: somatropin [rDNA origin] for injection 原产地英文化合物名称: Recombinant Human Growth Hormone 中文参考商品译名: Humatrope 5x6毫克支/盒 中文参考药品译名: 注射用基因重组人类生长激素 中文参考化合物名称: 基因重组人类生长激素 生产厂家中文参考译名: 美国礼来 生产厂家英文名: Eli Lilly and Co. ------------------------------------------------------------ 原产地英文商品名: Humatrope -3x12mgCartridge 原产地英文药品名: somatropin [rDNA origin] for injection 原产地英文化合物名称: Recombinant Human Growth Hormone 中文参考商品译名: Humatrope 3x12毫克支/盒 中文参考药品译名: 注射用基因重组人类生长激素 中文参考化合物名称: 基因重组人类生长激素 生产厂家中文参考译名: 美国礼来 生产厂家英文名: Eli Lilly and Co. ------------------------------------------------------------- 原产地英文商品名: Humatrope -6x5mgVial 原产地英文药品名: somatropin [rDNA origin] for injection 原产地英文化合物名称: Recombinant Human Growth Hormone 中文参考商品译名: Humatrope 6x5毫克瓶 中文参考药品译名: 注射用基因重组人类生长激素 中文参考化合物名称: 基因重组人类生长激素 生产厂家中文参考译名: 美国礼来 生产厂家英文名: Eli Lilly and Co.