|
简介：
Saizen®思增®重组人生长激素
【成份及外观】
思增®的有效成份是基因重组人生长激素，它是用哺乳动物细胞基因重组技术生产的，其结构与人垂体分泌的生长激素完全相同，是真正的人生长激素。
思增®以冻干粉针形式供应，溶解后供皮下或肌肉注射。思增®有两种规格：4iu/瓶和10iu/瓶。
【药理学特性】
思增®通过作用于软骨组织增加骨骼的长度从而促进人体的线性生长，这一作用分别通过促生长因子或胰岛素样生长因子介导，这是思增®最重要的作用，除此之外思增®尚具有下列作用。
1.促进骨骼肌及心肌细胞生长，增强肌力。
2.促进蛋白质的合成，增加体内氮贮量。
3.增加脂肪氧化分解，使体内脂及储备减少，血浆脂及酸浓度升高。
4.提高营养物质转换率，增强营养治疗的效能。
5.提高1,25（OH）D3水平，增加肠道对钙磷元素的吸收。
6.调节免疫系统功能，增强免疫防御能力。
【药代动力学】
思增®的血浆半衰期约3小时，皮下注射4iu/m2后约4-6小时出现GH峰值，8小时后可见IGF-1升高，后者5天后达到峰值，15天后才反回到治疗前水平。
【适应症及用法】
儿童生长激素缺乏症
儿童生长激素缺乏导致的生长障碍是思增®的绝对适应症，思增®可以增加生长速度，增加最终身高。国内一项研究显示，思增®治疗前，治疗后3个月、6个月以及停药后3个月的生长速度分别为2.6±1.0、12.8±4.2、8.5±3.0和5.7±3.1cm/年（均与治疗前比P＜0.01）。
用法：每周0.6-0.8iu/kg或每周12-20iu/m2,每周剂量分3次或6次给药，晚上注射，至患儿长至满意的高度或骨骺闭合。
特钠氏综合征
特钠氏综合征是一种染色体病，大约每2500例新生女婴中有一例发生此病，特纳氏综合征最重要的临床特征是卵巢不发育和身材矮小。已经证明生长激素可以增加特纳氏综合征患儿的生长速度及最终身高，在一项包括30例患儿的随机双盲前瞻性研究中，病人的最终身高可以长至151.9cm，比他们的预期身高高出8.1cm。
用法：每周1.0iu/kg,或每周28iu/m2
儿童慢性肾功能不全导致的生长障碍
儿童慢性肾功能不全（CRI）的其中一个结果是导致生长发育障碍。15岁以前患上慢性肾疾病的儿童，有将近一半患儿的最终身高比平均值低2.5个标准差，三项研究（其中包括一项随机双盲对照研究）表明生长激素明显在增加CRI儿童（包括晚期CRI）的生长速度而不加速骨骺的闭合，美国FDA已经批准生长激素用于治疗肾移植前的CRI儿童。
用法：每周30iu/m2或每周1.0iu/kg,必要时可加大剂量，治疗6个月后可能需要调整剂量。
手术及创伤后高代谢状态（负氮平衡）
创伤后的代谢牲为身体蛋白质丢失，肌肉蛋白质合成减少，游离谷氨酰胺下降及负氮平衡，同时伴有免疫功能下降，伤口不愈合和感染机会增加。已有报道生长激素和适量热卡蛋白质营养液一起给予术后病人时，能减少负氮平衡和肌肉游离谷氨酰胺的丢失，增加蛋白质合成，加速伤口愈合和降低死亡率。
用法：4-8iu/天，皮下或肌注共5-7天
烧伤
烧伤是一种特别严重的创伤、它破坏了人体解剖结构，扰乱了体液平衡和新陈代谢。对于大面积烧伤的病人，暴露的伤口加重了高代谢状态，也为致病进入伤口和体内提供了门路。已经有研究报道生长激素能加速伤口的愈合，缩短高代谢期，降低感染的危险性，加快供皮区伤口的愈合，从而缩短治疗的时间。
用法：8-16iu/d 烧伤后3-7天开始，共10-14天
脓毒败血症
除了促合成代谢外，生长激素的另一个作用是免疫调节作用。生长激素通过促进骨髓细胞成熟，刺激吞噬细胞迁移，触发吞噬细胞产生超氧化阴离子及细胞因子以及提高调理素的活力等方面的作用来保护宿主免受致病菌的侵犯，生长激素对于预防和治疗严重的脓毒症应该具有积极的作用。
用法：0.3iu/kg·d
成人生长激素缺乏症
生长激素的分泌随年龄的增和而下降，正常成年人20岁以后，平均每10年下降14%，成年人生长激素缺乏的表现包括：心理健康水平降低、脂肪积聚。腰围增加，细胞外水份减少，皮肤变薄及皮肤胶原减少，肌肉的力量下降，运动能力下降，血脂升高，肾小球滤过率和基础代谢率降低，骨密度下降等。小剂量生长激素替代治疗能改善上述症状，提高生活质量。
用法：0.25iu/kg·w或15iu/w疗程2-6个月，第一个月用半剂量。
【禁忌症】
1.糖尿病患者应在严密的实验室监测下接受治疗。
2.进展期的脑部肿瘤患者不应使用思增® 。
3.孕期及哺乳期不应使用思增® 。
【副作用及过量】
1.长期注射同一部位会出现局部脂肪萎缩，可以通过改变每天的注射部位避免。
2.用药过度会出现甲状腺机能减退，可用甲状腺素加以纠正。
3.部分病人出现高血糖，可同时用胰岛素纠正。
免疫源性
1. 266例（217例为初治，49例为复治）患者中，只有1.1%产生思®抗体，这些抗体无任何生长抑制作用。
2. 接受本药治疗长达4年的患者血清中未检测到针对缩主细胞蛋白的抗体。
3. 一些接受其它生长激素治疗的患者，接受思增治疗数月后，原有抗体检测结果转阴。
特别注意事项
1. 10iu思增的溶剂中含有苄乙醇不能用于新生儿，如用于新生儿，可用生理盐水或无菌注射用水溶解本药。
2. 溶解时，把溶剂沿瓶壁缓慢注入瓶内然后轻搓小瓶直至溶解，不能用力振摇。
【贮存】
1.思增的冻干粉剂应存放在2-8℃冰箱中。
2.以生理盐水溶解后应立即使用。
3.用含苄乙醇的生理盐水溶解后2-8℃下可保存14天。
【制造商】瑞士雪兰诺大药厂
据报道，雪兰诺10日宣布，成人生长激素缺乏症(AGHD)用药Saizen(注射用生长激素)获准在美国上市。根据FDA批准，儿童时期生长激素缺乏，到成年后仍生长激素缺乏的患者可使用该药物进行继续治疗。另外，单纯生长激素缺乏或多种激素缺乏患者，也可使用Saizen及其相应设备Cool.Click。
【原产地英文商品名】Saizen 8.8mg/Cartridge 1Cartridge/box
【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】
注：以下产品是不同的规格和不同的价格，购买时请以电话咨询为准
·思增 8.8毫克/支 5支/盒
·思增 8.8毫克/支 1支/盒
·思增 5毫克/瓶 5瓶/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
【曾用名】思真、帅健
Saizen®
Saizen® (somatropin for injection) is a recombinant human growth hormone made by DNA technology which is therapeutically equivalent to the natural growth hormone (GH) produced by the body.
Saizen® is indicated for the treatment of growth hormone deficiency (GHD) in children and adults, Turner's syndrome, and chronic renal failure and children born short for gestational age (SGA). Treatment of GH deficient children with Saizen® leads to accelerated growth. The overall effect of GH therapy in GHD children who respond well is that, as adults, they will be taller than they would have been if left untreated.
The role of GH in the human body:
Growth hormone (GH) is a protein produced by the pituitary gland, which is situated under the hypothalamus of the brain. This hormone controls children's growth and regulates a number of metabolic and physiological processes throughout life. Saizen® works by replacing the GH the body normally produces.
The Saizen® Device Family: Merck Serono is committed to simplifying treatment by offering a family of easy-to-use drug delivery devices. This opportunity to choose the best solution for individual patients' needs is intended to increase convenience and improve adherence to GH treatment.
The Saizen® Device Family is composed of several innovative products:
easypod™
easypod™ is an easy-to-use daily electronic injection device for delivery of Merck Serono's recombinant human GH Saizen® (somatropin). Part of the Saizen® device family, easypod™ is the only device that enables physicians and nurses to measure patient adherence to therapy. It is approved and launched in several countries in Europe and submitted for FDA approval in the U.S.
cool.click™
cool.click™ is a needle-free device that delivers Saizen® through the skin in less than one second. The drug is delivered subcutaneously and provides the equivalent biological dose of Saizen® as syringe and needle injections. Because it is needle-free, cool.click™ reduces pain and anxiety for patients who are undergoing daily treatment for GH deficiency.
one.click™
one.click™ is a new generation of autoinjector developed by Merck Serono for the injection of Saizen®. It allows the insertion of the needle and the delivery of the drug in one single step and comes with a new reconstitution device, click.easy™, which simplifies the reconstitution procedure. The dosage can be easily set and adjusted, should an incorrect dosage be initially set. In addition, one.click™ has a hidden needle that is kept out-of-sight before and during injection, to reduce anxiety. click.easy™
click.easy™, the easy-to-use reconstitution device, is a member of the Saizen® Device Family. Both one.click™ and cool.click™ are for use with Saizen® 8mg. click.easy™.
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.
-------------------------------------------------------------------
Important Safety Information about Saizen®
Saizen® is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. It is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency that meets the criteria of adult onset or childhood onset.
Growth hormone should be used with caution in patients with insulin resistance, glucose intolerance, diabetes, hypothyroidism, intracranial hypertension, and in women who are pregnant or nursing. GH should not be used in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment; in the presence of active neoplasia; and in patients with proliferative or preproliferative diabetic retinopathy; or in patients hospitalized with acute critical illnesses.
In children with GHD, adverse events are infrequent, and include injection site reactions, hypothyroidism, and hypoglycemia.
In patients with AGHD, the most common adverse events associated with growth hormone therapy are joint and muscle pain, edema, carpal tunnel syndrome, and tingling.
Saizen® is available in 5 mg (vial) and 8.8 mg (vial, click.easy® cartridge) strengths. |
