胰脂肪酶

维基百科,自由的百科全书
跳到导航 跳到搜索

胰脂肪酶(Pancrelipases),特别是它的缓释剂型(例如: Creon, Pancreaze, Pertzye, Ultresa, Zenpep) 是猪源性胰淀粉酶的商用混合物(作用于淀粉水解酶),胰脂肪酶和胰凝乳蛋白酶(一种蛋白酶),其治疗目的是为了给那些没有足够胰腺酶的婴儿、小孩、成人在食物消化上的改善,因为它们会影响胰腺,如囊性纤维化慢性胰腺炎或在胰腺和肠之间的通道堵塞等作用。[1]这产品中的三个组成部分是类似那些通常由人类胰腺产生的消化酶。长期的胰腺酶替代产品(PERPs),有一些甚至使用了一个多世纪,2006年美国食品药品管理局要求制药公司提交猪源性PERP产品的保密合约;Creon®(AbbVie公司)是最早的美国食品药品管理局指令后,批准商业PERP产品的公司,在2009年正式在市场上市。[2]

胰脂肪酶通常是用在治疗外分泌胰腺功能和一些不消化上的疾病,伴随囊性纤维化,胰脏切除手术并发症,或慢性胰腺炎的第一个方法。制剂通常填充在硬质胶囊里以耐胃酸颗粒。胰脂肪酶类似于胰液,但具有较多的脂肪酶成分。

美国食品药品管理局具体要求制造商提交风险评估、REMS和用药指南,以确保病人充分了解有关于高剂量的猪源性PERP产品管理相关的潜在风险,特别是关于“从猪身上传染病毒性疾病到患者的理论风险”,病人对药的依赖性(用药量)应减少到药品标签之剂量用量。

参考文献[编辑]

  1. ^ MedlinePlus (2014) Pancrelipase, see [1], accessed 20 July 2014. The full quotation from which this derives also contains a definition of each term preceding each ellipsis: "used to improve digestion of food in children and adults who do not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food) such as cystic fibrosis (an inborn disease that causes the body to produce thick, sticky mucus that may clog the pancreas, the lungs, and other parts of the body), chronic pancreatitis (swelling of the pancreas that does not go away), or a blockage in the passages between the pancreas and the intestine."
  2. ^ U.S. Food and Drug Administration (2009) FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States: Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency, News & Events, FDA News Release, May 7, 2009

参见[编辑]