胰脂肪酶

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胰脂肪酶(Pancrelipases),特別是它的緩釋劑型(例如: Creon, Pancreaze, Pertzye, Ultresa, Zenpep) 是豬源性胰澱粉酶的商用混合物(作用於澱粉水解酶),胰脂肪酶和胰凝乳蛋白酶(一種蛋白酶),其治療目的是為了給那些沒有足夠胰腺酶的嬰兒、小孩、成人在食物消化上的改善,因為它們會影響胰腺,如囊性纖維化慢性胰腺炎或在胰腺和腸之間的通道堵塞等作用。[1]這產品中的三個組成部分是類似那些通常由人類胰腺產生的消化酶。長期的胰腺酶替代產品(PERPs),有一些甚至使用了一個多世紀,2006年美國食品藥品管理局要求製藥公司提交豬源性PERP產品的保密合約;Creon®(AbbVie公司)是最早的美國食品藥品管理局指令後,批准商業PERP產品的公司,在2009年正式在市場上市。[2]

胰脂肪酶通常是用在治療外分泌胰腺功能和一些不消化上的疾病,伴隨囊性纖維化,胰臟切除手術併發症,或慢性胰腺炎的第一個方法。製劑通常填充在硬質膠囊裡以耐胃酸顆粒。胰脂肪酶類似於胰液,但具有較多的脂肪酶成分。

美國食品藥品管理局具體要求製造商提交風險評估、REMS和用藥指南,以確保病人充分了解有關於高劑量的豬源性PERP產品管理相關的潛在風險,特別是關於「從豬身上傳染病毒性疾病到患者的理論風險」,病人對藥的依賴性(用藥量)應減少到藥品標籤之劑量用量。

參考資料[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