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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2016/03/04 06:42:12」(JST)

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Pancrelipases are commercial mixtures of pig-derived pancreatic amylase (a hydrolase acting on starch), pancreatic lipase, and chymotrypsin (a protease). They are used to improve food digestion in people who do not have enough pancreatic enzymes due to chronic pancreatitis, cystic fibrosis or obstruction of the pancreatic duct.^[1] The three components in the product are digestive enzymes akin to those normally produced by the human pancreas. Longstanding pancreatic enzyme replacement products (PERPs)—some in use for a century or more—fell under a 2006 FDA requirement that pharmaceutical companies with porcine-derived PERP products submit an NDA for each; Creon® (AbbVie Inc.) was the first of the commercial PERP products approved after the FDA directive, reaching market in 2009.^[2]

Pancrelipases are generally a first line approach in treatment of exocrine pancreatic insufficiency and other digestive disorders, accompanying cystic fibrosis, complicating surgical pancreatectomy, or resulting from chronic pancreatitis (see above). The formulations are generally hard capsules filled with gastro-resistant granules. Pancrelipases are similar to pancreatins, but with an increased lipase component.^{[citation needed]}

The specific requirement and reasoning for the FDA directive was that manufacturers submit a Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide to ensure patients were adequately informed regarding potential risks associated with administration of high doses of porcine-derived PERP products, especially with regard to "the theoretical risk of transmission of viral disease from pigs to patients", the risk of which (alongside other off-target effects) is reduced by patient adherence to label dosing instructions.^[2]

Brand names

Brand names include Creon, Pancreaze, Pertzye, Ultresa, Zenpep. There is currently a novel non-porcine derived Pancreatic Enzyme Replacement Therapy produced by Anthera Pharmaceuticals known as Sollpura (Liprotamase)

References

^ 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."
^ ^a ^b 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, see [2], accessed 20 July 2014.

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UpToDate Contents

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1. 胃瘻チューブ：造設および定期的なケア gastrostomy tubes placement and routine care
2. 慢性膵炎の治療 treatment of chronic pancreatitis
3. 進行膵外分泌癌に対する支持療法 supportive care of the patient with advanced exocrine pancreatic cancer
4. 原発性胆汁性肝硬変の治療の概要 overview of the treatment of primary biliary cirrhosis
5. 嚢胞性線維症：膵機能不全の評価およびマネージメント cystic fibrosis assessment and management of pancreatic insufficiency

English Journal

Efficacy and Safety of Pancrelipase/Pancreatin in Patients With Exocrine Pancreatic Insufficiency and a Medical History of Diabetes Mellitus.

Whitcomb DC1, Bodhani A, Beckmann K, Sander-Struckmeier S, Liu S, Fuldeore M, Pollack PF, Khurmi RP.
Pancreas.Pancreas.2016 May-Jun;45(5):679-86. doi: 10.1097/MPA.0000000000000514.
OBJECTIVES: The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency (EPI) with (n = 36) and without (n = 18) concurrent diabetes mellitus (DM).METHODS: This was a retrospe
PMID 26495784

Do pancrelipase delayed-release capsules have a protective role against nonalcoholic fatty liver disease after pancreatoduodenectomy in patients with pancreatic cancer? A randomized controlled trial.

Satoi S1, Sho M2, Yanagimoto H1, Yamamoto T1, Akahori T2, Kinoshita S2, Nagai M2, Hirooka S1, Yamaki S1, Nishiwada S2, Ryota H1, Ikeda N3, Nakajima Y2, Kon M1.
Journal of hepato-biliary-pancreatic sciences.J Hepatobiliary Pancreat Sci.2016 Mar;23(3):167-73. doi: 10.1002/jhbp.318. Epub 2016 Feb 14.
BACKGROUND: The aim of this randomized controlled trial (RCT) was to investigate whether pancrelipase protects against nonalcoholic fatty liver disease (NAFLD) development after pancreatoduodenectomy in patients with pancreatic cancer better than conventional pancreatic enzyme supplementation.METHOD
PMID 26748629

Clinical Characteristics and Risk Factors for the Development of Postoperative Hepatic Steatosis After Total Pancreatectomy.

Hata T1, Ishida M, Motoi F, Sakata N, Yoshimatsu G, Naitoh T, Katayose Y, Egawa S, Unno M.
Pancreas.Pancreas.2016 Mar;45(3):362-9. doi: 10.1097/MPA.0000000000000462.
OBJECTIVES: The occurrence of hepatic steatosis after pancreatectomy is known to be associated with the remnant pancreatic function. However, other risk factors for hepatic steatosis after pancreatectomy remain unknown. The aims of this study were to identify other risk factors in addition to the re
PMID 26495776

Japanese Journal

膵頭十二指腸切除後の非アルコール性脂肪性肝疾患の発生と高力価膵消化酵素補充剤(パンクレリパーゼ)の導入効果 : 膵癌と非膵癌症例の比較

胆膵の病態生理 = The Japanese journal of bilio-pancreatic pathophysiology 31(1), 27-33, 2015
NAID 40020490725

胃癌術後の栄養障害に対するパンクレリパーゼの使用経験

日本静脈経腸栄養学会雑誌 30(6), 1272-1276, 2015
NAID 130005114942

肝性脳症で発症し，栄養管理と膵外分泌酵素補充により改善を得た膵頭十二指腸切除術後非アルコール性脂肪性肝疾患の1例

日本消化器外科学会雑誌 48(4), 321-327, 2015
NAID 130005065288

Related Pictures

★リンクテーブル★

リンク元	「パンクレリパーゼ」

「パンクレリパーゼ」

Pancrelipase
Clinical data
AHFS/Drugs.com	monograph
MedlinePlus	a604035
Routes of; administration	Oral
Legal status	US: ℞-only;
Identifiers
CAS Number	53608-75-6
ATC code	A09AA02
DrugBank	DB00085
ChemSpider	none
UNII	FQ3DRG0N5K
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　　[★]

英: pancrelipase
商: リパクレオン
関: 健胃消化剤

[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."

[FDA2009-2] 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, see [2], accessed 20 July 2014.

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pancrelipase