近日，美国FDA批准Creon（pancrelipase Delayed-Release Capsules）胰酶替代药物用于成人与儿童囊性纤维化和其它原因所致的胰酶缺乏症. 批准日期：2009年3月  公司：ABBVIE INC CREON（胰脂肪酶 pancrelipase）缓释胶囊，用于口服使用 美国首次批准：2009年 作用机制 CREON中的胰腺酶催化脂肪水解为单酸甘油酯，甘油和游离脂肪酸，蛋白质成肽和氨基酸，并且在十二指肠和近端小肠中淀粉成糊精和短链糖，例如麦芽糖和麦芽三糖，由此起作用 由胰腺生理分泌的消化酶 适应症和用法 CREON是猪来源的脂肪酶，蛋白酶和淀粉酶的组合，其指示用于治疗由于囊性纤维化，慢性胰腺炎，胰腺切除术或其他病症引起的外分泌胰腺功能不全。 剂量和给药 CREON不能与任何其他胰脂肪酶产品互换。 不要粉碎或咀嚼胶囊和胶囊内容物。对于不能吞咽完整胶囊的婴儿或患者，可将内容物撒在软酸性食物例如苹果酱上。剂量不应超过囊性纤维化基金会共识会议指南中规定的建议最大剂量。 婴儿（长达12个月） 在每次喂养之前，婴儿可以每120mL配方或每次母乳喂养给予3,000个脂肪酶单位（一个胶囊）。 在给药前不要将CREON胶囊内容物直接混入配方奶粉或母乳中。 儿童年龄大于12个月和小于4岁 对于小于4岁的儿童，以每餐1千个脂肪酶单位/kg体重开始，至每个膳食最多2,500个脂肪酶单位/ kg体重（或小于或等于10,000个脂肪酶单位/ kg体重/天），或小于每天摄入4,000脂肪酶单位/ g脂肪。 儿童4岁及以上和成人 对于大于4岁的人，每餐每500kg脂肪酶单位/kg体重开始，到每餐最多2500脂肪酶单位/kg体重（或小于或等于10,000脂肪酶单位/kg体重每天） ），或小于每天摄入4,000脂肪酶单位/g脂肪。 由于慢性胰腺炎或胰腺切除术导致外分泌胰腺功能不全的成人 基于临床症状，存在的脂肪的程度和饮食的脂肪含量来个体化剂量。 剂量形式和强度 延迟释放胶囊：3,000 USP单位的脂肪酶; 9,500 USP单位的蛋白酶; 15,000 USP单位的淀粉酶 延迟释放胶囊：6,000 USP单位的脂肪酶; 19,000 USP单位的蛋白酶; 30,000 USP单位的淀粉酶 延迟释放胶囊：12,000 USP单位的脂肪酶; 38,000 USP单位的蛋白酶; 60,000 USP单位的淀粉酶 延迟释放胶囊：24,000USP单位的脂肪酶; 76,000 USP单位的蛋白酶; 120,000 USP单位的淀粉酶 延迟释放胶囊：36,000 USP单位的脂肪酶; 114,000 USP单位的蛋白酶; 180,000 USP单位的淀粉酶 禁忌症 没有 警告和注意事项 纤维化结肠病与在囊性纤维化患者的治疗中大量使用胰腺酶替代物有关。当CREON的剂量超过每餐每千克体重2,500脂肪酶单位（或大于10,000脂酶单位/千克体重每天）时，请谨慎行事。 为了避免刺激口腔粘膜，不要咀嚼CREON或留在口中。 当对患有痛风，肾损伤或高尿酸血症的患者开处方CREON时要小心。 存在所有胰腺酶产物（包括CREON）的病毒传播的理论风险。 向对猪来源的蛋白质具有已知过敏反应的患者施用胰脂肪酶时要小心。 不良反应 在接受CREON的至少2名囊性纤维化患者（大于或等于4％）中发生的不良反应是呕吐，头晕和咳嗽。 接受CREON的至少1例慢性胰腺炎或胰腺切除术患者（大于或等于4％）中发生的不良反应是高血糖，低血糖，腹痛，异常粪便，肠胃胀气，频繁排便和鼻咽炎。 ------------------------------------------------- 注：以下产品不同规格和不同价格，采购以咨询为准 ------------------------------------------------- CREON 12000 CAP 100  LIPASE/PROTEASE/AMYLASE     00032-1212-01  CREON 12000 CAP 250  LIPASE/PROTEASE/AMYLASE     00032-1212-07  CREON 24000 CAP 100  LIPASE/PROTEASE/AMYLASE     00032-1224-01  CREON 24000 CAP 250  LIPASE/PROTEASE/AMYLASE     00032-1224-07  CREON 3000 CAP 70  LIPASE/PROTEASE/AMYLASE     00032-1203-70    CREON 36000 CAP 100  LIPASE/PROTEASE/AMYLASE     00032-3016-13  CREON 36000 CAP 250  LIPASE/PROTEASE/AMYLASE     00032-3016-28 CREON 6000 CAP 100  LIPASE/PROTEASE/AMYLASE     00032-1206-01 CREON 6000 CAP 250  LIPASE/PROTEASE/AMYLASE     00032-1206-07 完整资料附件： https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d CREON® (Pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis NEW DATA SUPPORT SAFE AND EFFECTIVE USE OF CREON TO TREAT EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS OR PANCREATIC SURGERY CREON®(pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in adults with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery. EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food and, if untreated, can lead to diarrhea, weight loss and ultimately malnutrition. Findings from this Phase III study, which have been submitted to the FDA, were presented at the American College of Gastroenterology Annual Scientific Meeting in San Diego, California, on Sunday, October 25th, by Dr. David C. Whitcomb, in a poster titled "Efficacy and safety of pancrelipase delayed-release capsules (CREON®) in patients with pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery," poster number P101. Among FDA-approved pancreatic enzyme replacement therapies (PERTs), this study provides important new data to eva luate PERT dosing specifically in patients with EPI due to CP or pancreatic surgery. "The maldigestion associated with EPI due to chronic pancreatitis and pancreatic surgeries can result in malnutrition as well as debilitating pain and GI symptoms that negatively impact quality of life for these patients," said David C. Whitcomb, M.D., Ph.D., University of Pittsburgh Medical Center. "These data support the use of PERT to improve the absorption of fat in patients receiving diets of at least 100 g of fat per day, which serves as an important demonstration to clinicians that EPI can be effectively treated without restricting patients' diets to be very low in fat." According to the study results, adults with CP or who have undergone pancreatic surgery, who took CREON®, had an improved coefficient of fat absorption (CFA) as compared to the placebo group. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is another way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The primary efficacy endpoint was the change in CFA from baseline to the end of the double-blind treatment period. The CFA improved by 32.1% in the CREON® group compared to 8.8% in the placebo group, representing a statistically significant difference between CREON® and placebo (P<0.0001). "These data add to the growing body of evidence supporting the efficacy and safety profile of CREON® across multiple conditions while also providing clarity around the appropriate dosing of pancreatic enzyme replacement therapy in these patients," said Elizabeth M. Mutisya, M.D., Vice President of U.S. Medical Affairs and Chief Medical Officer at Solvay Pharmaceuticals, Inc. "These CREON® study results are encouraging as dosing of pancreatic enzymes for patients with EPI due to CP or pancreatic surgery has not previously been well defined."