Kalnins Daina, Ellis Lynda, Corey Mary, Pencharz Paul B, Stewart Cynthia, Tullis Elizabeth, Durie Peter R
Division of Respiratory Medicine, Department of Pediatrics, The Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada.
J Pediatr Gastroenterol Nutr. 2006 Mar;42(3):256-61. doi: 10.1097/01.mpg.0000189356.93784.01.
To compare the efficacy of an enteric-coated buffered pancreatic enzyme (EC buffered PE) containing 1.5 mEq of bicarbonate per capsule with a conventional enteric-coated enzyme (EC-PE) capsule in cystic fibrosis patients with signs or symptoms of moderate to severe malabsorption.
In a double-blind crossover study, subjects were randomly assigned to two consecutive, 2-week phases using an EC buffered PE product and conventional EC-PE product. Seventy-two hour stool collections from each phase were analyzed for energy, fat, and nitrogen content and expressed as percent of estimated intake.
Twenty-one patients with cystic fibrosis and pancreatic insufficiency (14 female, mean age 20.6 +/- 11.5 years, range 8.8-41.9) completed the study. There was no significant difference in percent malabsorption of energy (19.4% vs. 19.0%), fat (20.7% vs. 20.2%), or nitrogen (10.4% vs. 10.7%) between the EC buffered PE product and the conventional EC-PE product. However, patients taking the EC buffered PE product received less enzyme based on actual enzyme activity measured in vitro (3,468 +/- 1,434 U lipase/g fat vs. 3,978 +/- 1,474 U lipase/g fat, P < 0.02).
In the doses used, nutrient absorption of patients taking EC buffered PE preparation offers no advantage over a conventional EC-PE preparation.
比较每粒含1.5 mEq碳酸氢盐的肠溶包衣缓冲胰酶（EC缓冲胰酶）与传统肠溶包衣胰酶（EC - 胰酶）胶囊对有中度至重度吸收不良体征或症状的囊性纤维化患者的疗效。
在一项双盲交叉研究中，受试者使用EC缓冲胰酶产品和传统EC - 胰酶产品被随机分配到两个连续的为期2周的阶段。对每个阶段收集的72小时粪便进行能量、脂肪和氮含量分析，并表示为估计摄入量的百分比。
21例患有囊性纤维化和胰腺功能不全的患者（14名女性，平均年龄20.6±11.5岁，范围8.8 - 41.9岁）完成了研究。EC缓冲胰酶产品和传统EC - 胰酶产品之间在能量吸收不良百分比（19.4%对19.0%）、脂肪（20.7%对20.2%）或氮（10.4%对10.7%）方面没有显著差异。然而，根据体外测量的实际酶活性，服用EC缓冲胰酶产品的患者接受的酶较少（脂肪酶3,468±1,434 U/g脂肪对3,978±1,474 U/g脂肪，P < 0.02）。
在所使用的剂量下，服用EC缓冲胰酶制剂的患者的营养吸收并不优于传统的EC - 胰酶制剂。
