EEVALUATE SAFETY & EFFICACY OF EURAND PEP CYSTIC FIBROSIS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 胰腺外分泌功能不全(EPI)以脂肪、蛋白质和碳水化合物吸收不良为特征，主要见于囊性纤维化(CF)。在过去的三十年里，用胰酶产品(PEP)治疗慢性胰腺炎患者的外周感染已经被很好地确立了。已经有许多研究表明，至少在短期使用时是有效和安全的。然而，在一些研究中，高剂量的PEPS与发展成纤维结肠病的风险增加有关。由于大多数PEP是在当前FDA要求和更高剂量可能的安全风险之前开发的，FDA希望完成安全性和有效性试验

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Exocrine pancreatic insufficiency (EPI) is characterized by poor absorption of fats, proteins and carbohydrates, which is primarily observed in cystic fibrosis (CF). Treatment of EPI in patients with CF with pancreatic enzyme products (PEPs) has been well established over the last thirty years. There have been many studies indicating efficacy and safety at least for short term use. High doses of PEPs, however, in some studies have been associated with increased risk of developing fibrosing colonopathy. Because most PEPs were developed before current FDA requirements and the possible safety risk of higher doses, the FDA wants safety and efficacy trials complete