EEVALUATE SAFETY & EFFICACY OF EURAND PEP CYSTIC FIBROSIS

评估安全性

• 批准号: 7625785
• 负责人: Gavin R Graff
• 金额: $ 0.98万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7625785
• 关键词: Carbohydrates; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; Dose; Exocrine pancreatic insufficiency; Fatty acid glycerol esters; Fibrosis; Funding; Grant; Institution; Pancreatic enzyme; Personal Satisfaction; Proteins; Research; Research Personnel; Resources; Risk; Safety; Source; United States Food and Drug Administration; United States National Institutes of Health; absorption; cystic fibrosis patients; efficacy trial

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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 胰腺外分泌功能不全（EPI）的特征在于脂肪、蛋白质和碳水化合物的吸收不良，这主要在囊性纤维化（CF）中观察到。 在过去的三十年中，用胰酶产品（PEP）治疗CF患者的EPI已经得到了很好的确立。 有许多研究表明至少短期使用的有效性和安全性。 然而，在一些研究中，高剂量的PEP与发生纤维化结肠病的风险增加有关。 由于大多数PEP是在FDA要求之前开发的，并且更高剂量可能存在安全风险，因此FDA希望完成安全性和有效性试验