Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, St. John Hospital and Medical Center, Detroit, MI.
Ann Pharmacother. 2011 May;45(5):658-66. doi: 10.1345/aph.1P770. Epub 2011 May 3.
To review the pharmacology, dosage regimens, efficacy, and safety of currently marketed pancreatic enzyme products (PEPs).
Studies were identified by PubMed (1966-January 2011), clinicaltrials.gov, fda.gov, and International Pharmaceutical Abstracts. Search terms included pancreatic enzyme, lipase, Creon, Zenpep, Pancreaze, and exocrine pancreatic insufficiency (EPI).
All human studies evaluating the efficacy of currently approved or potential PEPs were reviewed.
PEPs are composed of porcine lipase, amylase, and protease and are used in patients with EPI secondary to cystic fibrosis, chronic pancreatitis, and pancreatectomy. In 1938, PEPs were exempted from the Food, Drug, and Cosmetic Act of 1938 and never underwent a formal Food and Drug Administration (FDA) review process. In response to reports of treatment failures during product interchange, the FDA conducted a review of available PEP products. This review found a large variability of response between the unapproved PEP products, which resulted in the FDA requiring approval of all PEP products by April 2010. The 3 delayed-release, enteric-coated PEPs currently approved by the FDA (Creon, Zenpep, and Pancreaze) have demonstrated efficacy and safety in EPI secondary to cystic fibrosis. Creon has also demonstrated safety and efficacy in EPI secondary to chronic pancreatitis and pancreatectomy. Cost difference between the 3 products is minimal. Treatment-related adverse events in clinical studies for all PEPs were less than or similar to those with placebo.
At this time, Creon is an appropriate first-line agent, as it has been approved for chronic pancreatitis, pancreatectomy, and cystic fibrosis.
综述目前市售胰酶制剂（PEP）的药理学、剂量方案、疗效和安全性。
通过 PubMed（1966 年 1 月至 2011 年 1 月）、clinicaltrials.gov、fda.gov 和国际药学文摘检索研究。检索词包括胰酶、脂肪酶、Creon、Zenpep、Pancreaze 和外分泌胰腺功能不全（EPI）。
所有评估目前批准或潜在 PEP 疗效的人类研究均被纳入。
PEP 由猪源脂肪酶、淀粉酶和蛋白酶组成，用于治疗囊性纤维化、慢性胰腺炎和胰腺切除术后继发 EPI 的患者。1938 年，PEP 被豁免于 1938 年《食品、药品和化妆品法案》，从未经过正式的食品和药物管理局（FDA）审查程序。针对产品替换期间治疗失败的报告，FDA 对现有的 PEP 产品进行了审查。该审查发现，未经批准的 PEP 产品之间的反应存在很大差异，这导致 FDA 要求所有 PEP 产品于 2010 年 4 月前获得批准。目前 FDA 批准的 3 种延迟释放、肠溶包衣 PEP（Creon、Zenpep 和 Pancreaze）已被证明在囊性纤维化继发 EPI 中有效且安全。Creon 也被证明在慢性胰腺炎和胰腺切除术后继发 EPI 中安全有效。这 3 种产品之间的成本差异很小。所有 PEP 的临床研究中与治疗相关的不良事件少于或与安慰剂相似。
目前，Creon 是一种合适的一线药物，因为它已被批准用于慢性胰腺炎、胰腺切除术和囊性纤维化。
