Johns Hopkins University School of Medicine; Department of Medicine.
Ther Clin Risk Manag. 2009 Jun;5(3):507-20. doi: 10.2147/tcrm.s3196. Epub 2009 Jul 12.
Pancreatic enzyme supplements (PES) are used in chronic pancreatitis (CP) for correction of pancreatic exocrine insufficiency (PEI) as well as pain and malnutrition. The use of porcine pancreatic enzymes for the correction of exocrine insufficiency is governed by the pathophysiology of the disease as well as pharmacologic properties of PES. Variability in bioequivalence of PES has been noted on in vitro and in vivo testing and has been attributed to the differences in enteric coating and the degree of micro-encapsulation. As a step towards standardizing pancreatic enzyme preparations, the Food and Drug Administration now requires the manufacturers of PES to obtain approval of marketed formulations by April 2010. In patients with treatment failure, apart from evaluating drug and dietary interactions and compliance, physicians should keep in mind that patients may benefit from switching to a different formulation. The choice of PES (enteric coated versus non-enteric coated) and the need for acid suppression should be individualized. There is no current standard test for evaluating adequacy of therapy in CP patients and studies have shown that optimization of therapy based on symptoms may be inadequate. Goals of therapy based on overall patient presentation and specific laboratory tests rather than mere correction of steatorrhea are needed.
胰酶补充剂（PES）用于慢性胰腺炎（CP）中，以纠正胰腺外分泌不足（PEI）以及疼痛和营养不良。猪源性胰酶用于纠正外分泌不足是基于疾病的病理生理学以及 PES 的药理学特性。在体外和体内测试中已经注意到 PES 的生物等效性存在差异，这归因于肠溶性包衣和微囊化程度的差异。为了标准化胰酶制剂，食品和药物管理局现在要求 PES 的制造商在 2010 年 4 月之前获得已上市制剂的批准。在治疗失败的患者中，除了评估药物和饮食相互作用以及依从性之外，医生还应牢记患者可能受益于改用不同的制剂。PES 的选择（肠溶性与非肠溶性）和酸抑制的需求应个体化。目前尚无评估 CP 患者治疗充分性的标准检测方法，研究表明，基于症状的治疗优化可能不足。需要基于患者整体表现和特定实验室检测的治疗目标，而不仅仅是纠正脂肪泻。
