Nakajima Kei, Oshida Haruki, Muneyuki Toshitaka, Kakei Masafumi
Division of Clinical Nutrition, Department of Medical Dietetics, Faculty of Pharmaceutical Sciences, Josai University, Keyakidai, Sakado.
Core Evid. 2012;7:77-91. doi: 10.2147/CE.S26705. Epub 2012 Jul 19.
Pancreatic exocrine insufficiency (PEI) is often observed in patients with pancreatic diseases, including chronic pancreatitis, cystic fibrosis, and tumors, or after surgical resection. PEI often results in malnutrition, weight loss and steatorrhea, which together increase the risk of morbidity and mortality. Therefore, nutritional interventions, such as low-fat diets and pancreatic enzyme replacement therapy (PERT), are needed to improve the clinical symptoms, and to address the pathophysiology of pancreatic exocrine insufficiency. PERT with delayed-release pancrelipase is now becoming a standard therapy for pancreatic exocrine insufficiency because it significantly improves the coefficients of fat and nitrogen absorption as well as clinical symptoms, without serious treatment-emergent adverse events. The major adverse events were tolerable gastrointestinal tract symptoms, such as stomach pain, nausea, and bloating. Fibrosing colonopathy, a serious complication, is associated with high doses of enzymes. Several pancrelipase products have been approved by the US Food and Drug Administration in recent years. Although many double-blind, placebo-controlled trials of pancrelipase products have been conducted in recent years, these studies have enrolled relatively few patients and have often been less than a few weeks in duration. Moreover, few studies have addressed the issue of pancreatic diabetes, a type of diabetes that is characterized by frequent hypoglycemia, which is difficult to manage. In addition, it is unclear whether PERT improves morbidity and mortality in such settings. Therefore, large, long-term prospective studies are needed to identify the optimal treatment for pancreatic exocrine insufficiency. The studies should also examine the extent to which PERT using pancrelipase improves mortality and morbidity. The etiology and severity of pancreatic exocrine insufficiency often differ among patients with gastrointestinal diseases or diabetes (type 1 and type 2), and among elderly subjects. Finally, although there is currently limited clinical evidence, numerous extrapancreatic diseases and conditions that are highly prevalent in the general population may also be considered potential targets for PERT and related treatments.
胰腺外分泌功能不全（PEI）常见于患有胰腺疾病的患者，包括慢性胰腺炎、囊性纤维化和肿瘤，或在手术切除后。PEI常导致营养不良、体重减轻和脂肪泻，这些因素共同增加了发病和死亡风险。因此，需要进行营养干预，如低脂饮食和胰腺酶替代疗法（PERT），以改善临床症状，并解决胰腺外分泌功能不全的病理生理学问题。使用缓释胰酶的PERT目前正成为治疗胰腺外分泌功能不全的标准疗法，因为它能显著提高脂肪和氮的吸收系数以及临床症状，且无严重的治疗中出现的不良事件。主要不良事件为可耐受的胃肠道症状，如胃痛、恶心和腹胀。纤维性结肠病是一种严重并发症，与高剂量酶有关。近年来，几种胰酶产品已获得美国食品药品监督管理局的批准。尽管近年来对胰酶产品进行了许多双盲、安慰剂对照试验，但这些研究纳入的患者相对较少，且持续时间往往不到几周。此外，很少有研究涉及胰腺性糖尿病问题，这是一种以频繁低血糖为特征且难以管理的糖尿病类型。此外，尚不清楚PERT在这种情况下是否能改善发病率和死亡率。因此，需要进行大规模、长期的前瞻性研究，以确定胰腺外分泌功能不全的最佳治疗方法。这些研究还应检查使用胰酶的PERT在多大程度上能改善死亡率和发病率。胃肠道疾病或糖尿病（1型和2型）患者以及老年受试者中，胰腺外分泌功能不全的病因和严重程度往往不同。最后，尽管目前临床证据有限，但普通人群中高度流行的许多胰腺外疾病和病症也可能被视为PERT及相关治疗的潜在靶点。
