慢性胰腺炎所致外分泌性胰腺功能不全患者的胰酶替代疗法：一项关于症状控制和生活质量的为期1年的疾病管理研究

Pancreatic enzyme replacement therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis: a 1-year disease management study on symptom control and quality of life.

作者信息

D'Haese Jan G, Ceyhan Güralp O, Demir Ihsan Ekin, Layer Peter, Uhl Waldemar, Löhr Matthias, Rychlik Reinhard, Pirilis Konstantinos, Zöllner York, Gradl Birgit, Foerster Douglas, Möbius Julia, Henniges Friederike, Friess Helmut

机构信息

From the *Department of Surgery, Klinikum Rechts der Isar, Technische Universität München, Munich; †Department of Internal Medicine, Israelitisches Krankenhaus, Hamburg; ‡Department of Surgery, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany; §Department of Surgical Gastroenterology, Karolinska Institutet, Stockholm, Sweden; ∥Institut für Empirische Gesundheitsökonomie, Burscheid; ¶Leibniz University, Hannover; #Hamburg University of Applied Sciences, Hamburg, Germany; **Abbott Products Operations AG, Allschwil, Switzerland; ††School of Public Health, University Bielefeld, Bielefeld; ‡‡Abbott Arzneimittel GmbH, Hannover; and §§Abbott Products, Hannover, Germany.

出版信息

Pancreas. 2014 Aug;43(6):834-41. doi: 10.1097/MPA.0000000000000131.

DOI:10.1097/MPA.0000000000000131

PMID:24717829

Abstract

OBJECTIVE

Exocrine pancreatic insufficiency (EPI) is frequent in patients with chronic pancreatitis (CP). This 1-year, prospective, multicenter, observational, disease management study aimed to assess symptom improvement and quality of life in patients with CP with EPI who were receiving pancreatic enzyme replacement.

METHODS

Patients with CP and chronic EPI were either assigned to cohort 1 that consisted of patients already taking pancreatin (Kreon; Abbott Arzneimittel GmbH, Hannover, Germany) or cohort 2 that consisted of patients with newly diagnosed EPI without prior pancreatic enzyme treatment. Symptoms were documented, and quality of life was assessed using the gastrointestinal quality of life index (GIQLI) at baseline, 6 months, and 1 year.

RESULTS

A total of 294 patients were evaluated (cohort 1, n = 206; cohort 2, n = 88). The proportion of patients experiencing gastrointestinal symptoms and recurrent pain after 1 year was significantly reduced in both cohorts (P < 0.001). The alleviation of symptoms was reflected in GIQLI score improvements at 1 year in both cohorts (P < 0.001), independent of CP severity and etiology. Improvements in GIQLI score were more pronounced in cohort 2 (P < 0.001).

CONCLUSIONS

Pancreatin demonstrated symptom relief and improvement in quality of life in patients with CP-related EPI in this disease management study.

摘要

目的

外分泌性胰腺功能不全（EPI）在慢性胰腺炎（CP）患者中很常见。这项为期1年的前瞻性多中心观察性疾病管理研究旨在评估接受胰酶替代治疗的CP合并EPI患者的症状改善情况和生活质量。

方法

CP合并慢性EPI的患者被分为两组，第1组由已服用胰酶（克辽林；德国汉诺威雅培制药有限公司）的患者组成，第2组由新诊断为EPI且未接受过胰酶治疗的患者组成。记录症状，并在基线、6个月和1年时使用胃肠道生活质量指数（GIQLI）评估生活质量。

结果

共评估了294例患者（第1组，n = 206；第2组，n = 88）。两组患者在1年后出现胃肠道症状和反复疼痛的比例均显著降低（P < 0.001）。症状的缓解反映在两组患者1年时GIQLI评分的改善上（P < 0.001），且与CP的严重程度和病因无关。第2组GIQLI评分的改善更为显著（P < 0.001）。