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药物性胰腺炎的致病因素:一项全国性评估。

Causative Agents of Drug-Induced Pancreatitis: A Nationwide Assessment.

作者信息

Chung Eun Kyoung, Lee Ji Hyun, Jang Dong Kee, Lee Sang Hyub, Lee Jin Ho, Park Byung-Joo, Kwon Kyenghee, Lee Jun Kyu

机构信息

College of Pharmacy, Dongguk University Biomedi Campus.

Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang.

出版信息

Pancreas. 2018 Nov/Dec;47(10):1328-1336. doi: 10.1097/MPA.0000000000001152.

DOI:10.1097/MPA.0000000000001152
PMID:30308533
Abstract

OBJECTIVES

The aim of this study was to analyze causes of drug-induced acute pancreatitis (DIAP) in Korea and factors associated with serious DIAP.

METHODS

Case records of DIAP voluntarily reported to the Korea Adverse Event Reporting System from 2004 to 2013 were reviewed. When a patient took 2 or more drugs, each drug was identified as a potential cause. The seriousness of each case was determined based on the International Conference on Harmonization E2D Guideline. Logistic regression was performed to identify factors associated with the seriousness of DIAP.

RESULTS

During the study period, 210 (0.05%) of 442,523 adverse event reports were (0.05%) DIAP. The most common causative medication of the DIAP cases with certain, probable/likely, and possible causality (n = 74) was L-asparaginase (n = 18), followed by azathioprine (n = 6), methylprednisolone (n = 6), and fenofibrate (n = 5). Serious events occurred in 43 cases (58%) with certain, probable/likely, and possible causality. They were significantly associated with the year of report (odds ratio, 0.572; P = 0.025) and the number of concurrently used medications (odds ratio, 2.659; P = 0.006).

CONCLUSIONS

L-Asparaginase is the most common cause of DIAP in Korea. Serious DIAP is more likely to occur in patients taking multiple medications.

摘要

目的

本研究旨在分析韩国药物性急性胰腺炎(DIAP)的病因及与严重DIAP相关的因素。

方法

回顾了2004年至2013年自愿向韩国不良事件报告系统报告的DIAP病例记录。当患者服用2种或更多药物时,每种药物都被确定为潜在病因。根据国际协调会议E2D指南确定每个病例的严重程度。进行逻辑回归分析以确定与DIAP严重程度相关的因素。

结果

在研究期间,442,523份不良事件报告中有210份(0.05%)为DIAP。在因果关系确定为肯定、很可能/可能和可能的DIAP病例(n = 74)中,最常见的致病药物是L-天冬酰胺酶(n = 18),其次是硫唑嘌呤(n = 6)、甲泼尼龙(n = 6)和非诺贝特(n = 5)。在因果关系确定为肯定、很可能/可能和可能的43例(58%)病例中发生了严重事件。它们与报告年份(比值比,0.572;P = 0.025)和同时使用的药物数量(比值比,2.659;P = 0.006)显著相关。

结论

L-天冬酰胺酶是韩国DIAP最常见的病因。严重DIAP更可能发生在服用多种药物的患者中。

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