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药物相关性急性胰腺炎:荷兰21年的自发报告

Drug-associated acute pancreatitis: twenty-one years of spontaneous reporting in The Netherlands.

作者信息

Eland I A, van Puijenbroek E P, Sturkenboom M J, Wilson J H, Stricker B H

机构信息

Department of Internal Medicine, Erasmus University Medical School, Rotterdam, The Netherlands.

出版信息

Am J Gastroenterol. 1999 Sep;94(9):2417-22. doi: 10.1111/j.1572-0241.1999.01367.x.

DOI:10.1111/j.1572-0241.1999.01367.x
PMID:10484002
Abstract

OBJECTIVE

Drugs are considered a rare cause of acute pancreatitis. We conducted a descriptive study to assess which drugs have been associated with acute pancreatitis in spontaneous adverse drug reaction reports in The Netherlands.

METHODS

Our study is based on reports of drug-associated acute pancreatitis reported to the Netherlands Center for Monitoring of Adverse Reactions to Drugs and The Netherlands Pharmacovigilance Foundation LAREB between 1 January 1977 and 1 January 1998. We used an algorithm to validate the diagnosis and to assess the causal relationship between acute pancreatitis and use of the suspected drug.

RESULTS

A total of 55 cases were available for review. We excluded 11 (20.0%) reports, as we could not confirm the diagnosis of acute pancreatitis. Another 10 (18%) cases were excluded, as the causal relationship with the suspected drug was unlikely. In the remaining 34 reports, acute pancreatitis was labeled as definite in 11 (32%) and as probable in 23 (68%). The age of the patients ranged from 17 to 84 yr with a median of 41; 24 (71%) patients were female. Of the 34 cases, 27 (79%) recovered, five (15%) died, and in two (6%) the outcome is unknown. Azathioprine, cimetidine, interferon-alpha, methyldopa, metronidazole, olsalazine, and oxyphenbutazon all had a definite causal relationship with acute pancreatitis. Doxycycline, enalapril, famotidine, ibuprofen, maprotiline, mesalazine, and sulindac had a probable causal relationship with acute pancreatitis.

CONCLUSIONS

A variety of drugs was associated with acute pancreatitis in Dutch adverse drug reaction reports. Quantitative information about drug-induced pancreatitis is scanty. Epidemiological studies to assess the risk of drug-induced acute pancreas, therefore, are needed.

摘要

目的

药物被认为是急性胰腺炎的罕见病因。我们开展了一项描述性研究,以评估在荷兰自发的药品不良反应报告中,哪些药物与急性胰腺炎有关。

方法

我们的研究基于1977年1月1日至1998年1月1日期间向荷兰药品不良反应监测中心和荷兰药物警戒基金会LAREB报告的药物相关性急性胰腺炎病例。我们使用一种算法来验证诊断,并评估急性胰腺炎与可疑药物使用之间的因果关系。

结果

共有55例病例可供审查。我们排除了11例(20.0%)报告,因为我们无法确诊急性胰腺炎。另外10例(18%)病例被排除,因为与可疑药物的因果关系不太可能。在其余34例报告中,11例(32%)急性胰腺炎被判定为确诊,23例(68%)为很可能。患者年龄在17至84岁之间,中位数为41岁;24例(71%)为女性。在这34例病例中,27例(79%)康复,5例(15%)死亡,2例(6%)结局未知。硫唑嘌呤、西咪替丁、α-干扰素、甲基多巴、甲硝唑、奥沙拉嗪和羟基保泰松均与急性胰腺炎有明确的因果关系。强力霉素、依那普利、法莫替丁、布洛芬、马普替林、美沙拉嗪和舒林酸与急性胰腺炎很可能存在因果关系。

结论

在荷兰的药品不良反应报告中,多种药物与急性胰腺炎有关。关于药物性胰腺炎的定量信息很少。因此,需要开展流行病学研究来评估药物性急性胰腺炎的风险。

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