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瑞士炎症性肠病队列中因药物相关副作用而需要停药的频率及类型

Frequency and type of drug-related side effects necessitating treatment discontinuation in the Swiss Inflammatory Bowel Disease Cohort.

作者信息

Godat Sébastien, Fournier Nicolas, Safroneeva Ekaterina, Juillerat Pascal, Nydegger Andreas, Straumann Alex, Vavricka Stephan, Biedermann Luc, Greuter Thomas, Fraga Montserrat, Abdelrahman Karim, Hahnloser Dieter, Sauter Bernhard, Rogler Gerhard, Michetti Pierre, Schoepfer Alain M

机构信息

Division of Gastroenterology and Hepatology.

Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital.

出版信息

Eur J Gastroenterol Hepatol. 2018 Jun;30(6):612-620. doi: 10.1097/MEG.0000000000001078.

Abstract

BACKGROUND AND AIM

Systematic analyses of inflammatory bowel disease (IBD) drug-related side effects necessitating treatment cessation in large cohorts of patients with IBD are scarce. We aimed to assess the frequency and type of drug-related side effects requiring drug cessation in patients included in the Swiss IBD Cohort.

PATIENTS AND METHODS

A retrospective review was performed of data from the Swiss IBD Cohort physician questionnaires documenting a treatment cessation for the following drug categories: aminosalicylates, topical and systemic steroids, thiopurines, methotrexate, tumor necrosis factor-antagonists, and calcineurin inhibitors (tacrolimus, cyclosporine).

RESULTS

A total of 3192 patients were analyzed, of whom 1792 (56.1%) had Crohn's disease, 1322 (41.4%) had ulcerative colitis, and 78 (2.5%) had IBD unclassified. Of 3138 patients treated with IBD drugs, 2129 (67.8%) presented with one or several drug-related side effects necessitating drug cessation. We found a significant positive correlation between the number of concomitantly administered IBD drugs and the occurrence of side effects requiring drug cessation (P<0.001). Logistic regression modeling identified Crohn's disease diagnosis [odds ratio (OR)=1.361, P=0.017], presence of extraintestinal manifestations (OR=2.262, P<0.001), IBD-related surgery (OR=1.419, P=0.006), and the increasing number of concomitantly used IBD drugs [OR=2.007 (P<0.001) for two concomitantly used IBD drugs; OR=3.225 (P<0.001) for at least three concomitantly used IBD drugs] to be associated significantly with the occurrence of IBD drug-related adverse events that necessitated treatment cessation.

CONCLUSION

Physicians should keep in mind that the number of concomitantly administered IBD drugs is the main risk factor for drug-related adverse events necessitating treatment cessation.

摘要

背景与目的

对大量炎症性肠病(IBD)患者中因药物相关副作用而需要停药的情况进行系统分析的研究较少。我们旨在评估瑞士IBD队列中患者因药物相关副作用而需要停药的频率和类型。

患者与方法

对瑞士IBD队列医师调查问卷中的数据进行回顾性分析,这些问卷记录了以下药物类别停药情况:氨基水杨酸类、局部和全身用类固醇、硫唑嘌呤、甲氨蝶呤、肿瘤坏死因子拮抗剂以及钙调神经磷酸酶抑制剂(他克莫司、环孢素)。

结果

共分析了3192例患者,其中1792例(56.1%)患有克罗恩病,1322例(41.4%)患有溃疡性结肠炎,78例(2.5%)患有未分类的IBD。在3138例接受IBD药物治疗的患者中,2129例(67.8%)出现一种或多种需要停药的药物相关副作用。我们发现同时使用的IBD药物数量与需要停药的副作用发生之间存在显著正相关(P<0.001)。逻辑回归模型确定克罗恩病诊断[比值比(OR)=1.361,P=0.017]、肠外表现的存在(OR=2.262,P<0.001)、IBD相关手术(OR=1.419,P=0.006)以及同时使用IBD药物数量的增加[两种同时使用的IBD药物时OR=2.007(P<0.001);至少三种同时使用的IBD药物时OR=3.225(P<0.001)]与需要停药的IBD药物相关不良事件的发生显著相关。

结论

医生应牢记,同时使用的IBD药物数量是导致需要停药的药物相关不良事件的主要危险因素。

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