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用于治疗克罗恩病的药物的安全性。

Safety of drugs used for the treatment of Crohn's disease.

机构信息

a Department of Gastroenterology and Liver Services , Concord Hospital , Sydney , Australia.

b Faculty of Medicine and Health , University of Sydney , Sydney , Australia.

出版信息

Expert Opin Drug Saf. 2019 May;18(5):357-367. doi: 10.1080/14740338.2019.1612874. Epub 2019 May 6.

Abstract

INTRODUCTION

Medications in treating Crohn's disease (CD) have evolved over the last two decades, particularly with the use of biologic agents. There are, however, concerns about the safety and adverse events associated with these medications. The authors review the safety profile of immunosuppressive medications used in Crohn's disease in adult patients.

AREAS COVERED

The authors performed a literature search until October 2018 to examine safety data on thiopurines, methotrexate, anti-TNFα agents, vedolizumab and ustekinumab. The authors focused on 'trial' and 'real-world' data for the biologic agents. Safety in pregnancy and the elderly are also presented.

EXPERT OPINION

Available data in CD suggest that immunosuppressive medications are relatively safe, although there are concerns about an elevated risk of serious infections, skin cancer and lymphoma particularly with thiopurines and anti-TNFα agents. Data on vedolizumab and ustekinumab suggest these newer biologic agents are well tolerated; however, longer term data in CD are required to identify risks with extended use. Apart from methotrexate, there appear to be no adverse congenital outcomes with exposure of drugs during pregnancy.

摘要

简介

在过去的二十年中,治疗克罗恩病(CD)的药物已经发生了变化,特别是生物制剂的使用。然而,人们对这些药物的安全性和不良事件仍存在担忧。作者回顾了用于成人克罗恩病患者的免疫抑制剂药物的安全性概况。

涵盖领域

作者进行了文献检索,截至 2018 年 10 月,以检查硫唑嘌呤、甲氨蝶呤、抗 TNF-α 制剂、vedolizumab 和 ustekinumab 的安全性数据。作者专注于生物制剂的“试验”和“真实世界”数据。还介绍了妊娠和老年人群的安全性。

专家意见

CD 中的现有数据表明,免疫抑制剂药物相对安全,尽管人们担心严重感染、皮肤癌和淋巴瘤的风险增加,特别是在使用硫唑嘌呤和抗 TNF-α 制剂时。vedolizumab 和 ustekinumab 的数据表明,这些较新的生物制剂耐受性良好;然而,需要更长时间的 CD 数据来确定延长使用的风险。除了甲氨蝶呤外,药物暴露于怀孕期间似乎没有不良的先天结局。

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