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类风湿关节炎、银屑病关节炎和强直性脊柱炎中使用抗TNF药物的感染风险:一项系统评价和荟萃分析。

Risk of infections using anti-TNF agents in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: a systematic review and meta-analysis.

作者信息

Minozzi Silvia, Bonovas Stefanos, Lytras Theodore, Pecoraro Valentina, González-Lorenzo Marien, Bastiampillai Anan Judina, Gabrielli Eugenia Maria, Lonati Andrea Carlo, Moja Lorenzo, Cinquini Michela, Marino Valentina, Matucci Andrea, Milano Giuseppe Maria, Tocci Giuliano, Scarpa Raffaele, Goletti Delia, Cantini Fabrizio

机构信息

a Department of Epidemiology , Lazio Regional Health Service , Rome , Italy.

b Humanitas Clinical and Research Center , Milan , Italy.

出版信息

Expert Opin Drug Saf. 2016 Dec;15(sup1):11-34. doi: 10.1080/14740338.2016.1240783.

Abstract

Five anti-tumor necrosis factor (anti-TNF) agents have received regulatory approval for use in rheumatology: adalimumab, golimumab, infliximab, certolizumab, and etanercept. Apart from their well-documented therapeutic value, it is still uncertain to what extent they are associated with an increased risk of infectious adverse events. Areas covered: We conducted a systematic review and meta-analysis of published randomized studies to determine the effect of anti-TNF drugs on the occurrence of infectious adverse events (serious infections; tuberculosis; opportunistic infections; any infection). We searched Medline, Embase, and the Cochrane Library up to May 2014 to identify eligible studies in adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis that evaluated anti-TNF drugs compared with placebo or no treatment. Expert opinion: Our study encompassed data from 71 randomized controlled trials involving 22,760 participants (range of follow-up: 1-36 months) and seven open label extension studies with 2,236 participants (range of follow-up: 6-48 months). Quantitative synthesis of the available data found statistically significant increases in the occurrence of any infections (20%), serious infections (40%), and tuberculosis (250%) associated with anti-TNF drug use, while the data for opportunistic infections were scarce. The quality of synthesized evidence was judged as moderate. Further evidence from registries and long-term epidemiological studies are needed to better define the relationship between anti-TNF agents and infection complications.

摘要

五种抗肿瘤坏死因子(抗TNF)药物已获得监管批准,可用于风湿病治疗:阿达木单抗、戈利木单抗、英夫利昔单抗、赛妥珠单抗和依那西普。除了其有充分记录的治疗价值外,它们在多大程度上与感染性不良事件风险增加相关仍不确定。涵盖领域:我们对已发表的随机研究进行了系统评价和荟萃分析,以确定抗TNF药物对感染性不良事件(严重感染;结核病;机会性感染;任何感染)发生情况的影响。我们检索了截至2014年5月的Medline、Embase和Cochrane图书馆,以确定在类风湿性关节炎、银屑病关节炎或强直性脊柱炎成年患者中评估抗TNF药物与安慰剂或不治疗相比的合格研究。专家意见:我们的研究纳入了来自71项随机对照试验的数据,涉及22760名参与者(随访时间范围:1 - 36个月)以及7项开放标签扩展研究的数据,涉及2236名参与者(随访时间范围:6 - 48个月)。对现有数据的定量综合分析发现,使用抗TNF药物与任何感染(增加20%)、严重感染(增加40%)和结核病(增加250%)的发生有统计学显著增加,而机会性感染的数据较少。综合证据的质量被判定为中等。需要来自登记处和长期流行病学研究的进一步证据,以更好地界定抗TNF药物与感染并发症之间的关系。

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