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系统评价与荟萃分析:生物制剂在老年炎症性肠病患者中的感染或癌症风险。

Systematic review with meta-analysis: biologics and risk of infection or cancer in elderly patients with inflammatory bowel disease.

机构信息

Department of Biomedical Sciences, Humanitas University, Milan, Italy.

IBD Center, Humanitas Clinical and Research Center - IRCCS, Milan, Italy.

出版信息

Aliment Pharmacol Ther. 2020 May;51(9):820-830. doi: 10.1111/apt.15692. Epub 2020 Mar 13.

DOI:10.1111/apt.15692
PMID:32170782
Abstract

BACKGROUND

Uncertainty exists concerning the risk of infection and cancer associated with biologic therapies in elderly patients with inflammatory bowel disease (IBD).

AIMS

To identify, synthesise and critically appraise the available evidence on the topic.

METHODS

We systematically searched Medline/PubMed, Embase and Scopus, through October 2019, and recent conference proceedings, to identify studies investigating the risk of serious infections, opportunistic infections, any infection and cancer in elderly IBD patients (>60 years) exposed to biologics as compared to those unexposed to biologics. Two reviewers independently extracted study data and assessed each study's risk of bias. We examined heterogeneity, and calculated summary effect estimates using fixed- and random effects models. Quality of evidence was determined with GRADE.

RESULTS

We included 15 studies (one post hoc analysis of a randomised trial, nine cohort and five case-control studies). Elderly IBD patients treated with biologics were at increased risk of developing serious infections (random effects summary relative risk: 2.70, 95% CI: 1.56-4.66; seven studies; I  = 57%) and opportunistic infections (3.16, 1.09-9.20; four studies; I  = 73%). The occurrence of any infection (1.67, 0.51-5.43; five studies; I  = 75%) and cancer (0.90, 0.64-1.26; nine studies; I  = 0%) was not significantly affected. Nevertheless, our confidence in the effect estimates is rather limited; the quality of evidence is low to very low.

CONCLUSIONS

Biologics are likely to increase the risk of serious and opportunistic infections in old IBD patients. Large prospective studies are needed to further assess the biologic treatments' long-term safety profile in this population.

摘要

背景

在患有炎症性肠病(IBD)的老年患者中,生物疗法相关的感染和癌症风险存在不确定性。

目的

确定、综合和批判性评价现有关于该主题的证据。

方法

我们系统地检索了 Medline/PubMed、Embase 和 Scopus,检索时间截至 2019 年 10 月,并查阅了最近的会议记录,以确定研究生物制剂治疗与未治疗的老年 IBD 患者(>60 岁)发生严重感染、机会性感染、任何感染和癌症风险的研究。两名审查员独立提取研究数据并评估了每个研究的偏倚风险。我们检查了异质性,并使用固定效应和随机效应模型计算了汇总效应估计。使用 GRADE 确定证据质量。

结果

我们纳入了 15 项研究(一项随机试验的事后分析、9 项队列研究和 5 项病例对照研究)。接受生物制剂治疗的老年 IBD 患者发生严重感染的风险增加(随机效应汇总相对风险:2.70,95%CI:1.56-4.66;7 项研究;I²=57%)和机会性感染(3.16,1.09-9.20;4 项研究;I²=73%)。任何感染(1.67,0.51-5.43;5 项研究;I²=75%)和癌症(0.90,0.64-1.26;9 项研究;I²=0%)的发生率没有显著增加。然而,我们对效应估计的信心相当有限;证据质量为低到极低。

结论

生物制剂可能会增加老年 IBD 患者发生严重和机会性感染的风险。需要进行大型前瞻性研究,以进一步评估该人群中生物治疗的长期安全性。

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