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英夫利昔单抗抗体与炎症性肠病患者输注反应风险:系统评价和荟萃分析。

Antibodies to infliximab and risk of infusion reactions in patients with inflammatory bowel disease: a systematic review and meta-analysis.

机构信息

Center for Inflammatory Bowel Disease, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.

出版信息

Inflamm Bowel Dis. 2014 Jan;20(1):1-6. doi: 10.1097/01.MIB.0000436951.80898.6d.

Abstract

OBJECTIVES

Antibodies to infliximab (ATIs) have been associated with a risk of infusion reactions in some studies of patients with inflammatory bowel disease. However, many factors, such as immunomodulators and dosing schedule, may influence this association. The aim of this article was to provide a pooled estimate of the risk of infusion reactions according to patients' ATI status and analyze the relationship of immunomodulators to this risk.

DESIGN

Public databases were searched for eligible studies. Quality assessment was undertaken for all studies using Grading of Recommendations Assessment, Development and Evaluation criteria. Raw data from studies meeting inclusion criteria were pooled for meta-analysis of effect estimates. Sensitivity analysis was performed for all outcomes. Funnel plot was performed to assess for publication bias.

RESULTS

Eight studies met the inclusion criteria, with a pooled total of 1351 subjects. Seven of the 8 studies had a high risk of bias in at least 1 quality domain. The cumulative data indicated that there was a higher risk ratio (RR) of any acute infusion reaction (RR 2.4; 95% confidence interval [CI] 1.5-3.8, P < 0.001) and severe infusion reactions (RR 5.8, 95% CI 1.7-19, P = 0.004) in patients with ATIs when compared with patients without ATIs. The RR of delayed hypersensitivity reactions was not significantly different between ATI+ and ATI- patients (RR 2.8, 95% CI 0.2-33, P = 0.4). Patients prescribed immunomodulators during maintenance infliximab therapy had a reduction in their risk for ATI development (RR 0.6, 95% CI 0.4-0.9, P = 0.02) and infusion reactions (RR 0.6, 95% CI 0.4-0.8, P < 0.001).

CONCLUSIONS

The presence of ATIs is associated with a significantly higher risk of acute infusion reactions, but not delayed hypersensitivity reactions, in patients with inflammatory bowel disease. Concomitant immunomodulators reduce this risk.

摘要

目的

一些关于炎症性肠病患者的研究表明,英夫利昔单抗(ATI)抗体与输注反应的风险有关。然而,许多因素,如免疫调节剂和剂量方案,可能会影响这种关联。本文的目的是根据患者的 ATI 状态提供输注反应风险的汇总估计,并分析免疫调节剂与这种风险的关系。

设计

公共数据库被搜索以寻找合格的研究。所有研究均使用推荐评估、制定和评估(Grading of Recommendations Assessment, Development and Evaluation,GRADE)标准进行质量评估。符合纳入标准的研究的原始数据被汇总进行效应估计的荟萃分析。对所有结果进行敏感性分析。进行漏斗图以评估发表偏倚。

结果

八项研究符合纳入标准,共有 1351 名受试者。八项研究中有七项在至少一个质量域存在高偏倚风险。累积数据表明,ATI 患者的任何急性输注反应(RR 2.4;95%置信区间 [CI] 1.5-3.8,P<0.001)和严重输注反应(RR 5.8,95% CI 1.7-19,P=0.004)的风险比(RR)更高。ATI+和 ATI-患者的迟发性超敏反应 RR 无显著差异(RR 2.8,95% CI 0.2-33,P=0.4)。在维持英夫利昔单抗治疗期间使用免疫调节剂的患者,ATI 发展和输注反应的风险降低(RR 0.6,95% CI 0.4-0.9,P=0.02;RR 0.6,95% CI 0.4-0.8,P<0.001)。

结论

在炎症性肠病患者中,ATI 的存在与急性输注反应的风险显著增加相关,但与迟发性超敏反应无关。同时使用免疫调节剂可降低这种风险。

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