Tuberculosis associated with infliximab, a tumor necrosis factor (alpha)-neutralizing agent
Tuberculosis associated with infliximab, a tumor necrosis factor (alpha)-neutralizing agent
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DOI：
10.1056/nejmoa011110
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发表时间：
2001-10-11
影响因子：
158.5
通讯作者：
Braun, MM
中科院分区：
文献类型：
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作者：
Keane, J;Gershon, S;Braun, MM
背景：英夫利昔单抗是一种抗肿瘤坏死因子（TNF-(α)）的人源抗体，用于治疗克罗恩病和类风湿性关节炎。全世界约有14.7万名患者接受了英夫利昔单抗治疗。与结核病相关的过量TNF-(α)可能导致体重减轻和盗汗，但在动物模型中，它在宿主对结核病的反应中具有保护作用。没有直接证据表明TNF-(α)对肺结核患者有保护作用。方法：我们通过美国食品和药物管理局的MedWatch自发报告系统，分析了截至2001年5月29日收到的所有英夫利昔单抗治疗后结核病的报告。结果：在英夫利昔单抗治疗12周后，有70例报告结核病例。48例患者在三次或更少的输注后出现结核病。40例患者有肺外疾病（播散性疾病17例，淋巴结疾病11例，腹膜疾病4例，胸膜疾病2例，脑膜、肠、椎旁、骨、生殖器和膀胱疾病各1例）。33例患者的活检证实了该诊断。在70份报告中，64份来自结核病发病率较低的国家。与英夫利昔单抗治疗相关的肺结核报告频率远高于与该药物相关的其他机会性感染的报告频率。此外，在接受英夫利昔单抗治疗的患者中，报告的肺结核病例率高于现有的背景率。结论：活动性结核可能在开始英夫利昔单抗治疗后不久发生。在开药前，医生应筛查患者是否有潜伏性结核感染或疾病。[J] .中华医学杂志，2001;35(5):391 - 391。版权所有(C) 2001马萨诸塞州医学协会。
Background: Infliximab is a humanized antibody against tumor necrosis factor (alpha) (TNF-(alpha)) that is used in the treatment of Crohn's disease and rheumatoid arthritis. Approximately 147,000 patients throughout the world have received infliximab. Excess TNF-(alpha) in association with tuberculosis may cause weight loss and night sweats, yet in animal models it has a protective role in the host response to tuberculosis. There is no direct evidence of a protective role of TNF-(alpha) in patients with tuberculosis.Methods: We analyzed all reports of tuberculosis after infliximab therapy that had been received as of May 29, 2001, through the MedWatch spontaneous reporting system of the Food and Drug Administration.Results: There were 70 reported cases of tuberculosis after treatment with infliximab for a median of 12 weeks. In 48 patients, tuberculosis developed after three or fewer infusions. Forty of the patients had extrapulmonary disease (17 had disseminated disease, 11 lymph-node disease, 4 peritoneal disease, 2 pleural disease, and 1 each meningeal, enteric, paravertebral, bone, genital, and bladder disease). The diagnosis was confirmed by a biopsy in 33 patients. Of the 70 reports, 64 were from countries with a low incidence of tuberculosis. The reported frequency of tuberculosis in association with infliximab therapy was much higher than the reported frequency of other opportunistic infections associated with this drug. In addition, the rate of reported cases of tuberculosis among patients treated with infliximab was higher than the available background rates.Conclusions: Active tuberculosis may develop soon after the initiation of treatment with infliximab. Before prescribing the drug, physicians should screen patients for latent tuberculosis infection or disease. (N Engl J Med 2001;345:1098-104.) Copyright (C) 2001 Massachusetts Medical Society.