MMWR Morb Mortal Wkly Rep. 2004 Aug 6;53(30):683-6.
The Food and Drug Administration (FDA) has determined that tuberculosis (TB) disease is a potential adverse reaction from treatment with the tumor necrosis factor-alpha (TNF-alpha) antagonists infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira); the three products are labeled accordingly. These products work by blocking TNF-alpha, an inflammatory cytokine, and are approved for treating rheumatoid arthritis and other selected autoimmune diseases. TNF-alpha is associated with the immunology and pathophysiology of certain infectious diseases, notably TB; blocking TNF-alphacan allow TB disease to emerge from latent Mycobacterium tuberculosis infection. In 2002, a California county health department reported three cases of TB disease occurring in association with infliximab therapy. This report summarizes those cases and nine subsequently reported cases and provides interim recommendations for TB prevention and management in recipients of these blocking agents. Health-care providers should take steps to prevent TB in immunocompromised patients and remain vigilant for TB as a cause of unexplained febrile illness.
美国食品药品监督管理局(FDA)已确定,结核病是使用肿瘤坏死因子-α(TNF-α)拮抗剂英夫利昔单抗(类克)、依那西普(恩利)和阿达木单抗(修美乐)治疗可能出现的不良反应;这三种产品均已据此标注。这些产品通过阻断炎性细胞因子TNF-α发挥作用,被批准用于治疗类风湿关节炎和其他特定自身免疫性疾病。TNF-α与某些传染病(尤其是结核病)的免疫学和病理生理学相关;阻断TNF-α可使潜伏性结核分枝杆菌感染引发结核病。2002年,加利福尼亚州某县卫生部门报告了3例与英夫利昔单抗治疗相关的结核病病例。本报告总结了这些病例以及随后报告的9例病例,并针对接受这些阻断剂治疗的患者提出了结核病预防和管理的临时建议。医疗保健提供者应采取措施预防免疫功能低下患者发生结核病,并对作为不明原因发热性疾病病因的结核病保持警惕。