生物製劑治療期間定期監測結核病發生風險之必要性：台灣專家之臨床經驗與建議

Necessity of monitoring the tuberculosis risk of using biologics: experience and opinions from Taiwan experts

生物製劑透過抑制免疫作用達到某些自體免疫疾病的治療效果，但可能增加感染如結核病的風險。人體遭到結核分枝桿菌入侵時，有多重防禦機轉以限制入侵菌的生長與擴散，然而，因疾病特性使然，類風濕性關節炎、乾癬或乾癬性關節炎等疾病的患者比一般正常人容易受到感染，加上台灣的結核病盛行率高於歐美，屬中度風險國家，因此台灣免疫性疾病患者使用生物製劑治療時必須承受更高的結核病風險，日久更會衍生嚴重的公共衛生防疫問題。不論作用機轉為何，所有生物製劑都可能增加結核病風險。因此，透過治療前結核篩檢及治療期間之追蹤以落實各項生物製劑的風險管理計畫，實為政府、醫界、廠商責無旁貸的任務。

Biological products exert therapeutic effects on certain autoimmune diseases by inhibiting the activity of the immune system. Such inhibition, however, increases the risk of tuberculosis (TB). When exposed to Mycobacterium tuberculosis, the human body activates multiple defense mechanisms to suppress the growth and spread of the bacteria. Because of the disease characteristics, patients with rheumatoid arthritis, psoriasis or psoriatic arthritis are more vulnerable to TB infection compared with general population. In addition, the prevalence of TB in Taiwan is higher than that in European and North American regions, indicating that Taiwan is a medium-risk country for TB. Patients in Taiwan must assume greater risk of infection when using biological products to treat their immune disease. Over time, more severe public health concerns will arise. Regardless of their mechanism, all biological products are likely to increase the risk of TB. Therefore, providing pre-treatment TB screening test and follow-up examinations during the treatment period to implement risk management plan for various biologic agents is the inevitable responsibility of the government, medical community, and relevant manufacturers.