免疫生物製劑對結核病、B型與C型病毒肝炎活化之影響

Impact of Immune Biological Agents on the Reactivation of Tuberculosis and Viral Hepatitis B and C

自從包括抗腫瘤壞死因子製劑（anti-tumor necrosis factor-α agents）與B 細胞清除療法（B cell depleting therapy）等免疫生物製劑誕生，自體免疫疾病的治療又進入了另一個新境界。此類生物製劑針對特定的免疫細胞、細胞表面受器或細胞激素分子設計以抑制特定的訊息傳導，因此療效較傳統藥物為佳。但是隨著治療的突破，也帶來慢性感染控制的新挑戰。這些生物製劑往往是在已開發國家所研發，在這些國家不但肺結核與B 或C 型肝炎的病患較少，這些病患也常常被排除在上市前的臨床試驗外，因此這些藥物對於肺結核的影響與B 型、C 型病毒性肝炎的影響，無法由較早期的臨床試驗研究得知，只能由上市後大規模的生物製劑登錄研究了解。因此這不但是台灣醫界在使用這些藥品的挑戰，也是全世界在生物製劑的使用上非常重要的議題。本文將分別探討抗腫瘤壞死因子製劑與B 細胞清除治療，對於結核菌與病毒性肝炎的影響分別陳述，並且提供可能的預防篩檢及治療策略。

Since the launch of immune biologics such as anti-tumor necrosis factor α (TNF-α) agents and B cell depleting therapy, a new era of autoimmune disease treatment begin. These immune biologics target at specific immune cells, cell surface markers or cytokines to block specific immune pathways, which bring about therapeutic breakthrough. However, new challenges for chronic infection control emerge after treatment success. These agents was designed in developed countries, where tuberculosis, hepatitis B and C are less prevalent. In addition, these patients were not included in pre-marketing clinical trials. Therefore, the impact of these agents on tuberculosis or viral hepatitis cannot be revealed by pre-clinical trials. Important safety information could only be available from large-scale post-marketing registry. These safety issues are not only important in Taiwan but also in the world. This article will summarize the impact of TNF-α antagonists and B cell depleting therapy on tuberculosis and viral hepatitis. Screening/prevention strategy and therapeutic considerations will also be discussed.