目的：透過系統評讀 (systematic review)、臨床試驗及國家級之次級資料庫的大型資料分析發現，使用anti TNF-α 生物製劑的安全性是值得探討的，特別是結核病(tuberculosis, TB) 等不良反應，本研究目的為分析臺灣使用生物製劑的類風濕性關節炎病人結核病的風險，以供醫療人員參考。

方法： 本研究將利用2001 年 ~ 2010 年之全民健康保險研究資料庫 (NHIRdatabase) 分析我國以生物製劑治療類風濕性關節炎而導致結核病的發生率。

結果： 經過資料處理程序， 單用disease-modifying antirheumatic drugs(DMARDs) 的病人數為3,806 人 (92.8%)，併用生物製劑的病人數為294 人 (7.2%)。結核病病人數為52 人，其中單用DMARDs 的病人數為43 人 (82.7%)，單用生物製劑的人數為9 人 (17.3%)。在未經過傳統用藥之累積劑量的調整之前，不同用藥組別間的風險明顯不同，併用生物製劑組的結核病風險是單用傳統用藥組的2.729 倍 (OR =2.729; 95% CI = .284 ~ 5.798)。但將傳統用藥之累積劑量，以及基本資料、過去病史、社經地位以及醫院特性等校正因子放入模式中之後，併用生物製劑組的風險不再顯著。
結論：併用生物製劑組在尚未調整傳統用藥前，其所增加的風險可能有部分歸因於傳統用藥的劑量較高所致，而非生物製劑的使用所導致，而更明確的原因需要在未來的研究中進一步證實。

Methods: This study used the 2001 ~ 2010 National Health Insurance Research Database to analyze the incidence of tuberculosis caused by biologics used to treat rheumatoid arthritis and understand the use of biologics in the treatment of rheumatoid arthritis patients in Taiwan.

Results: Data showed that 3,806 (92.8%) patients solely used DMARDs (diseasemodifying antirheumatic drugs) and 294 (7.2%) patients used biologics. Fifty-two patients were diagnosed with tuberculosis, and out of those, 43 (82.7%) solely used DMARDs and 9 (17.3%) used biologics. Prior to adjustment, the groups using different medications exhibited significantly different risks. The risk of tuberculosis for the biologics group was 2.729 times (OR = 2.729; 5% CI = 1.284 ~ 5.798) greater than that for the traditional medication group. However, after adding the accumulated defined daily doses (DDDs) of  raditional medication along with basic information, medical history (presented using CCI), social status, and hospital characteristics into the model, the risk for the biologics group was no longer significant.

Conclusion: This shows that before adjusting traditional medication for thebiologics group, the increased risk could be caused by a high dosage of traditional medication rather than by biologics. More definitive reasons must be further verified in future studies.