| 摘要: | 結核病是僅次於HIV排名第2的主要傳染病死因。雖然，在先進國家結核病人數已有下降或趨於穩定的趨勢，但在非洲、東南亞、西太平洋地區及前蘇聯，結核病的人數一直呈上升的趨勢。目前，結核病的治療多以短期直接觀察法（short-course directly observed treatment, DOTS）進行，治癒率可達約80％。但其中的第一線藥物isoniazid、rifampin、pyrazinamide過去研究有產生肝毒性危害的風險。根據估計，全球每年因為藥物引起的肝傷害（dru induced liver injury, DILI）的發生率約為81/1,000,000，若根據此數據推算，台灣地區每年約有1800人的DILI新病例。而台灣地區每年約有15,000人的結核病確定新病例，接受DOTS治療的結果，保守估計每年約有幾百名的肝炎新病例產生，約佔每年DILI發生人數的10％。本計畫擬以前瞻性世代研究的方法以中華民國防癆協會病人為對象，探討特定的結核病藥物及用量對於結核病病患導致DILI的機率及程度的差異，並根據病患的人口特徵、過去疾病史及用藥史，找出可能的相關因子。並分析健保資料庫來了解肝炎個案過去的用藥行為，釐清危險因子，包括病例對照分析及世代分析。先進行病例對照分析，辨別有肝病變病患是否先有結核病，並分析用藥史。世代分析則以1996-1997年有結核病病人追蹤到2004年，評估肝病變發生率及藥物相關相對危險。
The tuberculosis is a leading cause of death and disability second to HIV infection among communicable diseases. While the incidence is in a decline trend in western countries, the disease remains a prevalent scourge in many developing areas including Africa, Southeastern Asia, West Pacific and previous Soviet nations, and Mainland China, etc. There has been a concern in the increasing trend of this disease in Taiwan as well. Public health measures to identify and treat cases are of importance in the disease prevention and control. The short-course directly observed treatment (DOTS) has been considered as an appropriate measure of prophylaxis and treatment with an effectiveness of 80%. However, the first line medication using isoniazid, rifampin or pyrazinamide has been shown with an elevated risk of hepatotoxicity. The incidence of drug induced liver injury (DILI) due to the treatment of Tb was estimated as 81/1,000,000. We might be able to identify 1,800 DILI cases annually. Approximately 15,000 new Tb cases received DOTS treatment in Taiwan, we expect that 10% of these patients may develop DILI. This study is designed as a prospective study to follow-up new patients cared at Tb Prevention Association in Taipei. Information on patients？？ sociodemographic characteristics, treatment received, and comorbidity will be collected. We will measure the risk of DILI among patients. Further nested case-control analysis will be performed. In addition, we will use the national health insurance data to identify the prevalence of DILI among Tb patients receiving medication of Tb treatment. |
