社團法人臺灣臨床藥學會

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【原著】由藥害救濟案例探討結核病治療藥物之使用
The Use of Antituberculosis Agents – Observation from the ADR Cases of Drug Relief Payment Applications
結核病治療藥物、藥害救濟、藥物不良反應
林宇泰 、張上淳 、林國華 、回德仁 、高純琇
1財團法人藥害救濟基金會 、2國立台灣大學醫學院內科/附設醫院感染科 、3國立台灣大學醫學院藥學系
本文乃回溯 1999  年 1 月至  2005 年 3 月底,疑似使用抗結核病藥物所導致之藥物不良反應申請藥害救濟,並經衛生署藥害救濟審議委員會完成審議,共計25 件申請案例,所進行的分析研究。其中,以申訴肝臟(10 件)、視覺方面(8 件)與 皮膚黏膜(4 件)的不良反應為最多。此25 件申請案中,獲得救濟給付的案例共有11 件(44 %),以死亡給付之 6 件為最多,嚴重疾病給付有 5 件次之。由申請案之 病歷資料的整理與分析,顯示發生肝臟不良反應之個案中,全部有發生 AST、ALT 值高於正常的五倍(>200 U/L)及出現倦怠/食慾不振的現象;有 8 件發生黃疸。另外,有4件個案於用藥後曾監測到血液中尿酸數值有異常偏高(>8.0 mg/dL)的現象,其用藥後至出現高尿酸血症不良反應之平均天數為 21.8±8.5 天(範圍:10~28 天)。 同時發現在臨床上,於抗結核病藥物用藥期間,對病人進行肝功能監測之比例相當 低(6 人,24 %),可見國內對病患可能發生不良反應的監視,仍有待加強。
 
In this  paper, we retrospectively reviewed the  applications for Drug Relief Payment during January 1999 and March 2005 and reached conclusion by the Drug Relief Review Committee,and focused on the ADR cases suspected due to the use of antituberculosis. A total of 25 cases, related to liver damages(10 cases),vision impairment (8 cases), and skin and mucous (4 cases), were retrieved. The  payments were  granted in 11 cases (44%), in which 6 cases were  of death payments and  5 cases were  of serious illness payments. For the cases of liver damages, all cases showed elevated AST and ALT values with five-fold higher than normal (>200 U/L), fatigue, and lack of appetite; 8 cases had jaundice. Moreover, there were 4 cases found had extraordinarily high blood uric acid level (>8.0 mg/dL) with a retention time of  21.8±8.5 days  (mean±SD) (range 10−28 days). Unfortunately, only 6 cases (24%) out of these 25 cases had regular liver function monitoring during tuberculosis treatment. It is suggested that the monitoring system of possible adverse drug reactions in Taiwan have  room for improvement.
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