預測抗結核藥物治療期間肝毒性之評分系統的驗證

The Verification of Tuberculosis Therapy Hepatotoxicity (TTH) Scale

高郁雯(Yuwen-Wen Kao)

指導教授 ： 李仁愛

共同指導教授 ： 陳香吟

臺北醫學大學/藥學院/藥學研究所/碩士(2007年)

https://doi.org/10.6831/TMU.2007.00122

摘要

結核病（Tuberculosis，TB）是目前全球共共衛生的重要議題。目前結合病的基本治療療程至少需要六個月的密集治療期間，此治療方式雖可獲得極佳的治療效果，但是治療期間病患發生肝毒性的比例卻也相當高。如果能在用藥之初即評估病人用藥期間是否會發生肝毒性，便能預防此副作用的發生，以達到有效治療及安全用藥的目的。本研究在驗證Hsiao（2003）所建立之Tuberculosis Therapy Hepatotoxicity (TTH)評分系統。此評分系統就是在預測結合病患在服用抗結合藥物期間發生肝毒性的可能性。
本研究為回溯性研究。以台北市立萬芳醫院病歷管理系統，收集2002年7月1日至2003年12月31日共一年半間，曾於台北市立萬芳醫院處方抗結核病藥物的臨床實例。本研究共收入254位病人為研究對象，發生肝毒性的有126人，其中肝功能指數異常者為74位（29.1%），發升肝損傷者52位（20.5%）。
抗結合藥物服用期間發生肝毒性的危險因子，結果發現年齡≧35歲、單一合併肝臟疾病、肝功能檢驗基準值不正常為統計上有意義的危險因子。
在驗證TTH評分系統時，以≧5分為切點，整體正確率為72.4%，肝毒組的正確預測率達71.4%，誤判率為14.2%，非肝毒組的正確預測率為73.4%。
本研究結果顯示，Tuberculosis Therapy Hepatotoxicity (TTH)評分量表的ROC curve曲線下面積為0.785，具有一定的臨床實用性。

關鍵字

抗結核藥物 ； 肝毒性 ； 評分系統

並列摘要

Tuberculosis is a very important issue of public health. The standard therapy of tuberculosis contains six-month intensive medications which included isoniazid, rifampin, pyrazinamide, and ethambutol. Three of these medications were hepatotoxic. If the occurrence of hepatotoxicity can be predicted, the side effects will be avoided and patient safety will be achieved. Predicting the occurrence of hepatotoxicity and preventing its The primary purpose of this study was to verify the Tuberculosis Therapy Hepatotoxicity (TTH) Scale developed by Hsiao (2003) to predict the occurrence of hepatotoxicity during the medication of anti-tuberculosis therapy.
Patients who had prescribed with anti-tuberculosis medications from July 1, 2002 through December 31, 2003 at Taipei Medical University Municipal Wan-Fang Hospital were enrolled in this study. The medical charts of patients in enrollment group were retrospectively reviewed.A total of 254 patients were enrolled in this study and a high percentage (126, 49.6%) of patients developed hepatotoxicity. Among patients developed hepatotoxicity, 74 (29.1%) had abnormal liver function tests, and 52 (20.5%) had liver injury.
Age older than 35 years old, concomitant liver disease and abnormal baseline liver function test were independent risk factors related to hepatotoxicity.
With the cut point of score ≧5, Tuberculosis Therapy Hepatotoxicity (TTH) Scale had the average accuracy rate of 72.4% for all, and the average accuracy rate of 71.4% for the heptototxicity group.
This study showed that Tuberculosis Therapy Hepatotoxicity (TTH) Scale had good clinical practicability. The area under the ROC curve was 0.785. It could predict the occurrence of hepatotoxicity in hepatotoxicity group at a precise rate of 71.4%.

並列關鍵字

Antituberculosis medication ； hepatotoxicity ； scale

參考文獻

9. 行政院衛生署：結核病診治指引。台北：行政院衛生署；2004。

6. Chen SY, Su CP, Ma MM. Predictive model of diagnosing probable cases of severe acute respiratory syndrome in febrile patients with exposure risk. Ann Emerg Med 2004;43(1):1-5.

7. McIntyre K. Drug-Related Hepatotoxicity. N Engl J Med 2006;354(20):2191-3.

16. Daniel TM. The history of tuberculosis. Respiratory medicine 2006;100(11):1862-70.

20. Blumberg HM, Leonard MK, Jasmer RM. Update on the Treatment of Tuberculosis and Latent Tuberculosis Infection. JAMA 2005;293(22):2776-84.