Management of Anti-tuberculosis Drug-related Hepatotoxicity: Comparison of the Fluoroquinolone-containing Regimen and Re-challenge with the Standard Regimen

前言：傳統抗結核藥物多有導致肝毒性的潛在不良反應，一旦臨床上發生藥物引發之肝毒性，治療常因此中斷或必須延長療程。目前對於抗結核藥物致肝毒性時的處置並無統一的規範，本回溯性研究旨在比較傳統治療藥物之重新投予及使用fluoroquinolone類藥物取代部份傳統藥物此兩種處置模式之差異。方法：本回溯性研究收錄了60位因抗結核藥物引發肝毒性之結核病人，其中33位於肝毒性發生時採停用全部或部份藥物，等肝功能恢復再重新投予傳統藥物之模式，另外27位於肝毒性醫生時改用fluoroquinolone類藥物取代部份傳統藥物。我們比較兩組病志之所用藥物、療程長短、系列肝功能變化、治療效果、預後、及治療期間的藥物不良反應有無差異。Levofloxacin (n=2)及ciprofloxacin (n=6)為本研究中主要使用的fluoroquinolone類藥物。結果：傳統藥物組之平均療程為8.9±3.6月，而fluoroquinolone組為9.4±4.7月(p=0.642)傳統藥物組中有29人(87.9%)而fluoroquinolone組有21人(77.8%)達到治癒或完治的標準。沒有任何一個治療失敗的案例。在傳統藥物組平均達17.6±12.9個月及fluoroquinolone組達18±9.8個月的追蹤之後，沒有任何一個人在臨床上有複發的跡象。在藥物所需費用方面，fluoroquinolone組（平均每人每日新台幣153.9±53.5元）明顯較傳統藥物組（平均每人每日新台幣32±14.7元）來得高。此外，兩組在藥物不良反應方面並沒有統計上的差異。結論：臨床上因抗結核藥物導致肝毒性時，使用fluoroquinolone類藥物取代部份傳統藥物的處置方式在療程長短、治療效果、預後及不良反應方面和重新投予傳統藥物的處置模式並無顯著差異，但應將使用fluoroquhiolone類藥物的費用列入治療選擇的考量。設計良好、隨機、控制的前瞻性研究有助於更進一步釐清此抗結核藥物致肝毒性之臨床處置議題，進而建立標準的處置模式。

關鍵字

抗結核藥物；肝毒性；藥物不良反應； fluoroquinolones

並列摘要

Purpose: The aim of this study was to compare the fluoroquinolone-containing regimen with a re-challenge of the standard regimen in the management of drug-related hepatotoxicity during anti-tuberculosis therapy. Materials and Methods: Of the 60 patients with drug-related hepatotoxicity enrolled in this study, 33 were in the standard regimen group and 27 were in the fluoroquinolone-containing regimen group. Levofloxacin (n=21) and ciprofloxacin (n=6) were the main fluoroquinolones used in this study. The inpatient and outpatient medical records were reviewed for demographic characteristics, dosage and duration of each anti-tuberculosis drug, serial results of liver function tests, treatment outcomes, adverse effects, and medication cost. Results: The duration of treatment was 8.90±3.6 months in the standard regimen group and 9.4±4.7 months in the fluoroquinolone group (ρ=0.642). In all, 29 (87.9%) in the standard regimen group and 21 (77.8%) in the fluoroquinolone group were either cured or completed treatment. No case of treatment failure or relapse was noted after a mean follow-up duration of 17.6±12.9 months in the standard regimen group and 18±9.8 months in the fluoroquinolone group (ρ=0.904). There was a significant difference in the daily cost of medication between the standard regimen group (32±14.7 NTD) and the fluoroquinolone group (153.9±53.5 NTD, p＜0.001). Patients in both groups reported similar adverse effects. Conclusion: The use of fluoroquinolone to replace partial first-line anti-tuberculosis drugs in managing drug-related hepatotoxicity seemed to be not superior to a re-challenge with the standard regimen, in terms of treatment duration, treatment outcomes, and self-reported adverse effects. Cost may be an important concern with fluoroquinolone use. A well-designed randomized controlled prospective study is required to further investigate the observations in the present study.

並列關鍵字

tuberculosis treatment ； hepatotoxicity ； adverse drug reactions ； fluoroquinolones

國際替代計量

Management of Anti-tuberculosis Drug-related Hepatotoxicity: Comparison of the Fluoroquinolone-containing Regimen and Re-challenge with the Standard Regimen

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