Fluoroquinolone 類抗生素與肌腱病變的風險—不良反應資料庫與觀察性研究綜論

Fluoroquinolone-Associated Tendinopathy-Review from Adverse Drug Reaction Databases and Observational Studies

吳承誌(Cheng-Chih Wu) ； 戴慶玲(Ching-Ling Tai) ； 王郁青(Yu-Chin Lily Wang)

《臺灣臨床藥學雜誌》 26卷1期 (2018/01) Pp. 11-20

https://doi.org/10.6168/FJCP.201801_26(1).0002

摘要

臺灣食品藥物管理署 (Taiwan Food and Drug Administration, TFDA) 於 2008 年發布 fluoroquinolone 類抗生素可能增加肌腱炎或肌腱斷裂風險的藥物安全簡訊。目前尚未發現此不良反應與 fluoroquinolone 類抗生素的取代基有關，無法透過修飾取代基減少不良反應發生的機率。肌腱斷裂可能造成慢性疼痛甚或需手術治療。致病機轉包括缺血影響、基質退化機制和毒性物質傷害。突發性疼痛是常見的初始症狀，不一定伴隨發炎反應。透過統計化信號偵測的方式，不良反應通報資料庫的研究顯示fluoroquinolone 類抗生素的種類和累積劑量皆與肌腱病變不良反應的發生有關。除此之外，觀察性研究指出更多危險因子，包括合併使用類固醇、年齡老化、性別、近期使用與過去使用 fluoroquinolone 類抗生素。結合兩種不同研究來源所得的結果可提供不同面向的風險資訊，透過連結致病機轉與臨床實務的觀察結果，強化醫療專業人員與病患對於藥物不良反應的認知。惟有完整的評估過程，才能提升用藥安全。

關鍵字

Fluoroquinolone 類抗生素 ； 肌腱病變 ； 肌腱斷裂

並列摘要

The Taiwan Food and Drug Administration (TFDA) announced that fluoroquinolone is associated with elevated risk on tendinitis or tendon rupture in the Taiwan Drug Safety Newsletter in 2008. However, due to lack of evidence between the substitutions of fluoroquinolone structure and tendinitis or tendon rupture, it is impossible to eliminate the potential risk through structural modification on fluoroquinolone. Tendon injuries can result in chronic pain or even surgical intervention. The causes of the fluoroquinolone induced tendinopathy are multifactorial, including ischemic structure modification, matrix degrading phenomenon, and toxic substance damage. Sudden onset of pain is the common symptom, which may or may not accompany with inflammatory reactions. The statistical signal detection from adverse event databases showed that individual fluoroquinolone and cumulative dosage were all related to tendinopathy. Other risk factors, such as concomitant use with steroids, patient’s age, gender, and recent or past use of fluoroquinolone were identified through observational studies. The combination of the statistical findings and the clinical observations provides integrated understanding of the risk information, and leads to adverse drug reaction (ADR) recognition among health professional and patients. Only the intact evaluation process on ADR can ensure the medication safety.

並列關鍵字

Fluoroquinolone ； Tendinopathy ； Tendon Rupture