目的：Baclofen 是一種作用於中樞神經的γ-aminobutyric acid (GABA) 促效劑，用來緩解痙攣症狀。在常用劑量下，baclofen 少有嚴重副作用，但在末期腎臟病(end-stage renal disease, ESRD)、急性腎衰竭患者卻有發生神經毒性之案例報告。因此，我們進行baclofen 導致神經毒性之案例系列報告與相關文獻回顧。
方法：採回溯性案例分析，自2008 年1 月1 日至2017 年4 月30 日期間，納入因使用baclofen 導致神經毒性且通報至藥物不良反應系統的個案，再將資料進行統計分析。
結果：共收納15 位個案進行分析。納入個案年齡大於65 歲占66.7%、女性占60.0%、中至重度腎功能不全 (creatinine clearance [CrCl] < 60 ml/min) 占60.0%。神經毒性在服藥後1 至3 天出現。每日劑量範圍為5 ~ 20 mg。4 位個案接受血液透析及11 位個案給與支持性療法後，神經毒性症狀皆獲得改善。
結論： 本研究和文獻回顧顯示， 開立baclofen 時須注意病人腎功能。使用baclofen 後，應監測患者的腎功能與注意精神狀態的變化。並且不建議用於ESRD 或急性腎衰竭病人。此外，血液透析可有效改善baclofen 導致神經毒性的症狀。
Objective: Baclofen is a centrally acting derivative of γ-aminobutyric acid (GABA) commonly prescribed for the symptomatic relief of spasticity. Baclofen-induced severe neurotoxicity is rare at typical therapeutic doses and has been reported in patients with ESRD or acute renal failure. In this study, we report case series and review the literature regarding baclofen-induced neurotoxicity and safety of baclofen use in impaired renal function.
Methods: We retrospectively reviewed the medical records of baclofen-induced neurotoxicity episode notified to the adverse drug reaction information system during the hospital course from January 1, 2008 to April 30, 2017.
Results: In this study period, there were 15 cases with baclofen-induced neurotoxicity reviewed after inclusion. The majority of patients were elderly (66.7% above 65 years) females (60.0%) on moderate to severe renal insufficiency (creatinine clearance [CrCl] < 60 ml/min, 60.0%). Manifestations of baclofen toxicity were usually start 1–3 days after starting baclofen. The daily dose of baclofen ranged from 5 to 20 mg. An analysis of these 15 patients revealed that four were resolved neurotoxicity with hemodialysis and the other with supportive care.
Conclusions: Our cases and literature review highlight the importance of considering kidney function when prescribing baclofen. Patients taking baclofen must be monitored closely for toxicity when declining renal function or altered mental status. We recommended avoiding the use of baclofen for patients with end-stage renal disease (ESRD) or acute kidney injury. Besides, hemodialysis is useful in treatment of patients with baclofen-induced neurotoxicity to improve clinical symptoms.
