本學會關於「含Tramadol成分藥品使用於發生顯著呼吸抑制病人」立場聲明
最新日期:2021-04-29
台灣安寧緩和醫學學會關於
「含Tramadol成分藥品使用於發生顯著呼吸抑制病人」立場聲明
台灣安寧緩和醫學學會長期關注末期病人的痛苦,茲以專業立場及醫學倫理思維,謹就衛生福利部食品藥物管理署109年8月10日「含tramadol成分藥物禁止使用於發生顯著呼吸抑制病人」之公告,表達如下:
一. 弱效及強效鴉片類藥物為疼痛控制不可或缺之藥物
對於輕度至中度之疼痛,含tramadol成分藥物為常用之第一線藥物。相較於非類固醇抗發炎藥(NSAIDs),tramadol等鴉片類藥物可減少腎功能受損、消化性潰瘍及腸胃出血的風險,更適合某些病人長期使用。
以癌症疼痛為例,依據美國National Comprehensive Cancer Network (NCCN)Guidelines及歐洲 European Society for Medical Oncology(ESMO) Guidelines二個重要癌症疼痛控制指引,弱效及強效鴉片類藥物為癌症疼痛控制不可或缺之藥物。
二. 臨床情境千緒萬端,個別病例差異懸殊,實不宜以禁用一詞概括性規範
當病人使用後出現顯著呼吸抑制情況,如呼吸過度緩慢、微弱時,醫師自當依據治療目標與病人最大利益,提供適當之專業處置,包括停止或減量使用鴉片類藥物、給予解劑,或進行緊急處置。
三. 呼吸困難(breathlessness)與呼吸抑制(respiratory distress)二者於臨床醫學上為不同之概念,
尤不應混淆
Tramadol等鴉片類藥物可減緩呼吸速率、減少呼吸中樞對低血氧及高二氧化碳感受性,舒緩呼吸困難導致的窒息感。因此,美國NCCN、歐洲ESMO及英國National Health Service (NHS)的臨床指引,均揭載鴉片類藥物用於安寧緩和醫療病人之呼吸困難,有不可取代之角色。
四. 短效tramadol成分藥品導致呼吸抑制之機率級別為罕見(rare),亦即千分之一至萬分之一
Tramadol導致呼吸抑制,通常為與酒精或其他麻醉與鎮靜藥物併用造成;對於有嚴重氣喘、二氧化碳滯留、嚴重睡眠呼吸中止的病人,使用tramadol成分藥品固應審慎,但也勿過度渲染、放大其風險。
五. 平衡行善原則與不傷害原則,以同理心維護末期病人之最大利益
籲請醫界同道,在含tramadol成分及其他鴉片類藥品之使用上,本於實證知識及醫學倫理,落實醫病共享決策之精神,妥善溝通病人之治療目標,平衡行善(舒緩疼痛與呼吸困難)與不傷害(減少藥物副作用)原則,並以同理心維護末期病人之最大利益。
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