篇名

中醫用藥失當案:中藥仿單標示外使用與交互作用之法律問題【學習式判解評析】   試閱

並列篇名

A Case about the Improper Traditional Chinese Medication: Legal Questions about Off-Label Use of Traditional Chinese Medicine and Its Interaction

作者
中文摘要

本案中醫師開立含有麻黃及咖啡因成分之處方為病人施以減重療程,導致病人心臟性休克死亡。由於麻黃製劑所含之麻黃鹼量,將因原料品種、產地、批號及藥廠而不同,即使換算為生藥之劑量相同,麻黃鹼成分與含量亦不相同,造成安全劑量難以精確認定。此外,仿單之適應症、效能、用法用量必須依典籍標示,科學根據薄弱,使仿單標示之參考價值倍受質疑。再者,麻黃鹼與咖啡因的交互作用及配伍禁忌,是否為所有中醫師都應知悉,亦屬可議。本文就歷審判決之疑點提出評析。

英文摘要

A Chinese medicine physician wrote a prescription with ingredients like ephedra and caffeine for the therapy losing weight for a patient which lead him/her to cardiogenic shock and to death. Since the ephedrine the preparations of ephedra have are different form each other, depending on its breeds, origins, batch numbers and pharmaceutical factories , it could have different ingredients of ephedrine and contents in the crude drugs, even though there doses are the same. It would be difficult consequently to confirm the safe dose. Besides, it has less scientific basis that the indication, effects, dosage and administration must correspond to the classical texts and makes the label therefore doubtful. It is also doubtful whether all of the Chinese medicine physicians realize that it would be a taboo to make the ephedra and caffeine have interactions and compatibility uses. Judgments concerning this case in all of instances would be analyzed and commented in this essay.

起訖頁

072-090

出版單位
DOI

10.53106/241553062021080058005  複製DOI  DOI查詢

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