Coady Peyton, Dretchen Kenneth L, Mesa Michael
Mesa Science Associates, Frederick, MD, USA.
Ther Adv Allergy Rhinol. 2023 Mar 26;14:27534030231161784. doi: 10.1177/27534030231161784. eCollection 2023 Jan-Dec.
Despite epinephrine's historical use for over a century and Food and Drug Administration (FDA) approval for EpiPen's use in 1987 to treat anaphylaxis, little information exists regarding selection of the 0.3 mg adult dose. A review of literature was conducted to provide a historical retrospective regarding the evolution of the dosage selected for today's EpiPen. The first adrenal gland extract, isolation of the epinephrine active ingredient, observation of physiological effect, selection of the intramuscular route for administration, the dosage range recommended by independent physicians based on their clinical observations and selection of the ultimate standardized dosage are profiled.
This retrospective review illustrates the drug development process prior to the rigors required for today's clinical trials and provides clinical evidence supporting the dose in EpiPen and other similar life-saving epinephrine products.
尽管肾上腺素已使用了一个多世纪，且美国食品药品监督管理局（FDA）于1987年批准了EpiPen用于治疗过敏反应，但关于0.3毫克成人剂量的选择，几乎没有相关信息。我们进行了文献回顾，以对当今EpiPen所选用剂量的演变进行历史回顾。文中概述了首个肾上腺提取物、肾上腺素活性成分的分离、生理效应的观察、肌肉注射给药途径的选择、独立医生根据临床观察推荐的剂量范围以及最终标准化剂量的选择。
这项回顾性研究阐明了在当今临床试验所需的严格要求之前的药物研发过程，并提供了支持EpiPen及其他类似救命肾上腺素产品中剂量的临床证据。
