Epinephrine Administered in Anaphylaxis: The Evolution of 0.3 mg Dosage.

0 OTORHINOLARYNGOLOGY Therapeutic advances in allergy and rhinology Pub Date : 2023-03-26 eCollection Date: 2023-01-01 DOI:10.1177/27534030231161784
Peyton Coady, Kenneth L Dretchen, Michael Mesa
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Abstract

Background: 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.

Conclusion: 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.

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过敏性休克时使用的肾上腺素:0.3 毫克剂量的演变。
背景:尽管使用肾上腺素已有一个多世纪的历史,美国食品药品管理局(FDA)也于 1987 年批准 EpiPen 用于治疗过敏性休克,但有关 0.3 毫克成人剂量选择的信息却很少。我们对文献进行了回顾,以提供有关当今 EpiPen 所选剂量演变的历史回顾。回顾了首次肾上腺提取、肾上腺素活性成分的分离、生理效应的观察、肌肉注射途径的选择、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:本回顾性报告展示了当今临床试验所需的严格要求之前的药物开发过程,并提供了支持 EpiPen 和其他类似救命肾上腺素产品剂量的临床证据。
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