Parish Hannah G, Bowser Corinna S, Morton Jacquelyn R, Brown Julie C
Seattle Children's Hospital, Seattle, Washington.
Narbeth Allergy & Asthma, Narbeth, Pennsylvania.
Ann Allergy Asthma Immunol. 2016 Jul;117(1):79-87. doi: 10.1016/j.anai.2016.04.006. Epub 2016 May 21.
Epinephrine is a lifesaving drug in the treatment of anaphylaxis and cardiac resuscitation. Current US storage recommendations are for controlled room temperature (20°C-25°C), with excursions permitted from 15°C to 30°C. Maintaining epinephrine within this required range is challenging, particularly for patients carrying autoinjectors and during storage in emergency vehicles.
To study epinephrine degradation with extreme temperature exposure for epinephrine concentrations used in anaphylaxis and cardiac resuscitation.
We searched the literature for all studies of epinephrine in sealed syringes, vials, or ampules in concentrations between 1:1,000 and 1:10,000, that measured epinephrine in samples exposed to temperatures above and/or below the recommended storage temperature compared with control samples.
Nine studies were included. Heat exposure resulted in epinephrine degradation but only with prolonged exposure. Constant heat resulted in more degradation. None of the studies that evaluated epinephrine exposure to extreme cold found significant degradation. None of the studies evaluating the effects of real-world temperature fluctuations detected significant degradation. Only 2 small studies (1 evaluating heat and 1 freezing) involved autoinjectors, and all 40 devices tested fired correctly.
Temperature excursions in real-world conditions may be less detrimental than previously suggested. Freezing and limited heat excursions did not result in epinephrine degradation. Refrigeration of epinephrine appears to reduce degradation. However, the effect of extreme temperatures, particularly freezing, on autoinjectors is not sufficiently well established. More research in needed at clinically relevant high temperatures, with limited exposure to heat, and involving autoinjector devices.
肾上腺素是治疗过敏反应和心脏复苏的救命药物。美国目前的储存建议是控制在室温(20°C - 25°C),允许在15°C至30°C范围内波动。将肾上腺素维持在这个要求的范围内具有挑战性,特别是对于携带自动注射器的患者以及在急救车辆中储存时。
研究在过敏反应和心脏复苏中使用的肾上腺素浓度在极端温度暴露下的降解情况。
我们检索了文献中所有关于密封注射器、小瓶或安瓿中浓度在1:1000至1:10000之间的肾上腺素的研究,这些研究测量了与对照样品相比暴露于高于和/或低于推荐储存温度的样品中的肾上腺素。
纳入了9项研究。热暴露导致肾上腺素降解,但仅在长时间暴露时。持续加热导致更多降解。没有一项评估肾上腺素暴露于极寒环境的研究发现有显著降解。没有一项评估实际温度波动影响的研究检测到显著降解。只有2项小型研究(1项评估热暴露,1项评估冷冻)涉及自动注射器,并且所有测试的40个装置均能正常发射。
实际情况下的温度波动可能不像以前认为的那样有害。冷冻和有限的热波动不会导致肾上腺素降解。肾上腺素冷藏似乎能减少降解。然而,极端温度,特别是冷冻对自动注射器的影响尚未充分明确。需要在临床相关的高温、有限热暴露以及涉及自动注射器装置方面进行更多研究。