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直升机中储存的用于紧急医疗服务的药物的稳定性:一项前瞻性观察研究。

Stability of Drugs Stored in Helicopters for Use by Emergency Medical Services: A Prospective Observational Study.

机构信息

Department of Anesthesiology and Intensive Care Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland; Department of Emergency Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Swiss Air-Ambulance, Rega (Rettungsflugwacht/Garde Aérienne), Zürich, Switzerland.

Department of Anesthesiology and Intensive Care Medicine, Cantonal Hospital Münsterlingen, Münsterlingen, Switzerland.

出版信息

Ann Emerg Med. 2022 Oct;80(4):364-370. doi: 10.1016/j.annemergmed.2022.05.038. Epub 2022 Aug 1.

DOI:10.1016/j.annemergmed.2022.05.038
PMID:35927113
Abstract

STUDY OBJECTIVE

Drugs stored in rescue helicopters may be subject to extreme environmental conditions. The aim of this study was to measure whether drugs stored under the real-life conditions of a Swiss helicopter emergency medical service (HEMS) would retain their potency over the course of 1 year.

METHODS

A prospective, longitudinal study measuring the temperature exposure and concentration of drugs stored on 2 rescue helicopters in Switzerland over 1 year. The study drugs included epinephrine, norepinephrine, amiodarone, midazolam, fentanyl, naloxone, rocuronium, etomidate, and ketamine. Temperatures were measured inside the medication storage bags and the crew cabins at 10-minute intervals. Drug stability was measured on a monthly basis over the course of 12 months using high-performance liquid chromatography. The medications were considered stable at a minimum remaining drug concentration of 90% of the label claim.

RESULTS

Temperatures ranged from -1.2 °C to 38.1 °C (29.84 °F to 100.58 °F) inside the drug storage bags. Of all the temperature measurements inside the drug storage bags, 37% lay outside the recommended storage conditions. All drugs maintained a concentration above 90% of the label claim. The observation periods for rocuronium and etomidate were shortened to 7 months because of a supply shortage of reference samples.

CONCLUSION

Drugs stored under the real-life conditions of Swiss HEMS are subjected to temperatures outside the manufacturer's approved storage requirements. Despite this, all drugs stored under these conditions remained stable throughout our study. Real-life stability testing could be a way to extend drug exchange intervals.

摘要

研究目的

存储在救援直升机中的药物可能会受到极端环境条件的影响。本研究的目的是测量在瑞士直升机紧急医疗服务(HEMS)的实际条件下储存的药物在 1 年内是否会保持其效力。

方法

这是一项前瞻性、纵向研究,测量了瑞士两架救援直升机上储存的药物在 1 年内的温度暴露和浓度。研究药物包括肾上腺素、去甲肾上腺素、胺碘酮、咪达唑仑、芬太尼、纳洛酮、罗库溴铵、依托咪酯和氯胺酮。每隔 10 分钟测量一次药物储存袋和机组人员舱内的温度。在 12 个月的时间里,每月使用高效液相色谱法测量药物稳定性。药物稳定性被定义为最小剩余药物浓度保持在标签声称的 90%以上。

结果

药物储存袋内的温度范围为-1.2°C 至 38.1°C(29.84°F 至 100.58°F)。在药物储存袋内的所有温度测量中,37%的温度超出了推荐的储存条件。所有药物的浓度均保持在标签声称的 90%以上。由于参考样品供应短缺,罗库溴铵和依托咪酯的观察期缩短至 7 个月。

结论

在瑞士 HEMS 的实际条件下储存的药物会受到超出制造商批准的储存要求的温度影响。尽管如此,在我们的研究中,所有在这些条件下储存的药物都保持稳定。实际稳定性测试可能是延长药物更换间隔的一种方法。

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