Temperature Variations around Medication Cassette and Carry Bag in Routine Use of Epoprostenol Administration in Healthy Volunteers

BackgroundAccording to several treatment guidelines, epoprostenol is an important treatment option for pulmonary arterial hypertension. However, the pharmacokinetic characteristics and poor stability of epoprostenol at room temperature make its administration challenging. We therefore studied temperature fluctuations between the drug administration cassette and atmosphere to promote the safe use of epoprostenol. Methods and FindingsFive healthy volunteers carried a portable intravenous infusion pump attached to a medication cassette containing saline in a bag during their ordinary activities over 16 days during which the mean atmospheric temperature was 29.6±1.5°C. The temperature around the medication cassette was not less than 25°C on any occasion, and the mean period over 24 h during which the temperature around the cassette exceeded 35°C and 40°C was 96.9±156.4 min and 24.4±77.3 min, respectively. Significant correlations were observed between the temperatures outside the bag and around the cassette, as well as between temperatures around the cassette and of the saline solution in the cassette (r = 0.9258 and 0.8276, respectively). There were no differences in the temperatures outside the bag or around the cassette with respect to the bag material. ConclusionsTemperatures around a medication cassette and outside the bag containing the medication increase with sunlight exposure. The temperature around cassettes used for administering epoprostenol must therefore be kept low for as long as possible during hot summer conditions to maintain the drug stability.

研究背景：根据多项治疗指南，依前列醇（epoprostenol）是肺动脉高压（pulmonary arterial hypertension）的重要治疗选择。然而，依前列醇的药代动力学特性及室温下稳定性较差，使其临床给药颇具挑战。为此，本研究针对给药药盒与环境之间的温度波动展开分析，以期推动依前列醇的安全临床应用。
研究方法与结果：5名健康受试者在日常活动中携带连接有含生理盐水药盒的便携式静脉输液泵，试验周期共16天，期间环境平均温度为29.6±1.5℃。所有测试场景下，药盒周边温度均不低于25℃；24小时内药盒周边温度超过35℃和40℃的平均时长分别为96.9±156.4分钟和24.4±77.3分钟。药袋外侧与药盒周边的温度，以及药盒周边与盒内生理盐水的温度均存在显著相关性（相关系数r分别为0.9258和0.8276）。不同药袋材质对药袋外侧及药盒周边的温度无显著影响。
研究结论：药盒周边及含药药袋外侧的温度会随日照暴露增加而升高。因此在炎热夏季，需尽可能长时间维持依前列醇给药药盒周边的低温环境，以保障药物稳定性。