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重组特利加压素输注用于肝肾综合征的稳定性研究。

An investigation of reconstituted terlipressin infusion stability for use in hepatorenal syndrome.

机构信息

School of Pharmacy and Biomedical Sciences, Faculty of Health Sciences, Curtin University, Kent St, Bentley, WA, 6102, Australia.

Pharmacy Department, Sir Charles Gairdner Hospital, Nedlands, WA, 6009, Australia.

出版信息

Sci Rep. 2020 Dec 3;10(1):21037. doi: 10.1038/s41598-020-78044-4.

DOI:10.1038/s41598-020-78044-4
PMID:33273555
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7712657/
Abstract

Hepatorenal syndrome (HRS) is a fatal complication of renal dysfunction associated with ascites, liver failure and advanced cirrhosis. Although the best option for long-term survival is liver transplantation, in the critical acute phase, vasoconstrictors are considered first-line supportive agents. Terlipressin is the most widely used vasoconstrictor globally but owing to its short elimination half-life, it is usually administered six hourly by slow intravenous bolus injection. This requires patients to remain in hospital, increasing hospital bed costs and affecting their quality of life. An alternative option for administration of terlipressin is as a continuous infusion using an elastomeric infusor device in the patient's home. However, stability data on terlipressin in elastomeric infusor devices is lacking. This research aimed to evaluate the stability of terlipressin reconstituted in infusor devices for up to 7 days at 2-8 °C and subsequently at 22.5 °C for 24 h, to mimic home storage and administration temperatures. We report that terlipressin was physically and chemically stable under these conditions; all reconstituted infusor concentrations retained above 90% of the original concentration over the test conditions. No colour change or precipitation in the solutions were evident.

摘要

肝肾综合征(HRS)是一种与腹水、肝功能衰竭和晚期肝硬化相关的肾功能衰竭的致命并发症。尽管肝移植是长期生存的最佳选择,但在危急的急性期,血管收缩剂被认为是一线支持性药物。特利加压素是全球应用最广泛的血管收缩剂,但由于其半衰期短,通常通过缓慢静脉推注每 6 小时给药一次。这要求患者留在医院,增加医院床位成本,并影响他们的生活质量。特利加压素在家中使用弹性输注器装置进行连续输注是替代给药的一种选择。然而,弹性输注器装置中特利加压素的稳定性数据缺乏。本研究旨在评估特利加压素在输注器装置中复溶后在 2-8°C 下长达 7 天,随后在 22.5°C 下 24 小时的稳定性,以模拟家庭储存和给药温度。我们报告称,特利加压素在这些条件下物理和化学性质稳定;所有复溶的输注器浓度在测试条件下均保持在原始浓度的 90%以上。溶液中没有明显的颜色变化或沉淀。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b79b/7712657/8f20776ecb60/41598_2020_78044_Fig2a_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b79b/7712657/19111b971ed5/41598_2020_78044_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b79b/7712657/8f20776ecb60/41598_2020_78044_Fig2a_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b79b/7712657/19111b971ed5/41598_2020_78044_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b79b/7712657/8f20776ecb60/41598_2020_78044_Fig2a_HTML.jpg

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本文引用的文献

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Curr Med Res Opin. 2019 May;35(5):859-868. doi: 10.1080/03007995.2018.1552575. Epub 2019 Jan 4.
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Terlipressin: Current and emerging indications in chronic liver disease.特利加压素:慢性肝脏疾病中的现有和新兴适应证。
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