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弹性输注装置中的头孢洛扎他唑巴坦用于门诊治疗的体外稳定性研究。

Ceftolozane-tazobactam in an elastomeric infusion device for ambulatory care: an in vitro stability study.

机构信息

Infectious Diseases Department, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.

Internal Medicine, University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Crawley, Western Australia, Australia.

出版信息

Eur J Hosp Pharm. 2020 Mar;27(e1):e84-e86. doi: 10.1136/ejhpharm-2019-002093. Epub 2019 Dec 16.

DOI:10.1136/ejhpharm-2019-002093
PMID:32296512
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7147556/
Abstract

OBJECTIVES

Published in vitro stability data for ceftolozane-tazobactam supports intermittent short duration infusions. This method of delivery is not feasible for many outpatient antimicrobial therapy services that provide only one or two visits per day. This study aimed to assess time, temperature and concentration-dependent stability of ceftolozane-tazobactam in an elastomeric infusion device for continuous infusion across clinically relevant ranges encountered in outpatient antimicrobial therapy.

METHODS

Ceftolozane-tazobactam was prepared to achieve initial concentrations representing total daily doses for 'renal', 'standard' and 'high' dose schedules in elastomeric infusion devices with a volume of 240 mL. Infusion devices incubated at room and body temperature were serially sampled over 48 hours. Refrigerated infusion devices were sampled over 10 days. Concentrations of ceftolozane and tazobactam were separately quantified using a validated ultra-high performance liquid chromatography-photodiode array method.

RESULTS

The greatest loss of ceftolozane occurred at 37°C, however, stability remained above 90% at 24 hours. Tazobactam was more stable than ceftolozane under these conditions. There was minimal loss at 4°C for either component over 7 days.

CONCLUSIONS

Ceftolozane-tazobactam is suitable for ambulatory care delivered as a continuous infusion via an elastomeric infusion device.

摘要

目的

已发表的头孢洛扎他唑巴坦的体外稳定性数据支持间歇性短时间输注。对于许多每天仅提供一次或两次就诊的门诊抗菌治疗服务,这种输送方法是不可行的。本研究旨在评估头孢洛扎他唑巴坦在弹性输注装置中连续输注时,在门诊抗菌治疗中遇到的临床相关范围内时间、温度和浓度依赖性稳定性。

方法

将头孢洛扎他唑巴坦制备为初始浓度,以代表“肾功能不全”、“标准”和“高”剂量方案的每日总剂量,在体积为 240ml 的弹性输注装置中。在室温及体温下孵育的输注装置在 48 小时内进行连续取样。冷藏的输注装置在 10 天内进行取样。使用经过验证的超高效液相色谱-光电二极管阵列法分别定量头孢洛扎他唑巴坦和他唑巴坦的浓度。

结果

37°C 时头孢洛扎他唑巴坦的损失最大,但在 24 小时时稳定性仍保持在 90%以上。在这些条件下,他唑巴坦比头孢洛扎他唑巴坦更稳定。在 4°C 下,两种成分在 7 天内的损失最小。

结论

头孢洛扎他唑巴坦适合通过弹性输注装置连续输注用于门诊治疗。

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Evidence of clinical response and stability of Ceftolozane/Tazobactam used to treat a carbapenem-resistant Pseudomonas Aeruginosa lung abscess on an outpatient antimicrobial program.在门诊抗菌治疗方案中,使用头孢洛扎/他唑巴坦治疗耐碳青霉烯类铜绿假单胞菌肺脓肿的临床反应及稳定性证据。
Int J Antimicrob Agents. 2018 Jun;51(6):941-942. doi: 10.1016/j.ijantimicag.2018.02.008. Epub 2018 Feb 19.
2
Chemical Stability of Ceftolozane/Tazobactam in Polyvinylchloride Bags and Elastomeric Pumps.头孢洛扎/他唑巴坦在聚氯乙烯袋和弹性泵中的化学稳定性
Curr Ther Res Clin Exp. 2017 Mar 6;84:22-25. doi: 10.1016/j.curtheres.2017.03.002. eCollection 2017.
3
Antibiotic stability related to temperature variations in elastomeric pumps used for outpatient parenteral antimicrobial therapy (OPAT).门诊胃肠外抗菌治疗(OPAT)中使用的弹性泵内抗生素稳定性与温度变化的关系。
J Antimicrob Chemother. 2017 May 1;72(5):1462-1465. doi: 10.1093/jac/dkw582.
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Extended stability of antimicrobial agents in administration devices.抗菌药物在给药装置中的稳定性延长。
J Antimicrob Chemother. 2017 Apr 1;72(4):1217-1220. doi: 10.1093/jac/dkw556.
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Ceftolozane/tazobactam pharmacokinetic/pharmacodynamic-derived dose justification for phase 3 studies in patients with nosocomial pneumonia.头孢洛扎/他唑巴坦用于医院获得性肺炎患者3期研究的药代动力学/药效学推导剂量合理性
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