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九种时间依赖性抗生素用于门诊胃肠外抗菌治疗(OPAT)的稳定性

Stability of Nine Time-Dependent Antibiotics for Outpatient Parenteral Antimicrobial Therapy (OPAT) Use.

作者信息

d'Huart Elise, Boutouha Ibtissem, Berardi Clara, Vigneron Jean, Demore Béatrice, Charmillon Alexandre

机构信息

Pharmacy Department, CHRU-Nancy, F-54000 Nancy, France.

Infostab-A Nonprofit Association, F-54180 Heillecourt, France.

出版信息

Antibiotics (Basel). 2025 May 3;14(5):466. doi: 10.3390/antibiotics14050466.

Abstract

The use of an elastomeric diffuser is favored to administer outpatient antibiotic therapy. A study published in 2022 highlighted the instability of several antibiotics in elastomeric devices at 37 °C. The objective was to evaluate the stability of nine time-dependent antibiotics that are unstable at 37 °C at lower concentrations and a reduced storage temperature of 32 °C. Chemical stability was assessed by pH measurement and high-performance liquid chromatography. Physical stability was evaluated by visual and subvisual inspection. The solutions were considered stable if the remaining drug percentage was ≥90%, the maximum variation in pH was less than 1, the particle count was within acceptable limits and the visual aspect remained unchanged after storage. Solutions showing stability for 24 h are composed of 12.5 mg/mL cefiderocol in NS (normal saline) and 50-133 mg/mL piperacillin in NS-D5W (5% dextrose). Additionally, 12.5 mg/mL amoxicillin in NS; 12.5 mg/mL cefepime in NS-D5W; 12.5 mg/mL cefiderocol in D5W; 25 mg/mL cefiderocol in NS-D5W; 12.5 mg/mL cefotaxime in NS-D5W; 12.5 mg/mL cefoxitin in NS-D5W; 12.5 mg/mL ceftazidime in NS-D5W; 25 mg/mL ceftazidime in NS; 25 mg/mL cloxacillin in NS-D5W; and 25-50 mg/mL oxacillin in NS were shown to be stable for 12 h. Notably, 25 mg/mL amoxicillin in NS, 50 mg/mL cloxacillin in NS and 25 mg/mL oxacillin in D5W were shown to be stable for 8 h. These 12-24 h stability data indicate that these antibiotics can be administered by continuous infusion using only one-two elastomeric devices per day, facilitating outpatient parenteral antimicrobial therapy (OPAT).

摘要

使用弹性体扩散器有利于门诊抗生素治疗。2022年发表的一项研究强调了几种抗生素在37℃的弹性体装置中的不稳定性。目的是评估9种浓度较低且储存温度降至32℃时在37℃不稳定的时间依赖性抗生素的稳定性。通过pH测量和高效液相色谱法评估化学稳定性。通过目视和亚目视检查评估物理稳定性。如果剩余药物百分比≥90%、pH的最大变化小于1、颗粒计数在可接受范围内且储存后外观保持不变,则认为溶液稳定。显示24小时稳定性的溶液包括12.5mg/mL头孢地尔在生理盐水(NS)中以及50 - 133mg/mL哌拉西林在5%葡萄糖生理盐水(NS - D5W)中。此外,12.5mg/mL阿莫西林在NS中;12.5mg/mL头孢吡肟在NS - D5W中;12.5mg/mL头孢地尔在5%葡萄糖溶液(D5W)中;25mg/mL头孢地尔在NS - D5W中;12.5mg/mL头孢噻肟在NS - D5W中;12.5mg/mL头孢西丁在NS - D5W中;12.5mg/mL头孢他啶在NS - D5W中;25mg/mL头孢他啶在NS中;25mg/mL氯唑西林在NS - D5W中;以及25 - 50mg/mL苯唑西林在NS中显示稳定12小时。值得注意的是,25mg/mL阿莫西林在NS中、50mg/mL氯唑西林在NS中以及25mg/mL苯唑西林在D5W中显示稳定8小时。这些12 - 24小时的稳定性数据表明,这些抗生素可以通过每天仅使用一两个弹性体装置进行连续输注给药,便于门诊胃肠外抗菌治疗(OPAT)。

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