PDF(Pubmed)
Abstract：
In order to use aseptically prepared elastomeric infusers, outpatient parenteral antimicrobial therapy (OPAT) services require extended stability data for antimicrobial agents to assign a product shelf-life. In the UK, the relevant standards for stability testing and shelf-life assignment are published in \'A Standard Protocol for Deriving and Assessment of Stability-Part 1 (Aseptic Preparations-Small Molecules), commonly called the Yellow Covered Document (YCD). A previous systematic review published in 2017 failed to identify data on the stability of antimicrobials in elastomeric devices for OPAT services that met YCD requirements in force at the time. The aim of this review was to update that search, following a subsequent change to YCD requirements in 2017 and 2019 and expand that dataset to identify progress made in providing assurance about the stability of antimicrobial agents for OPAT services.
Searches were undertaken for papers relating to extended stability of antimicrobials. Citations were included when antimicrobial shelf-life was assessed using a stability-indicating method and considered a period of storage, either refrigerated or at room temperature, followed by in-use testing at a temperature at or above 32°C.
Of 267 initial citations, six met the inclusion criteria and underwent full text review for data extraction. Included antimicrobials were cefazolin, ceftazidime, piperacillin/tazobactam, flucloxacillin and ceftolozane/tazobactam. Of these, only flucloxacillin and piperacillin demonstrated YCD compliant stability over the 24-hour infusion period while cefazolin, ceftazidime and ceftolozane/tazobactam could be infused over 12-hour period.
Contrary to the position found in 2017 review, high-quality data are now available to support the use of a number of antimicrobial agents in extended infusion in elastomeric devices for OPAT services. There is a need to expand the dataset, as well as developing international consensus on the ideal parameters for stability assessment of such infusions in elastomeric devices.
Searches were undertaken for papers relating to extended stability of antimicrobials. Citations were included when antimicrobial shelf-life was assessed using a stability-indicating method and considered a period of storage, either refrigerated or at room temperature, followed by in-use testing at a temperature at or above 32°C.
Of 267 initial citations, six met the inclusion criteria and underwent full text review for data extraction. Included antimicrobials were cefazolin, ceftazidime, piperacillin/tazobactam, flucloxacillin and ceftolozane/tazobactam. Of these, only flucloxacillin and piperacillin demonstrated YCD compliant stability over the 24-hour infusion period while cefazolin, ceftazidime and ceftolozane/tazobactam could be infused over 12-hour period.
Contrary to the position found in 2017 review, high-quality data are now available to support the use of a number of antimicrobial agents in extended infusion in elastomeric devices for OPAT services. There is a need to expand the dataset, as well as developing international consensus on the ideal parameters for stability assessment of such infusions in elastomeric devices.
摘要：
为了使用无菌制备的弹性体注入器，门诊肠胃外抗菌治疗(OPAT)服务需要延长抗菌药物的稳定性数据,以确定产品的保质期.在英国,稳定性测试和保质期分配的相关标准发表在“稳定性衍生和评估的标准协议-第1部分（无菌制剂-小分子）”中，通常称为黄色封面文件(YCD)。2017年发表的先前的系统评价未能确定OPAT服务的弹性体设备中抗菌药物稳定性的数据，这些数据符合当时有效的YCD要求。这次审查的目的是更新搜索，随后在2017年和2019年对YCD要求进行了更改，并扩展了该数据集，以确定在为OPAT服务提供抗微生物剂稳定性保证方面取得的进展。
进行与抗微生物剂的延长稳定性相关的论文的搜索。当使用稳定性指示方法评估抗微生物剂保质期并将其视为储存期时，冷藏或在室温下，然后在32°C或以上的温度下进行使用测试。
在267次初始引用中，6人符合纳入标准,并接受了全文审查以进行数据提取.包括抗生素头孢唑啉，头孢他啶,哌拉西林/他唑巴坦,氟氯西林和头孢洛赞/他唑巴坦。其中,只有氟氯西林和哌拉西林在24小时输注期间表现出YCD顺应性稳定性，而头孢唑林，头孢他啶和头孢洛赞/他唑巴坦可以在12小时内输注。
与2017年评论中的立场相反，现在有高质量的数据支持在OPAT服务的弹性装置的延长输注中使用多种抗微生物剂。需要扩展数据集，以及就弹性体设备中此类输液稳定性评估的理想参数达成国际共识。
进行与抗微生物剂的延长稳定性相关的论文的搜索。当使用稳定性指示方法评估抗微生物剂保质期并将其视为储存期时，冷藏或在室温下，然后在32°C或以上的温度下进行使用测试。
在267次初始引用中，6人符合纳入标准,并接受了全文审查以进行数据提取.包括抗生素头孢唑啉，头孢他啶,哌拉西林/他唑巴坦,氟氯西林和头孢洛赞/他唑巴坦。其中,只有氟氯西林和哌拉西林在24小时输注期间表现出YCD顺应性稳定性，而头孢唑林，头孢他啶和头孢洛赞/他唑巴坦可以在12小时内输注。
与2017年评论中的立场相反，现在有高质量的数据支持在OPAT服务的弹性装置的延长输注中使用多种抗微生物剂。需要扩展数据集，以及就弹性体设备中此类输液稳定性评估的理想参数达成国际共识。
