对门诊亲肠道抗微生物治疗方案的抗微生物稳定性测试指南的审查:是时候全球协调测试框架了吗?
Saiyuri Naicker1, Jason A Roberts1,2,3,4, Vesa Cheng1,5,6
1The University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Queensland, Australia.
JAC-antimicrobial resistance
|December 2, 2024
概括
门诊亲肠道抗微生物疗法 (OPAT) 的抗微生物稳定性测试缺乏全球共识,导致获得不平等的机会. 协调国际指导方针对于一致的治疗计划和服务提供至关重要.
科学领域:
- 制药科学 制药科学
- 传染性疾病 传染性疾病
- 卫生政策 卫生政策
背景情况:
- 抗微生物稳定性对于门诊亲肠道抗微生物疗法 (OPAT) 治疗计划至关重要.
- 目前对稳定性评估的区域法规不一致,造成了对抗微生物药物获取的差异.
研究的目的:
- 对OPAT的抗微生物稳定性测试进行国际监管共识的审查.
- 描述各监管机构对抗微生物药物建议的变化.
主要方法:
- 在OPAT中对抗微生物药物稳定性测试的国际监管准则和标准的文献综述.
- 分析指南的区域差异,特别是温度和特定OPAT指南的区域差异.
主要成果:
- 在抗微生物药物稳定性测试指南中存在显著差异,特别是在温度参数方面.
- 许多地区缺乏针对抗菌素稳定性的具体监管指导或OPAT指导方针.
- 只有英国的NHS提供了关于抗微生物药物稳定性测试的非监管性,OPAT特定的建议.
结论:
- 需要对抗微生物药物稳定性测试进行协调,以建立一个针对OPAT的全球监管框架.
- 解决当前指导方针中已识别的变化领域至关重要.
- 全球框架应整合共识标准,专家意见和药典最佳实践.
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