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扩大抗生素、疫苗和诊断试剂的研发和获取,以应对抗微生物药物耐药性。

Expanding antibiotic, vaccine, and diagnostics development and access to tackle antimicrobial resistance.

机构信息

One Health Trust, Bengaluru, India; High Meadows Environmental Institute, Princeton University, Princeton, NJ, USA.

One Health Trust, Bengaluru, India.

出版信息

Lancet. 2024 Jun 8;403(10443):2534-2550. doi: 10.1016/S0140-6736(24)00878-X. Epub 2024 May 23.

DOI:10.1016/S0140-6736(24)00878-X
PMID:38797178
Abstract

The increasing number of bacterial infections globally that do not respond to any available antibiotics indicates a need to invest in-and ensure access to-new antibiotics, vaccines, and diagnostics. The traditional model of drug development, which depends on substantial revenues to motivate investment, is no longer economically viable without push and pull incentives. Moreover, drugs developed through these mechanisms are unlikely to be affordable for all patients in need, particularly in low-income and middle-income countries. New, publicly funded models based on public-private partnerships could support investment in antibiotics and novel alternatives, and lower patients' out-of-pocket costs, making drugs more accessible. Cost reductions can be achieved with public goods, such as clinical trial networks and platform-based quality assurance, manufacturing, and product development support. Preserving antibiotic effectiveness relies on accurate and timely diagnosis; however scaling up diagnostics faces technological, economic, and behavioural challenges. New technologies appeared during the COVID-19 pandemic, but there is a need for a deeper understanding of market, physician, and consumer behaviour to improve the use of diagnostics in patient management. Ensuring sustainable access to antibiotics also requires infection prevention. Vaccines offer the potential to prevent infections from drug-resistant pathogens, but funding for vaccine development has been scarce in this context. The High-Level Meeting of the UN General Assembly in 2024 offers an opportunity to rethink how research and development can be reoriented to serve disease management, prevention, patient access, and antibiotic stewardship.

摘要

全球范围内,越来越多的细菌感染对现有抗生素均无反应,这表明需要投资并确保获得新的抗生素、疫苗和诊断方法。传统的药物开发模式依赖于可观的收入来推动投资,而如果没有激励措施,这种模式在经济上已不可行。此外,通过这些机制开发的药物不太可能为所有有需要的患者所负担,尤其是在低收入和中等收入国家。基于公私伙伴关系的新型公共资金模式可以为抗生素和新型替代品的投资提供支持,并降低患者的自付费用,使药物更易获得。通过临床试验网络和基于平台的质量保证、制造和产品开发支持等公共产品可以实现成本降低。准确和及时的诊断对于保持抗生素的有效性至关重要;然而,诊断技术的推广面临着技术、经济和行为方面的挑战。在 COVID-19 大流行期间出现了新技术,但需要更深入地了解市场、医生和消费者的行为,以改善在患者管理中使用诊断技术。确保可持续获得抗生素还需要进行感染预防。疫苗有潜力预防耐药病原体引起的感染,但在这种情况下,疫苗开发的资金一直很匮乏。2024 年联合国大会高级别会议提供了一个机会,可以重新思考如何重新调整研发工作,以服务于疾病管理、预防、患者获得和抗生素管理。

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