Access to diphtheria antitoxin for therapy and diagnostics
Access to diphtheria antitoxin for therapy and diagnostics
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DOI：
10.2807/1560-7917.es2014.19.24.20830
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发表时间：
2014-06-19
期刊：
影响因子：
19
通讯作者：
Efstratiou, A.
中科院分区：
文献类型：
--
作者：
Both, L.;White, J.;Efstratiou, A.
白喉最有效的治疗方法是迅速给予白喉抗毒素（DAT）和联合抗生素治疗。DAT是一种马免疫球蛋白制剂，被列入世界卫生组织基本药物。基本药物应在正常运作的卫生系统中随时以适当的剂量、适当的剂量、有保证的质量和个人和社区能够负担的价格提供。然而，DAT供应稀少，患者经常无法获得，因为在一些国家停产，经济可行性低，以及对血液衍生产品安全生产的监管要求高。DAT也是白喉诊断的基石，但欧盟（EU）和其他地方的几个诊断参考实验室在采购DAT进行致敏性测试时经常面临问题。总体而言，全球获得DAT用于治疗和诊断应用的机会似乎不足。因此，除了努力改善目前DAT的供应外，还需要加速研究和开发替代品，包括用于治疗的单克隆抗体和基于分子的诊断方法。鉴于这种疾病的罕见性，为所有欧盟国家集中组织一个小型库存并在国家内部和国家之间保持DAT可用性的库存将是有益的。
The most effective treatment for diphtheria is swift administration of diphtheria antitoxin (DAT) with conjunct antibiotic therapy. DAT is an equine immunoglobulin preparation and listed among the World Health Organization Essential Medicines. Essential Medicines should be available in functioning health systems at all times in adequate amounts, in appropriate dosage forms, with assured quality, and at prices individuals and the community can afford. However, DAT is in scarce supply and frequently unavailable to patients because of discontinued production in several countries, low economic viability, and high regulatory requirements for the safe manufacture of blood-derived products. DAT is also a cornerstone of diphtheria diagnostics but several diagnostic reference laboratories across the European Union (EU) and elsewhere routinely face problems in sourcing DAT for toxigenicity testing. Overall, global access to DAT for both therapeutic and diagnostic applications seems inadequate. Therefore - besides efforts to improve the current supply of DAT - accelerated research and development of alternatives including monoclonal antibodies for therapy and molecular-based methods for diagnostics are required. Given the rarity of the disease, it would be useful to organise a small stockpile centrally for all EU countries and to maintain an inventory of DAT availability within and between countries.