Hospital for Children and Adolescents and Dept. of Clinical Pharmacology, University of Helsinki and Poison Information Centre, Helsinki University Central Hospital, P.O. Box 790, 00029, Helsinki, Finland.
Eur J Clin Pharmacol. 2012 Jan;68(1):1-10. doi: 10.1007/s00228-011-1089-1. Epub 2011 Jul 6.
This review was conducted to examine the current status of paediatric medicines initiatives across the globe.
The authors made a non-systematic descriptive review of current world situation.
Two regions, the United States (US) and the European Union (EU), and the World Health Organization (WHO) have introduced strong paediatric initiatives to improve children's health through improving access to better paediatric medicines. The experience from the US initiative indicates that it is possible to stimulate development and study of paediatric medicines and provide important new information for improvement of paediatric therapy. The early results from the EU initiative are similarly encouraging. In Canada, Japan, Australia and other developed countries, specific paediatric medicines initiatives have been less extensive and weaker, with modest results. Disappointingly, current evidence suggests that results from clinical trials outside the US often do not benefit children in the country in which the trials were largely conducted. Pharmaceutical companies that have derived a financial benefit commensurate with the cost of doing the paediatric trials in one country do not seem to be making the results of these trials available to all countries if there is no financial incentive to the company. The WHO campaign 'make medicines child size' has produced substantive accomplishments in building improved foundations to improve mechanisms that will enhance children's access to critical medicines in resource-limited settings. However, practically all of this work has been performed using an amalgamation of short-term funding from a variety of sources as opposed to a sustained, programmatic commitment.
Although much still needs to be done, it's clear that with concerted efforts and appropriate resources, change is possible but slow. Retaining and fostering public and political interest in paediatric medicines is challenging, but pivotal for success.
本综述旨在考察全球儿科药物倡议的现状。
作者对当前世界形势进行了非系统性描述性综述。
两个地区，美国（US）和欧盟（EU）以及世界卫生组织（WHO）已经推出了强有力的儿科倡议，通过改善获取更好的儿科药物的途径来改善儿童健康。美国倡议的经验表明，刺激儿科药物的开发和研究并为儿科治疗的改进提供重要的新信息是可能的。欧盟倡议的早期结果同样令人鼓舞。在加拿大、日本、澳大利亚和其他发达国家，具体的儿科药物倡议范围较小且较弱，结果也较为温和。令人失望的是，目前的证据表明，在美国以外进行的临床试验的结果往往不能使进行试验的国家的儿童受益。从在一个国家进行儿科试验中获得与成本相称的经济利益的制药公司，如果对公司没有经济激励，似乎不会将这些试验的结果提供给所有国家。世卫组织的“使药品适合儿童体型”运动在为改善资源有限环境中儿童获得关键药物的机制奠定基础方面取得了实质性成就。然而，几乎所有这些工作都是利用各种来源的短期资金混合而成的，而不是持续的、有计划的承诺。
尽管仍有许多工作要做，但很明显，只要齐心协力并提供适当的资源，变革是可能的，但速度缓慢。保持和培养公众和政治对儿科药物的兴趣具有挑战性，但对成功至关重要。
