Department of Clinical Pharmacology, University of Helsinki, Helsinki, Finland.
Arch Dis Child. 2011 Aug;96(8):764-8. doi: 10.1136/adc.2009.180000. Epub 2011 Mar 25.
Diseases causing high mortality in children under 5 years of age in resource limited settings (RLS) could be treated if children in these countries had access to existing medicines. It took 30 years before the WHO Essential Medicines List (EML) considered the issue of medicines for children, with the first EML for children being published in 2007. Recent data indicate that less than half of the key paediatric essential medicines are available in countries of sub-Saharan Africa. Problems include substandard medicines, irrational use of medicines, inefficiency and even possible corruption in pharmaceutical management systems. These are global issues which affect RLS most. Clinical trials in developing countries for the benefit of children are needed but challenging in several ways. In this review, the authors will consider the following areas where progress could improve paediatric pharmacotherapy in RLS: registration and regulation of medicines, rational use of medicines, clinical trials in children and restriction of corruption in pharmaceutical management systems.
在资源有限环境下（RLS），如果这些国家的儿童能够获得现有药物，那么导致 5 岁以下儿童高死亡率的疾病是可以治疗的。直到 30 年后，世界卫生组织（WHO）基本药物清单（EML）才考虑到儿童用药问题，第一份儿童基本药物清单于 2007 年发布。最近的数据表明，撒哈拉以南非洲国家只有不到一半的关键儿科基本药物可用。问题包括药品标准低、用药不合理、效率低下，甚至在药品管理系统中存在腐败现象。这些都是影响 RLS 的全球性问题。为了儿童的利益，在发展中国家开展临床试验是必要的，但在几个方面都具有挑战性。在这篇综述中，作者将考虑以下几个方面，这些方面的进展可能会改善 RLS 中的儿科药物治疗：药品注册和监管、合理用药、儿童临床试验和限制药品管理系统中的腐败。
