The difference between effectiveness and efficacy of antimalarial drugs in Kenya
The difference between effectiveness and efficacy of antimalarial drugs in Kenya
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DOI：
10.1111/j.1365-3156.2004.01291.x
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发表时间：
2004-09-01
影响因子：
3.3
通讯作者：
Snow, RW
中科院分区：
文献类型：
--
作者：
Amin, AA;Hughes, DA;Snow, RW
目的 证明肯尼亚抗疟（AM）药物的有效性和疗效之间的差异。方法 2001 年至 2002 年间，我们在肯尼亚的四个地区进行了一系列关联调查，调查内容包括（i）社区使用国家推荐的一线和二线 AM 药物； (ii) 零售和批发领域常用的增材制造产品； (iii) 最常用的一线和二线增材制造产品的质量。将这些与依从性和临床疗效的估计相结合，得出总体药物有效性。结果 磺胺多辛-乙胺嘧啶 (SP) 的总体建模有效性估计为 62%，而报告的 SP 临床疗效为 85%。对于阿莫地喹，模型有效性为 48%，而同期报告的有效性为 99%。结论 AM 产品的质量和患者对剂量方案的依从性是药物有效性的重要决定因素，应与临床疗效一起衡量。监管药物质量和提高患者依从性的注册后措施将极大地提高 AM 药物的性能。
OBJECTIVE To demonstrate the difference between effectiveness and efficacy of antimalarial (AM) drugs in Kenya.METHODS We undertook a series of linked surveys in four districts of Kenya between 2001 and 2002 on (i) community usage of nationally recommended first- and second-line AM drugs; (ii) commonly stocked AM products in the retail and wholesale sectors; and (iii) quality of the most commonly available first- and second-line AM products. These were combined with estimates of adherence and clinical efficacy to derive overall drug effectiveness.RESULTS The overall modelled effectiveness for sulphadoxine-pyrimethamine (SP) was estimated to be 62% compared with 85% for reported SP clinical efficacy. For amodiaquine the modelled effectiveness was 48% compared with 99% reported efficacy during the same time period.CONCLUSIONS The quality of AM products and patient adherence to dosage regimens are important determinants of drug effectiveness, and should be measured alongside clinical efficacy. Post-registration measures to regulate drug quality and improve patient adherence would contribute significantly to AM drug performance.