Ruebush Trenton K, Marquiño Wilmer, Zegarra Jorge, Neyra Daniel, Villaroel Rodolfo, Avila Juan Carlos, Díaz César, Beltrán Efraín
National Center for Infectious Diseases, Centers for Disease Control and Prevention, U.S. Naval Medical Research Center Detachment, Lima, Peru.
Am J Trop Med Hyg. 2003 Apr;68(4):391-7.
The World Health Organization (WHO) has developed guidelines for in vivo antimalarial drug efficacy testing for Plasmodium falciparum and Plasmodium vivax in areas with low-to-moderate transmission, such as the Americas. These guidelines are used widely by ministries of health and national malaria control programs to assess the efficacy of their first-line and second-line drugs for the treatment of malaria and to provide the information necessary to update national malaria treatment policies. Following the WHO guidelines, we have conducted in vivo efficacy trials with a variety of drugs and drug combinations against P. falciparum and P. vivax at 13 sites in Peru, Bolivia, and Ecuador. Based on these experiences, we have identified several modifications that we believe should be made in the WHO recommendations to make them more suitable to the relatively low levels of P. falciparum transmission in the Americas and to the logistic challenges of carrying out such studies in sparsely populated areas, such as the Amazon Basin. These include changes in inclusion and exclusion criteria, in enrollment and follow-up procedures, and in the measurement of study outcomes.
世界卫生组织（WHO）制定了在中低传播地区（如美洲）对恶性疟原虫和间日疟原虫进行体内抗疟药物疗效测试的指南。这些指南被各国卫生部和国家疟疾控制项目广泛用于评估其一线和二线抗疟药物治疗疟疾的疗效，并为更新国家疟疾治疗政策提供必要信息。按照WHO指南，我们在秘鲁、玻利维亚和厄瓜多尔的13个地点，针对多种药物和药物组合对恶性疟原虫和间日疟原虫进行了体内疗效试验。基于这些经验，我们确定了一些修改建议，认为应在世卫组织的建议中做出这些修改，以使它们更适合美洲相对较低的恶性疟原虫传播水平，以及在人口稀少地区（如亚马逊盆地）开展此类研究时面临的后勤挑战。这些修改包括纳入和排除标准、入组和随访程序以及研究结果测量方面的变化。
