A Trial of Combination Antimalarial Therapies in Children from Papua New Guinea
A Trial of Combination Antimalarial Therapies in Children from Papua New Guinea
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DOI：
10.1056/nejmoa0804915
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发表时间：
2008-12-11
影响因子：
158.5
通讯作者：
Davis, Timothy M. E.
中科院分区：
文献类型：
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作者：
Karunajeewa, Harin A.;Mueller, Ivo;Davis, Timothy M. E.
背景：在多种疟原虫全年传播强烈的地方，例如巴布亚新几内亚，疟疾控制很困难。方法：2005 年 4 月至 2007 年 7 月期间，我们对传统氯喹-磺胺多辛-乙胺嘧啶和青蒿琥酯-磺胺多辛-乙胺嘧啶进行了一项开放标签、随机、平行组研究， 双氢青蒿素-哌喹和蒿甲醚-本芴醇治疗巴布亚新几内亚0.5至5岁的恶性疟或间日疟儿童。主要终点是在开始治疗恶性疟原虫后第 42 天时的充分临床和寄生虫学反应率，经过对通过寄生虫 DNA 多态性位点的聚合酶链反应 (PCR) 基因分型确定的再感染进行校正后。次要终点包括第 42 天时间日疟原虫未通过 PCR 基因分型校正的充分临床和寄生虫学反应率。 结果：在 2802 名筛查发热儿童中，包括 482 名恶性疟疾儿童和 195 名间日疟疾儿童。对恶性疟原虫的充分临床和寄生虫学反应率最高的是蒿甲醚-苯芴醇组（95.2%），而氯喹-磺胺多辛-乙胺嘧啶组为81.5%（P=0.003），青蒿琥酯-磺胺多辛-乙胺嘧啶组为85.4%（P=0.02），而青蒿素-磺胺多辛-乙胺嘧啶组为88.0%。 双氢青蒿素哌喹组(P=0.06)。双氢青蒿素-哌喹组中间日疟原虫的充分临床和寄生虫学反应率（69.4%）是其他三个治疗组的两倍多。体外氯喹和哌喹水平可抑制当地恶性疟原虫分离株生长 50%，显着相关（P
Background: Malaria control is difficult where there is intense year-round transmission of multiple plasmodium species, such as in Papua New Guinea.Methods: Between April 2005 and July 2007, we conducted an open-label, randomized, parallel-group study of conventional chloroquine-sulfadoxine-pyrimethamine and artesunate-sulfadoxine-pyrimethamine, dihydroartemisinin-piperaquine, and artemether-lumefantrine in children in Papua New Guinea 0.5 to 5 years of age who had falciparum or vivax malaria. The primary end point was the rate of adequate clinical and parasitologic response at day 42 after the start of treatment with regard to Plasmodium falciparum, after correction for reinfections identified through polymerase-chain-reaction (PCR) genotyping of polymorphic loci in parasite DNA. Secondary end points included the rate of adequate clinical and parasitologic response at day 42 with regard to P. vivax without correction through PCR genotyping.Results: Of 2802 febrile children screened, 482 with falciparum malaria and 195 with vivax malaria were included. The highest rate of adequate clinical and parasitologic response for P. falciparum was in the artemether-lumefantrine group (95.2%), as compared with 81.5% in the chloroquine-sulfadoxine-pyrimethamine group (P=0.003), 85.4% in the artesunate-sulfadoxine-pyrimethamine group (P=0.02), and 88.0% in the dihydroartemisinin-piperaquine group (P=0.06). The rate of adequate clinical and parasitologic response for P. vivax in the dihydroartemisinin-piperaquine group (69.4%) was more than twice that in each of the other three treatment groups. The in vitro chloroquine and piperaquine levels that inhibited growth of local P. falciparum isolates by 50% correlated significantly (P