A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum
A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum
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DOI：
10.1086/367542
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发表时间：
2003-03-01
影响因子：
11.8
通讯作者：
Hoffman, SL
中科院分区：
文献类型：
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作者：
Hale, BR;Owusu-Agyei, S;Hoffman, SL
他非诺喹是一种很有前途的新型8-氨基喹啉药物，可能对葡萄糖-6-磷酸脱氢酶（G6 PD）功能正常的非妊娠人群预防疟疾有用。在加纳北方的成年居民中进行了一项随机、双盲、安慰剂对照的化学预防试验，以确定他非诺喹预防恶性疟原虫感染的最低有效周剂量。主要终点是13周研究药物覆盖期间疟疾血涂片结果阳性。相对于安慰剂，所有4种剂量的他非诺喹均表现出对恶性疟原虫感染的显著保护作用：25 mg/周，保护效力为32%。（95%置信区间[CI]，20%-43%）; 50 mg/周，84%（95% CI，75%-91%）; 100 mg/周，87%（95% CI，78%-93%）; 200 mg/周，86%（95% CI，76%-92%）。甲氟喹剂量为250 mg/周也显示出对恶性疟原虫感染的显著保护作用（保护效力，86%; 95% CI，72%-93%）。研究组之间报告的不良事件几乎没有差异，没有证据表明他非诺喹剂量与身体不适报告或异常实验室参数发生之间存在关系。在本研究人群中，他非诺喹剂量为50、100和200 mg/周对恶性疟原虫感染安全、耐受性良好且有效。
Tafenoquine is a promising new 8-aminoquinoline drug that may be useful for malaria prophylaxis in nonpregnant persons with normal glucose-6-phosphate dehydrogenase (G6PD) function. A randomized, double-blind, placebo-controlled chemoprophylaxis trial was conducted with adult residents of northern Ghana to determine the minimum effective weekly dose of tafenoquine for the prevention of infection by Plasmodium falciparum. The primary end point was a positive malaria blood smear result during the 13 weeks of study drug coverage. Relative to the placebo, all 4 tafenoquine dosages demonstrated significant protection against P. falciparum infection: for 25 mg/week, protective efficacy was 32% (95% confidence interval [CI], 20%-43%); for 50 mg/week, 84% (95% CI, 75%-91%); for 100 mg/week, 87% (95% CI, 78%-93%); and for 200 mg/week, 86% (95% CI, 76%-92%). The mefloquine dosage of 250 mg/week also demonstrated significant protection against P. falciparum infection (protective efficacy, 86%; 95% CI, 72%-93%). There was little difference between study groups in the adverse events reported, and there was no evidence of a relationship between tafenoquine dosage and reports of physical complaints or the occurrence of abnormal laboratory parameters. Tafenoquine dosages of 50, 100, and 200 mg/week were safe, well tolerated, and effective against P. falciparum infection in this study population.