Successful double-blinded, randomized, placebo-controlled field trial of azithromycin and doxycycline as prophylaxis for malaria in western Kenya

Successful double-blinded, randomized, placebo-controlled field trial of azithromycin and doxycycline as prophylaxis for malaria in western Kenya
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DOI:
10.1086/516281
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发表时间:
1998-01-01
影响因子:
11.8
通讯作者:
Shanks, GD
Shanks, GD
中科院分区:
医学1区
文献类型:
--
作者:
Andersen, SL;Oloo, AJ;Shanks, GD

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阿奇霉素在动物模型和早期临床试验中预防疟疾。我们测定了三种抗生素方案(阿奇霉素,每天250 mg;阿奇霉素,每周1,000 mg;多西环素,每天100 mg)对232名居住在疟疾高传播区的成年志愿者的预防效果,为期10周。在研究期间,任何被证实的寄生虫血症都被认为是预防性失败。213名志愿者(92%)完成研究,预防效果如下:每日服用阿奇霉素82.7%(95%可信区间,68.5%-91.1%),每周服用阿奇霉素64.2%(95%可信区间,47.1%-77.1%),每日服用多西环素92.6%(95%可信区间,79.9%-97.5%)。AU方案耐受性良好,我们得出结论,在这种情况下,每天服用100 mg多西环素和250 mg阿奇霉素都是预防疟疾的有效方法。如果对非免疫志愿者的研究证实了半免疫志愿者的这些结果,那么对于那些有多西环素或其他抗疟疾药物治疗禁忌症的人来说,每天一次的阿奇霉素方案可能会有特殊的作用。
Azithromycin prevents malaria in animal models and early clinical trials. We determined the prophylactic efficacy of three antibiotic regimens given for 10 weeks (azithromycin, 250 mg daily; azithromycin, 1,000 mg weekly; and doxycycline, 100 mg daily) relative to that of placebo for 232 adult volunteers residing in apt area of intense malaria transmission. Any confirmed parasitemia during the study was considered a prophylactic failure. Two hundred thirteen volunteers (92%) completed the study, The prophylactic efficacies were as follows: daily azithromycin, 82.7% (95% confidence interval [CI], 68.5%-91.1%); weekly azithromycin, 64.2% (95% CI, 47.1%-77.1%); and daily doxycycline, 92.6% (95% CI, 79.9%-97.5%). AU regimens were well tolerated, We concluded that both 100 mg of doxycycline and 250 mg of azithromycin, given daily, were effective as prophylaxis for malaria in this setting. If studies with nonimmune volunteers confirm these results for semi-immune volunteers, a daily azithromycin regimen may have special utility for individuals with contraindications to treatment with doxycycline or other antimalarial agents.