甲氟喹在巴西男性受试者中的II期临床试验。
A phase II clinical trial of mefloquine in Brazilian male subjects.
作者信息
de Souza J M
出版信息
Bull World Health Organ. 1983;61(5):815-20.
Mefloquine was compared with sulfadoxine-pyrimethamine for safety and efficacy in a randomized, double-blind clinical trial in adult males from a malaria-endemic area of Brazil. A total of 99 oligosymptomatic and symptomatic volunteers with Plasmodium falciparum parasitaemia took part in the trial; 49 were given 1000 mg of mefloquine and the remainder received 1500 mg of sulfadoxine plus 75 mg of pyrimethamine, in a single oral dose.Mefloquine was 100% successful in clearing parasitaemia within 7 days; there were no recrudescences. Sulfadoxine-pyrimethamine was less successful; 35 cases showed an S-type response, 8 an RI response, 3 an RII, and 2 an RIII response. The side-effects of mefloquine were mild and transient and included headache, nausea, vomiting, dizziness, and diarrhoea. A satisfactory weight gain and rise in haemoglobin level were seen in both groups.
在巴西疟疾流行地区针对成年男性进行的一项随机双盲临床试验中，对甲氟喹和磺胺多辛-乙胺嘧啶的安全性和疗效进行了比较。共有99名患有恶性疟原虫血症的轻症和有症状志愿者参与了试验；49人单次口服1000毫克甲氟喹，其余人则接受1500毫克磺胺多辛加75毫克乙胺嘧啶。甲氟喹在7天内清除寄生虫血症的成功率为100%；没有复发情况。磺胺多辛-乙胺嘧啶的成功率较低；35例显示为S型反应，8例为RI反应，3例为RII反应，2例为RIII反应。甲氟喹的副作用轻微且短暂，包括头痛、恶心、呕吐、头晕和腹泻。两组均观察到体重有令人满意的增加以及血红蛋白水平上升。
Zotero 插件