Awadzi K, Opoku N O, Addy E T, Quartey B T
Onchocerciasis Chemotherapy Research Centre, Hohoe Hospital, Ghana.
Trop Med Parasitol. 1995 Jun;46(2):131-7.
Ivermectin is the drug of choice for the treatment of onchocerciasis. However at the recommended dose of 150 micrograms/kg, it neither kills nor permanently sterilises the adult worms. We investigated whether high doses given with and without a preceding 150 micrograms/kg 'clearing' dose would be tolerable as well as effective against the adult worms. Seventy-five healthy males with moderate to heavy infections with Onchocerca volvulus were enrolled in a double-blind trial to receive one of the following treatment regimens: 150 micrograms/kg followed by placebo (9 patients); 400 micrograms/kg with (9 patients) or without (16 patients) a clearing dose; 600 micrograms/kg with (8 patients) or without (16 patients) a clearing dose and 800 micrograms/kg with (8 patients) or without (9 patients) a clearing dose. Detailed examinations were conducted before and at various times after treatment. A preliminary report on the clinical and laboratory safety as at 30 days is presented. All the regimens were well tolerated. No clinical or laboratory drug related effects were observed. The overall severity of the Mazzotti reaction was similar in all groups. Ocular reactions were minimal and there were no changes in ocular function or in fluorescein angiograms. The groups were similar in the extent of microfilaricidal activity; there was however a suggestion that microfilariae were killed more rapidly at 400 micrograms/kg and 600 micrograms/kg but not at 800 micrograms/kg. This needs further study. Single doses of ivermectin up to 800 micrograms/kg are well tolerated; no special precautions for treatment monitoring are required and a 'clearing' dose is not necessary.
伊维菌素是治疗盘尾丝虫病的首选药物。然而，按每千克体重150微克的推荐剂量使用时，它既不能杀死成虫，也不能使其永久绝育。我们研究了在给予150微克/千克的“清除”剂量前后给予高剂量伊维菌素是否既能耐受又能有效对抗成虫。75名感染中度至重度旋盘尾丝虫的健康男性参加了一项双盲试验，接受以下治疗方案之一：150微克/千克后接安慰剂（9名患者）；400微克/千克，有（9名患者）或无（16名患者）清除剂量；600微克/千克，有（8名患者）或无（16名患者）清除剂量；以及800微克/千克，有（8名患者）或无（9名患者）清除剂量。在治疗前和治疗后的不同时间进行了详细检查。本文给出了截至30天的临床和实验室安全性初步报告。所有治疗方案耐受性良好。未观察到临床或实验室与药物相关的效应。所有组中马佐蒂反应的总体严重程度相似。眼部反应轻微，眼部功能或荧光素血管造影均无变化。各治疗组在杀微丝蚴活性程度上相似；然而，有迹象表明，400微克/千克和600微克/千克剂量时微丝蚴被杀灭得更快，但800微克/千克剂量时并非如此。这需要进一步研究。单剂量高达800微克/千克的伊维菌素耐受性良好；无需特殊的治疗监测预防措施，也无需“清除”剂量。
