[A study in the Ivory Coast (1985-1987) of the efficacy and tolerance of ivermectin (Mectizan) in human onchocerciasis. I. A comparative double-blind study of 220 patients with onchocerciasis treated with a single oral dose of 100, 150 or 200 mcg/kg].

M Larivière, B Beauvais, M Aziz, J F Garin, J Abeloos, F Derouin, M Bamba, C Bossebceuf, M Ferly-Therizol, C Sarfati
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Abstract

Two hundred and twenty adult males living in endemic onchocerciasis areas in Ivory Coast, with a mean of 59 to 64 mf/mg of skin microfilariae, having or not ocular lesions, were divided into 4 homogeneous groups and treated by placebo or by a single oral dose of 100, 150 or 200 mcg/kg of ivermectin. Parasitological, clinical, ophthalmological, biological data were gathered before treatment (J less than 1) and at day 4 and 3, 6, 12 months post treatment. The doses of 150 to 200 mcg/kg gave the best results with a reduction of microfilariae of 75 to 79% at day 4 and of 97 to 99% at 3 months. A slight increase appears at six months reaching to 10% of the initial level, at 12 months. These posologies reduce also the number of ocular microfilariae 12 months after treatment. The percentage of patients presenting microfilariae in the cornea varies from 4 to 14% according to the given dose whereas it was initially between 26 and 33%, and in the anterior chamber from 22 to 16% instead of 62 to 67%. In patients who were still positive after treatment the detected number of ocular microfilariae was very small. Side effects starting 12 to 24 hours after treatment are similar to those appearing during the normal evolution of onchocerciasis. They were observed in 36% of subjects receiving a placebo and 56 to 65% of treated subjects. Statistically they are neither correlated with the intensity of parasitism nor to the given posology and disappear spontaneously few days later or after administration of aspirin and/or antihistaminic. Ivermectin given at a single oral dosage of 150 to 200 mcg/kg is a powerful microfilaricidal drug with a rapid and prolonged action and without major side effects.

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[在科特迪瓦(1985-1987)研究伊维菌素(Mectizan)对人盘尾丝虫病的疗效和耐受性。一项针对220例盘尾丝虫病患者的比较双盲研究,单次口服剂量分别为100、150或200微克/千克。
生活在科特迪瓦盘尾丝虫病流行地区的220名成年男性,皮肤微丝虫病平均为59至64毫微克/毫克,有或没有眼部病变,被分为4个均匀组,分别用安慰剂或单次口服伊维菌素100、150或200毫微克/公斤进行治疗。在治疗前(小于1个月)和治疗后第4天、第3、6、12个月收集寄生虫学、临床、眼科、生物学资料。150 ~ 200mcg /kg的剂量效果最好,第4天微丝虫减少75 ~ 79%,3个月减少97 ~ 99%。在6个月时出现轻微增长,达到初始水平的10%,在12个月时。治疗12个月后,这些病理学也减少了眼微丝蚴的数量。根据给药剂量,出现角膜微丝蚴的患者百分比从26%到33%不等,从22%到16%不等,而在前房,这一比例从62%到67%不等。在治疗后仍呈阳性的患者中,检测到的眼微丝蚴数量很少。治疗后12至24小时开始出现的副作用与盘尾丝虫病正常发展过程中出现的副作用相似。在接受安慰剂的受试者中,有36%的人出现了这种症状,而接受治疗的受试者中有56%至65%出现了这种症状。从统计学上讲,它们与寄生的强度或给定的疾病无关,并在几天后或服用阿司匹林和/或抗组胺药后自行消失。伊维菌素单次口服剂量为150至200微克/公斤,是一种强大的杀微丝药物,作用迅速而持久,无重大副作用。
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