Ogbuagu K F, Eneanya C I
Department of Community Medicine, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria.
Ann Trop Med Parasitol. 1998 Apr;92 Suppl 1:S139-45.
A multi-centre, double-blind, placebo-controlled trial of the effect of Mectizan (ivermectin, MSD) treatment on the skin disease and severe itching associated with onchocerciasis was carried out in the forest zones of Nigeria, Ghana and Uganda. Overall, 4072 subjects, none of whom had received Mectizan previously, were enrolled and allocated into four groups, to receive Mectizan every 3, 6 or 12 months or placebo every 3 months. Subjects with skin lesions were stratified within each treatment group to ensure equal representation. Each subject was given a clinical examination and interviewed on enrolment and then 3-monthly for 15 months. The presence and severity of itching were determined by open-ended questions followed by probing questions. Skin lesions were classified and their severity graded using a standard system. Analysis of the results was restricted to the data from the 1530 subjects who received all their scheduled treatments and attended all the follow-up visits. From 6 months onwards, all subjects who had received Mectizan reported less severe itching, had lower prevalences of reactive skin lesions and had less severe skin lesions than those in the placebo group (P < 0.05 for each). The greatest reductions, in both itching and skin disease, were seen in subjects treated with Mectizan every 6 months. Mectizan treatment is therefore beneficial for the control of troublesome itching and for reducing the prevalence and severity of skin disease causes by Onchocerca. it is recommended that mass distribution of Mectizan to communities in the study areas be carried out at 6-monthly intervals for maximum efficacy.
在尼日利亚、加纳和乌干达的森林地区开展了一项多中心、双盲、安慰剂对照试验，以研究美迪善（伊维菌素，默克公司生产）治疗盘尾丝虫病相关皮肤病和严重瘙痒的效果。总体而言，共招募了4072名此前未接受过美迪善治疗的受试者，并将其分为四组，分别每3个月、6个月或12个月接受一次美迪善治疗，或每3个月接受一次安慰剂治疗。有皮肤病变的受试者在每个治疗组内进行分层，以确保各层分布均衡。每位受试者在入组时接受临床检查和访谈，之后每3个月进行一次，持续15个月。通过开放式问题及后续追问问题来确定瘙痒的存在及严重程度。皮肤病变采用标准系统进行分类和严重程度分级。结果分析仅限于1530名接受了所有预定治疗并参加了所有随访的受试者的数据。从6个月起，所有接受美迪善治疗的受试者报告的瘙痒程度均低于安慰剂组，反应性皮肤病变的患病率更低，皮肤病变也更轻（每项比较P<0.05）。每6个月接受一次美迪善治疗的受试者在瘙痒和皮肤病方面的改善最为显著。因此，美迪善治疗有助于控制令人困扰的瘙痒，并降低盘尾丝虫引起的皮肤病的患病率和严重程度。建议在研究地区的社区每6个月进行一次美迪善的大规模分发，以实现最大疗效。
