Burnham G M
Department of International Health, Johns Hopkins University, School of Hygiene and Public Health, Baltimore, Maryland 21205.
Trans R Soc Trop Med Hyg. 1993 May-Jun;87(3):313-7. doi: 10.1016/0035-9203(93)90144-f.
A three-year placebo-controlled, double-blind trial involving 7148 persons was conducted to determine adverse reactions to ivermectin given annually for treatment of onchocerciasis by mass distribution. Musculoskeletal pains, oedema of the face or extremities, itching and papular rash were statistically associated with ivermectin treatment in the first year. In the second year of treatment these reactions were less frequently reported, although still more prevalent in ivermectin recipients. During the third year of treatment all persons received ivermectin. Persons who had missed ivermectin treatment in the second year did not have significantly more adverse reactions after treatment in the third year. Those who had received placebo during the first 2 years reported some adverse reactions more frequently following ivermectin than did those who had received ivermectin from the beginning of the study. Oedema was the adverse reaction of greatest concern to patients and this involved the face most commonly. A single episode of bullous skin lesions developed in 5 persons who had received ivermectin. These lesions did not reoccur with subsequent treatment. No episode of hypotension after treatment was observed.
开展了一项为期三年的安慰剂对照双盲试验，涉及7148人，以确定通过大规模分发每年给予伊维菌素治疗盘尾丝虫病的不良反应。在第一年，肌肉骨骼疼痛、面部或四肢水肿、瘙痒和丘疹性皮疹与伊维菌素治疗在统计学上相关。在治疗的第二年，这些反应的报告频率较低，尽管在接受伊维菌素治疗的患者中仍然更为普遍。在治疗的第三年，所有人员都接受了伊维菌素治疗。在第二年错过伊维菌素治疗的人员在第三年治疗后并没有出现明显更多的不良反应。在前两年接受安慰剂治疗的人员在接受伊维菌素治疗后报告的一些不良反应比从研究开始就接受伊维菌素治疗的人员更频繁。水肿是患者最关注的不良反应，最常累及面部。5名接受伊维菌素治疗的人员出现了单次大疱性皮肤病变。这些病变在后续治疗中未再次出现。治疗后未观察到低血压发作。
