Brown K R, Neu D C
Merck Sharp & Dohme Research Laboratories, West Point, Pennsylvania 19486.
Acta Leiden. 1990;59(1-2):169-75.
Initial clinical trials with ivermectin were performed in patients with both roundworm infestation and onchocerciasis. Obvious clinical safety allowed for rapid progression through 5-30-50-100-150-200 mcg/kg in infected patients. Initial studies showed some effect at 50 mcg/kg; subsequent double-blind controlled studies, either with placebo or diethylcarbamazine (DEC), confirmed the efficacy of ivermectin as well as further defining its safety profile. Absence of adverse eye findings or serious systemic reactions justified the further open trials. Studies of patients treated at 6, 12, or 18 month intervals showed a long lasting effect of ivermectin in reducing skin microfilaria counts. Phase III studies confirmed safety and efficacy and further refined the dose to 150 mcg/kg every 12 months. Large trials in Liberia and other countries in West Africa, and subsequently under Onchocerciasis Control Program (OCP), included approximately 120,000 persons carefully followed during which few patients with serious adverse experiences were reported. These extensive field trials confirmed the relative safety allowing for broad distribution of ivermectin in programs not able to provide physician monitoring.
伊维菌素的初步临床试验是在患有蛔虫感染和盘尾丝虫病的患者中进行的。明显的临床安全性使得感染患者能够迅速从5微克/千克递增至30微克/千克、50微克/千克、100微克/千克、150微克/千克和200微克/千克。初步研究表明，在50微克/千克时就有一定效果；随后采用安慰剂或乙胺嗪（DEC）进行的双盲对照研究，证实了伊维菌素的疗效，并进一步明确了其安全性。未出现眼部不良反应或严重全身反应，这为进一步的开放试验提供了依据。对每隔6、12或18个月接受治疗的患者进行的研究表明，伊维菌素在减少皮肤微丝蚴数量方面具有持久效果。III期研究证实了安全性和有效性，并将剂量进一步优化为每12个月150微克/千克。在利比里亚和西非其他国家进行的大型试验，以及随后在盘尾丝虫病控制计划（OCP）下进行的试验，纳入了约12万人并进行了仔细跟踪，期间报告的严重不良事件患者很少。这些广泛的现场试验证实了其相对安全性，使得伊维菌素能够在无法提供医生监测的项目中广泛分发。
