Whitworth J A, Morgan D, Maude G H, Downham M D, Taylor D W
Medical Research Council Laboratory, Sierra Leone.
Trans R Soc Trop Med Hyg. 1991 Jul-Aug;85(4):501-5. doi: 10.1016/0035-9203(91)90236-r.
We have studied the adverse reactions reported after ivermectin in 1745 villagers in southern Sierra Leone, allocated at random to receive ivermectin or placebo and treated 'double-blind' with 4 doses at six-monthly intervals. Six months after the fourth dose all eligible villagers received ivermectin regardless of their previous treatment. At the first treatment round more adverse reactions were reported by villagers treated with ivermectin than by those who received placebo. Reactions occurred most often on the second day after treatment. There were significant correlations between an individual's skin microfilarial load and the risk of developing adverse reactions. On re-treatment there was no significant excess of reported adverse reactions in the ivermectin group compared to the placebo group. Unlike other adverse reactions, the risk of cutaneous reactions after the first dose of ivermectin was not correlated with skin microfilarial load. In addition, after re-treatment with ivermectin, cutaneous reactions were reported significantly more often than with placebo. We confirm that ivermectin is safe for mass distribution, but adverse reactions should be monitored and treated after the first dose. Throughout this study ivermectin was well tolerated, with significantly more villagers returning for re-treatment after ivermectin than placebo, and all adverse reactions were self-limiting or successfully managed with symptomatic treatment. We question whether strict clinical monitoring should be routine at re-treatment, when only cutaneous reactions were consistently reported. If clinical monitoring could be used more selectively, distribution campaigns might be easier to manage and more cost-effective.
我们对塞拉利昂南部1745名村民使用伊维菌素后的不良反应进行了研究。这些村民被随机分配接受伊维菌素或安慰剂，并以双盲方式每六个月服用4剂进行治疗。在第四剂服用六个月后，所有符合条件的村民无论之前接受何种治疗均接受伊维菌素治疗。在第一轮治疗中，接受伊维菌素治疗的村民报告的不良反应比接受安慰剂的村民更多。反应最常发生在治疗后的第二天。个体皮肤微丝蚴负荷与发生不良反应的风险之间存在显著相关性。在再次治疗时，与安慰剂组相比，伊维菌素组报告的不良反应没有显著过量。与其他不良反应不同，首次服用伊维菌素后发生皮肤反应的风险与皮肤微丝蚴负荷无关。此外，再次使用伊维菌素治疗后，报告的皮肤反应明显比使用安慰剂时更频繁。我们证实伊维菌素用于大规模分发是安全的，但在首次给药后应监测和治疗不良反应。在整个研究过程中，伊维菌素耐受性良好，接受伊维菌素治疗后回来接受再次治疗的村民明显多于接受安慰剂治疗的村民，并且所有不良反应都是自限性的或通过对症治疗成功处理。我们质疑在再次治疗时，当只有皮肤反应持续被报告时，严格的临床监测是否应成为常规操作。如果临床监测可以更有选择性地使用，分发活动可能会更易于管理且更具成本效益。
