Randomized, controlled, double-blind trial with ivermectin on Loa loa microfilaraemia:: efficacy of a low dose (∼25 μg/kg) versus current standard dose (150 μg/kg)
Randomized, controlled, double-blind trial with ivermectin on Loa loa microfilaraemia:: efficacy of a low dose (∼25 μg/kg) versus current standard dose (150 μg/kg)
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DOI：
10.1016/j.trstmh.2007.03.018
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发表时间：
2007-08-01
影响因子：
2.2
通讯作者：
Boussinesq, Michel
中科院分区：
文献类型：
--
作者：
Kamgno, Joseph;Pion, Sebastien D. S.;Boussinesq, Michel
神经系统的。伊维菌素治疗后的严重不良事件（SAE）可能发生在Loa loa微丝蚴密度高的个体中，并且在非洲为控制盘尾丝虫病和淋巴丝虫病而组织的大规模伊维菌素分发的背景下是主要关注的问题。由于这些SAE是由标准剂量伊维菌素的快速和大量杀微丝蚴作用引起的（150 μ g/kg），我们进行了一项随机、对照、双盲试验，以确定伊维菌素是否以以下方式给药：（a）单次两剂1.5 mg（即，对于60 kg的人，25 μ g/kg）;或（B）以2周间隔给予两次剂量的1.5 mg，与标准剂量相比，导致Loa微丝蚴蟾蜍的更渐进的减少。两个剂量的伊维菌素带来了一个显着较小的减少罗阿微丝蚴血症比标准剂量。然而，这一下降与标准剂量后获得的下降没有足够的差异，公共卫生计划需要很大的安全裕度。在第一次给药后15天给予伊维菌素第二次给药，未导致Loa微丝蚴血症进一步减少。最后，在25 μ g/kg治疗组中观察到的反应变异性表明，即使是较低的剂量也不会对大量患者产生影响。低剂量伊维菌素（
Neurological. serious adverse events (SAEs) following ivermectin treatment may occur in individuals harbouring high Loa loa microfilarial densities and are of major concern in the context of mass ivermectin distributions organized in Africa for onchocerciasis and lymphatic filariasis control. As those SAEs are induced by the rapid and massive microfilaricidal effect of a standard dose of ivermectin (150 mu g/kg), we performed a randomized, controlled, double-blind trial to determine whether ivermectin given as: (a) a single tow dose of 1.5 mg (i.e. 25 mu g/kg for a 60 kg person); or (b) two doses of 1.5 mg given at a 2 week interval leads to a more progressive decrease in Loa microfilarial toads compared with the standard dosage. A tow dose of ivermectin brought about a significantly smaller decrease in Loa microfilaraemia than the standard dose. However, this decrease was not sufficiently different from that obtained after the standard dose to be acceptable to public health programmes, which require a wide safety margin. A second tow dose of ivermectin given 15 days after the first dose did not lead to a further decrease in Loa microfilaraemia. Lastly, the variability in the response observed in the group treated with 25 mu g/kg suggests that even lower doses would have no effect on a significant number of patients. Ivermectin given at a low dose (