The co-administration of ivermectin and albendazole safety, pharmacokinetics and efficacy against Onchocerca volvulus
The co-administration of ivermectin and albendazole safety, pharmacokinetics and efficacy against Onchocerca volvulus
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DOI：
10.1179/000349803235001697
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发表时间：
2003-03-01
影响因子：
--
通讯作者：
Quartey, BT
中科院分区：
文献类型：
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作者：
Awadzi, K;Edwards, G;Quartey, BT
进行了一项随机、双盲、安慰剂对照试验，以确定伊维菌素与阿苯达唑联合给药是否比单独使用伊维菌素更安全且更有效地对抗盘尾丝虫，以及是否发生显着的药代动力学相互作用。 42 名男性盘尾丝虫病患者单独接受伊维菌素（200 微克/公斤）、单独阿苯达唑（400 毫克）或联合治疗。安全性是根据治疗前、住院期间和第 30 天的详细临床和实验室检查结果确定的。杀微丝虫功效是根据第 0 天（治疗前）和第 30 天之间皮肤计数的减少来估计的。为了确定对成虫蠕虫的功效，两名独立观察者检查了从第 180 天切除的结节制备的组织学载玻片；第 30 天至第 365 天之间皮肤微丝蚴计数的变化提供了杀成虫活性水平的额外指标。治疗后 72 小时确定伊维菌素和阿苯达唑亚砜的药代动力学参数。伊维菌素与阿苯达唑联合给药并没有比单独使用伊维菌素产生更严重的不良反应。两位结节检查者发现，该组合不能杀灭巨丝虫，并且在对生殖活动的影响方面并不明显优于单独使用伊维菌素；两种方案在抑制皮肤微丝蚴方面的相似功效也支持了这一点。没有显着的药代动力学相互作用。尽管伊维菌素与阿苯达唑联合用药似乎安全，但在控制盘尾丝虫病方面，与单独使用伊维菌素相比并无优势。该组合不需要改变任一组分的剂量。
A randomized, double-blind, placebo-controlled trial was conducted, to determine whether the co-administration of ivermectin with albendazole is safe and more effective against Onchocerca volvulus than ivermectin alone, and whether a significant pharmacokinetic interaction occurs. Forty-two male onchocerciasis patients received ivermectin (200 mug/kg) alone, albendazole (400 mg) alone or the combination. Safety was determined from the results of detailed clinical and laboratory examinations before treatment, during hospitalization and on day 30. Microfilaricidal efficacy was estimated from the reductions in skin counts between day 0 (pretreatment) and day 30. To determine efficacy against the adult worms, two independent observers examined histology slides prepared from nodules excised on day 180; changes in the skin counts of skin microfilariae between days 30 and 365 provided additional indicators of the level of adulticidal activity. Pharmacokinetic parameters for ivermectin and albendazole sulphoxide were defined over 72 h post-treatment. The co-administration of ivermectin with albendazole did not produce more severe adverse effects than ivermectin alone. Both nodule examiners found that the combination was not macrofilaricidal and that it was not clearly superior to ivermectin alone in the effects on reproductive activity; this was supported by the similar efficacy of the two regimens in the suppression of skin microfilariae. There was no significant pharmacokinetic interaction. Although the co-administration of ivermectin with albendazole appears safe, it offers no advantage over ivermectin alone in the control of onchocerciasis. The combination does not require an alteration in the dosage of either component.