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与单剂量伊维菌素相比,阿苯达唑400毫克治疗30天对低盘尾丝虫微丝蚴血症成年患者的疗效和安全性:一项非劣效性随机对照试验。

Efficacy and safety of albendazole 400 mg for 30 days compared to single dose of ivermectin in adult patients with low Loa loa microfilaremia: A non-inferiority randomized controlled trial.

作者信息

Ndong Akomezoghe Luccheri, M'Bondoukwé Noé Patrick, Mawili Mboumba Denise Patricia, Ndong Ngomo Jacques Mari, Moutombi Ditombi Bridy Chesly, Mihindou Coella Joyce, Sibi Matotou Roger Hadry, Migueba Valentin, Bouyou Akotet Marielle Karine

机构信息

Department of Parasitology-Mycology-Tropical Medicine, Faculty of Medicine, Université des Sciences de la Santé, Libreville, Gabon.

出版信息

PLoS Negl Trop Dis. 2025 Jun 20;19(6):e0012383. doi: 10.1371/journal.pntd.0012383. eCollection 2025 Jun.

DOI:10.1371/journal.pntd.0012383
PMID:40540522
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12212867/
Abstract

BACKGROUND

Loa loa infection is endemic in central African countries and particularly in Gabon. Treatment typically involves the use of ivermectin and albendazole, with albendazole often administered to reduce microfilaremia in individuals with high microfilaremia before taking ivermectin. This study aims to evaluate the efficacy and safety of albendazole in patients with low microfilaremia.

METHODOLOGY AND PRINCIPAL FINDINGS

The study was conducted from November 2021 to April, 2022 in the Woleu-Ntem province of northern Gabon. Following a questionnaire, direct examination of 10 µL of blood and leukoconcentration technique were perfomed for Loa loa detection. Of 406 identified microfilaremic cases, 48 volunteers were randomized, 21 women and 27 men, their mean age was 51 ± 13 years. Overall, 24 received, daily 400 mg albendazole for30 days and 24 others were treated with a single course of 200 μg/kg ivermectin. Microfilaremia and adverse events were monitored from D0 to D30. In the per-protocol analysis, the mean microfilaremia decreased significantly by 82.3% and 90.4% in the albendazole and ivermectin groups, respectively (p< 0.001). The risk difference between both treatments was 8.1% [95% CI: 16.8; -0.6%]. In the intention-to-treat analysis, the mean microfilaremia decreased significantly by 82.4% and 90.8% in the ALB and IVM groups, respectively (p< 0.001), with a risk difference of 8.4% [95% CI: 16.2; 0.6%]. Eosinophil levels decreased by day 30, although they were not significantly different following albendazole and ivermectin treatments.

CONCLUSIONS/SIGNIFICANCE: Albendazole demonstrated microfilaricidal activity in individuals with low Loa loa microfilaremia following a 30-day treatment. The monitoring of parasite density 3-10 months post-treatment is needed to complete the present findings.

摘要

背景

罗阿丝虫感染在中非国家流行,在加蓬尤为常见。治疗通常使用伊维菌素和阿苯达唑,在服用伊维菌素前,阿苯达唑常被用于降低高微丝蚴血症患者的微丝蚴血症。本研究旨在评估阿苯达唑在低微丝蚴血症患者中的疗效和安全性。

方法和主要发现

该研究于2021年11月至2022年4月在加蓬北部的沃勒-恩特姆省进行。通过问卷调查、对10μL血液进行直接检查以及白细胞浓缩技术进行罗阿丝虫检测。在406例确诊的微丝蚴血症病例中,48名志愿者被随机分组,其中21名女性和27名男性,平均年龄为51±13岁。总体而言,24人每天接受400mg阿苯达唑治疗30天,另外24人接受单剂量200μg/kg伊维菌素治疗。从第0天到第30天监测微丝蚴血症和不良事件。在符合方案分析中,阿苯达唑组和伊维菌素组的平均微丝蚴血症分别显著下降了82.3%和90.4%(p<0.001)。两种治疗方法之间的风险差异为8.1%[95%CI:16.8;-0.6%]。在意向性分析中,阿苯达唑组和伊维菌素组的平均微丝蚴血症分别显著下降了82.4%和90.8%(p<0.001),风险差异为8.4%[95%CI:|16.2;0.6%]。嗜酸性粒细胞水平在第30天时下降,尽管阿苯达唑和伊维菌素治疗后无显著差异。

结论/意义:阿苯达唑在对低微丝蚴血症的罗阿丝虫感染者进行30天治疗后显示出杀微丝蚴活性。需要在治疗后3至10个月监测寄生虫密度以完善本研究结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/3b47c8e1c450/pntd.0012383.g006.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/4373055cf851/pntd.0012383.g002.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/f27121571ad3/pntd.0012383.g004.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/3b47c8e1c450/pntd.0012383.g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/8cf29122757e/pntd.0012383.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/4373055cf851/pntd.0012383.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/a568f28e7bbb/pntd.0012383.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/f27121571ad3/pntd.0012383.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/cda343f96274/pntd.0012383.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b1b/12212867/3b47c8e1c450/pntd.0012383.g006.jpg

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