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埃塞俄比亚西北部单剂量阿苯达唑抗钩虫感染的体内和体外疗效:开放标签试验

In vivo and in vitro efficacy of a single dose of albendazole against hookworm infection in northwest Ethiopia: open-label trial.

作者信息

Bezie Wolelaw, Aemero Mulugeta, Tegegne Yalewayiker, Eshetu Tegegne, Addisu Ayenew, Birhanie Meseret, Derso Adane, Zeleke Ayalew Jejaw

机构信息

Adet primary Hospital Laboratory, Adet, Ethiopia.

Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O.Box: 196, Gondar, Ethiopia.

出版信息

Trop Med Health. 2021 Mar 20;49(1):25. doi: 10.1186/s41182-021-00308-0.

DOI:10.1186/s41182-021-00308-0
PMID:33743835
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7980320/
Abstract

BACKGROUND

Control of hookworm and other soil-transmitted helminth infections primarily relies on preventive chemotherapy using a single dose of albendazole/mebendazole drugs on high-risk groups. Herein, the efficacy of a single dose (400 mg) of albendazole (ALB) was investigated both in vivo and in vitro model in northwest Ethiopia.

METHODS

An open-label, single-arm clinical trial was conducted to assess anti-hookworm effect of albendazole. Stool samples were collected and examined using McMaster and Harada-Mori filter paper culture. Eligible hookworm-infected patients were treated with a single dose of ALB. After 14-21 days post-treatment, stool samples were also taken again and re-examined using the abovementioned technique. Egg reduction rate (ERR) and larval motility were used as a therapeutic outcome measure. An independent t test was used to compare the mean difference in egg counts, and probit analysis was performed for calculating the lethal concentration dose of albendazole. P value < 0.05 at 95% CI was considered statistically significant.

RESULTS

A total of 70 participants had completed the drug efficacy study. The efficacy of ALB against hookworm in terms of CR and ERR was 87% and 93%, respectively. Participants who had not eaten one or more hours prior to treatment had higher CR than those who had eaten within 1 h before treatment (97.4% vs 74.2%), while individuals with heavy infection intensity had a lower post-treatment ova clearing rate than those who were with light infection intensity (43% vs 94.6%). The in vitro larvicidal effect of ALB was 63-93% after applying 50-250 μg/ml concentration of ALB solution. The LC50 and LC99 were 152 μg/ml and 573 μg/ml, respectively.

CONCLUSION

A single dose of albendazole was found to be effective for treating hookworm infections according to WHO anthelminthic evaluation standard in the study area. Preventive chemotherapy might therefore be extended to risk groups, with proper continuous monitoring of its efficacy to strengthen and keep the ongoing control and prevention measures one step ahead.

TRIAL REGISTRATION

This trial is retrospectively registered with www.pactr.org , number PACTR202010511829332 on October 26, 2020.

摘要

背景

钩虫及其他土壤传播的蠕虫感染的控制主要依靠对高危人群使用单剂量阿苯达唑/甲苯达唑药物进行预防性化疗。在此,在埃塞俄比亚西北部的体内和体外模型中研究了单剂量(400毫克)阿苯达唑(ALB)的疗效。

方法

进行了一项开放标签、单臂临床试验,以评估阿苯达唑的抗钩虫效果。收集粪便样本并使用麦克马斯特法和原田-森氏滤纸培养法进行检查。符合条件的钩虫感染患者接受单剂量阿苯达唑治疗。治疗后14 - 21天,再次采集粪便样本并使用上述技术重新检查。虫卵减少率(ERR)和幼虫活力用作治疗效果指标。使用独立t检验比较虫卵计数的平均差异,并进行概率分析以计算阿苯达唑的致死浓度剂量。95%置信区间的P值<0.05被认为具有统计学意义。

结果

共有70名参与者完成了药物疗效研究。阿苯达唑对钩虫的治愈率(CR)和虫卵减少率分别为87%和93%。治疗前未进食一小时或更长时间的参与者的治愈率高于治疗前1小时内进食的参与者(97.4%对74.2%),而感染强度高的个体治疗后的虫卵清除率低于感染强度低的个体(43%对94.6%)。应用50 - 250μg/ml浓度的阿苯达唑溶液后,其体外杀幼虫效果为63% - 93%。半数致死浓度(LC50)和99%致死浓度(LC99)分别为152μg/ml和573μg/ml。

结论

根据世界卫生组织驱虫评估标准,在研究区域发现单剂量阿苯达唑对治疗钩虫感染有效。因此,预防性化疗可能会扩展到高危人群,并对其疗效进行适当的持续监测,以加强并使现行的控制和预防措施领先一步。

试验注册

本试验于2020年10月26日在www.pactr.org上进行回顾性注册,注册号为PACTR202010511829332。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2404/7980320/2e60ec8d4eb4/41182_2021_308_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2404/7980320/2e60ec8d4eb4/41182_2021_308_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2404/7980320/2e60ec8d4eb4/41182_2021_308_Fig1_HTML.jpg

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