吡喹酮对加蓬兰巴雷内血吸虫感染孕妇的安全性和有效性--freeBILy-加蓬随机、单盲、对照试验的临床结果。

IF 4.8 2区 医学 Q1 INFECTIOUS DISEASES
Jacob Gerstenberg , Yabo J. Honkpehedji , Jean-Claude Dejon-Agobe , Saidou Mahmoudou , Mario Recker , Romuald Beh Mba , Moustapha Nzamba Maloum , Romeo Laclong Lontchi , Paul A. Nguema Moure , Brice Meulah , Jeannot F. Zinsou , Jean-Ronald Edoa , Bayode R. Adegbite , Michael Ramharter , Bertrand Lell , Selidji T. Agnandji , Peter G. Kremsner , Paul L.A.M. Corstjens , Pytsje T. Hoekstra , Govert J. van Dam , Ayola A. Adegnika
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引用次数: 0

摘要

目的:尽管有证据表明吡喹酮治疗妊娠期血吸虫病是安全的,但许多国家仍拒绝治疗。只有两项随机对照试验研究了吡喹酮对妊娠期血吸虫病的治疗效果,其中没有一项涉及血吸虫:方法:使用尿液显微镜和循环阳离子抗原检测法对加蓬兰巴雷内地区怀孕后三个月的孕妇进行血吸虫感染筛查。对两种检测结果均呈阳性的参与者进行随机分配(3:1),在怀孕期间服用单剂量吡喹酮 40 毫克/千克,或在怀孕期间不服用任何药物。研究人员在分配时均采用盲法。主要结果是减少虫卵(ERR)和抗原产生(IRR),探索性结果包括评估治愈率、不良事件、母体血红蛋白水平、分娩时母体贫血发生率、妊娠结局和新生儿人体测量参数:在接受筛查的 761 名妇女中,有 165 人符合条件并被随机选中(干预组 n=124,对照组 n=41)。124 人完成了研究(分别为 90 人和 34 人)。扭转疗法显著提高了 ERR(95.0%[91%-97%] vs. 27.0%[-42%-63%])和 IRR(95%[91%-97%] vs. 56%[14%-78%])。常见的不良反应有头晕、恶心和呕吐。干预组产妇分娩时贫血的发生率明显降低(OR:0.40[0.16;0.96],P=0.04)。没有观察到不良妊娠结局的风险增加:这项首次研究吡喹酮治疗血吸虫孕妇的随机对照试验发现,吡喹酮安全、有效,并能减少孕妇贫血。我们建议对确诊的感染进行治疗,以防止孕妇发病。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and efficacy of praziquantel in pregnant women infected with Schistosoma haematobium in Lambaréné, Gabon – Clinical results from the randomized, single-blinded, controlled freeBILy-Gabon trial

Objectives

Despite evidence of praziquantel's (PZQ) safety for treating schistosomiasis in pregnancy, many countries withhold treatment. Only two randomized controlled trials have investigated PZQ in pregnancy, none involving Schistosoma haematobium.

Methods

Pregnant women during the second trimester in Lambaréné (Gabon) were screened for S. haematobium infection using urine microscopy and circulating anodic antigen detection. Participants positive for either test were randomized (3:1) to single-dose PZQ 40 mg/kg during pregnancy versus no treatment during pregnancy. Investigators were blinded for allocation. Primary outcomes were reduction of egg (egg reduction rate [ERR]) and antigen production (infection reduction rate [IRR]) while explorative outcomes included assessment of cure rate, adverse events, maternal hemoglobin levels, maternal anemia prevalence at delivery, pregnancy outcomes, and newborn anthropometric parameters.

Results

Of 761 women screened 165 were eligible and randomized (intervention n = 124, control n = 41). Of them, 124 completed the study (n = 90 and n = 34, respectively). Treatment led to a significantly higher ERR (95.0% [91-97%] vs 27.0% [−42-63%]) and IRR (95% [91-97%] vs 56% [14-78%]). Common adverse events were dizziness, nausea, and vomiting. Maternal anemia at delivery was significantly lower in the intervention group (odds ratio: 0.40 [0.16;0.96], P = 0.04). No increased risk for adverse pregnancy outcomes was observed.

Conclusions

This first randomized controlled trial investigating PZQ in pregnant women with S. haematobium found PZQ to be safe, effective, and reducing maternal anemia. We recommend treating confirmed infections to prevent morbidity in pregnant women.
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来源期刊
CiteScore
18.90
自引率
2.40%
发文量
1020
审稿时长
30 days
期刊介绍: International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.
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