Lancet Infect Dis:感染血吸虫的孕妇可放心使用吡喹酮治疗

2015-10-26 崔倩 译 MedSci原创

尽管WHO建议,孕妇可以使用吡喹酮治疗,但许多国家继续拒绝治疗,并且等待着对照试验的安全性和有效性数据。这项研究的目的是评估治疗12-16周的妊娠期的孕妇血吸虫病是否可以改善孕产妇和新生儿的结局,并收集孕产妇和新生儿的安全性数据。这一阶段2,随机,双盲,安慰剂对照试验是在菲律宾莱特岛东北部血吸虫病流行地区的六市卫生中心的72个行政区域(村)完成的。那些感染了日本血吸虫但其他方面健康的孕妇(12-1

尽管WHO建议,孕妇可以使用吡喹酮治疗,但许多国家继续拒绝使用,并且等待着对照试验的安全性和有效性数据。这项研究的目的是评估治疗12-16周的妊娠期的孕妇血吸虫病是否可以改善孕产妇和新生儿的结局,并收集孕产妇和新生儿的安全性数据。

这一随机双盲、安慰剂对照的2期试验是在菲律宾莱特岛东北部血吸虫病流行地区的六个市卫生中心的72个行政区域(村)完成的。那些感染了日本血吸虫但其他方面健康的孕妇(12-16周妊娠)被随机分配(1:1)接受胶囊包装的吡喹酮(总剂量60mg/kg,两次分开剂量)或安慰剂。参加者、研究者、助产士和实验室工作人员都不知道治疗情况。主要成果是出生体重。收集安全数据,包括立即反应,研究药物给药24h确定的后剂量毒理学,以及孕产妇和新生儿严重不良事件。分析遵循意向性治疗原则。研究人员使用广义线性模型来调整确定的混杂因素,比如村庄、直辖市范围内的观测潜在的聚类分析。

在2007年08月13日和2012年12月3日期间,370孕妇患者参与此研究,被随机分配到每个治疗组(安慰剂组184名,吡喹酮组186名)。大多数女性有低强度感染(n=334,90%)。吡喹酮治疗没有对新生儿体重有显著的影响(两组均为2.85千克,β=-0.002[95%Cl -0.088至0.083];p=0.962)。在非怀孕参与者中,治疗耐受性良好,反应原性率相似(严重反应吡喹酮组发生5例,安慰剂组发生2例,其中包括头痛,发烧,全身乏力)。在流产、胎死宫内、先天性异常方面没有显著差异。

这项研究的结果提供了来自对照试验的重要数据,支持了WHO建议的扩大包括怀孕女性的治疗政策。

原始出处:

Remigio M Olveda,Luz P Acosta,Veronica Tallo,et al.Efficacy and safety of praziquantel for the treatment of human schistosomiasis during pregnancy,Lancet Infectious Diseases,2015.10.25

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    2016-01-04 HinsMax
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    2015-11-11 howi
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    2015-11-02 nizongzan

    0

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    2015-11-02 nizongzan

    为了积分兑换

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    2015-10-28 ylz8404
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    2015-10-28 梦想天空

    0

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