NEJM:HIV感染孕妇和产后妇女异烟肼预防性治疗的差异

2019-10-03 xing.T MedSci原创

由此可见,在妊娠期间开始异烟肼预防性治疗的风险似乎大于在产后开始治疗的风险。

在正在接受抗逆转录病毒疗法的人免疫缺陷病毒(HIV)感染孕妇中,异烟肼预防结核病的安全性、有效性和适当时机尚不清楚。

近日,顶级医学期刊NEJM上发表了一篇研究文章,在这项多中心、双盲、安慰剂对照的非劣效性试验中,研究人员随机分配了感染HIV的孕妇,接受28周的异烟肼预防性治疗,该疗法在妊娠期间(即时组)或分娩后第12周(延期组)开始。 在分娩后的第48周中对母亲和婴儿进行随访。该研究的主要结局是3级或更高级别的治疗相关母亲不良事件的综合结局,或者由于毒性作用而永久终止试验方案。非劣质性边界是主要结果之间的组间差异(每100人每年少于5次事件)的95%置信区间的上限。

该研究共招募了956名妇女。即时组的477名妇女中有72名女性(15.1%)发生了主要结局事件,延期组的479名女性中有73名(15.2%)发生了主要结局事件(发生率分别为每100人每年15.03次和14.93次事件;发生率差异, 0.10;95%置信区间[CI]为-4.77至4.98,符合非劣效性标准)。即时组中有2名妇女和延期组中有4名妇女死亡(发生率分别为每100人每年0.40人和0.78人;发生率差异为-0.39;95%CI为-1.33至0.56);所有死亡均发生在产后,其中4人死于肝衰竭(因肝衰竭而死亡的妇女中有2人接受了异烟肼[每组1人])。6名妇女发展为结核病(每组3名);即时组的发生率为每100人每年0.60人,延期组的发生率为每100人每年0.59人(发生率差异为0.01;95%CI为-0.94至0.96)。在不良妊娠结局(死产或自然流产、婴儿低出生体重、早产或婴儿先天异常)有关的事件方面,即时组的发生率高于延期组(23.6% vs. 17.0%;差异为6.7%;95%CI为0.8至11.9%)。

由此可见,在妊娠期间开始异烟肼预防性治疗的风险似乎大于在产后开始治疗的风险。 

原始出处:

Amita Gupta,et al.Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women.NEJM.2019.https://www.nejm.org/doi/full/10.1056/NEJMoa1813060

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    2019-10-03 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

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