Clin Infect Dis:在南非接受耐多药/耐利福平肺结核治疗的孕妇的母婴结局

2020-04-13 MedSci原创 MedSci原创

前言

前言

 

     据估计,2017年全球有超过50万人患有耐多药/耐利福平(MDR/RRR)结核病,其中育龄妇女(15-45岁)的负担最高。在这个年龄段的妇女中,结核病是感染致其死亡的主要原因,也是孕产妇死亡的常见非产科原因。

 

研究背景

     

     据统计,2011年全球大约有216,500名孕妇患结核病,以非洲最为严重。与非孕妇相比,妊娠期的生理变化不仅使孕妇患结核病的风险增加了一倍,还使其治疗复杂化,如果不治疗,妊娠相关的结核病可导致高达40%的死亡率。在同时感染结核病和人体免疫缺陷病毒(HIV)的妇女中,孕产妇死亡的风险剧增,且这些孕妇的新生儿的死亡率也会增加。

 

      妊娠期一线抗结核药物的安全性已经得到了证实,而且治疗可改善孕产妇和新生儿的预后,因此WHO建议,对药物治疗敏感的孕妇结核病患者应与非孕妇一样进行治疗。由于孕妇及其婴儿常被排除在临床试验和扩大准入方案之外,关于其二线结核病药物的安全性和疗效的数据非常有限。本文,研究人员报告了在南非夸祖鲁-纳塔尔的MDR/RR结核病孕妇队列中的治疗、妊娠和婴儿结局,重点是孕期接触过贝达喹啉的妇女及其婴儿。

 

研究方法

 

     采用观察性研究设计,查阅2013年1月1日-2017年12月31日在南非夸祖鲁-纳塔尔的King Dinuzulu医院(KDH)进行多药/利福平耐药(MDR/RR)-结核病治疗的孕妇病历。收集患者的收集人口统计学、临床和实验室数据,以描述产妇治疗和妊娠结局,并进行临床评估来描述婴儿结局。

 

     研究期间,HIV感染的孕妇接受抗逆转录病毒治疗(ART)。未接受过ART治疗的患者在接受MDR / RR-TB治疗两周后开始接受ART治疗。研究结局为孕产妇的治疗结局,妊娠结局以及婴儿结局。

 

研究结果

基线特征

   

     2013年1月1日至2017年12月30日期间,共有10,042名MDR/RR结核病患者在KDH医院接受治疗; 其中有4,720名(47%)为女性,126人怀孕。研究纳入108名孕期接受二线结核治疗至少两周的孕妇,其中88名(81%)为HIV感染者。下表详细列出了这些孕妇的基线特征。

表1.基线特征

 

RR-结核病治疗结局

 

     72名(67%)妇女报告MDR/RR-结核病的治疗结果良好。多变量分析发现,基线时的孕产妇血红蛋白较低是孕产妇治疗结果不佳的一个预测因素(未校正危险比[uHR]0.67,p=0.006)。8名产妇在分娩后死亡,时间中位数为67天(IQR:32-299),但8名婴儿全部存活。其中4名产妇的死亡与结核病有关,但均与结核病药物治疗无关。

表2.RR-结核病治疗结局

 

妊娠结局

 

    109名婴儿中有99名(91%)为活产儿,平均胎龄为38周(SD,3.10),中位出生体重为2800克(IQR 2430-3200),但是总体而言,52名(48%)妇女的妊娠结局不佳。联合HIV感染的孕妇妊娠结局不良的风险更高(uHR 3.35,p=0.030)。

 

婴儿结局

 

     该研究报道了99名活产婴儿中的86个婴儿在生长12个月后的结局,其中72例(84%)活产婴儿具有良好的结局,具体如下表所示。

表3.婴儿结局

 

贝达喹啉暴露对结局的影响

   

     58名(54%)妇女孕期接受了贝达喹啉治疗,49名(45%)婴儿在子宫内接触过贝达喹啉。与未接触过贝达喹啉的婴儿相比,接触过的婴儿出生体重较低(45% vs 26%;P=0.034)。但是,胎儿子宫内暴露于贝达喹啉的妇女(49%的妇女妊娠结局良好)与未暴露者(57%的妇女妊娠结局良好)的妊娠结局没有差异(p = 0.312)。

 

      多变量分析结果显示,贝达喹啉常与左氧氟沙星联合使用,都与低出生体重风险的增加独立相关。在12个月时接受评估的86名儿童中,72名(84%)结局良好;88%暴露于贝达喹啉的婴儿发育正常,而未暴露于贝达喹啉的婴儿则为82%。

 

讨论

   

      越来越多的证据表明,感染HIV会导致不良的妊娠结局,包括早产和死产。自2015年以来,南非已使用贝达奎林对孕妇进行了治疗。在该研究中,宫内暴露于贝达奎林的胎儿中有90%活着出生,与未暴露的胎儿和新生儿死亡情况相似。虽然与未暴露于苯达吉林的婴儿相比,暴露于苯达吉林的婴儿早产的比例没有差异,但暴露于苯达吉林的婴儿中,更多的婴儿出生时体重偏低。考虑到用于治疗MDR/RR结核病的药物之间存在着广泛的关联性,因此无法排除其他二线抗结核药物和ART单独或联合使用的可能性。

 

      尽管这是迄今最大的一项研究,记录了一群在妊娠期间接受过MDR / RR-结核治疗的妇女的治疗,妊娠和婴儿结局,但其研究规模仍然有限。此外,关于不良事件,药物之间的相互作用的变化以及药物和药物剂量变化的原因的研究数据质量差,限制了该研究的分析及结果。

 

研究意义及展望

     

     该研究中,研究人员发现孕妇中的MDR/RR-结核病治疗结果与非妊娠期的成年人相当。虽然接触过贝达奎林的婴儿中,有更多的婴儿出生时体重较低,但80%以上的婴儿在一年后体重增加,发育正常,未来需要更多的研究来探讨二者之间的关系。总之,该研究结果表明,在孕妇中使用贝达喹啉治疗是安全的,且有利于孕妇的治疗、妊娠和婴儿结局。

 

参考文献

Marian LovedayJennifer Hughes, et al., Maternal and infant outcomes among pregnant women treated for multidrug/rifampicin-resistant tuberculosis in South Africa. Clin Infect Dis. 2020 Mar 6:ciaa189. doi: 10.1093/cid/ciaa189.

 

 

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