Maternal and Infant Outcomes Among Pregnant Women Treated for Multidrug/Rifampicin-Resistant Tuberculosis in South Africa.
Maternal and Infant Outcomes Among Pregnant Women Treated for Multidrug/Rifampicin-Resistant Tuberculosis in South Africa.
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DOI：
10.1093/cid/ciaa189
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发表时间：
2021-04-08
期刊：
影响因子：
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通讯作者：
Seddon JA
中科院分区：
文献类型：
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作者：
Loveday M;Hughes J;Sunkari B;Master I;Hlangu S;Reddy T;Chotoo S;Green N;Seddon JA
由于被排除在临床试验和扩大准入计划之外，有关二线结核病药物在孕妇及其婴儿中的安全性和有效性的数据严重有限。纳入从2013年1月1日至2017年12月31日在南非夸祖鲁-纳塔尔的迪努祖鲁国王医院开始治疗耐多药/利福平(MDR/RR)结核病的孕妇。我们进行了一项记录回顾，以描述产妇治疗和妊娠结局，并进行了临床评估，以描述婴儿结局。在108名接受MDR/RR结核病治疗的孕妇中，88人(81%)携带人类免疫缺陷病毒。据报道，72名(67%)女性获得了良好的MDR/RR-结核病治疗结果。109个婴儿中有99个(91%)是活着出生的，但总体而言，52个(48%)妇女的妊娠结局不佳。58名妇女(54%)接受贝达奎兰治疗，49名婴儿(45%)在宫内暴露于贝达奎兰。据报道，与未接触贝达奎兰的婴儿相比，暴露于贝达奎兰的婴儿出生体重较低(45%比26%；P=.034)。在多变量分析中，贝达奎林和左氧氟沙星这两种经常联合使用的药物都与低出生体重风险的增加独立相关。在86名12个月后接受评估的儿童中，72名(84%)预后良好；接受贝达奎林治疗的婴儿中88%的婴儿发育正常，而未接受贝达奎林治疗的婴儿中这一比例为82%。妊娠妇女的MDR/RR-结核病治疗结果与非妊娠妇女相当。虽然接触贝达奎兰的婴儿出生体重较低，但超过80%的婴儿体重增加，并在1岁时正常发育。对多种药物/利福平耐药的结核病孕妇可以得到有效和安全的治疗。我们观察到贝达奎林的使用与低出生体重之间的关系，但这一发现的临床重要性尚不清楚。
Data on safety and efficacy of second-line tuberculosis drugs in pregnant women and their infants are severely limited due to exclusion from clinical trials and expanded access programs. Pregnant women starting treatment for multidrug/rifampicin-resistant (MDR/RR)-tuberculosis at King Dinuzulu Hospital in KwaZulu-Natal, South Africa, from 1 January 2013 to 31 December 2017, were included. We conducted a record review to describe maternal treatment and pregnancy outcomes, and a clinical assessment to describe infant outcomes. Of 108 pregnant women treated for MDR/RR-tuberculosis, 88 (81%) were living with human immunodeficiency virus.. Favorable MDR/RR-tuberculosis treatment outcomes were reported in 72 (67%) women. Ninety-nine (91%) of the 109 babies were born alive, but overall, 52 (48%) women had unfavorable pregnancy outcomes. Fifty-eight (54%) women received bedaquiline, and 49 (45%) babies were exposed to bedaquiline in utero. Low birth weight was reported in more babies exposed to bedaquiline compared to babies not exposed (45% vs 26%; P = .034). In multivariate analyses, bedaquiline and levofloxacin, drugs often used in combination, were both independently associated with increased risk of low birth weight. Of the 86 children evaluated at 12 months, 72 (84%) had favorable outcomes; 88% of babies exposed to bedaquiline were thriving and developing normally compared to 82% of the babies not exposed. MDR/RR-tuberculosis treatment outcomes among pregnant women were comparable to nonpregnant women. Although more babies exposed to bedaquiline were of low birth weight, over 80% had gained weight and were developing normally at 1 year. Pregnant women with Multidrug/Rifampicin-resistant-tuberculosis can be effectively and safely treated. We observed a relationship between the use of bedaquiline and low birth weight, but the clinical importance of this finding is unclear.