Isoniazid preventive therapy during infancy does not adversely effect growth among HIV-exposed uninfected children: secondary analysis of data from a randomized controlled trial.
Isoniazid preventive therapy during infancy does not adversely effect growth among HIV-exposed uninfected children: secondary analysis of data from a randomized controlled trial.
复制标题
婴儿期异烟肼预防性治疗不会对暴露于艾滋病毒的未感染儿童的生长产生不利影响：对随机对照试验数据的二次分析。
DOI：
10.1101/2023.10.19.23297259
复制
发表时间：
2023
期刊：
影响因子：
--
通讯作者：
John-Stewart,Grace
中科院分区：
文献类型：
--
作者：
Cherkos,AshenafiS;LaCourse,SylviaM;Enquobahrie,DanielA;Escudero,JaclynN;Mecha,Jerphason;Matemo,Daniel;Kinuthia,John;John-Stewart,Grace
背景异烟肼预防性治疗（IPT）可降低结核病（TB）的风险;对婴儿长期生长的影响尚不清楚。在最近的一项随机试验（RCT），我们评估了IPT对婴儿生长的影响，没有已知的TB exposition.MethodsThe婴儿结核病感染预防研究（iTIPS）试验是一个非盲随机对照试验艾滋病毒暴露未感染（HEU）的婴儿在肯尼亚。入选标准包括年龄6-10周，出生体重≥2.5 kg，妊娠≥37周。IPT组的婴儿每天接受10 mg/kg异烟肼，持续12个月，而对照试验没有接受干预;试验后观察性随访持续到24个月大。我们使用意向治疗线性混合效应模型，以比较生长率（体重为年龄的Z-评分[WAZ]和身高为年龄的Z-评分[HAZ]）之间的试验arms.ResultsAmong 298名婴儿，150名被随机分配到IPT，47.6%是女性，中位出生体重为3.4公斤（四分位距[IQR] 3.0-3.7），98.3%是母乳喂养。在12个月的干预期间和RCT后12个月的随访中，所有儿童的WAZ和HAZ均显著下降，男婴的HAZ下降更多。试验组间无生长差异，包括性别分层分析。在纵向线性分析中，两组的平均WAZ（β = 0.04 [95% CI：-0.14，0.22]）、HAZ（β = 0.14 [95% CI：-0.06，0.34]）和WHZ [β = -0.07 [95% CI：-0.26，0.11]）z评分相似，WAZ和HAZ生长轨迹也相似。随机分配到IPT的婴儿每月WHZ增加（β至24个月0.02 [95%CI：0.01，0.04]）比no-IPT arm.ConclusionIPT管理的HEU婴儿没有显着影响生长结果在生命的头两年。
BackgroundIsoniazid preventive therapy (IPT) decreases risk of tuberculosis (TB) disease; impact on long-term infant growth is unknown. In a recent randomized trial (RCT), we assessed IPT effects on infant growth without known TB exposure.MethodsThe infant TB Infection Prevention Study (iTIPS) trial was a non-blinded RCT among HIV-exposed uninfected (HEU) infants in Kenya. Inclusion criteria included age 6–10 weeks, birthweight ≥2.5 kg, and gestation ≥37 weeks. Infants in the IPT arm received 10 mg/kg isoniazid daily for 12 months, while the control trial received no intervention; post-trial observational follow-up continued through 24 months of age. We used intent-to-treat linear mixed-effects models to compare growth rates (weight-for-age z-score [WAZ] and height-for-age z-score [HAZ]) between trial arms.ResultsAmong 298 infants, 150 were randomized to IPT, 47.6% were females, median birthweight was 3.4 kg (interquartile range [IQR] 3.0–3.7), and 98.3% were breastfed. During the 12-month intervention period and 12-month post-RCT follow-up, WAZ and HAZ declined significantly in all children, with more HAZ decline in male infants. There were no growth differences between trial arms, including in sex-stratified analyses. In longitudinal linear analysis, mean WAZ (β = 0.04 [95% CI:-0.14, 0.22]), HAZ (β = 0.14 [95% CI:-0.06, 0.34]), and WHZ [β = -0.07 [95% CI:-0.26, 0.11]) z-scores were similar between arms as were WAZ and HAZ growth trajectories. Infants randomized to IPT had higher monthly WHZ increase (β to 24 months 0.02 [95% CI:0.01, 0.04]) than the no-IPT arm.ConclusionIPT administered to HEU infants did not significantly impact growth outcomes in the first two years of life.