Safety of Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis.
Safety of Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis.
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DOI：
10.1097/qai.0000000000001359
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发表时间：
2017-09-01
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影响因子：
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通讯作者：
Mills EJ
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作者：
Nachega JB;Uthman OA;Mofenson LM;Anderson JR;Kanters S;Renaud F;Ford N;Essajee S;Doherty MC;Mills EJ
补充数字内容在文本中可用。关于富马酸替诺福韦酯（TDF）为基础的抗逆转录病毒治疗（ART）对孕妇及其婴儿的不良反应的数据有限。我们对1980年1月至2017年1月期间发表的研究进行了系统回顾，比较了妊娠期间接受TDF与非TDF ART的HIV感染女性的不良结局。使用固定效应模型合并相关性的风险比（RR）。17项研究符合研究纳入标准。我们发现，暴露于（与未暴露于）基于TDF的ART方案的女性相比，早产（<37周妊娠）率（RR = 0.90，95%置信区间[CI]：0.81至0.99，I2 = 59%）和死产率（RR = 0.60，95% CI：0.43至0.84，I2 = 72.0%）显著降低。我们没有发现母体严重（3级）或潜在危及生命（4级）不良事件的风险增加（RR = 0.62; 95% CI：0.30 - 1.29），流产（RR = 1.09; 95% CI：0.80 - 1.48），极早产（妊娠<34周）分娩（RR = 1.08，95% CI：0.72 - 1.62），小于胎龄儿（RR = 0.87，95% CI：0.67 - 1.13），低出生体重（RR = 0.91; 95% CI：0.80 - 1.04），极低出生体重（RR = 3.18; 95% CI：0.65 - 15.63），先天性畸形（RR = 1.03; 95% CI：0.83 - 1.28），婴儿不良结局或婴儿死亡率（年龄>14天）（RR = 0.65; 95% CI：0.23至1.85），但增加新生儿死亡率（年龄<14天）的风险（RR = 5.64，95% CI：1.70至18.79）与基于TDR的ART暴露。出生时的拟人化参数没有发现差异;一项研究报告称，1岁时身长和头围的z评分存在微小差异。在怀孕期间，基于TDF的ART似乎对妇女及其婴儿通常是安全的。然而，数据仍然有限，需要进一步研究，特别是评估新生儿死亡率和婴儿生长/骨骼影响。
Supplemental Digital Content is Available in the Text. There are limited data on adverse effects of tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART) on pregnant women and their infants. We conducted a systematic review of studies published between January 1980 and January 2017 that compared adverse outcomes in HIV-infected women receiving TDF- vs. non–TDF-based ART during pregnancy. The risk ratio (RR) for associations was pooled using a fixed-effects model. Seventeen studies met the study inclusion criteria. We found that the rate of preterm (<37 weeks gestation) delivery (RR = 0.90, 95% confidence interval [CI]: 0.81 to 0.99, I2 = 59%) and stillbirth (RR = 0.60, 95% CI: 0.43 to 0.84, I2 = 72.0%) were significantly lower in women exposed (vs. not) to TDF-based ART regimen. We found no increased risk in maternal severe (grade 3) or potentially life-threatening (grade 4) adverse events (RR = 0.62; 95% CI: 0.30 to 1.29), miscarriage (RR = 1.09; 95% CI: 0.80 to 1.48), very preterm (<34 weeks gestation) delivery (RR = 1.08, 95% CI: 0.72 to 1.62), small for gestational age (RR = 0.87, 95% CI: 0.67 to 1.13), low birth weight (RR = 0.91; 95% CI: 0.80 to 1.04), very low birth weight (RR = 3.18; 95% CI: 0.65 to 15.63), congenital anomalies (RR = 1.03; 95% CI: 0.83 to 1.28), infant adverse outcomes or infant mortality (age >14 days) (RR = 0.65; 95% CI: 0.23 to 1.85), but increased neonatal mortality (age <14 days) risk (RR = 5.64, 95% CI: 1.70 to 18.79) with TDR-based ART exposure. No differences were found for anthropomorphic parameters at birth; one study reported minor differences in z-scores for length and head circumference at age 1 year. TDF-based ART in pregnancy seems generally safe for women and their infants. However, data remain limited and further studies are needed, particularly to assess neonatal mortality and infant growth/bone effects.