A survey of zidovudine use in pregnant women with human immunodeficiency virus infection.
A survey of zidovudine use in pregnant women with human immunodeficiency virus infection.
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人类免疫缺陷病毒感染孕妇使用齐多夫定的调查。
DOI：
10.1056/nejm199203263261303
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发表时间：
1992
期刊：
影响因子：
--
通讯作者：
Minkoff,H
中科院分区：
文献类型：
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作者：
Sperling,RS;Stratton,P;O'Sullivan,MJ;Boyer,P;Watts,DH;Lambert,JS;Hammill,H;Livingston,EG;Gloeb,DJ;Minkoff,H
背景和方法：齐多夫定治疗适应症的扩大使得阐明该药物对孕妇及其胎儿的安全性和毒性变得重要。我们要求儿科医生和产科医生在艾滋病（获得性免疫缺陷综合征）临床试验单位报告的信息，感染人类免疫缺陷病毒的孕妇继续怀孕，并已收到，或正在接受，齐多夫定在gestation.Results.Reports的43名妇女收到了来自17个机构。齐多夫定的剂量范围为每天300至1200毫克，24名妇女服用该药物至少两个孕期。报告了2例母体毒性（1例胃肠道和1例热毒性）。在12名婴儿中，在妊娠早期暴露于齐多夫定，未发生致畸异常。所有的婴儿，包括两对双胞胎，都是活着出生的。报告出生体重的38例足月单胎婴儿的平均出生体重为3287±670 g;在足月分娩的婴儿中报告了2例宫内生长迟缓。31名新生儿的血红蛋白值范围为7.0至12.4 mmol/L（每分升11.2至20克）; 7名新生儿中有3名血红蛋白值低于8.4 mmol/L结论：孕妇对齐多夫定的耐受性良好，显然与新生儿畸形无关，早产或胎儿窘迫。在新生儿中未观察到血液学毒性模式，但少数婴儿中观察到的贫血和生长迟缓可能部分是由于其母亲使用齐多夫定治疗所致。（N Engl J Med 1992;326：857-61.）
Background and Methods.The expanding indications for zidovudine treatment make it important to elucidate the safety and toxicity of this drug for pregnant women and their fetuses. We asked pediatricians and obstetricians at the AIDS (acquired immunodeficiency syndrome) Clinical Trials Units to report information about pregnant women infected with the human immunodeficiency virus who were continuing their pregnancies and had received, or were receiving, zidovudine during gestation.Results.Reports of 43 women were received from 17 institutions. Doses of zidovudine ranged from 300 to 1200 mg per day, and 24 women took the drug for at least two trimesters. There were two reported instances of maternal toxicity (one gastrointestinal and one heatologic.) No teratogenic abnormalities occurred in the 12 infants with first-trimester exposure to zidovudine. All the infants, including two sets of twins, were born alive. The 38 singleton infants born at term for whom birth weights were reported had a mean birth weight of 3287±670 g; two cases of intrauterine growth retardation were reported among the infants delivered at term. Hemoglobin values, which were available for 31 newborns, ranged from 7.0 to 12.4 mmol per liter (11.2 to 20 g per deciliter); 3 of the 7 newborns with hemoglobin values of less than 8.4 mmol per liter (13.5 g per deciliter) were born prematurely.Conclusions.Zidovudine was well tolerated by the pregnant women and was apparently not associated with malformations in the newborns, premature birth, or fetal distress. No pattern of hematologic toxicity was observed in the newborns, but the anemia and growth retardation seen in a minority of the infants could, in part, have resulted from their mothers' treatment with zidovudine. (N Engl J Med 1992;326:857–61.)