From the Division of Medical Genetics, Department of Pediatrics, University of Utah Health Sciences Center, Salt Lake City, Utah; the Utah Birth Defect Network, Utah Department of Health, Salt Lake City, Utah; and the North Carolina Birth Defects Monitoring Program, North Carolina Division of Public Health, Raleigh, North Carolina.
Obstet Gynecol. 2010 Jan;115(1):109-115. doi: 10.1097/AOG.0b013e3181c52616.
To investigate whether exposure during the first trimester of pregnancy to single-ingredient acetaminophen increases the risk of major birth defects.
Data from the National Birth Defects Prevention Study, a population-based, case-control study, were used. Women who delivered between January 1, 1997, and December 31, 2004, and participated in the telephone interview were included. Type and timing of acetaminophen use were assigned based on maternal report. Women reporting first-trimester acetaminophen use in a combination product were excluded, resulting in a total of 11,610 children in the case group and 4,500 children in the control group for analysis.
The prevalence of first-trimester single-ingredient-acetaminophen use was common: 46.9% (n=5,440) among women in the case group and 45.8% (n=2,059) among women in the control group (P=.21). Overall, acetaminophen was not associated with an increased risk of any birth defect. Among women reporting a first-trimester infection and fever, use of acetaminophen was associated with a statistically significantly decreased odds ratio (OR) for anencephaly or craniorachischisis (adjusted OR 0.35, 95% confidence interval [CI] 0.08-0.80), encephalocele (adjusted OR 0.17, 95% CI 0.03-0.87), anotia or microtia (adjusted OR 0.25, 95% CI 0.07-0.86), cleft lip with or without cleft palate (adjusted OR 0.44, 95% CI 0.26-0.75), and gastroschisis (adjusted OR 0.41, 95% CI 0.18-0.94).
Single-ingredient-acetaminophen use during the first trimester does not appear to increase the risk of major birth defects. It may decrease the risk of selected malformations when used for a febrile illness.
II.
研究孕妇在妊娠早期单次摄入对乙酰氨基酚是否会增加重大出生缺陷的风险。
本研究使用了全国出生缺陷预防研究（一项基于人群的病例对照研究）的数据。研究纳入了 1997 年 1 月 1 日至 2004 年 12 月 31 日期间分娩且参与了电话访谈的女性。根据母亲报告，确定对乙酰氨基酚的类型和使用时间。排除报告在妊娠早期使用复方产品的女性，因此在病例组中共有 11610 名儿童，在对照组中有 4500 名儿童进行分析。
妊娠早期单次摄入对乙酰氨基酚的情况较为常见：病例组中有 46.9%（n=5440）的女性，对照组中有 45.8%（n=2059）的女性（P=.21）。总体而言，对乙酰氨基酚与任何出生缺陷的风险增加均无关。在报告妊娠早期感染和发热的女性中，使用对乙酰氨基酚与无脑畸形或颅脊柱裂的比值比（OR）显著降低（调整 OR 0.35，95%置信区间 [CI] 0.08-0.80）、脑膨出（调整 OR 0.17，95% CI 0.03-0.87）、无耳或小耳畸形（调整 OR 0.25，95% CI 0.07-0.86）、唇裂伴或不伴腭裂（调整 OR 0.44，95% CI 0.26-0.75）和腹裂（调整 OR 0.41，95% CI 0.18-0.94）的风险降低。
妊娠早期单次摄入对乙酰氨基酚似乎不会增加重大出生缺陷的风险。当用于发热性疾病时，它可能会降低某些畸形的风险。
II 级。
