β受体阻滞剂在妊娠中的应用与先天畸形风险：一项国际队列研究。
β-Blocker Use in Pregnancy and the Risk for Congenital Malformations: An International Cohort Study.
机构信息
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (B.T.B., K.F.H.).
Aarhus University Hospital, Aarhus, Denmark (U.H., M.N.).
出版信息
Ann Intern Med. 2018 Nov 20;169(10):665-673. doi: 10.7326/M18-0338. Epub 2018 Oct 16.
BACKGROUND
β-Blockers are a class of antihypertensive medications that are commonly used in pregnancy.
OBJECTIVE
To estimate the risks for major congenital malformations associated with first-trimester exposure to β-blockers.
DESIGN
Cohort study.
SETTING
Health registries in the 5 Nordic countries and the U.S. Medicaid database.
PATIENTS
Pregnant women with a diagnosis of hypertension and their offspring.
MEASUREMENTS
First-trimester exposure to β-blockers was assessed. Outcomes were any major congenital malformation, cardiac malformations, cleft lip or palate, and central nervous system (CNS) malformations. Propensity score stratification was used to control for potential confounders.
RESULTS
Of 3577 women with hypertensive pregnancies in the Nordic cohort and 14 900 in the U.S. cohort, 682 (19.1%) and 1668 (11.2%), respectively, were exposed to β-blockers in the first trimester. The pooled adjusted relative risk (RR) and risk difference per 1000 persons exposed (RD1000) associated with β-blockers were 1.07 (95% CI, 0.89 to 1.30) and 3.0 (CI, -6.6 to 12.6), respectively, for any major malformation; 1.12 (CI, 0.83 to 1.51) and 2.1 (CI, -4.3 to 8.4) for any cardiac malformation; and 1.97 (CI, 0.74 to 5.25) and 1.0 (CI, -0.9 to 3.0) for cleft lip or palate. For CNS malformations, the adjusted RR was 1.37 (CI, 0.58 to 3.25) and the RD1000 was 1.0 (CI, -2.0 to 4.0) (based on U.S. cohort data only).
LIMITATION
Analysis was restricted to live births, exposure was based on dispensed medication, and cleft lip or palate and CNS malformations had few outcomes.
CONCLUSION
The results suggest that maternal use of β-blockers in the first trimester is not associated with a large increase in the risk for overall malformations or cardiac malformations, independent of measured confounders.
PRIMARY FUNDING SOURCE
The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Söderström König Foundation.
背景
β-受体阻滞剂是一类常用于治疗妊娠高血压的降压药物。
目的
评估β-受体阻滞剂在妊娠早期使用与主要先天畸形相关的风险。
设计
队列研究。
设置
5 个北欧国家和美国医疗补助数据库的健康登记处。
患者
患有高血压的孕妇及其子女。
测量方法
评估妊娠早期β-受体阻滞剂的使用情况。结局为任何主要先天畸形、心脏畸形、唇腭裂和中枢神经系统（CNS）畸形。采用倾向评分分层控制潜在混杂因素。
结果
在北欧队列中的 3577 名高血压孕妇和美国队列中的 14900 名孕妇中，分别有 682 名（19.1%）和 1668 名（11.2%）在妊娠早期接受了β-受体阻滞剂治疗。与β-受体阻滞剂相关的校正后相对风险（RR）和每 1000 名暴露者的风险差异（RD1000）分别为 1.07（95%CI，0.89 至 1.30）和 3.0（CI，-6.6 至 12.6），用于任何主要畸形；1.12（CI，0.83 至 1.51）和 2.1（CI，-4.3 至 8.4），用于任何心脏畸形；1.97（CI，0.74 至 5.25）和 1.0（CI，-0.9 至 3.0），用于唇腭裂。对于中枢神经系统畸形，调整后的 RR 为 1.37（CI，0.58 至 3.25），RD1000 为 1.0（CI，-2.0 至 4.0）（仅基于美国队列数据）。
局限性
分析仅限于活产儿，暴露情况基于配药情况，唇腭裂和中枢神经系统畸形的结局较少。
结论
结果表明，在妊娠早期使用β-受体阻滞剂并不会显著增加整体畸形或心脏畸形的风险，这与已测量的混杂因素无关。
主要资金来源
美国国立儿童健康与人类发育研究所和索德斯特罗姆-科尼基金会。
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