Lee H J, Han J Y, Yook J H, Choi J S, Ahn H K, Kim M Y, Song I O, Yang J H, Nava-Ocampo A A
Korean Motherisk Program, Department of Obstetrics and Gynecology, Cheil Hospital and Women's Healthcare Center, Kwandong University College of Medicine, Seoul, Korea.
J Obstet Gynaecol. 2010;30(6):563-6. doi: 10.3109/01443615.2010.487577.
No information is currently available on the safety of methylephedrine, a component of various cold medications available in South Korea. With previous approval by an Institutional Review Board, 349 women inadvertently exposed to methylephedrine during the 1st trimester of pregnancy and an age- and gravidity-matched control group, were enrolled in a prospective cohort study. Study outcomes, for example gestational age at birth, birth weight and major and minor malformations were evaluated in 282 cases and 280 controls. Exposure to methylephedrine was at a gestational age of 4.0 weeks (median), at doses ranging from 52.5 to 1,575 mg/day, for a median duration of 3 (range: 1-30) days. No differences were observed between cases and controls in any of the pregnancy outcomes studied. There were 4/265 (1.5%) babies born with major malformations in the case group and 4/260 (1.5%) in the control group. In conclusion, inadvertent exposure to methylephedrine as a component of over-the counter oral cold remedies in early pregnancy was not associated with an increased rate of adverse pregnancy outcomes. Co-exposure with acetaminophen, cigarette smoking or alcohol did not appear to modify the outcomes.
目前尚无关于甲基麻黄碱安全性的信息，甲基麻黄碱是韩国市面上多种感冒药的一种成分。经机构审查委员会事先批准，349名在妊娠早期意外接触甲基麻黄碱的女性以及一个年龄和妊娠次数匹配的对照组被纳入一项前瞻性队列研究。对282例病例和280名对照者评估了研究结果，如出生时的孕周、出生体重以及主要和次要畸形。接触甲基麻黄碱时的孕周为4.0周（中位数），剂量范围为52.5至1575毫克/天，中位持续时间为3天（范围：1至30天）。在所研究的任何妊娠结局方面，病例组和对照组之间均未观察到差异。病例组中有4/265（1.5%）的婴儿出生时患有主要畸形，对照组中有4/260（1.5%）。总之，妊娠早期意外接触作为非处方口服感冒药成分的甲基麻黄碱与不良妊娠结局发生率增加无关。与对乙酰氨基酚、吸烟或饮酒同时接触似乎并未改变结果。
