Abstract: Objective　To analyze the effect of medication during pregnancy on neonatal congenital malformation of body surface.Methods　From July to December 2013，multi stage stratified random sampling method was adopted.According to the proportion of urban and rural areas,the population density and birth rate,women of childbearing aged between 15 and 49 who were pregnant during 2010 to 2013 in Shaanxi province,were selected as study subjects.A face to face questionnaire survey was conducted to collect the basic information of respondents,medication during pregnancy,pregnancy outcomes.The respondents’ survived children underwent physical examination to confirm the type of malformation.For children who were not alive,investigation and evidence collection were carried out to verify the malformation diagnosis.Multivariable Poisson regression was conducted to analyse the risk factors of neonatal congenital malformation of body surface.Results　The study included 29 121 cases,newborn 29 482 cases,and 318 cases（107.86/10 000） with neonatal congenital malformation of body surface were found.The top 10 types of the congenital malformation of body surface were hemangioma（75 cases）,deformity of external（45 cases）,inguinal hernia（32 cases）,polydactyly（23 cases）,cleft lip and palate（13 cases）,cleft lip（11 cases）,cryptorchidism（10 cases）,hernia（9 cases）,blepharoptosis（7 cases）,and cleft palate（6 cases）.The univariate analysis results showed that,there were significant differences in incidence of neonatal congenital malformation of body surface among women with different place of residence,education level,occupation,average household monthly income and status of family history of birth defects in newborns（P<0.05）.The incidence of neonatal congenital malformation of body surface among children whose mother took cold medicine,antibiotics,tocolytic drugs,antitussives,antipyretic analgesics and other drugs during pregnancy was significantly higher than that among children whose mother did not take the above drugs（P<0.05）.The multivariable Poisson regression showed that,taking cold medicine〔OR=1.640,95%CI（1.037，2.593）〕,antibiotics 〔OR=1.701,95%CI（1.125，2.572）〕,tocolytic agents〔OR=3.954,95%CI（1.858，8.418）〕,antitussives 〔OR=3.736,95%CI（1.955，7.141）〕,antipyretic analgesics〔OR=2.858,95%CI（1.060，7.708）〕 and other drugs 〔OR=4.118,95%CI（2.351，7.215）〕during pregnancy were the risk factors for occurrence of neonatal congenital malformation of body surface（P<0.05）.Conclusion　Taking cold medicine,antibiotics,tocolytic agents,antitussives,and antipyretic analgesics during pregnancy can improve the risk of neonatal congenital malformation of body surface.

Key words: Congenital abnormalities, Pregnant women, Drugs

摘要： 目的　探讨妊娠期用药对新生儿体表先天畸形的影响。方法　于2013年7—12月，采用多阶段分层随机抽样方法，根据城乡比例，同时考虑人口密集度和生育水平，于陕西省抽取2010—2013年期间曾经妊娠的15～49岁育龄妇女为调查对象。采用面对面问卷调查的方式，收集调查对象基本情况、妊娠期用药、妊娠结局等信息，对调查对象存活的子女进行体格检查，确认畸形类型；对未存活的子女进行调查取证，核实畸形诊断。采用多因素Poisson回归分析新生儿体表先天畸形的影响因素。结果　本研究纳入调查对象29 121例，新生儿29 482例，发现体表先天畸形儿318例（107.86/万）。居前10位的体表先天畸形类型依次为血管瘤75例，外耳畸形45例，腹股沟疝32例，多指（趾）23例，腭裂伴唇裂13例，唇裂11例，隐睾10例，脐疝9例，上睑下垂7例，腭裂6例。单因素分析发现，不同居住地、文化程度、职业、家庭平均月收入以及有无家族出生缺陷史的妇女分娩的新生儿体表先天畸形发生率比较，差异均有统计学意义（P<0.05）。妊娠期使用感冒药、抗生素、保胎药、镇咳药、解热镇痛药及其他药的妇女分娩的新生儿体表先天畸形发生率高于未使用相应药物者，差异均有统计学意义（P<0.05）。多因素Poisson回归分析显示，妊娠期使用感冒药〔OR=1.640,95%CI（1.037，2.593）〕、抗生素〔OR=1.701,95%CI（1.125，2.572）〕、保胎药〔OR=3.954,95%CI（1.858，8.418）〕、镇咳药〔OR=3.736,95%CI（1.955，7.141）〕、解热镇痛药〔OR=2.858,95%CI（1.060，7.708）〕和其他药〔OR=4.118,95%CI（2.351，7.215）〕是新生儿体表先天畸形发生的危险因素（P<0.05）。结论　妊娠期使用感冒药、抗生素、保胎药、镇咳药、解热镇痛药可增加新生儿体表先天畸形发生的风险。

关键词: 先天畸形, 孕妇, 药物