Department of Pharmacoepidemiology, Andrija Stampar Institute of Public Health, 10000 Zagreb, Croatia.
Acta Neurol Belg. 2010 Jun;110(2):163-7.
The objectives of the study were to assess the prevalence of anxiolytic use in pregnancy, the rate of congenital malformations in neonates at in utero exposure to these agents, and the possible association of congenital malformations with the use of these drugs in pregnancy.
The study was conducted as cross-sectional study. The study was performed at university departments of gynecology and obstetrics in four Zagreb hospitals and included 893 pregnant women. Main outcome measures were pathological defects and congenital malformations.
The main anatomic group N drugs (nervous system) was predominated by the use of the benzodiazepine anxiolytic diazepam (FDA group D), which increased with gestational age. Diazepam was used by 74 (8.3%), 127 (14.2%) and 212 (23.7%) women in the first, second and third trimester respectively. Diazepam ranked second among twenty most frequently prescribed drugs in pregnancy. It was taken by 303 (33.9%) pregnant women, while congenital cardiovascular malformations were recorded in three children and genitourinary malformations in three children too.
The high utilization of diazepam in pregnancy that is not supported by professional guidelines is an issue of serious concern. In spite of some study limitations, its results pointed to inappropriate and even potentially harmful use of drugs in pregnant women from Zagreb, thus calling for upgrading the quality of therapy in this vulnerable period of life. In our opinion, other measures appear to be a more appropriate therapeutic modality than medicamentous therapy in many cases.
本研究旨在评估妊娠期间使用抗焦虑药物的流行率、在宫内接触这些药物的新生儿先天畸形的发生率，以及先天畸形与妊娠期间使用这些药物之间的可能关联。
本研究为横断面研究。研究在萨格勒布四家医院的妇产科系进行，共纳入 893 名孕妇。主要结局指标为病理性缺陷和先天畸形。
主要的解剖学组 N 药物（神经系统）以苯二氮䓬类抗焦虑药地西泮（FDA 组 D）的使用为主，且随孕周增加而增加。分别有 74 名（8.3%）、127 名（14.2%）和 212 名（23.7%）孕妇在孕早期、孕中期和孕晚期使用地西泮。地西泮在妊娠期最常开的二十种药物中排名第二。有 303 名（33.9%）孕妇服用该药，3 名儿童出现心血管先天畸形，3 名儿童出现泌尿生殖系统先天畸形。
尽管存在一些研究局限性，但本研究结果表明，萨格勒布孕妇对地西泮的高利用率并未得到专业指南的支持，这是一个严重关切的问题。表明孕妇用药存在不恰当甚至潜在有害的情况，因此需要提高这一生命脆弱期的治疗质量。我们认为，在许多情况下，其他措施似乎比药物治疗更适合作为治疗方式。
