Richard-Tremblay Audrey-Ann, Sheehy Odile, Bérard Anick
University of Montreal, Montreal, Quebec, Canada.
Curr Drug Saf. 2013 Jul;8(3):153-61. doi: 10.2174/15748863113089990034.
Recent evidence suggests that periconceptional folic acid use could not only prevent neural tube defects but also other malformations. The objectives of this study were to assess trends in dispensed high dose periconceptional folic acid (5 mg) and birth prevalence of major congenital malformations.
The Quebec Pregnancy Registry, an administrative database with information on periconceptional prescribed medication and diagnostic codes was used to conduct this study. All pregnant women insured by the Quebec public drug plan between January 1(st) 1998 and December 31(st) 2008 were included. The exposure was defined as the use of high dose periconceptional folic acid 30 days before, and during the first 70 days of pregnancy. The outcome measured was the birth prevalence of major congenital malformations among live births.
We identified 152,392 pregnancies and babies. The annual prevalence of high dose periconceptional folic acid use increased from 0.17% to 0.80% (p<0.05) during the study period; birth prevalence of congenital malformations increased by 15% (3.35% to 3.87%, p<0.05). More specifically, a 23% increase in the prevalence of cardiac malformation and 23% increase in musculoskeletal defects were observed, whereas there was no change in the prevalence of malformations of the nervous system.
Although there was an increase in the use of periconceptional high dose folic acid over the past decade, there was no decrease in the prevalence of major congenital malformations. A limitation of this study is the absence of data on low dose folic acid use, available over the counter, in our administrative database.
近期证据表明,孕期前叶酸的使用不仅可以预防神经管缺陷,还能预防其他畸形。本研究的目的是评估孕期前高剂量叶酸(5毫克)的配给趋势以及主要先天性畸形的出生患病率。
本研究使用了魁北克省妊娠登记处,这是一个包含孕期前处方药和诊断代码信息的行政数据库。纳入了1998年1月1日至2008年12月31日期间由魁北克公共药品计划承保的所有孕妇。暴露定义为在怀孕前30天及怀孕的前70天内使用高剂量孕期前叶酸。所测量的结果是活产中主要先天性畸形的出生患病率。
我们识别出152,392例妊娠和婴儿。在研究期间,孕期前高剂量叶酸使用的年患病率从0.17%增至0.80%(p<0.05);先天性畸形的出生患病率增加了15%(从3.35%增至3.87%,p<0.05)。更具体地说,观察到心脏畸形的患病率增加了23%,肌肉骨骼缺陷的患病率增加了23%,而神经系统畸形的患病率没有变化。
尽管在过去十年中孕期前高剂量叶酸的使用有所增加,但主要先天性畸形的患病率并未下降。本研究的一个局限性是我们的行政数据库中缺乏非处方低剂量叶酸使用的数据。