Källén Bengt
Tornblad Institute, University of Lund , Lund , Sweden.
Scand J Gastroenterol. 2014 Apr;49(4):442-8. doi: 10.3109/00365521.2013.879734. Epub 2014 Jan 21.
Most previous studies have failed to demonstrate any effect of maternal use of 5-aminosalicylates (5-ASA) on malformation risk, but the number of infants studied have, in most cases, been low. The objective of the study was to get data from a large study with prospectively ascertained exposure information.
The study was based on data in the Swedish Medical Birth Register (1996-2011) where identification of maternal drug use is made from midwife interviews in early pregnancy. The presence of congenital malformations was ascertained from three national registers. Adjusted odds ratios were calculated by the Mantel-Haenszel methodology.
Among 1,552,109 women, 3651 with 3721 infants had reported the use of 5-ASAs in early pregnancy. The risk of a major malformation was increased (1.37, 95% confidence interval = 1.17-1.62) and still more for a cardiovascular defect (1.74, 1.37-2.22). This effect seemed to be influenced by concomitant use of systemic glucocorticosteroids or immunosuppressants but some confounding by indication may also exist. There was no marked difference between the four 5-ASA drugs studied.
Infants born of women who use 5-ASA drugs in early pregnancy have an increased risk of a congenital malformation, notably a cardiovascular defect. This could be a drug effect or an effect of an active inflammatory bowel disease.
既往大多数研究未能证明孕妇使用5-氨基水杨酸酯（5-ASA）对畸形风险有任何影响，但在大多数情况下，所研究的婴儿数量较少。本研究的目的是从一项具有前瞻性确定暴露信息的大型研究中获取数据。
本研究基于瑞典医学出生登记处（1996 - 2011年）的数据，其中孕妇药物使用情况是通过孕早期助产士访谈确定的。先天性畸形的存在是从三个国家登记处确定的。调整后的比值比采用Mantel-Haenszel方法计算。
在1,552,109名女性中，有3651名孕妇报告在孕早期使用了5-ASA，其所生3721名婴儿。严重畸形风险增加（1.37，95%置信区间 = 1.17 - 1.62），心血管缺陷风险增加更明显（1.74，1.37 - 2.22）。这种影响似乎受到全身性糖皮质激素或免疫抑制剂同时使用的影响，但也可能存在一些指征性混杂因素。所研究的四种5-ASA药物之间没有明显差异。
孕早期使用5-ASA药物的女性所生婴儿先天性畸形风险增加，尤其是心血管缺陷。这可能是药物作用或活动性炎症性肠病的影响。
