Bártfai Zoltan, Somoskövi Akos, Puhó Erzsébet H, Czeizel Andrew E
Department of Respiratory Medicine, Semmelweis Medical University, Budapest, Hungary.
Congenit Anom (Kyoto). 2007 Mar;47(1):16-21. doi: 10.1111/j.1741-4520.2006.00136.x.
The objective of this study was to investigate the human teratogenic potential of oral prenoxdiazine treatment during pregnancy. The analysis of cases with congenital abnormalities and their matched controls without congenital abnormalities was performed in the large population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996. Of the 22,843 pregnant women who had offspring with congenital abnormalities, 158 (0.7%) were treated with prenoxdiazine. Of the 38,151 pregnant women who had babies without any defects in the study period (control group), 226 (0.6%) were treated with prenoxdiazine (adjusted prevalence odds ratio, 1.0; 95% confidence interval, 0.8-1.3). The comparison of cases and their matched controls did not show a significantly higher rate of prenoxdiazine treatment during the second and third months of gestation in the total (adjusted prevalence odds ratio, 1.4; 95% confidence interval, 0.9-2.2) or in any group of congenital abnormalities. Treatment with prenoxdiazine during pregnancy did not have any teratogenic risk to the fetus. Thus, prenoxdiazine treatment in pregnant women with an unproductive cough may be beneficial.
本研究的目的是调查孕期口服丙氧二氮的人类致畸潜力。在1980 - 1996年匈牙利先天性异常病例对照监测的大型人群数据集里，对有先天性异常的病例及其匹配的无先天性异常的对照进行了分析。在22,843名生育了先天性异常后代的孕妇中，158名（0.7%）接受了丙氧二氮治疗。在研究期间生育了无任何缺陷婴儿的38,151名孕妇（对照组）中，226名（0.6%）接受了丙氧二氮治疗（调整后的患病率比值比为1.0；95%置信区间为0.8 - 1.3）。病例与其匹配对照的比较显示，在妊娠第二和第三个月期间，总体上（调整后的患病率比值比为1.4；95%置信区间为0.9 - 2.2）或在任何先天性异常组中，丙氧二氮治疗的发生率均未显著更高。孕期使用丙氧二氮对胎儿没有任何致畸风险。因此，对患有无效咳嗽的孕妇使用丙氧二氮治疗可能有益。
