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Short-term oral diazepam treatment during pregnancy a population-based teratological case-control study

机译:妊娠期短期口服地西epa治疗基于人群的致畸病例对照研究

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Objective: To study the possible human teratogenicity of short-term (generally 3 weeks) oral diazepam treatment during pregnancy.Design and setting: A matched case-population control pair analysis based on the total (maternal self-reported and medically recorded) or medically recorded diazepam treatments, in addition to a comparison between cases and patient controls in the population-based large data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities from 1980 to 1996.Study participants: 38 151 population-control neonates without any congenital abnormalities, 22 865 neonates or fetuses with congenital abnormalities (cases)and 812 neonates or fetuses with Down's syndrome (patient controls).Main outcome measures: 24 congenital abnormality groups.Results: 2746 (12.0%) cases, 4130 (10.8%) population controls and 97 (11.9%) patient controls were born to mothers treated with diazepam during pregnancy. The matched case-population control pair analysis showed a higher rate of limb deficiencies, rectal-anal atresia/stenosis, cardiovascular malformations and multi ple congenital abnormalities after diazepam use during the second and third months of gestation, i.e. in the critical period for most major congenital abnormal ities, based on maternal self-reported and medically recorded information. How ever, the evaluation of only medically recorded diazepam use did not indicate a higher use of diazepam in any congenital abnormality group. Thus, the higher occurrence of diazepam treatment among cases in the primary analysis may be due to the lower proportion of maternal self-reported diazepam intake in the population control group, i.e. recall bias. The comparison of diazepam use between 24 congenital abnormality groups and patient controls as the referent group showed a difference only in the group of intestinal atresia/stenosis, prob ably due to chance error caused by multiple comparison.Conclusions: Short-term diazepam treatment in usual therapeutic doses during pregnancy did not present any detectable teratogenic risk to the fetus.
机译:目的:研究怀孕期间短期(通常为3周)口服地西m的可能的人致畸性设计和背景:基于总体(母亲自我报告和医学记录)或医学上匹配的病例-人群对照对分析记录了地西epa的治疗方法,并比较了1980年至1996年匈牙利基于病例的先天性异常病例对照监测的大型数据集中病例与患者对照之间的比较。研究对象:38 151名无任何先天性异常的人群对照新生儿22865例先天性异常的新生儿或胎儿(病例)和812例唐氏综合症的新生儿或胎儿(患者对照)。主要结果指标:24个先天性异常组。结果:2746(12.0%)例,4130(10.8%)人口对照孕期接受地西epa治疗的母亲中有97例(11.9%)患者对照组出生。匹配的病例-人群对照对分析显示,在妊娠的第二个月和第三个月,即在大多数主要疾病的关键时期,使用地西epa后肢体虚弱,直肠肛门闭锁/狭窄,心血管畸形和多发性先天性畸形的发生率更高。先天性异常,基于母亲的自我报告和医学记录的信息。但是,仅对医学上记录的地西epa使用情况进行评估并没有表明在任何先天性异常组中都增加了地西higher的使用。因此,在初步分析中,地西epa治疗的发生率较高,这可能是由于人群对照组母体自我报告的地西intake摄入量所占比例较低,即回忆偏倚。在24个先天性异常组和以患者为对照组的对照组之间比较地西epa的使用,仅在肠道闭锁/狭窄组中存在差异,这可能是由于多次比较引起的偶然误差所致。结论:通常进行短期地西epa治疗怀孕期间的治疗剂量对胎儿没有任何可检测到的致畸风险。

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