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关于苯二氮䓬类药物疑似致畸作用的药物流行病学观点。

Pharmacoepidemiological perspectives on the suspected teratogenic effects of benzodiazepines.

作者信息

Bergman U

机构信息

Department of Clinical Pharmacology, Karolinska Institute, Huddinge University Hospital, Sweden.

出版信息

Bratisl Lek Listy. 1991 Nov;92(11):560-3.

PMID:1687207
Abstract

Abnormalities (dysmorphism, mental retardation etc) were reported (The Lancet 1987; i: 108-9) in children of mothers using high doses of benzodiazepines regularly during pregnancy in the area of Sweden with the highest use of benzodiazepines (Gothenburg). This signal was investigated in Sweden by use of available drug data bases, and in the USA by use of computerized health care data in Medicaid, including drugs and diagnoses. Neither the Swedish survey, nor the preliminary analysis of the pediatric profiles in the US-Medicaid population supported the occurrence of drug-associated abnormalities as described in The Lancet. Also, no significant findings were seen in a survey in Czechoslovakia on behavioural changes in children, whose mothers used diazepam during the second part of their pregnancy. Although available pharmacoepidemiology data do not confirm the hypothesis, this review points to existing geographic differences in use of benzodiazepines during pregnancy (frequency of chronic use and dosage level) and their potential clinical consequences. (Fig. 1, Ref. 25).

摘要

据报道(《柳叶刀》,1987年,第1期:108 - 109页),在瑞典使用苯二氮䓬类药物剂量最高的地区(哥德堡),孕期经常使用高剂量苯二氮䓬类药物的母亲所生子女出现了异常情况(畸形、智力发育迟缓等)。瑞典利用现有的药物数据库对此信号进行了调查,美国则利用医疗补助计划中的计算机化医疗保健数据(包括药物和诊断信息)进行调查。瑞典的调查以及对美国医疗补助计划人群中儿童资料的初步分析均未证实《柳叶刀》中所述的与药物相关的异常情况的发生。此外,在捷克斯洛伐克针对母亲在孕期后半段使用地西泮的儿童行为变化进行的一项调查中也未发现显著结果。尽管现有的药物流行病学数据并未证实这一假设,但本综述指出了孕期苯二氮䓬类药物使用方面存在的地域差异(长期使用频率和剂量水平)及其潜在的临床后果。(图1,参考文献25)

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