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孕期使用磺胺甲噻二唑的不良妊娠结局:一项基于人群的观察性研究。

Adverse pregnancy outcome in users of sulfamethizole during pregnancy: a population-based observational study.

作者信息

Ratanajamit Chaveewan, Skriver Mette Vinther, Nørgaard Mette, Jepsen Peter, Schønheyder Henrik Carl, Sørensen Henrik Toft

机构信息

Department of Clinical Epidemiology, Aarhus and Aalborg University Hospitals, DK-8000 Aarhus C, Denmark.

出版信息

J Antimicrob Chemother. 2003 Nov;52(5):837-41. doi: 10.1093/jac/dkg438. Epub 2003 Sep 30.

DOI:10.1093/jac/dkg438
PMID:14519675
Abstract

OBJECTIVE

To estimate the risk of adverse birth and neonatal outcome, and miscarriage in women who used sulfamethizole during pregnancy.

METHODS

The association between use of sulfamethizole and adverse birth and neonatal outcome was investigated in a case-control and a cohort study in Denmark. We used data from the Prescription Database, the Birth Registry and the Hospital Discharge Registry in North Jutland County to study any association between sulfamethizole use and first recorded miscarriage. The cohort analysis included 3484 women who received a prescription for sulfamethizole from 30 days before conception to date of delivery, and 60175 women who did not use a sulphonamide-containing drug during pregnancy or 30 days before conception. The case-control analysis included 3347 women who had a miscarriage, of whom 90 had taken sulfamethizole, and 22599 primiparous controls who had a live birth.

RESULTS

Among women who received prescriptions for sulfamethizole, adjusted odds ratios and 95% confidence intervals for adverse birth outcome were: malformation 1.17 (0.95-1.43); low birth weight 0.69 (0.49-0.98); pre-term birth 1.12 (0.97-1.30); stillbirth 1.02 (0.61-1.68); neonatal jaundice 1.14 (0.38-3.46); and for receiving a prescription for sulfamethizole within 1 week before miscarriage 1.66 (0.92-2.99).

CONCLUSIONS

We found no increased risk of congenital malformation, stillbirth or pre-term birth, and no association between use of sulfamethizole late in pregnancy and risk of neonatal jaundice. There was an increased risk of miscarriage after exposure to sulfamethizole during the week before miscarriage, but further studies are needed to evaluate whether this increased risk is causal.

摘要

目的

评估孕期使用磺胺甲噻二唑的女性出现不良分娩及新生儿结局以及流产的风险。

方法

在丹麦的一项病例对照研究和一项队列研究中,调查了磺胺甲噻二唑的使用与不良分娩及新生儿结局之间的关联。我们使用了日德兰半岛北部郡的处方数据库、出生登记册和医院出院登记册中的数据,以研究磺胺甲噻二唑使用与首次记录的流产之间的任何关联。队列分析纳入了3484名在受孕前30天至分娩日期期间接受磺胺甲噻二唑处方的女性,以及60175名在孕期或受孕前30天未使用含磺胺类药物的女性。病例对照分析纳入了3347名流产女性,其中90名服用过磺胺甲噻二唑,以及22599名活产初产妇作为对照。

结果

在接受磺胺甲噻二唑处方的女性中,不良分娩结局的校正比值比及95%置信区间为:畸形1.17(0.95 - 1.43);低出生体重0.69(0.49 - 0.98);早产1.12(0.97 - 1.30);死产1.02(0.61 - 1.68);新生儿黄疸1.14(0.38 - 3.46);流产前1周内接受磺胺甲噻二唑处方的比值比为1.66(0.92 - 2.99)。

结论

我们发现先天性畸形、死产或早产风险未增加,孕期晚期使用磺胺甲噻二唑与新生儿黄疸风险之间无关联。流产前一周接触磺胺甲噻二唑后流产风险增加,但需要进一步研究以评估这种风险增加是否具有因果关系。

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