孕早期使用双氯芬酸的安全性：一项前瞻性观察性队列研究。
Safety of diclofenac use during early pregnancy: A prospective observational cohort study.
机构信息
Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology, Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Augustenburger Platz 1, 13353, Berlin, Germany.
Beuth Hochschule für Technik - University of Applied Sciences, Department of Mathematics, Luxemburger Straße 10, 13353, Berlin, Germany.
出版信息
Reprod Toxicol. 2018 Apr;77:122-129. doi: 10.1016/j.reprotox.2018.02.007. Epub 2018 Mar 22.
Diclofenac is a widely used analgesic so that exposure during pregnancy may frequently occur. Most publications have evaluated the safety of NSAIDs on pregnancy outcome as a group of substances. Specific data on diclofenac are rare. This observational cohort study used the German Embryotox pharmacovigilance database to assess the risk of major birth defects and spontaneous abortion after first trimester exposure to diclofenac. A group of 260 women who took diclofenac during first trimester was compared to 778 non-exposed pregnancies. In the diclofenac exposed cohort 4 major birth defects were observed among 220 live-born infants and 25 spontaneous abortions occurred. Neither the rate of major birth defects (1.8% vs. 3.1%; OR adjusted 0.59; 95% CI 0.17-2.08) nor the risk of spontaneous abortion (HR adjusted 0.90; 95% CI 0.56-1.46) was increased. The study results do not indicate that diclofenac exposure during first trimester is associated with a teratogenic risk.
双氯芬酸是一种广泛使用的镇痛药，因此孕妇在怀孕期间可能经常接触到它。大多数出版物都评估了 NSAIDs（非甾体抗炎药）对妊娠结局作为一组物质的安全性。关于双氯芬酸的具体数据很少。这项观察性队列研究使用德国胚胎毒性药物警戒数据库，评估了在妊娠早期接触双氯芬酸后，主要出生缺陷和自然流产的风险。将 260 名在妊娠早期服用双氯芬酸的女性与 778 名未暴露的妊娠进行比较。在暴露于双氯芬酸的队列中，220 名活产婴儿中有 4 例主要出生缺陷，25 例自然流产。主要出生缺陷的发生率（1.8%比 3.1%；调整后的 OR 0.59；95%CI 0.17-2.08）和自然流产的风险（调整后的 HR 0.90；95%CI 0.56-1.46）均无增加。研究结果表明，妊娠早期接触双氯芬酸与致畸风险无关。
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