Abstract：
The objective of this meta-analysis was to determine whether maternal exposure to statins is associated with increased rates of major congenital malformations and other adverse pregnancy outcomes.
PubMed/Medline, Web of Science and Reprotox® databases were searched. Cohort and case control studies with prenatal exposure to statins were included.
Analysis of five cohort studies and one case-control study showed no significant increase in rate of major congenital malformations when the exposed group was compared with the control ([OR 1.27; 95% CI 0.80-2.04], [aOR 1.05; 95% CI 0.84-1.31]). A significant increase in heart defect risk was detected in the statin-exposed group when unadjusted ORs were combined (OR 2.47; 95% CI 1.36-4.49). Further analysis of the same outcome by using adjusted ORs showed no significant increase in heart defect risk in the statin-exposed group compared with the controls (aOR 1.24; 95% CI 0.93-1.66). A significantly lower live birth rate (OR 0.60, 95% CI 0.49-0.75) and a higher spontaneous abortion rate (OR 1.36; 95% Cl 1.06-1.75) were detected in the statin-exposed group.
Gestational statin exposure was not associated with a significant increase in risk of major congenital malformations, heart defects and other adverse pregnancy outcomes, except spontaneous abortion and live birth rate, which may be associated with maternal comorbidity and other unadjusted risk factors. Further research focusing on particular statins is needed to draw more definitive conclusions.
PubMed/Medline, Web of Science and Reprotox® databases were searched. Cohort and case control studies with prenatal exposure to statins were included.
Analysis of five cohort studies and one case-control study showed no significant increase in rate of major congenital malformations when the exposed group was compared with the control ([OR 1.27; 95% CI 0.80-2.04], [aOR 1.05; 95% CI 0.84-1.31]). A significant increase in heart defect risk was detected in the statin-exposed group when unadjusted ORs were combined (OR 2.47; 95% CI 1.36-4.49). Further analysis of the same outcome by using adjusted ORs showed no significant increase in heart defect risk in the statin-exposed group compared with the controls (aOR 1.24; 95% CI 0.93-1.66). A significantly lower live birth rate (OR 0.60, 95% CI 0.49-0.75) and a higher spontaneous abortion rate (OR 1.36; 95% Cl 1.06-1.75) were detected in the statin-exposed group.
Gestational statin exposure was not associated with a significant increase in risk of major congenital malformations, heart defects and other adverse pregnancy outcomes, except spontaneous abortion and live birth rate, which may be associated with maternal comorbidity and other unadjusted risk factors. Further research focusing on particular statins is needed to draw more definitive conclusions.
摘要：
这项荟萃分析的目的是确定母体暴露于他汀类药物是否与主要先天性畸形和其他不良妊娠结局的发生率增加有关。
PubMed/Medline,搜索了WebofScience和Reprotox®数据库。包括产前暴露于他汀类药物的队列和病例对照研究。
对5项队列研究和1项病例对照研究的分析表明，当暴露组与对照组相比时，主要先天性畸形的发生率没有显着增加（[OR1.27;95％CI0.80-2.04]，[aOR1.05；95%CI0.84-1.31]）。在他汀类药物暴露组中，当合并未调整的OR时，心脏缺陷风险显着增加（OR2.47；95％CI1.36-4.49）。使用校正OR对相同结果进行的进一步分析显示，与对照组相比，他汀类药物暴露组的心脏缺陷风险没有显着增加（aOR1.24；95％CI0.93-1.66）。在他汀类药物暴露组中，活产率显着降低（OR0.60，95％CI0.49-0.75）和自然流产率更高（OR1.36；95％Cl1.06-1.75）。
妊娠他汀类药物暴露与重大先天性畸形风险的显著增加无关。心脏缺陷和其他不良妊娠结局，除了自然流产和活产率，这可能与孕产妇合并症和其他未经调整的危险因素有关。需要针对特定他汀类药物进行进一步研究，以得出更明确的结论。
PubMed/Medline,搜索了WebofScience和Reprotox®数据库。包括产前暴露于他汀类药物的队列和病例对照研究。
对5项队列研究和1项病例对照研究的分析表明，当暴露组与对照组相比时，主要先天性畸形的发生率没有显着增加（[OR1.27;95％CI0.80-2.04]，[aOR1.05；95%CI0.84-1.31]）。在他汀类药物暴露组中，当合并未调整的OR时，心脏缺陷风险显着增加（OR2.47；95％CI1.36-4.49）。使用校正OR对相同结果进行的进一步分析显示，与对照组相比，他汀类药物暴露组的心脏缺陷风险没有显着增加（aOR1.24；95％CI0.93-1.66）。在他汀类药物暴露组中，活产率显着降低（OR0.60，95％CI0.49-0.75）和自然流产率更高（OR1.36；95％Cl1.06-1.75）。
妊娠他汀类药物暴露与重大先天性畸形风险的显著增加无关。心脏缺陷和其他不良妊娠结局，除了自然流产和活产率，这可能与孕产妇合并症和其他未经调整的危险因素有关。需要针对特定他汀类药物进行进一步研究，以得出更明确的结论。
