妊娠期间应用他汀类药物安全性的系统评价再评价

Safety of statins during pregnancy:an overview of systematic reviews

目的对妊娠期应用他汀类药物安全性的系统评价/meta分析进行再评价,为妊娠女性安全使用他汀类药物提供参考。方法检索国内外相关数据库截至2023年10月8日收录的妊娠期应用他汀类药物安全性的系统评价meta分析,采用系统评价和meta分析优先报告条目(PRISMA)对纳入文献进行报告质量评价,采用系统评价方法学质量评价工具2(AMSTAR 2)量表进行方法学质量评价,采用推荐意见分级的评估、制定与评价(GRADE)工具进行证据质量评价;以相对风险、比值比、均数差及其95%置信区间表示结局指标定量分析结果。结果共纳入12篇系统评价/meta分析。PRISMA质量评价结果为高质量、中等质量和低质量的文献分别为5、4和3篇;AMSTAR 2量表方法学质量评价为高质量和极低质量的文献分别为2和10篇;GRADE工具证据质量评价显示,48条证据体中4条为中级质量(8.3%),37条为低级质量(77.1%),7条为极低级质量(14.6%)。系统评价再评价结果显示,妊娠期间他汀类药物暴露不增加胎儿出生缺陷和早产的风险,但会增加自发流产风险;普伐他汀可能降低子宫胎盘功能不全者子痫前期发生率和新生儿重症监护病房入住率;他汀类药物暴露对胎儿心脏异常和人工流产风险存在不一致的结果。结论妊娠期间他汀类药物暴露不增加发生胎儿出生缺陷和早产的风险,但会增加发生自发流产的风险。

Objective statins in pregnancy and provide reference for the safe use of statins in pregnant women To re‑evaluate the systematic evaluation and meta‑analysis of safety of.Methods The systematic reviews/meta‑analysis on the safety of statins during pregnancy were retrieved from databases(up to October 8,2023).The preferred reporting items for systematic reviews and meta‑analyse(PRISMA)were used to evaluate the quality of the included literature,a measure tool to assess systematic reviews 2(AMSTAR 2)scale was used to evaluate the methodological quality of the included literature,and the grading of recommendations assessment,development,and evaluation(GRADE)tool was used to evaluate the evidence quality of the included literature.The results of quantitative analysis of outcome indicators were expressed by relative risk,odds ratio,mean difference and their 95%confidence interval.Results A total of 12 systematic reviews/meta‑analysis were included.There were 5,4 and 3 documents with high quality,medium quality,and low quality,respectively,which were evaluated by PRISMA.There were 2 and 10 docu‑ments with high and very low quality,which were evaluated by AMSTAR 2 scale.The GRADE tool evidence quality evaluation results showed that among the 48 evidence bodies,4 were of intermediate quality(8.3%),37 were of low quality(77.1%),and 7 were of very low quality(14.6%).The re‑evaluation results of systematic review/meta‑analysis showed that statins exposure during pregnancy did not increase the risk of fetal birth defects and premature delivery,but increased the risk of spontaneous abortion.Pravastatin might reduce the incidence of preeclampsia with uteroplacental insufficiency and neonatal intensive care unit occupancy in patients.There were inconsistent results of statin exposure on fetal cardiac abnormalities and the risk of arti‑ficial abortion.Conclusion Statins exposure during pregnancy does not increase the risks of fetal birth defects and premature birth,but increases the risk of spontaneous abortion。