亚洲女性产前他汀类药物暴露与不良出生结局：一项系统综述和荟萃分析。
完整摘要 · 中文译文
背景：妊娠期使用他汀类药物的安全性仍存在争议。我们旨在评估亚洲女性产前他汀类药物暴露与妊娠结局（包括低出生体重、早产和先天性畸形）之间的关联。 方法：我们按照PRISMA规范对评估亚洲人群产前他汀类药物暴露的研究进行了系统综述和荟萃分析。检索了PubMed、Embase、Cochrane图书馆、Web of Science和试验注册库，截止日期为2026年1月31日。符合条件的随机和观察性研究纳入亚洲人群，并报告低出生体重、早产或先天性畸形。使用随机效应逆方差模型合并校正后的风险比，并使用标准工具评估偏倚风险。 结果：来自台湾和韩国的三项全国性观察性队列研究被纳入定量合并，一项关于普伐他汀预防子痫前期的印度尼西亚随机试验进行了定性评价。产前他汀类药物暴露与先天性畸形无关（RR，0.98；95% CI，0.89-1.08；I² = 0%），但与低出生体重相关（RR，1.27；95% CI，1.07-1.49；I² = 49%）。与早产的关联无统计学意义（RR，1.24；95% CI，0.95-1.62；I² = 87%）。仅限于暴露组与未暴露组比较的敏感性分析得出了相似的结论。 结论：现有来自东亚国家队列的亚洲证据表明，产前他汀类药物暴露或继续使用与先天性畸形之间无明显关联。 n 与先天性异常。观察到与低出生体重的轻度关联，而早产的证据仍不明确。由于存在残余混杂、对照异质性、与早产相关的低出生体重以及他汀类药物间的药理学异质性，低出生体重这一发现应谨慎解读。 系统综述注册：PROSPERO CRD420251235975。
完整摘要 · 英文原文
BACKGROUND: The safety of statin use during pregnancy remains controversial. We aimed to evaluate the association between prenatal statin exposure and pregnancy outcomes in Asian women, including low birth weight, preterm birth, and congenital anomalies. METHODS: We conducted a PRISMA-compliant systematic review and meta-analysis of studies in Asian populations evaluating prenatal statin exposure. PubMed, Embase, the Cochrane Library, Web of Science, and trial registries were searched through January 31, 2026. Eligible randomized and observational studies included Asian populations and reported low birth weight, preterm birth, or congenital anomalies. Adjusted risk ratios were pooled using random-effects inverse-variance models, and risk of bias was assessed with standard tools. RESULTS: Three nationwide observational cohort studies from Taiwan and South Korea were included in the quantitative synthesis, and one Indonesian randomized trial of pravastatin for preeclampsia prevention was reviewed qualitatively. Prenatal statin exposure was not associated with congenital anomalies (RR, 0.98; 95% CI, 0.89-1.08; I2 = 0%), but was associated with low birth weight (RR, 1.27; 95% CI, 1.07-1.49; I2 = 49%). The association with preterm birth was not statistically significant (RR, 1.24; 95% CI, 0.95-1.62; I2 = 87%). Sensitivity analyses restricted to exposed versus unexposed comparisons yielded similar conclusions. CONCLUSIONS: The available Asian evidence, largely derived from nationwide East Asian cohorts, suggests no clear association between prenatal statin exposure or continuation and congenital anomalies. A modest association with low birth weight was observed, whereas evidence for preterm birth remained inconclusive. The low-birth-weight finding should be interpreted cautiously because of residual confounding, comparator heterogeneity, prematurity-related low birth weight, and pharmacological heterogeneity across statins. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD420251235975.