目的 挖掘和评价他汀类药物和乳腺疾病不良事件的关联性及特点。方法 收集美国食品药品监督管理局不良事件报告系统（FAERS）中2004年1季度—2025年2季度的他汀（阿托伐他汀、辛伐他汀、瑞舒伐他汀、普伐他汀、洛伐他汀、氟伐他汀和匹伐他汀）乳腺不良事件报告，采用报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信度递进神经网络法（BCPNN）及伽马泊松分布缩减法（MGPS） 4种方法对报告数据进行信号检测。结果 共提取他汀类药物的乳腺相关不良事件（ADE） 1 063份，其中阿托伐他汀485份，瑞舒伐他汀391份，辛伐他汀148份，普伐他汀20份，氟伐他汀11份，匹伐他汀4份，洛伐他汀4份。阿托伐他汀和瑞舒伐他汀年龄＞85岁发生乳腺ADE比例最高，分别是167（34.4%）和164（41.9%）。所有他汀类药物严重乳腺ADE比例＞45%。经过信号检测，阿托伐他汀乳腺ADE阳性信号数最多（包括乳头肿胀、乳头疼痛）；瑞舒伐他汀、辛伐他汀、氟伐他汀、普伐他汀阳性信号均为1个，分别是乳腺导管内乳头状瘤、乳房萎缩、乳房膨胀、乳房脓肿；匹伐他汀与洛伐他汀未检出乳腺相关ADE阳性信号；辛伐他汀引起乳房萎缩ROR[40.13，95%置信区间（CI） ＝（23.34，68.99）]，ROR025值最大。结论 他汀类药物与乳腺不良事件显著相关（匹伐他汀与洛伐他汀除外），其中辛伐他汀引起乳房萎缩关联性最强。应监测乳腺不良事件的发生情况，尤其辛伐他汀，以保障用药安全。

Objective To systematically detect, characterize, and evaluate potential associations between statin medications and breast-related adverse drug events (ADEs). Methods Individual case safety reports (ICSRs) involving seven statins—atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, and pitavastatin—and breast-related ADEs were retrieved from the U.S. FDA Adverse Event Reporting System (FAERS) for the period Q1 2004 to Q2 2025. Four quantitative signal detection methods were applied: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and gamma Poisson shrinker (GPS). Results A total of 1,063 breast-related ADE reports were identified across all statins: Atorvastatin (n = 485), rosuvastatin (n = 391), simvastatin (n = 148), pravastatin (n = 20), fluvastatin (n = 11), and both pitavastatin and lovastatin (n = 4 each). Among patients aged >80 years, the highest proportions of breast ADEs occurred with atorvastatin (41.9%, 164/391) and rosuvastatin (34.4%, 167/485). Over 45% of all reported breast ADEs were classified as serious per FAERS criteria. Signal detection revealed statistically robust associations for several statin-ADE pairs: atorvastatin calcium showed the greatest number of positive signals—namely nipple swelling and nipple pain—while single positive signals were detected for rosuvastatin (intraductal papilloma), simvastatin (breast atrophy), fluvastatin (breast swelling), and pravastatin (breast abscess). No statistically significant signals were identified for pitavastatin or lovastatin. Notably, simvastatin-associated breast atrophy exhibited the highest strength of association (ROR = 40.13; 95% CI: 23.34, 68.99). Conclusion Statins as a class demonstrate a statistically significant pharmacovigilance signal for breastrelated ADEs, with the exception of pitavastatin and lovastatin. Simvastatin shows the strongest empirical association with breast atrophy. These findings underscore the need for heightened clinical awareness and prospective monitoring—particularly for older adults receiving simvastatin—to support safe prescribing and early identification of breast-related complications.

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