Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Nat Commun. 2024 Nov 28;15(1):10317. doi: 10.1038/s41467-024-54097-1.
Several international pharmacovigilance agencies have issued warnings regarding the potential risk of myasthenia gravis (MG) following statin therapy. Our study investigated this association using population-based electronic health records in Hong Kong. We conducted a sequence of target trial emulation (TTE) for interpersonal comparison and a self-controlled case series (SCCS) study for intrapersonal comparison. In the TTE for MG onset, the incidence rates (per 100,000 person-years) and adjusted HRs were 51.91(31.80, 84.74)[HR:6.11 (3.73, 10.01)] in month 1, 16.27(9.81, 26.99)[HR:1.92(1.15, 3.19) in months 2-4, and 15.27(9.05, 25.79)[HR:1.80(1.06, 3.04)] in months 5-7. For risk of exacerbation, the adjusted HRs were 10.69(5.48, 20.84) in month 1, 1.50(0.55, 4.06) in months 2-4, and 2.79(1.33, 5.84) in months 5-7. No increased risks were found during the subsequent 18 months. A similar pattern was observed in SCCS analysis. Our findings recommend a minimum monitoring period of approximately six months for MG symptoms for patients starting using statin.
一些国际药物警戒机构已经发布了关于他汀类药物治疗后肌无力（MG）潜在风险的警告。我们的研究使用香港基于人群的电子健康记录来研究这种关联。我们进行了一系列靶向试验模拟（TTE）进行人际比较和自身对照病例系列（SCCS）研究进行个体内比较。在 MG 发病的 TTE 中，发病率（每 10 万人年）和调整后的 HR 分别为 51.91（31.80，84.74）[HR：6.11（3.73，10.01）]在第 1 个月，16.27（9.81，26.99）[HR：1.92（1.15，3.19）在第 2-4 个月，和 15.27（9.05，25.79）[HR：1.80（1.06，3.04）]在第 5-7 个月。对于恶化的风险，调整后的 HR 分别为 10.69（5.48，20.84）在第 1 个月，1.50（0.55，4.06）在第 2-4 个月，和 2.79（1.33，5.84）在第 5-7 个月。在随后的 18 个月中没有发现风险增加。SCCS 分析也观察到了类似的模式。我们的研究结果建议，开始使用他汀类药物的患者出现 MG 症状时，需要至少监测约六个月。
