莫诺拉韦与恩赛特韦治疗COVID-19相关短期临床事件的比较：基于日本社区药房记录的回顾性队列研究

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中文摘要

莫诺拉韦和恩赛特韦被广泛用于门诊2019冠状病毒病治疗；然而，真实世界安全性比较仍然有限。本回顾性队列研究利用日本社区药房记录，评估2023年1月至9月期间新开具这两种药物之一患者的29天随访期内急性临床事件风险。采用多变量Cox比例风险模型估计风险比（HR）。分析纳入2051例开具莫诺拉韦的患者和563例开具恩赛特韦的患者。开具莫诺拉韦的患者年龄更大，合并症患病率高于开具恩赛特韦的患者。然而，经多变量校正后，两组患者在腹泻或眩晕等主要症状风险或总体附加药物处方方面未观察到显著差异。例外是抗炎药，莫诺拉韦组风险显著更高（校正HR：3.44，95%置信区间：1.07-11.06）。这些结果表明，尽管在常规实践中莫诺拉韦与恩赛特韦的短期急性临床事件特征总体相当，但附加处方的差异，结合观察性研究设计和亚组分析统计效能有限，凸显了持续存在的临床不确定性。我们的发现提供了补充随机对照试验的真实世界证据，并强调未来需要更大规模研究。

英文摘要

Molnupiravir and ensitrelvir are widely used for outpatient coronavirus disease 2019 treatment; however, real-world safety comparisons remain limited. This retrospective cohort study evaluated acute clinical event risks over a 29-day follow-up using community pharmacy records from Japanese patients newly prescribed either drug between January and September 2023. Hazard ratios (HRs) were estimated using multivariable Cox proportional hazard models. The analysis included 2051 patients prescribed molnupiravir and 563 prescribed ensitrelvir. Patients prescribed molnupiravir were older and had a higher prevalence of comorbidities than those prescribed ensitrelvir. However, after multivariable adjustment, no significant differences in the risk of major symptoms, such as diarrhea or vertigo, or overall add-on drug prescription were observed between the patient groups. An exception was anti-inflammatory drugs, with a significantly higher risk in the molnupiravir group (adjusted HR: 3.44, 95% confidence interval: 1.07-11.06). These results indicate that while short-term acute clinical event profiles were broadly comparable between molnupiravir and ensitrelvir in routine practice, the differences in add-on prescriptions, combined with the observational study design and limited statistical power in sub-analyses, highlight persistent clinical uncertainty. Our findings provide real-world evidence complementary to that from randomized controlled trials and emphasize the need for larger future studies.