比较阴道给药米索前列醇和地诺前列酮的安全性：一项回顾性药物警戒研究
Comparing the Safety Profiles of Vaginally Administered Misoprostol and Dinoprostone: A Retrospective Pharmacovigilance Study.
摘要(中文译文)
米索前列醇（Misoprostol）与地诺前列酮（dinoprostone）是引产过程中宫颈成熟最常用的药物。然而，两者的安全性比较数据仍然有限，尤其是关于罕见不良事件和超说明书用药方面。数据来源于FDA不良事件报告系统（FAERS）数据库，时间范围为2004年第一季度至2023年第四季度。提取涉及米索前列醇和地诺前列酮阴道给药的不良事件（AE）报告，随后进行去重并排除未注明给药途径的病例。共纳入3，925例米索前列醇相关不良事件和1，191例地诺前列酮相关不良事件进行分析。随后比较两组之间的临床特征。在系统器官分类（SOC）和首选术语（PT）两个层面，采用比例失衡法和贝叶斯方法进行药物警戒信号检测，包括报告比值比（ROR）、比例报告比（PRR）、信息成分（IC）和经验贝叶斯几何均值（EBGM）。两种药物呈现出不同的安全性特征。地诺前列酮主要与妊娠相关并发症有关，其中子宫破裂和产后出血的信号更强。相比之下，米索前列醇更常与终止妊娠相关事件（包括不全流产）以及胃肠道不良反应（如腹痛）相关。米索前列醇在超说明书用药方面也显示出更强的信号。这些发现提示，阴道给药的米索前列醇和地诺前列酮具有不同的安全性特征，通过突出每种药物相关的潜在风险，可为引产期间的临床决策提供参考。然而，由于FAERS是自发报告系统，存在漏报、报告偏倚以及无法确定因果关系等局限性，结果应谨慎解读。需要进一步的前瞻性研究来验证这些安全性观察结果。
Abstract
Misoprostol and dinoprostone are the most commonly used agents for cervical ripening during labour induction. However, comparative safety data remain limited, particularly regarding rare adverse events and off-label use. Data were obtained from the FDA Adverse Event Reporting System (FAERS) database for the period from the first quarter of 2004 to the fourth quarter of 2023. Adverse event (AE) reports involving vaginal administration of misoprostol and dinoprostone were extracted, followed by deduplication and exclusion of cases without a specified route of administration. A total of 3,925 misoprostol-related and 1,191 dinoprostone-related AEs were included for analysis. Clinical characteristics were then compared between the two groups. Pharmacovigilance signal detection was performed at both the system organ class (SOC) and preferred term (PT) levels using disproportionality and Bayesian approaches, including reporting odds ratios (RORs), proportional reporting ratios (PRRs), information components (ICs), and empirical Bayesian geometric means (EBGMs). Distinct safety profiles were observed between the two agents. Dinoprostone was primarily associated with pregnancy-related complications, including stronger signals for uterine rupture and postpartum haemorrhage. In contrast, misoprostol was more frequently associated with pregnancy termination-related events, including incomplete abortion, as well as gastrointestinal adverse effects such as abdominal pain. Misoprostol also demonstrated a stronger signal for off-label use. These findings suggest that vaginally administered misoprostol and dinoprostone exhibit different safety profiles, which may inform clinical decision-making during labour induction by highlighting potential risks associated with each agent. However, because FAERS is a spontaneous reporting system subject to underreporting, reporting bias, and the inability to establish causality, the results should be interpreted with caution. Further prospective studies are warranted to validate these safety observations.
如何引用
AMA
Lingling Zeng, Qian Yang, Jinfa Huang, Hai Liang, Guilian Wang, Kaixian Deng. Comparing the Safety Profiles of Vaginally Administered Misoprostol and Dinoprostone: A Retrospective Pharmacovigilance Study.. Journal of visualized experiments : JoVE. 2026; doi:10.3791/71130.
APA
Lingling Zeng, Qian Yang, Jinfa Huang, Hai Liang, Guilian Wang, Kaixian Deng (2026). Comparing the Safety Profiles of Vaginally Administered Misoprostol and Dinoprostone: A Retrospective Pharmacovigilance Study.. Journal of visualized experiments : JoVE. https://doi.org/10.3791/71130
GB/T 7714
Lingling Zeng, Qian Yang, Jinfa Huang, Hai Liang, Guilian Wang, Kaixian Deng. Comparing the Safety Profiles of Vaginally Administered Misoprostol and Dinoprostone: A Retrospective Pharmacovigilance Study.[J]. Journal of visualized experiments : JoVE, 2026 doi:10.3791/71130.
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