Safety profiles of fondaparinux in pregnant women: a systematic review and meta-analysis.

IF 2.4 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-01-21 DOI:10.1007/s00228-025-03804-y

Dan Shan, Jinbiao Han, Yurou Ji, Yuexiao Wu, Ke Yi

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引用次数: 0

Abstract

Background: The prevalence of conditions necessitating anticoagulation therapy among pregnant women has been steadily increasing. Although low-molecular-weight heparin (LMWH) is commonly used, several studies have investigated the use of fondaparinux in pregnant women. However, the safety profile of fondaparinux in this population remains to be fully elucidated.

Methods: A comprehensive literature search across ten databases was conducted in September 2024. This meta-analysis was conducted following the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines for systematic reviews of observational studies. Dichotomous data from eligible studies were combined using the Mantel‒Haenszel model. Standard mean differences with 95% confidence intervals were assessed. Heterogeneity was evaluated using I² statistics and the Cochran Q test, and the quality of evidence was appraised using Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.

Results: Nine studies met the inclusion criteria. Based on the GRADE approach, the quality of evidence ranged from very low to low. Fondaparinux did not increase the incidence of bleeding-related adverse events (vaginal bleeding: OR = 0.99, 95% CI 0.43-2.30, P = 0.98; postpartum haemorrhage: OR = 0.35, 95% CI 0.07-1.73, P = 0.20). Fondaparinux was associated with reduced risks of hepatic transaminase elevation (OR = 0.20, 95% CI 0.08-0.49, P < 0.01), gastrointestinal reactions, allergies, and injection site skin reactions (OR = 0.19, 95% CI 0.09-0.41, P < 0.01).

Conclusion: The findings of this systematic review and meta-analysis suggest that the use of fondaparinux among pregnant women has certain advantages. However, these conclusions warrant further validation through high-quality, large-scale studies conducted in multiple countries. (PROSPERO-CRD42024591579).

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fondaparinux在孕妇中的安全性：一项系统回顾和荟萃分析。

背景：孕妇中需要抗凝治疗的疾病患病率稳步上升。虽然低分子肝素（LMWH）是常用的，但有几项研究调查了fondaparinux在孕妇中的使用。然而，fondaparinux在这一人群中的安全性仍有待充分阐明。方法：于2024年9月对10个数据库进行综合文献检索。本荟萃分析遵循流行病学观察性研究荟萃分析（MOOSE）指南进行，用于对观察性研究进行系统评价。使用Mantel-Haenszel模型将符合条件的二分类数据合并。以95%置信区间评估标准均值差异。采用I2统计量和Cochran Q检验评价异质性，采用推荐、评估、发展和评价分级（GRADE）方法评价证据质量。结果：9项研究符合纳入标准。基于GRADE方法，证据质量从非常低到低不等。Fondaparinux未增加出血相关不良事件的发生率(阴道出血：OR = 0.99, 95% CI 0.43-2.30, P = 0.98；产后出血：OR = 0.35, 95% CI 0.07 ~ 1.73, P = 0.20)。Fondaparinux与降低肝转氨酶升高风险相关（OR = 0.20, 95% CI 0.08-0.49， P）结论：本系统评价和荟萃分析的结果提示，孕妇使用Fondaparinux具有一定的优势。然而，这些结论需要通过在多个国家进行的高质量、大规模研究来进一步验证。(PROSPERO-CRD42024591579)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.