Shan Dan, Han Jinbiao, Ji Yurou, Wu Yuexiao, Yi Ke
Department of Obstetrics and Gynaecology, West China Second University Hospital, Sichuan University, No. 20, Renmin South Road, Section 3, Chengdu, 610041, Sichuan Province, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Sichuan Province, Chengdu, China.
Eur J Clin Pharmacol. 2025 Apr;81(4):465-477. doi: 10.1007/s00228-025-03804-y. Epub 2025 Jan 21.
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.
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 I statistics and the Cochran Q test, and the quality of evidence was appraised using Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.
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).
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).
孕妇中需要抗凝治疗的疾病患病率一直在稳步上升。尽管低分子量肝素（LMWH）被广泛使用，但已有多项研究探讨了磺达肝癸钠在孕妇中的应用。然而，磺达肝癸钠在该人群中的安全性仍有待充分阐明。
2024年9月对十个数据库进行了全面的文献检索。本荟萃分析遵循流行病学观察性研究的荟萃分析（MOOSE）指南进行观察性研究的系统评价。符合条件的研究中的二分数据使用Mantel-Haenszel模型进行合并。评估了具有95%置信区间的标准平均差。使用I统计量和Cochran Q检验评估异质性，并使用推荐分级、评估、制定和评价（GRADE）方法评估证据质量。
九项研究符合纳入标准。根据GRADE方法，证据质量从极低到低不等。磺达肝癸钠并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）。磺达肝癸钠与肝转氨酶升高风险降低相关（OR = 0.20，95%CI 0.08 - 0.49，P < 0.01），以及胃肠道反应、过敏和注射部位皮肤反应风险降低（OR = 0.19，95%CI 0.09 - 0.41，P < 0.01）。
本系统评价和荟萃分析的结果表明，孕妇使用磺达肝癸钠具有一定优势。然而，这些结论需要通过在多个国家进行的高质量、大规模研究进一步验证。（国际前瞻性系统评价注册库编号：CRD42024591579）
