Department of Pharmacy, West China Second University Hospital, Sichuan University, Renmin Nan Road 20, Chengdu, 610041, China.
Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.
Eur J Clin Pharmacol. 2024 Nov;80(11):1625-1657. doi: 10.1007/s00228-024-03736-z. Epub 2024 Aug 26.
To comprehensively evaluate and compare all the available reference guides for the safe use of drugs during pregnancy, with the goal of determining the scientificity and reliability of these reference guides.
We searched PubMed, EMbase, CNKI, Wanfang Database, and VIP database to comprehensively identify the available reference guides. Moreover, we selected 103 drugs based on relevant literatures, and compared the recommendations of each drug from different reference guides.
A total of 14 available reference guides were identified. However, none of these reference guides assessed the risk of bias of original studies or the quality of current evidence. Seven reference guides adopted expert consensus method to formulate pregnancy recommendations, while the rest reference guides did not report the formation method. Moreover, 77.7% of the selected drugs had inconsistent recommendations among different reference guides. In addition, the referenced human and animal studies for the same drug differed among different reference guides.
Our results indicate that current reference guides for the safe use of drugs during pregnancy are less scientific and reliable, and there are considerable discrepancies in recommendations from different reference guides concerning drug use during pregnancy. The reasons for the discrepancies in recommendations include ① the literature search in most reference guides was not comprehensive, ② none of the available reference guides assessed the risk of bias of original studies or the quality of current evidence, and ③ the method adopted by current reference guides to formulate recommendations had obvious subjectivity and lacked of scientificity.
全面评估和比较所有现有的孕期安全用药参考指南，以确定这些参考指南的科学性和可靠性。
我们检索了 PubMed、EMbase、CNKI、万方数据库和 VIP 数据库，以全面识别现有的参考指南。此外，我们根据相关文献选择了 103 种药物，并比较了不同参考指南中每种药物的推荐意见。
共确定了 14 种现有的参考指南。然而，这些参考指南均未评估原始研究的偏倚风险或当前证据的质量。7 种参考指南采用专家共识方法制定妊娠推荐意见，而其余参考指南则未报告形成方法。此外，77.7%的选定药物在不同参考指南中有不一致的推荐意见。此外，不同参考指南中同一药物的参考人类和动物研究也不同。
我们的研究结果表明，目前孕期安全用药参考指南的科学性和可靠性较差，不同参考指南对孕期用药的推荐意见存在较大差异。推荐意见存在差异的原因包括：①大多数参考指南的文献检索不够全面；②现有的参考指南均未评估原始研究的偏倚风险或当前证据的质量；③目前参考指南采用的制定建议的方法具有明显的主观性，缺乏科学性。
