Ding Ning, Zhao Luqing, Zhu Lingfei, Sun Weijia, Li Danyan, Li Jiake, Zhang Jun, Zhang Shengsheng
Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.
Clinical Medical College, Beijing University of Chinese Medicine, Beijing, China.
J Clin Pharm Ther. 2022 Dec;47(12):1952-1965. doi: 10.1111/jcpt.13817. Epub 2022 Nov 30.
The management of biological agents during pregnancy poses challenges as maternal and infant safety must be addressed. This study aims to compare the recommendations of existing guidelines on managing the use of biologics during pregnancy, lactation for patients with inflammatory bowel disease, and the influence on neonatal vaccination.
The PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang database, China Science and Technology Journal Database and China Biomedical Database were systematically searched from the inception date to 11 May 2022, to screen all relevant guidelines. Quality assessment was performed using the guideline methodology reporting tool AGREE II.
Fourteen guidelines and consensus statements with detailed recommendations were included. All guidance documents cover management comments during pregnancy, and most consider that biologics can be given safely during pregnancy but require suspension at the right time to protect the foetus. However, the roles of vedolizumab and ustekinumab are disputed. Five documents guide lactation and the use of most biologics during lactation is safe, but no guidelines recommend vedolizumab. Six papers provide recommendations for newborns' vaccination, suggesting a delay in infants' live vaccination schedule if their mothers are treated with biologics.
Our study concluded that future guidelines could consider incorporating newer, more robust evidence to update recommendations. The development of future guidelines needs to consider the involvement of multidisciplinary experts, adequately report on the evidence retrieval process, and provide strategies for implementation. Besides, more research is needed to explore the use of biologics during pregnancy and lactation in patients with inflammatory bowel disease.
孕期生物制剂的管理存在挑战，因为必须兼顾母婴安全。本研究旨在比较现有关于炎症性肠病患者孕期及哺乳期生物制剂使用管理指南的建议，以及对新生儿疫苗接种的影响。
从各数据库建库至2022年5月11日，系统检索PubMed、EMBASE、中国知网、万方数据库、中国科技期刊数据库和中国生物医学数据库，以筛选所有相关指南。使用指南方法学报告工具AGREE II进行质量评估。
纳入了14份有详细建议的指南和共识声明。所有指导文件都涵盖了孕期管理意见，大多数认为生物制剂在孕期可安全使用，但需要在适当时间停药以保护胎儿。然而，维多珠单抗和乌司奴单抗的作用存在争议。5份文件指导哺乳期用药，大多数生物制剂在哺乳期使用是安全的，但没有指南推荐维多珠单抗。6篇论文为新生儿疫苗接种提供了建议，表明如果母亲接受生物制剂治疗，婴儿的活疫苗接种计划应推迟。
我们的研究得出结论，未来的指南可考虑纳入更新、更有力的证据来更新建议。未来指南的制定需要考虑多学科专家的参与，充分报告证据检索过程，并提供实施策略。此外，还需要更多研究来探索炎症性肠病患者孕期及哺乳期生物制剂的使用情况。
