Servicio de Farmacia, Hospital Universitario Galdakao-Usansolo, Galdakao, Bizkaia, España.
Servicio de Farmacia, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Spain.
Farm Hosp. 2023 Jan-Feb;47(1):T39-T49. doi: 10.1016/j.farma.2022.12.016. Epub 2023 Jan 31.
The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning.
A bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected.
A total of 95 references were selected and the information on each drug was synthesized in tables. Drugs contraindicated in pregnancy are topical retinoids, pimecrolimus, cyclooxygenase 2 inhibitors, methotrexate, mycophenolate mofetil, leflunomide, acitretin, and thiopurines. The lack of data advises against the use of apremilast, tofacitinib, baricitinib, anakinra, abatacept, tocilizumab and the new biologicals. Topical salicylates, paracetamol, ultraviolet therapy and hydroxychloroquine treatment are safe, and anti-TNF biological therapy are considered low risk, with certolizumab being the drug of choice throughout pregnancy and lactation. Most are compatible with paternal exposure except for sulfasalazine, mycophenolate and leflunomide, for which suspension of treatment prior to conception is recommended, and cyclosporine with dose requirements of less than 2 mg/kg/day.
In this context of chronic treatments with teratogenic potential, it is necessary to highlight the importance of pregnancy planning to select the safest drug. Given the quality of the available data, it is still necessary to continuously update the information, as well as to promote observational studies of cohorts of pregnant patients and men of childbearing age, including prospective studies, in order to generate more scientific evidence.
本综述的目的是收集关于在妊娠和哺乳期使用的不同免疫介导性炎症疾病药物的现有证据,评估其对女性和男性生育能力的影响,为受孕前停药提供建议,并为常规临床实践提供帮助,以便为患者提供更好的生育计划建议。
进行了文献检索,检索了截至 2020 年 4 月发表的英文或西班牙文的综述研究、观察性研究和病例系列研究,分析了免疫介导性疾病患者在妊娠、哺乳和/或生育力方面的治疗管理。
共选择了 95 篇参考文献,并将每一种药物的信息综合在表格中。妊娠禁用药物包括局部维 A 酸、吡美莫司、环氧化酶 2 抑制剂、甲氨蝶呤、霉酚酸酯、来氟米特、阿维 A 酯和硫唑嘌呤。由于缺乏数据,不建议使用阿普米司特、托法替布、巴利昔单抗、阿那白滞素、阿巴西普、托珠单抗和新型生物制剂。局部水杨酸盐、对乙酰氨基酚、紫外线疗法和羟氯喹治疗是安全的,抗 TNF 生物治疗被认为是低风险的,而在整个妊娠和哺乳期,只有塞妥珠单抗是首选药物。除柳氮磺胺吡啶、霉酚酸酯和来氟米特外,大多数药物与父方暴露兼容,这些药物在受孕前需要停药,环孢素的剂量要求低于 2mg/kg/天。
在这种具有致畸潜力的慢性治疗背景下,必须强调妊娠计划的重要性,以选择最安全的药物。鉴于现有数据的质量,仍有必要不断更新信息,并促进对妊娠患者和育龄男性队列的观察性研究,包括前瞻性研究,以产生更多的科学证据。