抗TNF生物制剂与妊娠:英国风湿病学会生物制剂注册研究结果

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摘要：目的：英国风湿病协会生物制剂注册研究（BSRBR）收集了接受抗肿瘤坏死因子疗法的患者的妊娠等数据，以总结接受抗TNF的妇女的妊娠转归。
        方法：根据是否存在抗TNF暴露将患者分为4组：1.受孕时暴露于抗TNF治疗并暴露于甲氨蝶呤（mtx）和/或来氟米特(LEF)（n=21次妊娠）；2.受孕时暴露于抗TNF治疗（n=50）；3.受孕前曾暴露于抗TNF治疗；4.无抗TNF治疗暴露史（对照组，n=10）。
        结果：在受孕前或受孕时接受抗TNF治疗的患者共130次妊娠中，活产共88次。受孕时接受抗TNF治疗的患者的自发流产率最高（合并MTX/LEF者33%，不合并MTX/LEF者24%）。受孕前暴露于抗TNF治疗者自发流产率为17%，对照组为10%。总共进行了10次人工妊娠终止。
        结论：虽然目前的数据还是很有希望的，但还不能够得出妊娠期间抗TNF治疗安全性的确证证据。在得到等过的证据之前，指南中提到的生物制剂应避免受孕时应用的内容还不能更改。
        附原文：Objective The British Society for Rheumatology Biologics Register (BSRBR) has collected data on adverse events including pregnancies in patients with rheumatoid arthritis treated with anti-tumour necrosis factor (anti-TNF) therapy. The purpose of this report is to summarise the pregnancy outcomes in women treated with anti-TNF in the BSRBR. Methods Patients were categorised according to anti-TNF exposure as follows: (1) exposure to anti-TNF and to methotrexate (MTX) and/or lefl unomide (LEF) at conception (n=21 pregnancies); (2) exposure to anti-TNF at conception (n=50); (3) exposure to anti-TNF prior to conception (n=59); (4) no exposure to anti-TNF (control group; n=10). Results Eighty-eight live births in a total of 130 pregnancies were reported in patients who received anti-TNF before or during pregnancy. The rate of spontaneous abortion was highest among patients exposed to anti-TNF at the time of conception (with MTX/LEF 33% and without MTX/LEF 24%). This compared with 17% spontaneous abortions in those with prior exposure to anti-TNF and 10% spontaneous abortions in the control group. Ten terminations were performed. Conclusion Although the results to date have been promising, no fi rm conclusions can be drawn about the safety of anti-TNF during pregnancy and, without further evidence, guidelines which suggest these drugs should be avoided at the time of conception cannot yet be changed.
        引自：Anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register Suzanne M M Verstappen, Yvonne King, Kath D Watson, Deborah P M Symmons, Kimme L Hyrich; BSRBR Control Centre Consortium, BSR Biologics RegisterABSTRACT