抗TNF疗法与妊娠:英国风湿病协会生物制剂登记系统的130次妊娠结果

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Ann Rheum Dis doi:10.1136/ard.2010.140822 Clinical and epidemiological research Concise report Anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register   1.       Suzanne M M Verstappen, 2.       Yvonne King, 3.       Kath D Watson, 4.       Deborah P M Symmons, 5.       Kimme L Hyrich, 6.       ; BSRBR Control Centre Consortium, BSR Biologics Register + Author Affiliations 1.       Arthritis Research UK Epidemiology Unit, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK 1.       Correspondence to Dr Kimme Hyrich, Arthritis Research UK Epidemiology Unit, Manchester Academic Health Centre, University of Manchester, Stopford Building, Oxford Road, Manchester M13 9PT, UK; Kimme.Hyrich@manchester.ac.uk Accepted 15 November 2010 Published Online First 28 February 2011 Abstract 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 leflunomide (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 firm 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.

抗-TNF疗法与妊娠:英国风湿病协会生物制剂登记系统的130次妊娠结果 Suzanne M Yvonne King, M Verstappen,et al,Ann Rheum Dis doi:10.1136/ard.2010.140822   目的 英国风湿病协会生物制剂登记系统(BSRBR)收集了不良事件的数据,其中包括类风湿性关节炎患者接受抗肿瘤坏死因子(抗-TNF)治疗时发生妊娠。本报告目的是总结BSRBR系统中妇女接受抗-TNF治疗时妊娠的结果。 方法 根据患者抗-TNF暴露情况分类如下:(1) 在怀孕时应用抗anti-TNF和甲氨蝶呤(MTX)和/或来氟米特(LEF) (n = 21);(2)在怀孕时应用抗-TNF(n = 50);(3)在怀孕前应用抗-TNF(n = 59);(4)未应用抗-TNF(对照组,10例)。 结果 孕前或孕时应用抗-TNF治疗的RA患者130次妊娠中,共报道有88名活产儿。怀孕时应用抗-TNF的自发流产率最高 (合用MTX/ LEF 33%,未合用MTX / LEF 24%)。相较之下,怀孕前应用抗-TNF患者的自发流产率为17%，而对照组仅为10%。 结论 虽然目前的结果一直有望,但仍无法得出关于妊娠期间抗-TNF的安全性结论,也缺乏进一步的证据，因此指南中怀孕期间应避免使用这些药物的建议还不能被改变。