Baldwin Corisande, Avina-Zubieta Antonio, Rai Sharan K, Carruthers Erin, De Vera Mary A
Division of Rheumatology, Department of Medicine, University of British Columbia Faculty of Medicine, Vancouver, BC, Canada.
Division of Rheumatology, Department of Medicine, University of British Columbia Faculty of Medicine; Arthritis Research Centre of Canada, Richmond; and Dept.of Experimental Medicine, University of British Columbia Faculty of Medicine, Vancouver, Canada.
Clin Exp Rheumatol. 2016 Mar-Apr;34(2):172-83. Epub 2016 Mar 3.
Despite the high incidence of rheumatic diseases during the reproductive years, little is known about the impact of disease-modifying anti-rheumatic drug (DMARD) use during pregnancy. Our objective was to systematically review and appraise evidence in women with rheumatic disease on the use of traditional and biologic DMARDs during pregnancy and the risk of congenital malformation outcomes.
We conducted a systematic search of MEDLINE, EMBASE, and INTERNATIONAL PHARMACEUTICAL ABSTRACTS databases. Inclusion criteria were: 1) study sample including women with rheumatic disease; 2) use of traditional and/or biologic DMARDs during pregnancy; and 3) congenital malformation outcome(s) reported. We extracted information on study design, data source, number of exposed pregnancies, type of DMARD, number of live births, and number of congenital malformations.
Altogether, we included 79 studies; the majority were based on designs that did not involve a comparison group, including 26 case reports, 17 case series, 20 cross-sectional studies, and 4 surveys. Studies that had a comparator group included 1 case control, 10 cohort studies, and 1 controlled trial. Hydroxychloroquine and azathioprine represent the most studied traditional DMARD exposures and, among biologics, most of the reports were on infliximab and etanercept.
This is the first systematic review on the use of both traditional and biologic DMARDs during pregnancy among women with rheumatic diseases and congenital malformation outcomes, with a focus on study design and quality. Findings confirm the limited number of studies, as well as the need to improve study designs.
尽管风湿性疾病在育龄期发病率很高，但关于孕期使用改善病情抗风湿药物（DMARD）的影响却知之甚少。我们的目的是系统回顾和评估有关风湿性疾病女性孕期使用传统和生物DMARD以及先天性畸形结局风险的证据。
我们对MEDLINE、EMBASE和国际药学文摘数据库进行了系统检索。纳入标准为：1）研究样本包括患有风湿性疾病的女性；2）孕期使用传统和/或生物DMARD；3）报告了先天性畸形结局。我们提取了有关研究设计、数据来源、暴露妊娠数、DMARD类型、活产数和先天性畸形数的信息。
我们总共纳入了79项研究；大多数研究基于不涉及对照组的设计，包括26例病例报告、17例病例系列、20项横断面研究和4项调查。有比较组的研究包括1项病例对照研究、10项队列研究和1项对照试验。羟氯喹和硫唑嘌呤是研究最多的传统DMARD暴露药物，在生物制剂中，大多数报告涉及英夫利昔单抗和依那西普。
这是第一项关于风湿性疾病女性孕期使用传统和生物DMARD以及先天性畸形结局的系统评价，重点关注研究设计和质量。研究结果证实了研究数量有限，以及改进研究设计的必要性。
