The teratogenic risk of trimethoprim-sulfonamides: A population based case-control study
The teratogenic risk of trimethoprim-sulfonamides: A population based case-control study
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DOI：
10.1016/s0890-6238(01)00178-2
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发表时间：
2001-11-01
影响因子：
3.3
通讯作者：
Olsen, J
中科院分区：
文献类型：
--
作者：
Czeizel, AE;Rockenbauer, M;Olsen, J
目的：研究两种甲氧苄啶-磺胺类药物复方制剂：甲氧苄啶-磺胺异恶唑（复方新诺明）和甲氧苄啶-磺胺二甲嘧啶在妊娠期间对人体的致畸潜力。这些药物具有抗叶酸作用，其他抗叶酸药物在动物实验和人体实验中可诱导多种先天性畸形、神经管缺陷、心血管和其他畸形。设计：对1980年至1996年匈牙利先天性畸形病例对照监测的大人群数据集中先天性畸形病例和匹配的健康对照进行配对分析。38，151名新生儿无任何先天性异常的孕妇（对照组）和22，865例新生儿或胎儿先天性畸形的孕妇。主要结果：在配对的病例对照对中研究药物使用与先天性畸形的可能关联。病例组351例（1.5%）和对照组443例（1.2%）孕妇接受复方新诺明治疗（粗OR 1.3，95% CI 1.1-1.5）。此外，45例（0.2%）病例和39例（0.1%）对照孕妇接受了甲氧苄啶-磺胺二甲嘧啶治疗（粗OR 1.9，95%CI 1.3-3.0）。在妊娠第二至第三个月接受复方新诺明治疗的母亲所生婴儿中，发现多项先天性畸形（主要包括泌尿道和心血管畸形）的发生率较高。此外，较高的心血管畸形发生率的情况下出生的母亲与复方新诺明治疗和甲氧苄啶-磺胺二甲嘧啶治疗在第二个第三个月的pregnancy，either：结论：治疗复方新诺明在怀孕期间可能会增加心血管畸形的风险，特别是多种先天性异常，包括泌尿道和心血管系统的缺陷。在妊娠的第二个月和第三个月使用甲氧苄啶-磺胺二甲嘧啶治疗后，心血管畸形的发生率也较高。(C)2001 Elsevier Science Inc. All rights reserved.
Objective: To study human teratogenic potential of two trimethoprim-sulfonamide combinations: trimethoprim-sulfaiiiethoxazole (cotrimoxazole) and trimethoprim-sulfamethazine during pregnancy. These agents have antifolate effects and other antifolate agents can induce multiple congenital abnormalities, neural-tube defects, cardiovascular, and other malformations in animal experiments and in humans.Design: Pair analysis of cases with congenital abnormalities and matched healthy controls in the large population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996.Participants: 38,151 pregnant women who had newborn infants without any congenital abnormalities (control group) and 22,865 case pregnant women who had newborns or fetuses with congenital abnormalities.Main Outcome: Prevalence of drug use in matched case-control pairs to study the possible association with congenital abnormalities.Results: In the case group 351 (1.5%) and in the control group 443 (1.2%) pregnant women were treated with cotrimoxazole (crude OR 1.3 with 95% CI 1.1-1.5). In addition 45 (0.2%) case and 39 (0.1%) control pregnant women had trimethoprim-sulfamethazine treatment (crude OR 1.9 with 95% CI 1.3-3.0). A higher rate of multiple congenital abnormalities (including mainly urinary tract and cardiovascular abnormalities) was found in case infants born to mothers with cotrimoxazole treatment during the second-third months of pregnancy. In addition, a higher rate of cardiovascular malformations occurred in cases born to mothers with cotrimoxazole treatment and trimethoprim-sulfamethazine treatment during the second-third months of pregnancy, respectively.Conclusion: Treatment with cotrimoxazole during pregnancy may increase the risk of cardiovascular malformations, and particularly multiple congenital abnormalities including defects of the urinary tract and cardiovascular system. A higher rate of cardiovascular malformations was also found after treatment with trimethoprim-sulfamethazine the second-third months of pregnancy. (C) 2001 Elsevier Science Inc. All rights reserved.