Pregnancy outcome following in utero exposure to azathioprine: A French comparative observational study
Pregnancy outcome following in utero exposure to azathioprine: A French comparative observational study
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DOI：
10.1016/j.therap.2017.06.006
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发表时间：
2018-05-01
期刊：
影响因子：
2.6
通讯作者：
Jonville-Bera, Annie-Pierre
中科院分区：
文献类型：
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作者：
Alami, Zayneb;Agier, Marie Sara;Jonville-Bera, Annie-Pierre
研究目的-评估是否在怀孕期间接触硫唑嘌呤会增加出生缺陷和早产的风险。使用法国妊娠数据库TERAPPEL进行的前瞻性比较观察性研究。为了评价出生缺陷，前瞻性评估妊娠早期暴露于硫唑嘌呤的妊娠结局，并与暴露于用于相同适应症的另一种药物的妊娠结局进行比较。其次，早产率进行了比较胎儿暴露于硫唑嘌呤至少在第三个三个月和那些暴露在第一个三个月ONLY.Results从447个请求的风险评估妇女在怀孕期间接受硫唑嘌呤，193怀孕符合纳入标准。其中124例在妊娠早期暴露于硫唑嘌呤，并与124例暴露于用于相同适应症的另一种药物的妊娠进行比较。在妊娠早期使用硫唑嘌呤与所有出生缺陷的风险无统计学相关性（[7.3% vs. 5.4%]; [OR = 1.36; 95%CI：0.44-4.20]），与主要出生缺陷也无统计学相关性（5.2% vs. 1.8% [OR= 2.96; 95%CI：0.56-15.64]）。早产率（22.5% vs. 27.3%，P=0.579）相似，无论硫唑嘌呤的暴露期如何（至少在妊娠晚期或仅在妊娠早期）。本研究证实，妊娠早期暴露于硫唑嘌呤与出生缺陷率升高无关，暴露于硫唑嘌呤的妇女中早产率高可能是由潜在的母体疾病解释的。(C)2017法国药理学和治疗学会。由Elsevier Masson SAS出版。All rights reserved.
Aim of the study.-To evaluate whether azathioprine exposure during pregnancy increases the risk of birth defects and prematurity.Method.-Prospective comparative observational study using the French pregnancy database TERAPPEL. To evaluate birth defects, outcomes of pregnancies exposed to azathioprine during the 1st trimester were prospectively assessed and compared to that of pregnancies exposed to another drug used for the same indications. Secondly, the rate of preterm births was compared between fetuses exposed to azathioprine at least during the third trimester and those exposed during the first trimester only.Results From 447 requests for a risk assessment for women receiving azathioprine during pregnancy, 193 pregnancies meet inclusion criteria. One hundred and twenty-four of them were exposed to azathioprine during the 1st trimester and were compared to that of 124 pregnancies exposed to another drug used for the same indication. Azathioprine use during the first trimester was not statistically associated with the risk of all birth defects ([7.3% vs. 5.4%]; [OR = 1.36; 95%CI: 0.44-4.20]) nor with major birth defects (5.2% vs. 1.8% [OR= 2.96; 95%CI:0.56-15.64]). The rate of preterm births (22.5% vs. 27.3%, P=0.579) was similar regardless of the exposure period to azathioprine (at least during the third trimester or during the first trimester only).Conclusions.-This study confirms that first trimester exposure to azathioprine is not associated with an elevated rate of birth defects and that the high rate of preterm births among women exposed to azathioprine is probably explained by the underlying maternal disease. (C) 2017 Societe francaise de pharmacologie et de therapeutique. Published by Elsevier Masson SAS. All rights reserved.