The safety of pranlukast and montelukast during the first trimester of pregnancy: A prospective, two-centered cohort study in Japan

IF 1.3 4区 医学 Q3 PEDIATRICS Congenital Anomalies Pub Date : 2022-05-10 DOI:10.1111/cga.12471
Shiro Hatakeyama, Mikako Goto, Ayaka Yamamoto, Jiro Ogura, Norikazu Watanabe, Seiji Tsutsumi, Naho Yakuwa, Ritsuko Yamane, Satoru Nagase, Kunihiko Takahashi, Rika Kosaki, Atsuko Murashima, Hiroaki Yamaguchi
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引用次数: 1

Abstract

For leukotriene receptor antagonists (LTRAs), especially pranlukast, safety data during pregnancy is limited. Therefore, we conducted a prospective, two-centered cohort study using data from teratogen information services in Japan to clarify the effects of LTRA exposure during pregnancy on maternal and fetal outcomes. Pregnant women who being counseled on drug use during pregnancy at two facilities were enrolled. The primary outcome of this study was major congenital anomalies. The incidence of major congenital anomalies in women exposed to montelukast or pranlukast during the first trimester of pregnancy was compared with that of controls. Logistic regression analysis was performed to analyze the effects of maternal LTRA use during the first trimester of pregnancy on major congenital anomalies. The outcomes of 231 pregnant women exposed to LTRAs (montelukast n = 122; pranlukast n = 106; both n = 3) and 212 live births were compared with those of controls. The rate of major congenital anomalies in the LTRA group was 1.9%. Multivariable logistic regression analysis revealed that LTRA exposure was not a risk factor for major congenital anomalies (adjusted odds ratio, 0.78; 95% confidence interval, 0.23–2.05; p = 0.653). In addition, no significant difference was detected in stillbirth, spontaneous abortion, preterm birth, and low birth weight between the two groups. The present study revealed that montelukast and pranlukast were not associated with the risk of major congenital anomalies. Our findings suggest that LTRAs could be safely employed for asthma therapy during pregnancy.

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普鲁司特和孟鲁司特在妊娠早期的安全性:日本的一项前瞻性、双中心队列研究
对于白三烯受体拮抗剂(LTRAs),特别是普鲁卡斯特,妊娠期间的安全性数据有限。因此,我们进行了一项前瞻性、双中心队列研究,使用来自日本致畸物信息服务的数据,以阐明妊娠期间LTRA暴露对母体和胎儿结局的影响。在两个机构接受怀孕期间药物使用咨询的孕妇被纳入研究。这项研究的主要结果是主要的先天性异常。在妊娠前三个月暴露于孟鲁司特或普鲁司特的妇女的主要先天性异常的发生率与对照组比较。采用Logistic回归分析分析妊娠前三个月产妇使用LTRA对主要先天性异常的影响。231例暴露于LTRAs的孕妇的结局(孟鲁司特n = 122;Pranlukast n = 106;n = 3)和212例活产婴儿与对照组比较。LTRA组重大先天性畸形发生率为1.9%。多变量logistic回归分析显示LTRA暴露不是主要先天性异常的危险因素(校正优势比,0.78;95%置信区间为0.23-2.05;p = 0.653)。此外,两组在死胎、自然流产、早产、低出生体重方面无显著差异。目前的研究显示孟鲁司特和普鲁司特与重大先天性异常的风险无关。我们的研究结果表明,LTRAs可以安全地用于妊娠期间的哮喘治疗。
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来源期刊
Congenital Anomalies
Congenital Anomalies PEDIATRICS-
自引率
0.00%
发文量
49
审稿时长
>12 weeks
期刊介绍: Congenital Anomalies is the official English language journal of the Japanese Teratology Society, and publishes original articles in laboratory as well as clinical research in all areas of abnormal development and related fields, from all over the world. Although contributions by members of the teratology societies affiliated with The International Federation of Teratology Societies are given priority, contributions from non-members are welcomed.
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