Risk of major birth defects after first-trimester exposure to carbocisteine and ambroxol: A multicenter prospective cohort study using counseling data for drug safety during pregnancy

IF 1.3 4区 医学 Q3 PEDIATRICS
Mariko Usuda, Seung Chik Jwa, Mikako Goto, Mizuki Kobayashi, Hiroyuki Nagano, Naho Yakuwa, Ritsuko Yamane, Atsuko Murashima, Hideki Makabe
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引用次数: 0

Abstract

To assess the risk of major birth defects after first-trimester exposure to carbocisteine and ambroxol during pregnancy, we conducted a prospective cohort study using counseling data for drug use during pregnancy provided by the Japan Drug Information Institute in Pregnancy and Toranomon Hospital. Counseling information, including drug usage and participants' demographic information, was collected between April 1988 and December 2017. Pregnancy outcome data, including major birth defects, were obtained using a questionnaire administered 1 month after delivery. The risks of major birth defects after first-trimester exposure to carbocisteine (n = 588) and ambroxol (n = 341) were compared with those of nonteratogenic drug use during the first trimester (n = 1525). The adjusted odds ratio (aORs) for major birth defects was calculated using a multiple logistic regression analysis adjusted for confounders. The incidence of major birth defects was 1.2% (7/588) and 2.1% (7/341) in the carbocisteine and ambroxol groups, respectively, which was comparable to the control group (26/1525, 1.7%). Results of multiple logistic regression demonstrated similar nonsignificant risks for both carbocisteine (aOR: 0.66, 95% confidence interval [CI]: 0.40–1.1, p = 0.11) and ambroxol (aOR: 1.1, 95% CI: 0.18–7.2, p = 0.88). No specific major birth defects were reported in the carbocisteine or ambroxol groups. This study demonstrated that carbocisteine and ambroxol exposure during the first trimester was not associated with an increased risk of major birth defects. These results could help in counseling for the use of these drugs during pregnancy and further alleviate anxiety in patients.

Abstract Image

妊娠初期接触卡波司汀和氨溴索后出现重大先天缺陷的风险:一项利用孕期用药安全咨询数据进行的多中心前瞻性队列研究。
为了评估孕期第一胎暴露于卡波司汀和氨溴索后出现重大出生缺陷的风险,我们利用日本妊娠药物信息研究所和虎之门医院提供的孕期用药咨询数据进行了一项前瞻性队列研究。咨询信息包括药物使用情况和参与者的人口统计学信息,收集时间为 1988 年 4 月至 2017 年 12 月。妊娠结果数据(包括重大出生缺陷)通过产后 1 个月的问卷调查获得。将第一孕期接触卡博司汀(n = 588)和氨溴索(n = 341)后出现重大出生缺陷的风险与第一孕期使用非致畸药物(n = 1525)后出现重大出生缺陷的风险进行了比较。采用多重逻辑回归分析计算了重大出生缺陷的调整赔率(aORs),并对混杂因素进行了调整。卡博司坦组和氨溴索组的重大出生缺陷发生率分别为 1.2%(7/588)和 2.1%(7/341),与对照组(26/1525,1.7%)相当。多元逻辑回归结果显示,卡博司汀(aOR:0.66,95% 置信区间[CI]:0.40-1.1,p = 0.11)和氨溴索(aOR:1.1,95% CI:0.18-7.2,p = 0.88)的风险相似,但不显著。卡博司坦组和氨溴索组均未报告具体的重大先天缺陷。这项研究表明,妊娠头三个月接触卡波司汀和氨溴索不会增加重大出生缺陷的风险。这些结果有助于为孕期使用这些药物提供咨询,并进一步减轻患者的焦虑。
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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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