Department of Pharmacy, Saitama Medical University, Saitama, Japan.
Department of Obstetrics and Gynecology, Saitama Medical University, Saitama, Japan.
Congenit Anom (Kyoto). 2024 May;64(3):91-98. doi: 10.1111/cga.12557. Epub 2024 Mar 6.
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.
为了评估妊娠早期使用卡漠司汀和氨溴索后发生重大出生缺陷的风险，我们使用日本药品信息研究所和虎之门医院在妊娠期间提供的药物使用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。使用分娩后 1 个月进行的问卷调查获取妊娠结局数据，包括重大出生缺陷。将妊娠早期暴露于卡漠司汀（n=588）和氨溴索（n=341）与非致畸药物使用（n=1525）的重大出生缺陷风险进行比较。使用多因素逻辑回归分析调整混杂因素后，计算重大出生缺陷的调整优势比（aOR）。卡漠司汀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。多因素逻辑回归分析结果表明，卡漠司汀（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）的风险均无显著差异。卡漠司汀或氨溴索组均未报告特定的重大出生缺陷。本研究表明，妊娠早期暴露于卡漠司汀和氨溴索并不增加重大出生缺陷的风险。这些结果有助于在妊娠期间使用这些药物进行咨询，并进一步减轻患者的焦虑。
