Department of Obstetrics, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.
Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, China.
Acta Obstet Gynecol Scand. 2023 Jun;102(6):735-743. doi: 10.1111/aogs.14553. Epub 2023 Apr 19.
The potential teratogenic risk of traditional Chinese medicine (TCM) is of widespread concern; however, related evidence is largely absent in humans. This study aimed to compare the prevalence of congenital malformations between pregnant women with and without TCM exposure.
This was a multicenter prospective cohort study of 17 713 women who participated in a survey on periconceptional TCM exposure. Primary outcome was congenital malformations diagnosed from a survey conducted on the day 42 after delivery.
A total of 16 751 pregnant women with 273 congenital malformations were included in the analysis. Fetuses exposed to TCM had an increased risk of congenital malformations compared to those without exposure (odds ratio [OR] 2.10; 95% confidence interval [CI] 1.09-4.02) after controlling for potential confounders. There were significant associations with congenital malformations in women with early pregnant exposure (OR 2.04, 95% CI 1.00-4.20) and for those who received ≥2 TCM formulas (OR 5.84, 95% CI 1.44-23.65). Pre-pregnancy TCM exposure was significantly associated with an increased risk of congenital heart defects (OR 12.69; 95% CI 3.01-53.51).
Periconceptional TCM exposure is associated with an increased risk of congenital malformation. This effect was cumulative and sensitive to periconceptional age. Therefore, TCM deserves more attention and should be used cautiously for pregnant women and those trying to become pregnant.
传统中药（TCM）的潜在致畸风险引起了广泛关注；然而，相关证据在人类中基本缺失。本研究旨在比较有和无 TCM 暴露的孕妇先天性畸形的发生率。
这是一项对 17713 名参与围孕期 TCM 暴露调查的女性进行的多中心前瞻性队列研究。主要结局是在产后第 42 天进行的调查中诊断出的先天性畸形。
共有 16751 名孕妇，其中 273 名胎儿患有先天性畸形，纳入分析。控制潜在混杂因素后，与无 TCM 暴露的孕妇相比，TCM 暴露的胎儿先天性畸形的风险增加（比值比 [OR] 2.10；95%置信区间 [CI] 1.09-4.02）。对于早孕暴露的女性（OR 2.04，95% CI 1.00-4.20）和接受≥2 种 TCM 配方的女性（OR 5.84，95% CI 1.44-23.65），与先天性畸形存在显著关联。孕前 TCM 暴露与先天性心脏病（OR 12.69；95% CI 3.01-53.51）的风险增加显著相关。
围孕期 TCM 暴露与先天性畸形风险增加相关。这种影响是累积的，且对围孕期年龄敏感。因此，TCM 值得更多关注，孕妇和备孕者应谨慎使用。
