Risk of Major Congenital Malformations Associated with the Use of Japanese Traditional (Kampo) Medicine Containing Ephedra During the First Trimester of Pregnancy.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY

Drugs - Real World Outcomes Pub Date : 2024-06-01 Epub Date: 2024-01-19 DOI:10.1007/s40801-023-00411-0

Aoi Noda, Taku Obara, Fumiko Matsuzaki, Satoko Suzuki, Ryutaro Arita, Minoru Ohsawa, Ryo Obara, Kei Morishita, Fumihiko Ueno, Genki Shinoda, Masatsugu Orui, Keiko Murakami, Mami Ishikuro, Akiko Kikuchi, Shin Takayama, Tadashi Ishii, Hiroshi Kawame, Shigeo Kure, Shinichi Kuriyama

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引用次数: 0

Abstract

Background: Japanese traditional (Kampo) medicines containing ephedra may be used to treat colds during pregnancy. There are reports that ephedrine, a component of ephedra, has a risk of teratogenicity; however, the evidence remains equivocal.

Objective: This study aimed to evaluate the risk of major congenital malformations (MCMs) associated with exposure to Kampo medicines containing ephedra during the first trimester of pregnancy using the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study).

Methods: To 23,730 mother-infant pairs who participated in the TMM BirThree Cohort Study from July 2013 to March 2017, questionnaires in early and middle pregnancy were distributed approximately at weeks 12 and 26 of pregnancy, respectively. Infants' risk of MCMs in women who used Kampo medicines containing ephedra or acetaminophen during the first trimester was assessed, and the odds ratios (ORs) were estimated with unadjusted and adjusted analyses.

Results: Among 20,879 women, acetaminophen and Kampo medicines containing ephedra were used in 665 (3.19%) and 376 (1.80%) women, respectively, in the first trimester. Among the infants born to the mothers who used acetaminophen or Kampo medicine containing ephedra during the first trimester, 11 (1.65%) and 8 (2.13%), respectively, had overall MCMs. OR of overall MCMs was higher in women who used Kampo medicines containing ephedra than in those who used acetaminophen in the first trimester (adjusted OR, 1.45; 95% confidence interval (CIs), 0.57-3.71); however, the difference was not statistically significant.

Conclusions: In this study, there was no statistically significant association between the use of Kampo medicines containing ephedra during the first trimester of pregnancy and the risk of MCMs. Although some point estimates of ORs exceeded 1.00, the absolute magnitude of any increased risks would be low.

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妊娠头三个月服用含麻黄的日本传统 (Kampo) 药物导致重大先天畸形的风险。

背景：含有麻黄的日本传统（Kampo）药物可用于治疗孕期感冒。有报告称，麻黄碱（麻黄的一种成分）有致畸风险，但相关证据仍不明确：本研究旨在利用东北医学大型数据库项目出生和三代队列研究（TMM BirThree Cohort Study），评估怀孕头三个月接触含有麻黄成分的康普药物与重大先天性畸形（MCMs）相关的风险：对2013年7月至2017年3月期间参与TMM BirThree队列研究的23730对母婴分别在怀孕第12周和第26周左右发放了孕早期和孕中期调查问卷。评估了在怀孕头三个月使用含麻黄或对乙酰氨基酚的康普药物的妇女的婴儿患中枢神经系统疾病的风险，并通过未调整和调整分析估算了几率比（ORs）：在 20 879 名妇女中，有 665 名（3.19%）和 376 名（1.80%）妇女在怀孕头三个月使用过对乙酰氨基酚和含麻黄的康普药物。在怀孕头三个月使用对乙酰氨基酚或含麻黄的康普药物的母亲所生的婴儿中，分别有 11 名（1.65%）和 8 名（2.13%）婴儿患有多发性硬化症。在怀孕头三个月使用含麻黄的康普药物的妇女中，总体多发性硬化症的 OR 值高于使用对乙酰氨基酚的妇女（调整 OR 值为 1.45；95% 置信区间（CIs）为 0.57-3.71）；然而，两者之间的差异并无统计学意义：在这项研究中，妊娠头三个月使用含麻黄成分的康普药物与中枢神经系统疾病风险之间没有统计学意义上的显著关联。虽然一些ORs的点估计值超过了1.00，但任何风险增加的绝对值都很低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-

CiteScore

3.60

自引率

5.00%

发文量

审稿时长

8 weeks

期刊介绍： Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.