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日本炎性肠病孕妇的处方用药及其与先天畸形的关系。

Prescribing in pregnant women with inflammatory bowel disease and its relationship to congenital malformations in Japan.

机构信息

Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.

Division of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan.

出版信息

J Gastroenterol Hepatol. 2024 Jul;39(7):1291-1298. doi: 10.1111/jgh.16549. Epub 2024 Mar 27.

DOI:10.1111/jgh.16549
PMID:38538533
Abstract

BACKGROUND AND AIM

Inflammatory bowel disease (IBD) frequently affects younger patients and poses various challenges concerning pregnancy and childbirth. Maintaining good disease control throughout pregnancy is crucial, but expectant and pregnant patients may worry about the fetal impact of medications, leading to treatment discontinuation due to uncertainty about this issue. This study investigated the real-world drug-prescribing practices for pregnant patients with IBD in Japan and their potential connection to major congenital malformations (MCMs).

METHODS

Overall, 277 female IBD patients who gave birth between 2010 and 2019 were selected from the JMDC claims database. The prescribing patterns of IBD medications and MCMs in the patients' offspring were analyzed.

RESULTS

Among pregnant IBD patients, 74.4% received at least one medication from 90 days before pregnancy to 90 days after delivery. Trends in medication prescriptions during pregnancy in 2010-2019 revealed consistent use of oral 5-ASA, variable use of topical medications, a decrease in systemic steroids, and an increase in biologics. The prevalence of MCMs in children born to IBD-affected mothers did not differ significantly between those who did and did not receive IBD medications (8.6% vs 6.8%). Although circulatory system MCMs were slightly more common in the IBD medication group (4.9% vs 1.4%), this difference was not significant. Logistic regression analysis did not reveal an association between MCM risk and first-trimester use of IBD medications, including corticosteroids and biologics.

CONCLUSIONS

This study provides insights into medication patterns in pregnant IBD patients and suggests no increased risk of MCMs associated with first-trimester IBD medication use.

摘要

背景与目的

炎症性肠病(IBD)常影响年轻患者,在妊娠和分娩方面带来各种挑战。在整个妊娠期间维持良好的疾病控制至关重要,但预期和妊娠患者可能会担心药物对胎儿的影响,由于对此问题存在不确定性,从而导致停药。本研究调查了日本妊娠 IBD 患者的实际药物治疗情况及其与重大先天性畸形(MCM)的潜在关联。

方法

本研究从 JMDC 理赔数据库中选择了 2010 年至 2019 年间分娩的 277 名女性 IBD 患者。分析了患者后代中 IBD 药物和 MCM 的处方模式。

结果

在妊娠 IBD 患者中,74.4%的患者在妊娠前 90 天至分娩后 90 天期间至少接受了一种药物治疗。2010-2019 年妊娠期间药物处方的趋势表明,口服 5-ASA 的使用持续稳定,局部用药的使用存在差异,全身皮质类固醇的使用减少,生物制剂的使用增加。患有 IBD 的母亲所生子女的 MCM 发生率在接受和未接受 IBD 药物治疗的患者之间无显著差异(8.6% vs. 6.8%)。尽管循环系统 MCM 在 IBD 药物组中略为常见(4.9% vs. 1.4%),但差异无统计学意义。逻辑回归分析未发现 MCM 风险与包括皮质类固醇和生物制剂在内的 IBD 药物的孕早期使用之间存在关联。

结论

本研究深入了解了妊娠 IBD 患者的药物治疗模式,表明孕早期使用 IBD 药物不会增加 MCM 的风险。

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Prescribing in pregnant women with inflammatory bowel disease and its relationship to congenital malformations in Japan.日本炎性肠病孕妇的处方用药及其与先天畸形的关系。
J Gastroenterol Hepatol. 2024 Jul;39(7):1291-1298. doi: 10.1111/jgh.16549. Epub 2024 Mar 27.
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Limited risks of major congenital anomalies in children of mothers with IBD and effects of medications.IBD 母亲所生孩子出现重大先天畸形的风险有限,以及药物的影响。
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Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a meta-analysis.炎症性肠病女性暴露于5-氨基水杨酸类药物后的妊娠结局:一项荟萃分析。
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Use of pharmaceuticals by inflammatory bowel disease patients: a population-based study.炎症性肠病患者的药物使用情况:一项基于人群的研究。
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Health outcomes of 1000 children born to mothers with inflammatory bowel disease in their first 5 years of life.母亲在生命的前 5 年内患有炎症性肠病的 1000 名儿童的健康结果。
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