Safety of medication use during pregnancy in mainland China: based on a national health insurance database in 2015
Safety of medication use during pregnancy in mainland China: based on a national health insurance database in 2015
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DOI：
10.1186/s12884-019-2622-y
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发表时间：
2019-12
影响因子：
3.1
通讯作者：
Jingyuan Zhang;C. Ung;X. Guan;Luwen Shi
中科院分区：
文献类型：
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作者：
Jingyuan Zhang;C. Ung;X. Guan;Luwen Shi
背景妊娠期用药安全已引起全球关注，但有关中国人群的报道却很少。本研究旨在参考美国食品药品监督管理局（FDA）妊娠风险类别描述中国大陆孕妇的用药模式和风险。方法从中国健康保险协会（CHIRA）数据库中获取2015年全国代表性基本医疗保险（BMI）受益人样本的医院诊断和配药信息，计算每个风险类别的使用频率和涉及的药物数量。说明了每个风险类别中最常用的药物。通过多元逻辑回归评估与使用 D/X 类药物相关的因素。 结果 在 2015 年 11,373 名单胎分娩的妇女中，有 2896 名妇女有整个怀孕期间的记录，分别有 5377 名妇女和 7946 名妇女有妊娠第二个月和第三个月的记录。结果发现，11.1%的孕妇至少使用过一种药物，怀孕期间总共使用过321种药物。大多数孕妇使用的药物属于 FDA C 类药物（66.2%），其次是 B 类药物（57.8%）、A 类药物（16.8%）、X 类药物（7.5%）和 D 类药物（5.0%）。 D 类和 X 类最常用的药物分别是抗焦虑药和激素制剂。来自中西部地区 (p= 0.045) 或使用过四种或以上药物 (p< 0.001) 的女性更有可能使用 D/X 类药物。 结论 这项研究显示，中国大约十分之一的孕妇在怀孕期间至少使用过一种药物，其中相当多的人使用 FDA D 类或 X 类药物。本研究中确定的使用模式表明，可能存在次优的药物使用，需要在未来的研究中进行进一步的评估和干预。需要付出更多努力来揭示妊娠期用药的安全问题，并改进现有的临床实践信息系统。
BackgroundMedication safety during pregnancy has drawn global attention, little of which has been reported about the Chinese population. This study aims to describe patterns and risks of medication use among pregnant women in mainland China with reference to the U.S. Food and Drug Administration (FDA) pregnancy risk category.MethodsHospital diagnostic and drug dispensing information of a national representative sample of basic medical insurance (BMI) beneficiaries was obtained from the China Health Insurance Association (CHIRA) database in 2015. Prevalence of use and number of medicines involved in each risk category were calculated. Most commonly used medicines from each risk category were illustrated. Factors associated with the use of category D/X medicines were evaluated through multiple logistic regression.ResultsOut of 11,373 women who had singleton deliveries in 2015, there were 2896 women with records covering their entire pregnancies, 5377, and 7946 women with records through the 2nd, and the 3rd trimester, respectively. It was found that 11.1% pregnant women used at least one medication and a total of 321 medications had been used during pregnancy. Most pregnant women used medicines which were classified FDA category C (66.2%), followed by category B (57.8%), category A (16.8%), category X (7.5%) and category D (5.0%). The most commonly used medicines from category D and X were anxiolytics and hormonal preparations respectively. Women who were from mid-western area (p= 0.045) or used four or more medications (p< 0.001) were more likely to use category D/X medicines.ConclusionsThis study revealed that about one in ten pregnant women used at least one medication during pregnancy in China and a significant number of them used FDA Category D or X medicines. The usage patterns identified in the present study indicate that sub-optimal medicine use might exist warranting further evaluation and intervention in future studies. More efforts are needed to uncover the safety concerns about medication use during pregnancy and improve current information system for clinical practice.