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ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Volume 38 Issue 8
Aug.  2022
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Article Contents

Identification and analysis of the risk of liver-related adverse drug reaction in pregnant women

DOI: 10.3969/j.issn.1001-5256.2022.08.021
Research funding:

Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine (ZYYCXTD-C-202005);

the National Natural Science Foundation of China (81721002);

Project of China PLA General Hospital (2019MBD-023)

More Information
  • Corresponding author: XIAO Xiaohe, pharmacy302xxh@126.com(ORCID: 0000-0002-3719-6575); GUO Yuming, guoyuming_0520@126.com (ORCID: 0000-0003-3149-8422)
  • Received Date: 2021-12-14
  • Accepted Date: 2022-03-01
  • Published Date: 2022-08-20
  •   Objective  To investigate the potential medication risk by identifying and analyzing the features of liver-related adverse drug reaction (ADR) in pregnant women.  Methods  A retrospective study was performed for the reports on liver-related ADR in pregnant women from January 1, 2012 to December 31, 2016 in HILI Cloud (hilicloud.net). Main clinical features and medication rules were analyzed, and reporting odds ratio (ROR) was used to analyze the relative risk of related drugs.  Results  Methotrexate, mifepristone, and ritodrine were the high-frequency drugs reported for liver-related ADR in pregnant women and were mainly used for termination of ectopic pregnancy and treatment of hydatidiform mole. The relative risk analysis of liver-related ADR showed that in pregnant women, the use of methotrexate (ROR=37.52, 95% confidence interval [CI]=31.35-44.89), progesterone (ROR=7.33, 95%CI: 2.75-19.59), and dydrogesterone (ROR=6.58, 95%CI: 2.20-19.69) was strongly associated with the risk of liver injury, and the association of methotrexate with the risk of liver injury in pregnant women was significantly stronger than that in non-pregnant women (ROR=1.71, 95%CI: 1.47-4.36).  Conclusion  The potential risk of liver injury should be taken seriously in pregnant women using the drugs such as methotrexate and progesterone, so as to avoid serious adverse reactions.

     

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