Signal mining of adverse drug reactions in the heart and nervous system during pregnancy based on adverse reaction reports in the hospital
10.3760/cma.j.cn114015-20230607-00415
- VernacularTitle:基于医院不良反应报告数据的妊娠期心脏和神经系统药物不良反应的信号挖掘
- Author:
Tingting CHEN
1
;
Chaoxin CHEN
;
Fanxiang ZENG
;
Jinhua ZHANG
Author Information
1. 福建省妇幼保健院药剂科，福州 350001
- Publication Type:Journal Article
- Keywords:
Pregnancy;
Maternal exposure;
Cardiotoxicity;
Neurotoxicity;
Adverse drug reaction reporting systems;
Signal detection
- From:
Adverse Drug Reactions Journal
2024;26(2):82-86
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the spontaneous reports on adverse drug reaction (ADR) in a hospital and to mine the risk signals of drug that might be associated with cardiac and neurological ADRs in pregnant women.Methods:The ADR reports in the database of China Hospital Pharmacovigilance System reported by Fujian Maternal and Child Health Hospital from January 1st, 2000 to December 31st, 2022 was downloaded. ADR reports about pregnancy women were collected, and the proportions and clinical manifestations of ADRs classified as "cardiac disorders" and "nervous system disorders" according to systems and organs were analyzed by descriptive statistic method. Data mining was conducted on drugs that might be associated with cardiac disorders and nervous system disorders in ADR reports using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. The definition of risk signals in ROR method was the number of adverse reaction/event reports on the target drug (a) ≥3, and the lower limit of the 95% confidence interval ( CI) of ROR >1. The definition of risk signals in BCPNN method was the information component minus twice the standard deviation ( IC-2 SD) >0. When the calculation results of an adverse reaction/event was in accordance with above-mentioned conditions in both methods, a suspected drug risk signal was determined. Results:A total of 783 ADR reports about pregnancy women were included in the analysis. Ninety-four reports (12.0%) were about cardiac disorders, mainly manifested as palpitations; 121 reports (15.5%) were about nervous system disorders, mainly characterized by trembling and dizziness. These ADRs of cardiac disorders and nervous system disorders often occurred in the third trimester of pregnancy. Through the ROR and BCPNN methods, results showed that ritodrine hydrochloride injection (a=61, ROR=14.64, the lower limit of 95 %CI=9.08; IC-2 SD=1.36) and ritodrine hydrochloride tablets (a=24, ROR=8.34, the lower limit of 95 %CI=4.64; IC-2 SD=1.10) were risk signals of drug leading to cardiac disorders during pregnancy, while magnesium sulfate injection (a=37, ROR=6.66, the lower limit of 95 %CI=4.10; IC-2 SD=0.98) and ritodrine hydrochloride injection (a=45, ROR=3.72, the lower limit of 95 %CI=2.44; IC-2 SD=0.56) were risk signals of drug leading to nervous system disorders during pregnancy. Conclusion:Ritodrine and magnesium sulfate may be associated with cardiac and nervous system ADR in women during pregnancy, which should arouse clinical vigilance.
