Risk signal mining of omeprazole adverse reactions based on the database of Shandong Provincial Center for Adverse Drug Reaction Monitoring
10.3760/cma.j.cn114015-20230724-00551
- VernacularTitle:基于山东省药品不良反应监测中心数据库的奥美拉唑不良反应风险信号挖掘
- Author:
Xuelian ZHANG
1
;
Guanjie WANG
1
;
Zhenhua WANG
1
;
Qinghai SUN
1
;
Xiaoyao LI
1
Author Information
1. 潍坊市中医院临床药学科，潍坊 261000
- Publication Type:Journal Article
- Keywords:
Omeprazole;
Adverse drug reaction reporting systems;
Signal processing, computer-assisted;
Shandong Province Adverse Drug Reaction Monitoring Center
- From:
Adverse Drug Reactions Journal
2024;26(1):33-37
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine and evaluate the adverse reaction risk signals of omeprazole, and provide reference for the safe application of the drug.Methods:Data cleansing on all adverse reactions of omeprazole collected in the Shandong Provincial Center for Adverse Drug Reaction Monitoring database from January 2018 to December 2021 was performed, and information on patients′ gender, age, drug administration routes, and the systems/organs involved, clinical manifestations, and outcomes of adverse reactions was collected. The risk signals of adverse reactions associated with omeprazole were mined and evaluated using reporting odds ratio (ROR), proportional reporting ratio (PRR), and Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard methods. The risk signal judgment criteria for ROR and PRR methods were the number of reports ≥3, and the lower limit of 95% confidence interval ( CI) of ROR or PRR>1, and that of MHRA method was the number of reports≥ 3, PRR≥2, and χ2≥4. Results:A total of 2 706 adverse reaction reports with omeprazole as suspect drug were entered, including 234 severe adverse reactions (8.7%). Of them, 1 270 were male (46.9%) and 1 432 female (52.9%); the median age was 58 years, including 86 patients under 18 years old, 1 417 cases between 18-60 years old, and 1 203 cases over 60 years old. A total of 17 systems or organs were involved in adverse reaction related to omeprazole, and the top 5 were gastrointestinal system [1 412 cases (37.6%)], skin and its accessories [883 cases (23.5%)], nervous system [716 cases(19.1%)], respiratory system [269 cases (7.2 %)], and systemic system [207 cases (5.5%)]. The median occurrence time of adverse reactions from medication was 30 minutes, and 1 710 cases (63.2%) occurred within 1 day after medication. After treatments, 1 595 patients (58.9%) recovered, 1 098 patients (40.6%) were improved, and no deaths were reported. Twenty-seven risk signals were mined by ROR and PRR methods, respectively, and 21 by MHRA method. The top 5 adverse reactions in signal intensity mined using the ROR method were gastrointestinal bloating, headache, constipation, tongue numbness, and joint pain; the top 5 adverse reactions in signal intensity mined using the PRR method were gastrointestinal bloating, headache, constipation, tongue numbness, and dizziness; the top 5 adverse reactions in signal intensity mined using the MHRA method were gastrointestinal bloating, headache, constipation, bloating, and dry mouth. Among them, the signals not mentioned in the labels were chest tightness, chills, cyanosis, mouth numbness, overall trembling, and tongue numbness.Conclusions:The adverse reactions of omeprazole involve multiple systems/organs, and common adverse reactions include gastrointestinal bloating, headache, constipation, etc. Risk signals such as chest tightness, chills, cyanosis, numbness of the mouth, trembling of the whole body, and numbness of the tongue are not recorded in the labels, which should be vigilant and intervened in time in clinics.
