Study on Real World Safety of Runzao Zhiyang Capsules in 3 016 Cases Under Intensive Hospital Monitoring Based on Active Monitoring
Objective To evaluate the clinical safety of the use of Runzao Zhiyang Capsules after the market;To monitor the potential risk factors of drugs in time to understand the medication,incidence and clinical characteristics of adverse reactions of Runzao Zhiyang Capsules in real world;To explore the influencing factors of the occurrence of adverse reactions.Methods Prospective,multi-center,large sample,continuous hospital wide,and registered centralized monitoring was performed.Patients receiving medication were followed up on-site for 2 weekends,followed up for±3 days at 4 weekends,and followed up by phone for 6-8 weekends.This study adopted three levels of quality control measures,using EDC electronic monitoring platform to monitor the data,and using SAS 9.4 and R language to process the data.Results A total of 3 016 patients from 21 hospitals were included in the safety monitoring,and 87 adverse events occurred.There were 16 adverse reactions related to Runzao Zhiyang Capsules,with an incidence rate of 0.53%,which was within the occasional range;all adverse reactions were within the rare range.Analysis of influencing factors revealed that 10 variables,including cloloratadine tablets,male,and compound glycyrrhizin tablets,had a significant impact.Conclusion Runzao Zhiyang Capsules have a low incidence of adverse reactions and good safety in clinical use.Special attention should be paid to safety risks when used in combination with drugs such as cloloratadine tablets and compound glycyrrhizin tablets.
Runzao Zhiyang Capsulesreal world studyhospital centralized monitoringsafetyadverse reactions
国家科技期刊平台
NSTL
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