Automatic monitoring and evaluation of cinepazide maleate related ADR in 19487 hospitalized patients of five hospitals
GUO Dai-hong
WANG Xiao-yu
LIU Jia
ZHANG Xiao-li
ZHANG Mei
YONG Xiao-lan
WANG Fu-li
HU Peng-zhou
MA Liang
ZHAO Liang
Abstract：Objective: To figure out the rule and relevant factors of drug safety monitoring and assessment, and improve the military pharmacovigilance practice by conducting multi-center sentinel hospital ADR informationalized active monitoring study. Methods: Under the centralized training and uniform monitoring condition, automatic monitoring were conducted by the active monitoring and assessment of adverse drug events for hospitalized patients system, which covered 19487 cases used cinepazide in 5 hospital in January to December 2016. The warning cases that were detected by the system were manually evaluated, and then the data was submitted and analyzed statistically. Results: The incidence of cinepazide maleate related thrombocytopenia, hemoglobin decreased, leukocytopenia, liver damage and renal damage were 0.20%, 0.37%, 0.41%, 1.37% and 0.82%, respectively; the total incidence of ADR was 3.17%. No related agranulocytosis was detected. The miniature of drug utilization custom and population characteristic in different hospitals can be reflected by the monitoring results of multi-center, but the general trends were similar. Conclusion: The big data that came from real world studies was more meaningful in drug post-market evaluation. The special software on multi-center drug safety evaluation was reliable and efficient. With the improvement of manufacturing process, the cinepazide is safe in clinical practice.
Keywords：CinepazideAdverse drug reactionAutomatic monitoringSafety reevaluationReal world study
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 221-224 )