Analysis of 541 ADR reports associated with cinepazide maleate

HU Peng-zhou; MA Liang; GUO Dai-hong; FAN Qi; WANG Xiao-yu

Abstract：Objective: To research the possible risk factors of cinepazide maleate by analysing the spontaneous ADR reports and provide references for advanced clinical safety evaluation.Methods:With the retrospective method, all the ADR reports of cinepazide maleate were extracted in the database of PLA ADR monitoring center. The data in respect of patients' age, dosage and administration, systems and organs involved in ADR and clinical manifestations were analyzed statistically.Results:Among the 541 ADR reports,the severe and the new ADRs accounted for 3.32% and 9.24% respectively, beyond 50 years old was 79.48%, the used daily dose of 320 mg (73.01%) and the impairment of central and peripheral nervous system (38.01%) was the commonest. All of the 8 hematological system ADRs was leucopenia (1.21%), WBC range from 1.76 × 109·L-1 to 3.70 × 109·L-1, and a close correlation between the severity and the time of medication could be indicated.Conclusion: ADRs caused by cinepazide maleate is slight, severe ADRs can be prevented effectively by strengthening the monitoring of blood pressure and hemogram. To validate the correlation between the severity and the time of medication still need wider study.