The safety research on Dengzhanxixin injection

XIANG Jiao-jiao; YAO Si-yun; XIE Yan-ming; ZHAO Yuan-qi

doi:10.3969/j.issn.1001-9448.2018.03.035

Abstract：Objective To analyze the adverse reactions of Dengzhanxixin injection during clinical application among the cases from 19 general hospitals in Southern China. Methods The prospective, multi-centric, large-sample, registry study, intensive hospital monitoring protocol was adopted. All patients received Dengzhanxixin injection in the 19 general hospitals in Southern China from July 2012 to December 2014 were enrolled. The ADRs /AEs were collected for comprehensive analysis. Results A total of 17 946 patients were monitored. Eight cases of ADRs /AEs were judged by the group of security expert committee, and ended in the ADRs in 7 cases and AEs in 1 case. The rate of ADRs was 0. 39‰. Among 7 cases of ADRs, the indications of 6 cases were out of the instruction. Only 1 patient matched the instruction. There were 2 cases without drug combination and 5 cases with drug combination. The combination drugs were Citicoline sodium ( 2 cases) , Cerebrolysin Vial ( 1 case) , Cefmetazole ( 1 case) and Methimazole ( 1 case) . There were 4( 57. 2％) adverse reactions observed at the beginning of transfusion within 10min, 1 ( 14. 3％) in 30min, and 2( 28. 5％) in 1hour. The most common clinical manifestations of ADRs was skin allergic reaction ( 84. 6％) . 7 patients with ADRs were all improved or cured, and no death recorded. Conclusion The ADRs incidence of Dengzhanxixin injection in Southern China is 0. 39‰. The adverse reactions of Dengzhanxixin injection may be associated with the excess indications and drug combination. The rapid style and skin allergic reactions are the most common. The adverse reactions are mild with good prognosis.