Application analysis and adverse reactions centralized monitoring of 3000 casesKudiezi injection by non-intervention prospective multicenter open study
YU Qian
ZHAO A-na
FU Xiu-juan
Abstract：Objective:To re-evaluate the post-marketing safety ofKudiezi injection in seven hospitals of Jilin area, and provide references for the clinical use of drugs.Methods: Using the prospective centralized monitoring method of non-intervention in multicenter, 3000 cases usedKudiezi injection were observed from June 2012 to March 2014, the clinical application of the drug and the adverse reactions were analyzed.Results:The patients were mainly in the 40–80 years old, which was associated with the pharmacological effects ofKudiezi injection. About 26.83% of the patients were overdose use of drugs, although no adverse reaction was found in those patients, overdose use of drugs should be paid attention to. Indications of the drug comply with the package insert and the compare the reasons for withdrawal of drug were clear. One death case was associated with disease progression and advanced age; three cases of adverse reactions occurred in 3000 cases of patients, adverse reaction rate was 0.1%.Conclusion:Reasonable clinical application ofKudiezi injection should be strengthened, such as avoiding overdose use of drug, strengthening the monitoring of adverse reactions and reducing the incidence of adverse reactions. The safety re-evaluation model of traditional Chinese medicine injection was initially established, which can provide experience for future practice.
Keywords：Kudiezi injectionSafetyEvaluationProspective centralized monitoringAdverse reaction
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 167-170 )