Post-market re-evaluation on safety of Danhong injection

VernacularTitle:丹红注射液上市后安全性再评价报告
Author: Xing ZHAO ; Ping XU ; Qinghua HUANG ; Ruihua WANG
Publication Type:Journal Article
Keywords: Danhong injection; Safety; Re-evaluation
From: International Journal of Traditional Chinese Medicine 2012;(12):1070-1072
CountryChina
Language:Chinese
Abstract: Objective To study the safety of Danhong injection in application for providing reference to clinical drug usage.Methods 942 patients using Danhong injection from June 2010 to October 2011 in our hospital were chosen and asked to fill in the monitoring sheet of Danhong injection post-market re-evaluation.The data in these sheets were analyzed.Results Among the 942 selected cases,454 were male and 488 were female.The youngest patient was 15 years and the oldest was 102 years.The average age of the patients was 64.5 years.799 cases of patients were over the age of 50,accounting for 84.82％.20 cases had a history of allergy.815 cases took the injection for 7 to 14 days.150 cases used 5％ GS as solvent,while 792 cases used 0.9％ NS as solvent.4 cases of adverse drug reaction were discovered in 942 cases,and the incidence rate was 0.42％.Conclusion The incidence rate of adverse drug reaction is low.The incidence of adverse reaction has no relationship with diseases,age and gender of patients,solvent and dose.Adverse reaction of Danhong injection is mainly related to the patient's individual differences.