丹红注射液上市后安全性再评价报告

Post-market re-evaluation on safety of Danhong injection

目的观察丹红注射液在使用中的安全性，为规范临床合理用药提供参考。方法对本院2010年6月至2011年10月使用丹红注射液的942例住院患者进行观察，填写丹红注射液上市后再评价监测表，对数据进行统计分析。结果入选的942例中，男性454例（48．19％）、女性488例（51．81％）。筛选病例的年龄分布于各年龄段，平均64．5岁。50岁以上患者799例（84．82％）。有过敏史者20例（2．12％）.用药时间7～14d者815例（86．51％）。使用5％葡萄糖为溶媒的150例（15．92％），使用O．9％生理盐水792例（84．08％）。942例住院患者中出现不良反应4例，发生率为0．42％。结论丹红注射液的不良反应发生率较低，所发生的不良反应与患者基础疾病、年龄、性别、溶媒和剂量无关。

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.