丹红注射液上市后安全性再评价报告.PDFVIP

·1070· 国际中医中药杂志2012年12月第34卷第12期 Int J Trad Chin Med, December 2012, Vol. 34, No.12 ·临床调研· 丹红注射液上市后安全性再评价报告 赵兴 徐萍 黄庆华 王瑞华 【摘要】 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 7～14 d 者 815 例（86.51%）。使用 5%葡萄糖为溶媒的 150 例（15.92%），使用 0.9%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。 【关键词】 丹红注射液；安全性；再评价 Post-market re-evaluation on safety of Danhong injection ZHAO Xing, XU Ping, HUANG Qing-hua, WANG Rui-hua. The Fifth Central Hospital of Tianjin, Tianji 300450, China Corresponding author：ZHAO Xing, Email：dwzxyy@163.com 【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. Th