注射用血栓通(冻干)上市后医院临床应用与不良反应集中监测

Centralized Monitoring of Clinical Use and Adverse Reaction of Xueshuantong Injection( Freeze-dried) Post-marketing in the Hospital

目的:对注射用血栓通(冻干)上市后临床应用情况进行研究评价,为规范和指导临床合理用药提供依据。方法:采用医院集中监测的方法,以本院2015年8月~2016年4月入院并使用注射用血栓通(冻干)的住院患者为研究对象,记录患者基本情况、用药情况和不良反应发生情况,并进行数据统计和分析。结果:共观察病例1 830例,其中18.42%患者无用药指征;6.45%患者用药时间过长;有16例发生不良反应,发生率为0.87%,属于偶见。结论:我院注射用血栓通(冻干)临床应用欠规范,提示临床用药应严格按照说明书适应证及疗程,并密切监测患者有无不良反应发生,以确保临床用药安全、有效。

Objective：To assess the clinical use of Xueshuantong injection （freeze-dried）, and to provide reference for rational drug use. Methods：Based on hospital centralized monitoring method, the clinical data of Xueshuantong injection （freeze-dried） in our hospital from August 2015 to April 2016 was tracked and analyzed. Results：A total of 1 830 inpatients were enrolled in this study. Among them, 18.42% were not in accordance with the medication purpose, and 6.45% were received a over long course of treatment. And 16 cases of adverse drug reaction （ADR） were monitored, with the ADR incidence rate of 0.87%, which showed good safety. Conclusion： The clinical use of Xueshuantong injection （freeze-dried） in our hospital was partly irrational. In order to ensure the safe, effective and economical use, the drug should be strictly used according to the instructions.