205例银杏达莫注射液不良反应分析

Analysis of 205 cases of adverse drug reactions induced by Ginkgo leaf extract and dipyridamole injection

目的分析银杏达莫注射液用药致不良反应(ADR)发生特点,为临床合理用药提供依据。方法筛选2018年1月~2020年6月临沂市ADR数据库中银杏达莫注射液ADR报告205例,汇总分析。结果银杏达莫注射液不良反应例数中,女性多于男性,年龄集中在51岁以上;多在30 min内发生;不良反应累及全身多个系统,以中枢及外周神经系统损害、胃肠系统损害、皮肤及其附件损害、呼吸系统损害为主;不合理用药主要包括超适应证用药和浓度剂量不当。结论药品上市许可持有人或生产企业应主动开展临床和非临床研究、加强药品上市后监测,为临床合理用药提供依据;临床用药时应严格掌握本药的适应证,合理用药,减少不良反应的发生。

Objective To analyze the features of ADR induced by Ginkgo leaf extract and dipyridamole injection,and provid rational drug use of Ginkgo leaf extract and dipyridamole injection in clinic.Methods 205 cases of ADR caused by Ginkgo leaf extract and dipyridamole injection were collected and analyzed during Jan.2018~Jun.2020 in Linyi ADR monitoring system.Results ADR of Ginkgo leaf extract and dipyridamole injection was higher in female and over 51 years old.It usually happens within thirty minutes after taking the medicine.It affects multiple systems and mainly involves central and peripheral nervous system,followed by gastrointestinal system,skin and its appendants,respiratory system.Off-label drug use and improper concentration and dose were mainly included in unreasonable drug use.Conclusion The conduct clinical and non-clinical research and the ADR monitoring should be strengthened actively after drug marketing by the marketing authorization holder or pharmaceutical manufacturer.Hospital staff should master indication strictly and use drug reasonably to reduce the ADR.