A study on the risk of adverse reactions of Ginkgo Damo Injection based on real-world data
基于真实世界数据的银杏达莫注射液不良反应风险研究

摘要

目的 分析银杏达莫注射液在真实世界中的不良反应发生特征及相关风险因素。方法 提取国家药品不良反应监测中心2019年1月1日-2023年12月31日期间收录的银杏达莫注射液不良反应报告8713份，对患者人口学特征、用药情况、不良反应表现及转归等数据进行统计分析，并结合文献检索结果验证风险特征。结果 不良反应报告中女性较多，65岁及以上老年患者较多；82.99%的不良反应发生在用药当日，主要累及神经系统、皮肤及附属物、消化系统严重不良反应以速发型为主，多在用药后短时间内出现，但整体预后较好，多数患者经处理后可痊愈或好转。结论 银杏达莫注射液不良反应与患者年龄、性别、用药时机及联合用药等因素相关，临床应严格遵循说明书用药，加强特殊人群监测，降低用药风险。

Abstract

Objective To analyze the characteristics of adverse reactions and related risk factors of Ginkgo and Damo injection in the real world.
Methods A total of 8,713 adverse reaction reports of Ginkgo Damo injection collected by the National Center for Adverse Drug Reaction Monitoring from January 1, 2019 to December 31, 2023 were extracted. Statistical analysis was conducted on the demographic characteristics, medication use, adverse reaction manifestations and outcomes of the patients. And verify the risk characteristics in combination with the results of literature retrieval.
Results Among the adverse reaction reports, there were more females and more elderly patients aged 65 and above. 82.99% of adverse reactions occur on the day of medication, mainly involving the nervous system, skin and its appendages, and the digestive system. Severe adverse reactions are mainly immediate and often appear within a short period after medication. However, the overall prognosis is relatively good, and most patients can recover or improve after treatment.
Conclusion   The adverse reactions of Ginkgo and Damo injection are related to factors such as the patient's age, gender, timing of medication, and combined medication. In clinical practice, the use of drugs should strictly follow the instructions, strengthen the monitoring of special populations, and reduce the risk of medication.