53例银杏内酯注射液不良反应报告分析

Analysis of 53 Cases of Adverse Drug Reactions Related to Ginkgolide Injection

目的:分析银杏内酯注射液药品不良反应(ADR)发生规律、特点及影响因素,为临床合理用药提供参考依据。方法:选取2019年12月~2021年6月期间宁德市上报国家药品不良反应监测系统的53例银杏内酯注射液ADR报告进行统计和分析。结果:53例ADR报告中,女性患者多于男性,45岁及以上患者占96.23%,有48例次(87.27%)ADR发生在用药过程中,ADR累及系统/器官包括血管与淋巴管类疾病(35例次,27.34%)、呼吸系统、胸及纵隔疾病(23例次,17.97%)、各类神经系统疾病(19例次,14.84%)、心脏器官疾病(14例次,10.94%)、皮肤及皮下组织类疾病(13例次,10.16%)等,涉及临床表现128例次,其中新的ADR临床表现86例次(67.19%)。结论:建议医疗机构加强银杏内酯注射液的合理用药干预,加大患者用药过程中ADR监测;药品上市许可持有人加强药品上市后安全性研究,及时修订完善药品说明书,促进临床合理用药,保障患者用药安全。

Objective:To analyze the regularities,characteristics and relative factors of the adverse reactions related to ginkgolide injection,so as to provide references for clinical rational use of drug.Methods:A total of 53 cases of ADR reported to the National ADR Monitoring System in Ningde City from December 2019 to June 2021 were counted and analyzed.Results:Of the 53 cases,the female patients are more than male patients.The patients over 45 years old counted for 96.23%.48 cases(87.27%)of adverse reactions occurred in the course of medication.Multiple systems were affected including blood vessels and lymphatic vessels diseases(35 cases,27.34%),diseases of the respiratory system,thoracic and mediastinum(23 cases,17.97%),nervous system disorders(19 cases,14.84%),cardiac disorders(14 cases,10.94%),skin and subcutaneous tissue disorders(13 cases,10.16%),etc.A total of 128 cases of clinical manifestation were involved and new clinical manifestations of ADR were observed in 86 cases(67.19%).Conclusion:It is suggested that medical institutions should strengthen the intervention of rational use of ginkgolide injection and increase the ADR monitoring of patients in the process of medication.Drug marketing authorization holders should strengthen study on drug safety after marketing,timely revise and improve drug instructions,promote clinical rational drug use,and ensure drug safety of patients.