天麻素注射液210例不良反应报告分析

Adverse Drug Reactions Induced by Gastrodin Injection in 210 Case

目的总结天麻素注射液不良反应发生的特点,为天麻素注射液临床合理应用提供参考。方法采用回顾分析法收集上海市宝山区药品不良反应监测中心在2017年1月-2021年12月收到的210例天麻素注射液所引起的不良反应报告,统计并分析报告数变化趋势、患者年龄与性别的分布、用药方法、不良反应种类、其因果关系及转归、不良反应累及系统-器官分类、上报医院情况与报告人职业等相关情况。结果210例天麻素注射液不良反应报告中,2019年不良反应报告数量最多(64例,30.48%);年龄发生在23~95岁;男性78例,女性患者132例;发生不良反应所用剂量为0.2~1.0 g·d^(-1),涉及联合用药的有38例;一般不良反应187例,严重不良反应5例,新出现的不良反应18例;痊愈126例,好转84例;共报告不良反应267例次,不良反应主要临床表现以消化系统最多(73例,27.34%);社区服务中心上报例数最多(85例,40.48%);药师上报数量最多(89例,42.38%)。结论2017-2021年天麻素注射液不良反应发生呈先上升后下降趋势,发生率女性高于男性,常见于60~70岁人群,主要集中发生在给药后1 d内,主要表现以消化系统和皮肤及其附件损害居多。临床应用天麻素注射液时应严格遵循该药物说明书用药;密切观察患者状况,及时采取急救措施;制药企业应对药物说明书进行完善;医务人员应提高临床用药安全。

Objective To summarize the characteristics of adverse drug reactions(ADRs)caused by gastrodin injection and provide reference for clinical rational drug use.Methods Two hundred and ten ADR reports of gastrodin injection collected by Adverse Drug Reaction Monitoring Center of Baoshan District between January 2017 and December 2021 were retrospectively studied.The numbers of ADRs,distribu-tion of age and gender,treatments,types and causes of ADRs,systems or organs involved and the occupa-tions of reporters were analyzed.Results Among the 210 ADR reports of gastrodin injection,the number in 2019 was the largest(64 cases,30.48%).The age of patients ranged from 23 to 95.There were 78 males and 132 females.The dose of 0.2-1.0 g·d^(-1) was responsible for these ADRs.Thirty-eight of these cases involved coadministration.One hundred and eighty-seven of these cases were mild ADRs,five were serious ones and 18 were new ones.One hundred and twenty-six of these cases recovered and 84 improved.A total of 267 cases of ADRs were reported.The digestive system was the most involved(73 cases,27.34%).Eighty-five of the ADRs(40.48%)were reported by community service centers and 89(42.38%)by phar-macists.Conclusion Between 2017 and 2021,the incidence of ADRs induced by gastrodin injection increased before it decreased,and was higher among females than among males.People aged 60 to 70 were more vulnerable.Most of the cases of ADRs occurred within one day of administration,manifested as damage to the digestive system,skin and accessories.Clinical application of gastrodin injection should strictly follow the instructions.The condition of patients should be closely observed.Pharmaceutical companies are to update their instructions in time.