| 阮广新,何淑妍.79份抗血栓药说明书中出血预防和处理信息标注情况调查分析[J].中国药事,2022,36(11):1322-1327 |
| 79份抗血栓药说明书中出血预防和处理信息标注情况调查分析 |
| Investigation and Analysis of the Labeling of Bleeding Prevention and Treatment Information in 79 Pieces of Package Inserts of Antithrombotic Drugs |
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| DOI：10.16153/j.1002-7777.2022.11.016 |
| 中文关键词: 抗血栓药 药品说明书 出血 预防和处理 标注 分析 |
| 英文关键词: antithrombotic drugs package inserts of drugs bleeding prevention and treatment labeling analysis |
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| 中文摘要: |
| 目的： 了解抗血栓药说明书中出血预防和处理信息的标注情况及其存在问题，并提出建议。方法：收集《国家基本医疗保险、工伤保险和生育保险药品目录》(2020年)中的抗血栓药说明书79份， 对说明书中禁忌证、药物相互作用、实验室监测、剂量调整、出血处理信息的标注情况进行统计分析。 结果：79份抗血栓药说明书中禁忌证、药物相互作用、实验室监测、剂量调整、出血处理信息的标注率分别为91.14%、87.34%、67.09%、45.57%、64.56%。抗凝血药说明书对实验室监测、出血处理信息的标注率明显高于抗血小板药，差异有统计学意义(P＜0.05)；注射剂说明书对禁忌证、实验室监测及出血处理信息的标注率明显高于口服制剂(P＜0.05)。同品种不同厂家说明书内容的差异率为16.22%。结论：抗血栓药说明书中存在同品种不同厂家说明书标注信息有差异、药物相互作用信息标注不全、出血处理信息缺乏实用性等问题。建议药品监督部门完善说明书管理制度，加强对说明书的审批与监管，敦促药品上市许可持有人持续推进说明书的修订工作，并跟进临床真实数据与报道，及时更新完善说明书内容；医师及临床药师在临床治疗过程中应加强出血风险管理和用药监测，重视药品信息收集，及时反馈、上报药品不良反应/事件，保障患者合理安全用药。 |
| 英文摘要: |
| Objective: To investigate the labeling and exiting problems of bleeding prevention and treatment information in package inserts of antithrombotic drugs and put forward the suggestions. Methods: A total of 79 pieces of package inserts of antithrombotic drugs from Drug Catalogue for National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance (2020) were collected. Statistical analysis was performed on the labeling of contraindications, drug-drug interactions, laboratory monitoring, dose adjustment and bleeding treatment information in those drug inserts. Results: The labeling ratio of contraindications, drugdrug interactions, laboratory monitoring, dose adjustment and bleeding treatment in 79 pieces of package inserts of antithrombotic drugs were 91.14%, 87.34%, 67.09%, 45.57% and 64.56% respectively. The labeling rate of laboratory monitoring and bleeding treatment information for anticoagulant drugs was significantly higher than antiplatelet drugs, and the difference was statistically significant (P＜0.05).The labeling ratio of contraindications, laboratory monitoring and bleeding treatment information for injections was much higher than the oral agents (P＜0.05). The difference rate of instruction contents of the same variety produced by difference manufacturers was 16.22%. Conclusion: There are some problems in the package inserts of antithrombotic drugs, such as different labeling information on the same variety from different manufacturers, incomplete information of drugdrug interactions and lack of practical information of bleeding treatment. It is suggested that the drug regulatory departments should improve the management regulation of package inserts, strengthen the examination and supervision of package inserts; urge marketing authorization holders to promote revision work of package inserts continuously, follow up clinical real date and reports and update the content of package inserts timely. Physicians and pharmacists should strengthen risk management of bleeding and pharmaceutical monitoring during clinical treatment, attach importance to drug information collection, provide timely feedback and report adverse drug reaction/events, so as to ensure the rational and safe use of drugs for patients. |
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