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目的
为规范超说明书用药的管理，促进临床合理用药，保障患者用药安全，对超说明书用药进行分级管理。方法 以循证医学证据为分级管理依据，启动了全院临床科室超说明书用药备案评审工作。结果 在406条备案药物中，抗肿瘤药物超说明书用药占78.8%，依据国际指南用法的比例最高，占48.8%，其次为其他循证支持用法（包括文献报道）占36.4%，再次为国内指南用法占11.1%。结论 超说明书用药的管理应重点集中于证据等级较低、药物不良反应发生率较高，且曾发生过医患纠纷的药物。 |
| 关键词: 用药安全 药品说明书 循证医学 分级管理 |
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| Research on Classification Management of Off-label Drug Use on Evidence-based Medicine |
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| Abstract: |
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Objective To implement the classification management of off-label drug use to regulate off-label drug use, in order to promote the clinical rational drug use and to ensure the safety of patients’ drug use. Methods Implementing the record review work of off-label drug use by classification management based on the evidence-based medicine. Results Of the 406 registration drugs, antineoplastic drugs accounted for 78.8%, according to the international guidelines for the usage of the highest proportion, accounting for 48.8%, followed by other evidence-based support usage (including literature reported) accounted for 36.4%, and 11.1% for domestic usage guidelines. Conclusion The management of off-label drug use should focus on the drugs which have low level of evidence, higher incidence of adverse drug reactions, and ever lead to medical disputes. |
| Key words: drug use safety, medicine instructhon,evidence-based medicine, classification management |
