基于循证药学的血液科新型抗肿瘤药物超说明书用药评价

    Evaluation of off-label uses of novel antineoplastic drugs in hematology based on evidence-based pharmacy

    • 摘要:
      目的: 分析新型抗肿瘤药物超说明书用药情况,并进行循证药学证据分级和合理性分析。
      方法: 收集2022年10月至2024年12月血液科出院病人病历中新型抗肿瘤药物超说明书用药情况,运用Thomson Micromedex数据库的DrugDex分级系统进行分析和评价。
      结果: 血液科共有15种新型抗肿瘤药物存在超说明书用药情况,均为超适应证用药,涉及病例222份。其中推荐等级为Ⅰ级占超说明书使用病历4.05%(9/222),Ⅱa级占44.14%(98/222),Ⅱb级占50.90%(113/222),不确定者占0.90%(2/222)。循证医学评价分析结果合理率为99.09%(220/222)。
      结论: 血液科新型抗肿瘤药物超说明书用药中绝大多数有循证药学证据支持,但个别证据质量较低,需进一步加强管理,以降低潜在风险。

       

      Abstract:
      Objective To analyze the off-label use of novel anti-tumor drugs, and conduct evidence-based pharmaceutical evidence grading and rationality analysis.
      Methods The off-label use of new anti-tumor drugs in the medical records of discharged patients in the hematology department from October 2022 to December 2024 was collected, analyzed and evaluated using the DrugDex classification system of the Thomson Micromedex database.
      Results A total of 15 new anti-tumor drugs in the hematology department were used off-label, all of which were off-indication drugs, involving 222 cases. Among them, 4.05% (9/222) of the off-label use cases were graded as level I, 44.14% (98/222) as level IIa, 50.90% (113/222) as level IIb and 0.90% (2/222) as uncertain. The rationality rate of the results of evidence-based medical evaluation and analysis was 99.09% (220/222).
      Conclusions The vast majority of off-label use of novel anti-tumor drugs in the hematology department is supported by evidence-based pharmaceutical evidence, but the quality of individual evidence is low, and further management is needed to reduce potential risk.

       

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