某院阿帕替尼超适应证用药调查分析

Off-label indications use of apatinib in a hospital

目的调查分析某院阿帕替尼超适应证用药情况,为规范其临床应用提供循证参考。方法依据《新型抗肿瘤药物临床应用指导原则(2022年版)》《超说明书用药循证评价规范》《超说明书用药专家共识》等,建立新型抗肿瘤药物超适应证用药评价标准。采用回顾性分析方法,抽取某院2021年1月1日—2022年12月31日住院患者使用阿帕替尼的病例资料,统计阿帕替尼超适应证用药情况。利用新型抗肿瘤药物超适应证用药评价标准,对阿帕替尼的超适应证用药情况进行循证评价。结果共收集到该院使用阿帕替尼的病例83例,其中34例(41.0%)为超适应证用药,评价为“推荐使用”“限制使用”“特殊使用”和“不推荐使用”的分别占52.9%(18/34)、17.6%(6/34)、17.6%(6/34)和11.8%(4/34)。结论该院阿帕替尼的超适应证用药比较多见,且存在“不推荐使用”情况,需要加强管理,保障肿瘤患者的用药安全及临床获益。

Objective To analyze the off-label indications use of apatinib in a hospital,and provide evidence-based reference for standardizing clinical medication use.Methods According to the Guidelines for Clinical Application of New Anti-tumor Drugs(2022 Edition),Specification of Evidence-base Pharmaceutical Evaluation Method for Off-label Drug Use and Expert Consensuses of Off-label Drug Use,the evaluation criteria for off-label indication use were established.We retrospectively analyzed the data of inpatients receiving apatinib from January 1st,2021 to December 31st,2022 in a hospital,and conducted statistical analysis of the off-label indications.The evaluation criteria were used to evaluate the off-label indications use of apatinib based on evidence-based medicine.Results Totally 83 patients were given apatinib in a hospital,34(41.0%)of whom had off-label indications.18(52.9%),6(17.6%),6(17.6%)and 4(11.8%)patients were evaluated as“recommended use”“restricted use”“special use”and“not recommended use”,respectively.Conclusion The off-label indications use of apatinib in this hospital is relatively common,and“not recommended use”exists.Therefore,management should be strengthened to ensure drug safety and clinical benefit of tumor patients.