摘要
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.
作者
王旭东
黄佩文
邱季
WANG Xu-dong;HUANG Pei-wen;QIU Ji(Department of Pharmacy,Binhu Hospital of Hefei,Hefei 230000)
出处
《中南药学》
2023年第10期2773-2779,共7页
Central South Pharmacy
基金
安徽省卫生健康科研项目(No.AHWJ2022b104)。
关键词
阿帕替尼
循证医学
超适应证用药
合理用药
apatinib
evidence-based medicine
off-label indication
rational drug use