中国临床药学杂志2025，Vol.34Issue(5)：350-354,5.DOI:10.19577/j.1007-4406.2025.05.005
白蛋白结合型紫杉醇超说明书用药的综合评价
Systematic evaluation of the off-label use of nab-paclitaxel
摘要
Abstract
AIM To comprehensively evaluate the off-label use of nab-paclitaxel(nab-PTX)based on real-world data,and provide a reference for the clinical application and off-label drug use management of nab-PTX.METHODS Data of 161 hospitalized patients receiving off-label use of nab-PTX from January 1st,2021 to December 31st,2023 were collected and analyzed.The analysis focused on the types of diseases,level and strength of clinical evidence,efficacy,and safety of off-label use of nab-PTX.RESULTS Among the 161 cases analyzed,the off-label use of nab-PTX was predominantly observed in the following malignancies:metastatic pancreatic adenocarcinoma(60 cases,37.27％),platinum-resistant recurrent ovarian cancer(58 cases,36.02％),and locally advanced or metastatic non-small cell lung cancer(NSCLC)(43 cases,26.71％).The level of evidence-based evidence for the off-label use of nab-PTX in these cases was all relatively high(Class Ⅱ a or Class Ⅱ b),and the strength of evidence was Category B.The departments where off-label use of nab-PTX occurred were mainly the department of oncology(86.34％).The treatment response rates for metastatic pancreatic cancer,platinum-resistant recurrent ovarian cancer,and locally advanced or metastatic non-small cell lung cancer were 90.57％,84.62％,and 75.76％respectively,and the recurrence rates were 8.33％,15.91％,and 4.00％respectively.Adverse reactions mainly affected the hematological system(53.42％).CONCLUSION The off-label use of nab-PTX is predominantly observed in metastatic pancreatic adenocarcinoma,platinum-resistant recurrent ovarian cancer,and locally advanced or metastatic NSCLC.The efficacy of the off-label use of nab-PTX in patients is relatively high,but it is still necessary to pay attention to the risk of hematological injury.Complete blood counts and lymphocyte level should be monitored throughout clinical medication administration.The pharmacy department needs to further strengthen the supervision of off-label use of nab-PTX,enhancing clinical pharmaceutical care and medication tracking during off-label use to improveclinical efficacy and ensure medication safety.关键词
白蛋白结合型紫杉醇/超说明书用药/综合评价Key words
nab-paclitaxel/off-label use/systematic evaluation分类
医药卫生引用本文复制引用
俞苏纯,吴洪斌,傅翔..白蛋白结合型紫杉醇超说明书用药的综合评价[J].中国临床药学杂志,2025,34(5):350-354,5.基金项目
2023年度市东医院院级课题一般项目(编号YJYB26) （编号YJYB26）
