两家住院患者抗肿瘤药物超说明书使用分析

Analysis of Off-label Use of Anticancer Drugs in Inpatients in two Hospitals

目的:对陕西省抗肿瘤药物超说明书用药情况进行定性和定量研究,为强化超说明书用药的监管,减少不合理的超说明书用药提供依据。方法:回顾性收集陕西省两家医院2017年11~12月肿瘤住院患者的抗肿瘤药物应用情况,以及患者特征、肿瘤疾病和全身治疗的数据,并将每个个体的抗肿瘤药物治疗方案与相应的药品说明书、国际治疗指南进行比较。结果:1 178例患者中,355例(30.1%)接受了超说明书用药。所有药物应用的超说明书用药评价显示,主要的30种抗肿瘤药物中,超说明书最常见的为奈达铂(25.1%),其次为紫杉醇(21.1%)、多西他赛(15.8%)、顺铂(13.8%)。其中,美国国立综合癌症网络(NCCN)支持的占50.98%。结论:建立了以超说明书用药为主要评价内容的抗肿瘤药物医嘱点评方法,能够使临床药师全面深入判断抗肿瘤药物在超说明书用药环节存在的问题,为进一步开展相关研究提供思路。

Objective:To perform the qualitative and quantitative studies on the off-label use(OLU)of anticancer drugs in Shaanxi province in order to provide reference for strengthening OLU management and avoiding irrational application of OLU.Methods:The data of patients receiving systemic anticancer therapy during November and December 2017 in 2 hospitals in Shaanxi province were retrospectively collected.The individual data of patient characteristics,tumor disease and systemic treatment were collected,and each individual treatment was compared with the drug label and international treatment guidelines.Results:A total of 1178 consecutive patients were included in the study.Overall,30.1%(355 cases)of the patients received at least one off-label drug.The subsequent assessment of the OLU in all the drug applications revealed that among the major 30 anticancer drugs,the OLU with the most frequency was for nedaplatin(25.1%),followed by paclitaxel(21.1%),docetaxel(15.8%)and cisplatin(13.8%).The OLU supported by the current National Comprehensive Cancer Network(NCCN)guidelines accounted for 50.98%.Conclusion:A medical order evaluation method based on OLU of anticancer therapies is developed.The results of the research lay foundation for the further studies on the off-label use of drugs.