门诊肿瘤患者单抗类药物超药品说明书使用分析  

Survey on Off-label Drug Use of Monoclonal Antibody Antineoplastic Agents in Outpatients

作　　者：林永晴 乔涌起[2] 戴媛媛[2] 

机构地区：[1]中国药科大学,江苏南京211198 [2]中国医学科学院肿瘤医院,北京100021

出　　处：《中国药物评价》2016年第6期510-513,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:分析肿瘤专科医院门诊患者单抗类抗肿瘤药超药品说明书使用情况,并初步分析用药的合理性。方法:选取2014年9月至2015年2月某院门诊患者单抗类药物处方,结合病案资料分析患者单抗类药物使用情况,查阅药品说明书、指南及相关文献分析超药品说明书用药情况及其合理性。结果:门诊单抗类药物处方1923张涉及568例患者,5种单抗类药物西妥昔单抗注射液、尼妥珠单抗注射液、贝伐珠单抗注射液、利妥昔单抗注射液、注射用曲妥珠单抗的应用与说明书的相符率分别为63.16%,21.54%,44.67%,75.82%,99.59%;超药品说明书用药主要表现在超适应证用药,适应证符合说明书和/或相关指南之和的比率分别为89.47%,21.54%,89.33%,95.60%,99.59%。结论:门诊患者单抗类药物的使用存在不同程度的超药品说明书用药,超药品说明书用药基本符合指南或有相关临床研究支持,总体用药情况基本合理。Objective： To investigate the off-label drug use of monoclonal antibody antineoplastic agents in outpatients in a cancer hospital and to analyze their rationality. Methods ： Prescriptions of outpatients taking monoclonal antibody antineoplastie agents were selected from Sep. 2014 to Feb. 2015, and off-label drug use was analyzed according to the package inserts. Evidence supporting off-label drug use was searched in Guidelines, PubMed and Wangfang Data to evaluate the rationality. Results： Of total 1923 prescriptions that included 568 cases, the ratio of the usage of Cetuximab, Nimotuzumab, Bevacizumab, Rituximab and Trastuzumab consistent with package inserts is 63.16%, 21.54%, 44. 67% , 75.82% , 99. 59% respectively. The main type of off-label drug use was off-label indication. The indications consistent with package inserts or NCCN Guidelines was 89.47% ,21.54% ,89. 33% ,95.60% ,99. 59% respectively. Conclusion ： The ratio of off-label drug use of monoclonal antibody antineoplastic agents was common and different from each other. Off-label drug use was supported by evidence in NCCN guidelines and other results of clinieal research.

关 键 词：单抗类抗肿瘤药物 超药品说明书用药 西妥昔单抗 尼妥珠单抗 贝伐珠单抗 利妥昔单抗 曲妥珠单抗 

分 类 号：R95[医药卫生—药学]