某院西妥昔单抗合理使用评价标准的建立与应用

Establishment and application of evaluation criteria on rational use of cetuximab in a hospital

目的建立西妥昔单抗合理应用评价标准,评价我院西妥昔单抗临床使用情况,为临床合理用药提供参考。方法借鉴药物利用评价(DUE)标准,参考中国国家药品监督管理局(NMPA)、美国食品药品监督管理局(FDA)西妥昔单抗药品说明书,NCCN、CSCO相关指南,以及新型抗肿瘤药物临床应用指导原则等,建立西妥昔单抗DUE标准,评价我院150例患者的西妥昔单抗临床应用情况。结果西妥昔单抗不合理用药体现在以下方面:适应证不适宜(15例,10.00%),用法用量不适宜(8例,5.93%),预处理不适宜(20例,13.33%),治疗类型与治疗方案不适宜(8例,5.93%)。结论我院建立的西妥昔单抗DUE标准有较好的实用性和科学性,可为临床合理用药提供参考。

Objective To establish the evaluation criteria on rational use of cetuximab,and to analyze the application of cetuximab in our hospital,in order to promote the rational use of cetuximab.Methods Referring to drug utilization evaluation(DUE)criteria,the DUE criteria of cetuximab were established on the base of the specification approved by Chinese National Medical Products Administration(NMPA)and America Food and Drug Administration(FDA),related guidelines from Chinese Society of Clinical Oncology(CSCO)and National Comprehensive Cancer Network(NCCN),and the guiding principles for the clinical application of new anti-tumor drugs.And the use of cetuximab in 150 patients was evaluated according to the criteria.Results The unreasonable applications of cetuximab were mainly as follows:15 cases(10.00%)were unreasonable in indications,8 cases(5.93%)in usage and dosage,20 cases(13.33%)in premedication,and 8 cases(5.93%)in treatment types and regimens.Conclusion The established DUE criteria of cetuximab had a good practicability and scientificity.It is conducive to promote rational drug use in the clinic.