某肿瘤专科医院白蛋白结合型紫杉醇超适应证用药分析  

Investigation and Analysis of Off-Label Usage of Albumin-bound Paclitaxel in A Cancer Hospital

作　　者：陈富钦 刘海 梁蔚婷[1] 刘庆[1] 龚泳琪 黄红兵[1] 刘韬[1] 陈卓佳[1] CHEN Fuqin;LIU Hai;LIANG Weiting;LIU Qing;GONG Yongqi;HUANG Hongbing;LIU Tao;CHEN Zhuojia(Pharmaceutical Department of Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,CollaborativeInnovation Center for Cancer Medicine,Guangzhou,Guangdong 510060,China)

机构地区：[1]中山大学肿瘤防治中心药学部/华南肿瘤学国家重点实验室/肿瘤医学协同创新中心,广东广州510060

出　　处：《今日药学》2021年第2期95-99,共5页Pharmacy Today

摘　　要：目的调查分析某肿瘤专科医院白蛋白结合型紫杉醇超说明书使用情况,为规范临床用药提供循证依据。方法抽取2018年1月~2019年12月使用白蛋白结合型紫杉醇的1631份用药医嘱进行分析,依据国家药品监督管理局(NMPA)颁布的说明书、美国食品和药物管理局(FDA)批准的药品说明书以及美国国立综合癌症网络(NCCN)临床实践指南的推荐,对说明书外用药情况进行分析及评价。结果1631份病例中,用于说明书内适应证转移性乳腺癌有120例,占7.36%;用于说明书外适应证如黑色素瘤、胃癌、胰腺癌、非小细胞肺癌、肝癌、淋巴瘤、头颈部癌、卵巢癌、宫颈癌、鼻咽癌、食管癌、输尿管癌等共1511例,占92.64%;其中,白蛋白结合型紫杉醇用于非小细胞肺癌和胰腺癌符合美国FDA批准,分别为259例和353例;用于转移性黑色素瘤、局部晚期或转移性膀胱癌、宫颈癌、子宫内膜癌和复发性卵巢癌符合NCCN指南推荐,而食管癌、鼻咽癌等瘤种目前仍处于Ⅱ期或Ⅲ期临床试验中,尚无权威的指南推荐使用。结论某院白蛋白结合型紫杉醇的临床使用存在超说明书用药现象。国家相关部门及专业医药学术组织应制定权威的药物治疗指南,为临床合理超说明书用药提供依据。OBJECTIVE To investigate and analyze the off-label uses on indications of albumin-bound paclitaxel in a cancer hospital,and to provide evidence for standardizing clinical medication.METHODS 1631 medical advices including the uses of albumin-bound paclitaxel from January 2018 to December 2019 were selected,analyzed and evaluated according to the specification issued by the National Medical Products Administration(NMPA),the Food and Drug Administration(FDA)and the recommendations of the clinical practice guidelines of the National Comprehensive Cancer Network(NCCN).RESULTS In a total of 1631 medical advices,there were 120 cases conformed to the indications of specification,which accounting for 7.36%.1511 cases were off-label uses on indications of albumin-bound paclitaxel,including pancreatic cancer,non-small cell lung cancer,liver cancer,lymphoma,head and neck cancer,ovarian cancer,cervical cancer,nasopharyngeal carcinoma,melanoma,gastric cancer,esophageal cancer and ureteral cancer,which were accounted for 92.64%.Among them,albumin-bound paclitaxel was approved by the FDA for using in non-small cell lung cancer and pancreatic cancer,and was recommended to use for metastatic melanoma,locally advanced or metastatic bladder cancer,cervical cancer,endometrial carcinoma,and recurrent ovarian cancer by NCCN guidelines.There is no relevant guidelines or clinical evidence for other diseases such as esophageal cancer and nasopharyngeal carcinoma.CONCLUSION Off-label uses on indications exist in the clinical use of albumin-bound paclitaxel.Relevant departments and professional medical academic organizations should formulate authoritative drug treatment guidelines,and provide evidence for standardizing clinical medication.

关 键 词：白蛋白结合型紫杉醇 肿瘤专科 超说明书 

分 类 号：R925[医药卫生—药学]