某肿瘤医院帕博利珠单抗超适应证用药分析

Investigation an analysis of off-label usage of pembrolizumab in a cancer hospital

目的调查分析某肿瘤医院帕博利珠单抗超说明书用药使用情况,为规范临床用药提供循证依据。方法抽取2019年9月~2021年9月使用帕博利珠单抗的1274份病例数据进行分析。依照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)审批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,进行分析与评价。结果1274份病例中,用于说明书内适应证恶性黑色素瘤、非小细胞肺癌、食管癌、结直肠癌、头颈部鳞状细胞癌治疗的共962例,占75.51%;用于说明书外适应证乳腺癌、胃癌、胰腺癌、肝癌、小细胞肺癌、卵巢癌、子宫癌、鼻咽癌、尿路上皮癌等共312例,占24.49%;其中,帕博利珠单抗用于乳腺癌、胃癌、肝癌、子宫癌符合美国FDA批准;用于胰腺癌、鼻咽癌、小细胞肺癌、膀胱癌等符合NCCN指南推荐,而卵巢癌等瘤种暂无权威指南推荐使用。结论某院帕博利珠单抗的临床使用存在超说明书用药现象,相关部门或专业医药学术组织应为临床合理超适应证用药制定权威的药物治疗指南和提供依据。

Objective To investigate and analyze the off-label uses on indications of pembrolizumab in a cancer hospital,and to provide evidence for standardizing clinical medication.Methods 1,631 medical advices including the uses of pembrolizumab from September 2019 to September 2021 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 A total of 1,274 medical advices,there were 962 cases conformed to the indications of specification,which accounting for 75.51%.312 cases were off-label uses on indications of pembrolizumab,including breast cancer,gastric cancer,pancreatic cancer,liver cancer,small cell lung cancer,ovarian cancer,uterine cancer,nasopharyngeal carcinoma,and bladder cancer,which accounting for 24.49%.Among them,pembrolizumab is approved by the FDA for used in breast cancer,gastric cancer,liver cancer,and uterine cancer,recommended used for pancreatic cancer,nasopharyngeal carcinoma,small cell lung cancer and bladder cancer by NCCN guidelines.There is no relevant guidelines or clinical evidence for other diseases such as ovarian cancer.Conclusion Off-label uses on indications existed in the clinical use of pembrolizumab.Relevant departments and professional medical academic organizations should formulate authoritative drug treatment guidelines,and provide evidence for standardizing clinical medication.