某院日间化疗中心PIVAS尼妥珠单抗超药品说明书适应证用药分析

Analysis of Off-label Uses on Indications of Nimotuzumab in Daytime Chemotherapy Center of a Hospital

目的了解某院日间化疗中心PIVAS尼妥珠单抗超药品说明书适应证用药的情况,为加强该药超药品说明书适应证用药的管理提供循证依据,促进安全合理用药。方法提取2018年某院日间化疗中心PIVAS使用尼妥珠单抗的2973份医嘱,依据国家药品监督管理局颁布的说明书、相关指南以及国内外文献等,对该药超药品说明书适应证情况进行统计分析。结果尼妥珠单抗的临床使用存在着超药品说明书适应证现象,2973份医嘱共涉及768例患者,符合药品说明书适应证的有626例,占81.51%,超药品说明书适应证症有142例,占18.49%。其中,超药品说明书适应证的其他头颈部肿瘤(Ⅲ/Ⅳ鼻咽癌除外)、宫颈癌、脑胶质瘤、胰腺癌、食管癌以及非小细胞肺癌在国内外有相关的临床研究试验,而卵巢癌、子宫癌、子宫平滑肌瘤以及右眼鳞癌暂缺少相关的指南或临床数据。结论国家相关部门应建立健全超药品说明书用药相关法律法规,医疗机构应加强超药品说明书用药的管理,确保临床安全合理用药。

OBJECTIVE To investigate the off-label uses on indications of nimotuzumab in daytime chemotherapy center of a hospital,and to provide evidence for strengthening the administration of off-label uses on indications of the drug and promoting safe and rational use of medicines.METHODS 2973 medical advices including the uses of nimotuzumab in 2018 were selected from daytime chemotherapy center of a hospital,and statistical analysis was conducted on the off-label uses on indications of nimotuzumab according to the specification issued by National Medical Products Administration,relevant guidelines as well as domestic and foreign literatures and so on.RESULTS Off-label uses on indications existed in the clinical use of nimotuzumab.A total of 2973 medical advices involving768 patients were investigated and there were 626 cases conformed to the indications of specification of nimotuzumab,which accounting for 81.51%.142 cases were off-label uses on indications of nimotuzumab,which accounting for 18.49%.Among the cases of off-label uses on indications of nimotuzumab,there were related to clinical studies or trials at home or abroad for other head and neck tumors(exceptⅢ/Ⅳnasopharyngeal cancer),cervical cancer,glioma,pancreatic cancer,esophageal cancer and non-small cell lung cancer,while there were no relevant guidelines or clinical datas for ovarian cancer,uterine cancer,uterine leiomyoma and right eye squamous cell cancer.CONCLUSION Relevant departments should establish and improve the relevant laws and regulations on off-label uses,and medical institutions should strengthen the management of off-label uses to ensure safe and rational clinical uses.