某院免疫检查点抑制剂超适应证用药分析

目的：调查分析蚌埠市第三人民医院免疫检查点抑制剂（ICPi）超适应证用药情况，为规范该药的临床应用提供循证参考。方法：结合新型抗肿瘤药物临床试验的特点，建立超适应证用药评价标准。采用回顾性分析方法，抽取蚌埠市第三人民医院2019年1月1日-2020年12月31日住院患者使用ICPi的病例资料，对患者的临床诊断进行统计分析。利用新型抗肿瘤药物超适应证用药评价标准，对ICPi超适应证用药情况进行基于循证医学证据的合理性评价。结果：共收集到该院使用ICPi的病例30例，其中22例（73.3%）为超适应证用药，包括信迪利单抗20例、卡瑞利珠单抗1例和纳武利尤单抗1例。22例ICPi超适应证用药病例中，评价为限制使用、特殊使用和不推荐使用的分别占22.7%（5/22）、22.7%（5/22）和54.5%（12/22）。结论：该院ICPi的超适应证应用比较广泛，且存在无高级别循证医学证据支持的用药情况，需要加强管理，促进临床合理用药。

Evaluation of off-label indications use of immune checkpoint inhibitorsat a hospital

OBJECTIVE To explore the off-label indications of immune checkpoint inhibitors (ICPi) at Third Muncipal People's Hospital and provide evidence-based references for standardizing clinical medication. METHODS In conjunctions with the characteristics of clinical trials of new anti-tumor drugs, the evaluation criteria for off-label indications were established. Retrospective review was performed for clinical data of 30 inpatients using ICPi from January 1, 2019 to December 31, 2020 at Third Muncipal People's Hospital. And statistical analysis was made for clinical diagnosis of the patients. The evaluation criteria for off-label indications of new anti-tumor drugs were utilized for evaluating the off-label indications of ICPi based upon evidence-based medicine. RESULTS Among them, 22(73.3%) were of off-label indications, including sintilimab (n=20), camrelizumab (n=1) and nivolumab (n=1). Among 22 cases of off-label indications use of ICPi, 22.7%(5/22), 22.7%(5/22) and 54.5%(12/22) were evaluated as restricted, special and non-recommended uses respectively. CONCLUSION The off-label indications of ICPi and drug use without high-level evidence-based medicine are widespread at the hospital. Therefore management should be strengthened to promote rational drug use in clinical practices.