卡瑞利珠单抗临床应用评价和安全性分析

目的 对卡瑞利珠单抗临床应用情况和安全性进行评价，为临床免疫检查点抑制剂的合理使用和管理提供参考。方法 调取2019年1月—2020年12月使用卡瑞利珠单抗的病例，根据药品说明书、权威诊疗规范、临床诊疗指南和临床路径进行用药评价和安全性分析。结果 共150例患者使用卡瑞利珠单抗，一线治疗占54.0%。临床应用覆盖18个瘤种，符合药品说明书和特殊情况下的药物合理使用86例(57.3%)。存在用量(19.3%)、输液体积(9.3%)、给药顺序(6%)和预处理(14.7%)不适宜等用法用量问题；卡瑞利珠单抗所有级别不良反应发生率为56.7%，3级以上为20.6%，主要表现为血液毒性(28%)、内分泌毒性(18%)和肝脏毒性(14%)等；观察到新的不良反应1例为双眼视盘病变，治疗中并发肺结核1例。基线监测只有血常规和生化指标占16%。结论 卡瑞利珠单抗临床应用存在治疗前移、毒性监测缺乏等情况。基于现有证据，在无循证医学证据的情况下，笔者不推荐免疫检查点抑制剂治疗前移和互换使用。免疫检查点抑制剂亟待规范化管理，特别是超说明书使用和免疫相关性毒性的管理。

Evaluation on the Rationality and Safety Clinical Application of Camrelizumab

OBJECTIVE To evaluate and analyze the rationality and safety of camrelizumab, and provide references for the rational use and management of immune checkpoint inhibitors. METHODS According to the latest regulatory-approved drug labeling, clinical practice guidelines and clinical pathways, the rationality and safety of the cases treated with camrelizumab from January 2019 to December 2020 were analyzed. RESULTS A total of 150 patients were treated with camrelizumab, and as first-line treatment was 54.0%. The clinical application covers 18 tumor types and 86(57.3%) diagnosis were in accordance with the indications of drug labeling and rational use of off-label. There were off-label uses on dose(19.3%), infusion volume(9.3%), order of administration(6%) and pretreatment(14.7%). The incidence of adverse reactions of all-grade and high-grade of camrelizumab was 56.7% and 20.6%, respectively, mainly manifested as blood toxicity(28%), endocrine toxicity(18%) and skin toxicity(14%), etc. One case of bilateral optic disc disease and one case of pulmonary tuberculosis were observed. In routine monitoring, blood routine and biochemical were only 16%. CONCLUSION The clinical application of camrelizumab has problems such as treatment advancement and lack of toxicity monitoring. Based on available evidence, treatment advancement and interchange use of immune checkpoint inhibitors in the absence of evidence-based medicine is not recommended. It is urgent to standardize the management of immune checkpoint inhibitors, especially the rational use of off-label and immune checkpoint inhibitor related toxicities.