基于真实世界的肿瘤免疫治疗药物PD-1/PD-L1抑制剂使用情况分析

Use of programmed death-1/programmed death-ligand 1 inhibitors based on the real world

目的分析11种肿瘤免疫治疗药物程序性死亡受体1(PD-1)/程序性死亡受体配体1(PD-L1)抑制剂临床使用情况。方法从某医院医院信息系统与电子病历系统数据库中提取使用11种PD-1/PD-L1抑制剂患者的相关信息,运用描述性统计分析与数据挖掘等方法,对2018年1月至2022年3月期间11种PD-1/PD-L1抑制剂的病种分布、患者特征、药物来源、使用量等进行分析,同时对11种PD-1/PD-L1抑制剂超适应证使用情况进行分析。结果11种药物中医院有使用记录10种,其使用量逐年增高,2018年以来共使用2769人次,其中卡瑞利珠单抗使用量最高,约占52.8%;国产药物占92.3%,进口药物占7.7%;患者自备药物占95.4%,采购药物占4.6%。不同医保类型、进口/国产药物使用量比较差异均有统计学意义(P<0.05)。多种药物存在超适应证使用情况。结论PD-1/PD-L1抑制剂使用逐年增多,医院使用主要以患者自备为主,国产药物使用量大于进口药物,多存在超适应证用药情况。因此,医院管理部门应加强此类药物安全监管,完善病历书写及系统信息,为临床上有效、安全使用肿瘤免疫治疗药物提供更多真实世界证据。

Objective To analyze the clinical use of 11 kinds of tunor immunotherapy drugs:programmed death-1(PD-1)/programmed death-ligand 1(PD-L1)inhibitors.Methods Patient information from January 2018 to March 2022 was extracted from the health infor-mation and electronic medical record systems of hospitals.Descriptive statistical analysis and data mining were used to analyze the disease distribution,patient characteristics,drug sources,and consumption of 11 kinds of PD-1/PD-L1 inhibitors.Results Hospitals reported the use of 10 of the 11 drugs,which has increased yearly.Since 2018,a total of 2769 person-times have used one of the drugs.Karelizumab had the highest reported use and accounted for for 52.8%.Domestically-manufactured drugs accounted for 92.3%,and imported drugs accounted for 7.7%,Additionally,95.4%of patients brought their own drugs and 4.6%purchased drugs from the hospital.Statistically sig-nificant differences were found among different medical insurance types or different drug sources(P<0.05).Many drugs are out of indica-tions.Conclusion The use of PD-1/PD-L1 inhibitors is increasing yearly.The drugs most frequently used in hospitals are self-provided by patients.The use of domestically-manufactured drugs is greater than that of imported drugs,and there are many cases of over-indica-tions.Therefore,hospital management should strengthen the oversight of the use of such drugs,improve medical records and system infor-mation,and provide more evidence for the effective and safe use of drugs.