摘要
目的为临床合理使用程序性细胞死亡受体1(PD-1)抑制剂提供参考。方法收集某院2016年至2020年上报的5种PD-1抑制剂(卡瑞利珠单抗、帕博利珠单抗、特瑞普利单抗、替雷利珠单抗、信迪利单抗)共42例药品不良反应(ADR)报告,对患者的性别、年龄、超适应证用药、转归和ADR发生情况进行汇总分析。分别检索PubMed、ScienceDirect、Web of Science数据库,收集此5种PD-1抑制剂的国内外文献报道ADR案例,总结发生规律及特点、常见症状、治疗策略并提出使用建议。结果42例ADR中,27例存在超药品说明书使用情况;男性发生率明显高于女性,40岁及以上人群的发生率较高;在临床转归中痊愈和好转占比较高(66.67%)。5种PD-1抑制剂的125篇ADR文献案例报道与收集到的ADR报告中,皮肤和皮下组织疾病、内分泌疾病发生率均较高,收集到的ADR表现以发热/胃肠道反应多见,但案例报道中,免疫相关性肺炎/心肌炎/神经炎/肝炎较多。结论在使用PD-1抑制剂时,皮肤/发热/消化道反应/内分泌系统的ADR发生率较高,但是随着PD-1抑制剂的广泛使用,其他免疫相关不良事件(irAE)的发生也并不罕见,应注意用药监护及时应对。临床使用免疫检查点抑制剂时,应根据患者情况合理选择药物,做好使用前的基线检查,并全程监测患者的各项指标,以减少或避免irAE的发生。
ObjectiveTo provide a reference for clinical rational drug use of programmed cell death 1(PD-1)inhibitors.MethodsA total of 42 adverse drug reaction(ADR)reports induced by five kinds of PD-1 inhibitors(Carilizumab,Pabolizumab,Treprizumab,Tirelizumab and Cindilimab)reported by a hospital from 2016 to 2020 were collected,and the patients’gender and age,medication with off-label indication,outcome and the incidence of ADR were summarized and analyzed.The PubMed,ScienceDirect,and Web of Science databases were searched to collect the ADR cases induced by five PD-1 inhibitors and reported in the domestic and foreign literature.The occurrence rules and characteristics,common symptoms,and treatment strategies of ADR were summarized.The suggestions for the use of PD-1 inhibitors were put forward.ResultsAmong 42 ADR cases,27 cases were off-label drug use.The incidence of ADR in males was significantly higher than that in females,and that was higher in people aged 40 years and above.In terms of clinical outcome,recovery and improvement accounted for a relatively high percentage(66.67%).The incidence of skin and subcutaneous tissue diseases and endocrine diseases was high not only in125 ADR literature case reports induced by five PD-1 inhibitors but also in ADR reports collected from the hospital.The manifestation of ADR reports collected from the hospital were mostly fever/gastrointestinal reaction,but there were more cases of immune-related pneumonia/myocarditis/neuritis/hepatitis in 125 ADR literature case reports.ConclusionThe incidence of ADR induced by PD-1 inhibitors in skin/fever/gastrointestinal reaction/endocrine system is high.However,with the widespread use of PD-1 inhibitors,the occurrence of other immune-related adverse events(irAE)is not rare,and we should pay attention to medication monitoring and respond in time.When using immune checkpoint inhibitors in the clinic,the drugs should be selected reasonably according to the patients’conditions,the baseline examination before use and the monitoring of patien
作者
周楠
屈杰
徐翠香
刘屹
王建华
ZHOU Nan;QU Jie;XU Cuixiang;LIU Yi;WANG Jianhua(Shaanxi Provincial People's Hospital,Xi'an,Shaanxi,China 710068;Medical School of Yan'an University,Yan'an,Shaanxi,China 716099)
出处
《中国药业》
CAS
2022年第20期110-115,共6页
China Pharmaceuticals
基金
国家自然科学基金[81801647]
陕西省重点研发计划项目[2021ZDLSF01-07]
陕西省创新人才推进计划项目[2021KJXX-23]。
