中国临床药学杂志2023，Vol.32Issue(6)：431-435,5.DOI:10.19577/j.1007-4406.2023.06.007
信迪利单抗的临床应用评价和安全性分析
Clinical application evaluation and safety analysis of sintilimab
摘要
Abstract
AIM To evaluate the rationality and safety of sintilimab,so as to provide reference for clinical application.METHODS The basic information,medication information and occurrence of adverse reactions of the patirnts treated with sintilimab from May 1,2021 to October 31,2021 were collected.The medication evaluation and safety analysis of sintilimab were performed according to the drug instructions,authoritative guidelines and the Thomson classification of Micromedex database.RESULTS A total of 90 patients were treated with sintilimab for 209 times.There were some problems such as off-label drug use on indication(12.22％),off-label drug use on dosage(26.32％),inappropriate order of administration(3.35％),and most of the Thomson evidence of off-label drug use did not reach Grade B or above.The occurrence of immune-related adverse events(irAEs)was 50.00％,and the main manifestations were endocrine toxicity(18.89％),hematological toxicity(12.22％)and hepatotoxicity(12.22％).Gender,age,smoking history,drinking history,underlying diseases,radiotherapy history and different doses(100 mg and 200 mg)were not correlated with the incidence of irAEs of sintilimab.CONCLUSION The irrational use of sintilimab is widespread.The management of off-label drug use and medical record writing should be strengthened by hospital,and clinical pharmacists should check prescriptions seriously and pay attention to adverse reactions,so as to ensure the safety of patients and reduce medical risks.关键词
信迪利单抗/超说明书用药/合理性/安全性/临床药师Key words
sintilimab/off-label drug use/rationality/safety/clinical pharmacist引用本文复制引用
杨岩,闵旭红,王尚虎,张云玲..信迪利单抗的临床应用评价和安全性分析[J].中国临床药学杂志,2023,32(6):431-435,5.基金项目
2021年度安徽省卫生健康委科研项目立项项目(编号AHWJ2021b149) （编号AHWJ2021b149）
