今日药学

2021, v.31(05) 339-342

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某院呼吸系统新型抗肿瘤药超说明书用药分析
Analysis of Off-label Use of Novel Anti-tumor Drugs in Respiratory System in a Hospital

张秀敏;
ZHANG Xiumin;The Central Hospital of Shantou;

摘要(Abstract):

目的分析某院呼吸系统新型抗肿瘤药物超说明书用药情况,为临床合理用药提供参考。方法抽取某院2019年7月~2020年6月所有使用呼吸系统新型抗肿瘤药物的839例病例,从适应证、给药剂量、给药途径等方面分析超说明书用药。结果在12个呼吸系统新型抗肿瘤药物中,4个药品出现超说明书用药(包括贝伐珠单抗、重组人血管内皮抑制素、安罗替尼和依维莫司)。其中,超适应证给药的有82例(占9.82%),超剂量给药的有127例(占15.21%),超途径给药的有40例(占4.79%)。57例超适应证给药和28例超途径给药的病例有FDA说明书批准或国内外指南推荐。25例超适应证给药、12例超途径给药和127例超剂量给药的病例尚未有权威文献支持。结论临床上存在呼吸系统新型抗肿瘤药超说明书用药情况,但存在一定的风险,医院应制定和完善超说明书用药流程,保障患者用药安全。
OBJECTIVE To investigate and analyze the off-label use of novel anti-tumor drugs in respiratory system in a hospital, so as to provide references for rational use of drugs in the clinic. METHODS A total of 839 cancer patients using novel anti-tumor drugs in respiratiory system in the hospital from July 2019 to June 2020 were collected, and the off-label use of drug information were sorted out from the indications, dosage, and route of administration. RESULTS Totally 12 novel anti-tumor drugs in respiratory system were used in the hospital, and 4 drugs had off-label usage(including bevacizumab, recombinant human endostatin, amlotinib and ivemus).82 cases(9.82%) were super-indications, 127 cases(15.21%) were over-dose, and 40 cases(4.79%) were over-drug route.57 super-indications cases and 28 over-drug route cases were approved by FDA or recommended by guidelinces, while 25 super-indications cases, 12 over-drug route cases and 127 over-dose cases were not supported by authoritative literature. CONCLUSION The off-label use of novel anti-tumor drugs in respiratory system is inevitable in clinic, and this may cause risks.The process of off-label use of drugs should be formulated and improved to ensure the safety of patients.

关键词(KeyWords): 新型抗肿瘤药;超说明书用药;临床药学
novel antineoplastic;off-label use of drugs;clinical pharmacy

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作者(Author): 张秀敏;
ZHANG Xiumin;The Central Hospital of Shantou;

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