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安罗替尼超说明书用药情况及循证评价

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目的 调查某院安罗替尼超适应证用药情况,为临床合理应用安罗替尼提供参考.方法 收集2023年1月至2024年1月某院使用安罗替尼的住院处方,依照安罗替尼药品说明书对收集的处方是否超说明书进行判断.查阅相关文献和数据库,对被判定为超说明书用药的处方进行分类统计,并进行循证医学证据的收集.结果 本次调查共收集安罗替尼1702个病例,经比对最新药品说明书,超适应证用药的共有427例,占比25.09%.涉及病种20种,最常出现的适应证为结直肠癌116份,占比27.17%.427例超说明书用药中,有较强循证医学证据支持的适应证包括结直肠癌和卵巢癌,共164例,占比38.40%;有较弱的循证医学证据支持的适应证有食管恶性肿瘤、肝细胞癌、胆道癌等,共205例,占比48%.结论 安罗替尼用于治疗食管恶性肿瘤、肝细胞癌和胆道癌,缺乏高质量的循证证据,获益有限,建议临床应用安罗替尼时,应综合评估,充分考虑疾病相关指南和临床证据,确保药物的安全、合理使用.安罗替尼存在无证据支持的超说明书用药,应加强超说明书用药的管理,以提高用药的合理性与安全性.
Investigation and Evaluation of the Off-label Use of Anlotinib
OBJECTIVE To investigate the off-indication medication of anlotinib in a hospital,and to provide reference for clinical rational application of anlotinib.METHODS To collect the inpatient prescriptions of anlotinib in a hospital from January 2023 to January 2024,and to judge whether the collected prescriptions are off-label accord-ing to the drug instructions of anlotinib.Referring to relevant literature and databases,the prescriptions judged as off-label drug use were classified and statistically analyzed,and evidence-based medical evidence was collect-ed.RESULTS A total of 1702 cases of anlotinib were collected in this survey.By comparing the latest drug instruc-tions,there were 427 cases of off-indication medication,accounting for 25.09%.There were 20 kinds of diseases in-volved,and the most common indications were 116 cases of colorectal cancer,accounting for 27.17%.Among the 427 cases of off-label drug use,the indications supported by strong evidence-based medical evidence included colorectal cancer and ovarian cancer,a total of 164 cases,accounting for 38.40%;the indications supported by weak evidence-based medical evidence were esophageal malignant tumor,hepatocellular carcinoma,biliary tract cancer,etc.,a total of 205 cases,accounting for 48%.CONCLUSION Anlotinib is used to treat esophageal malignant tumors,hepato-cellular carcinoma,and biliary tract cancer.It lacks high-quality evidence-based evidence and has limited benefits.It is recommended that clinical application of anlotinib should be comprehensively evaluated,and disease-related guide-lines and clinical evidence should be fully considered to ensure the safe and rational use of drugs.

AnlotinibEvidence-based evaluationRational drug use

李灵琦、黄艳

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厦门大学附属第一医院制剂科,福建厦门 361005

安罗替尼 循证评价 合理用药

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(11)