安罗替尼药物利用评价标准的建立及应用

Establishment and application of drug use evaluation criteria for anlotinib

目的 建立安罗替尼的药物利用评价(DUE)标准,评价和分析安罗替尼临床应用情况。方法 以安罗替尼说明书为基础,参照国家卫生健康委员会、中国临床肿瘤学会指南工作委员会、美国国立综合癌症网络等发布的相关诊疗指南和专家共识,建立安罗替尼DUE标准,包括体力状况、基线血常规、适应证等十个指标。采用回顾性研究方法,对亳州市人民医院2020年7月1日至2020年12月31日使用过安罗替尼的住院患者用药进行合理性评价。结果 共纳入使用过安罗替尼患者81例,对相应141份病历进行评价,完全符合评价标准的有15份,不完全符合的有126份,不合理率为89.4%。安罗替尼临床应用常见的不合理指标为适应证(53.2%)、用药监护(46.8%)和联合用药(44.0%)。合理性较高(> 90%)的指标为体力状况(99.3%)、用法用量(94.3%)、疗效评价(92.9%)和禁忌证(90.8%)。结论 该院安罗替尼使用不合理率较高,存在超适应证用药、未进行用药监护和联合用药不合理等方面的问题。

AIM To establish drug use evaluation(DUE) criteria for anlotinib, and to evaluate and analyse clinical use of anlotinib. METHODS Based on the pharmaceutical instructions, DUE of anlotinib were established with reference to clinical practice guidelines and expert consensuses issued by the National Health Commission of the People’s Republic of China, guidelines working committee of Chinese Society of Clinical Oncology(CSCO), and the National Comprehensive Cancer Network(NCCN). DUE of anlotinib were included ten indicators such as physical condition, baseline blood routine and indications. A retrospective analysis method was used to rationally evaluate of patients who used anlotinib from July 1,2020 to December 31, 2020 in People’s Hospital of Bozhou. RESULTS A total of 81 patients who had used anlotinib were included, and 141 corresponding medical records were evaluated. Fifteen cases fully met the DUE criteria, 126 cases did not fully meet the DUE criteria, and the unreasonable rate was 89.4%. The most common types of irrational using of anlotinib were indications(53.2%), medication monitoring(46.8%) and drug combination(44.0%). The indicators with high rationality(> 90%) were physical condition(99.3%), usage and dosage(94.3%), efficacy evaluation(92.9%) and contraindications(90.8%) CONCLUSION The irrational rate of use of anlotinib is relatively high in this hospital, and there are problems such as off-label use, lack of medication monitoring and unreasonable drug combination.