首页|期刊导航|中国医院用药评价与分析|达雷妥尤单抗注射液的药物利用评价标准的建立与应用

达雷妥尤单抗注射液的药物利用评价标准的建立与应用OA

Establishment and Application of Drug Use Evaluation Criteria for Daratumumab Injection

中文摘要英文摘要

目的:建立达雷妥尤单抗注射液的药物利用评价(DUE)标准,对其临床使用情况进行评估与分析,为该药的合理应用提供参考.方法:基于达雷妥尤单抗注射液的国内外药品说明书,参考相关临床指南、文献及诊疗规范,采用德尔菲法构建包含用药指征、用药流程与用药结局等多个维度的DUE标准.对 2022 年 1 月至 2025 年 6 月新疆某大型三级甲等医院使用该药的住院病例进行用药合理性评价.结果:最终确立的达雷妥尤单抗注射液DUE标准包括4 个一级指标和14 个二级指标.共纳入1 012 例符合标准的病例,适应证符合的有 949 例(占 93.77%),其中用药指征完全符合的有 851 例(占 84.09%);存在超说明书适应证用药情况的有 63 例(占 6.23%).用药期间出现相关不良反应的有 85 例(占 8.40%),不良反应关联性评价均为"可能",结局多数为治愈或好转.症状缓解有具体描述的病例为 677 例(占 66.90%),未详细描述症状改善的有 335 例(占 33.10%).结论:该研究制定的达雷妥尤单抗注射液的DUE标准具有较好的科学性与实用价值.达雷妥尤单抗注射液在临床应用中出现的问题,可作为药学部门实施主动干预的重要方向,从而指导临床合理用药,保障患者用药安全.

OBJECTIVE:To establish drug use evaluation(DUE)criteria for daratumumab injection,evaluate and analyze the clinical application,so as to provide references for rational application.METHODS:Based on domestic and international drug dispensatories for daratumumab injection,and with reference to relevant clinical guidelines,literature,diagnostic and treatment specifications,the DUE criteria comprising multiple dimensions including medication indications,administration procedures and treatment outcomes was developed by using the Delphi method.Evaluation on medication rationality was performed on inpatients from Jan.2022 to Jun.2025 in a large gradeⅢ,level A hospital in Xinjiang.RESULTS:The finally established DUE criteria for daratumumab injection comprised 4 primary indicators and 14 secondary indicators.A total of 1 012 eligible cases were enrolled,949 cases(93.77%)met the indication criteria,of which 851 cases(84.09%)completely met the medication indications;63 cases(6.23%)involved off-label drug use.There were 85 cases(8.40%)of adverse drug reactions related to medication,all rated as"possibly"in correlation assessment,with most outcomes being cured or improved.Symptom relief was explicitly documented in 677 cases(66.90%),while 335 cases(33.10%)lacked detailed descriptions of symptom improvement.CONCLUSIONS:The DUE criteria established for daratumumab injection demonstrate good scientificity and practical applicability.Issues identified in the clinical application of daratumumab injection can serve as key targets for proactive interventions by pharmaceutical departments,thereby guiding rational clinical medication and ensuring patient medication safety.

阎新燕;焦敏;沈皓;滕威;龚福恺;吴建华

新疆维吾尔自治区人民医院药学部,乌鲁木齐 830001||新疆维吾尔自治区临床药学研究所,乌鲁木齐 830001新疆维吾尔自治区人民医院药学部,乌鲁木齐 830001||新疆维吾尔自治区药品使用监测与临床综合评价中心,乌鲁木齐 830001新疆维吾尔自治区人民医院药学部,乌鲁木齐 830001||新疆维吾尔自治区临床药学研究所,乌鲁木齐 830001新疆维吾尔自治区人民医院药学部,乌鲁木齐 830001||新疆维吾尔自治区临床药学研究所,乌鲁木齐 830001新疆维吾尔自治区人民医院药学部,乌鲁木齐 830001||新疆维吾尔自治区临床药学研究所,乌鲁木齐 830001||新疆维吾尔自治区药品使用监测与临床综合评价中心,乌鲁木齐 830001新疆维吾尔自治区人民医院药学部,乌鲁木齐 830001||新疆维吾尔自治区临床药学研究所,乌鲁木齐 830001||新疆维吾尔自治区药品使用监测与临床综合评价中心,乌鲁木齐 830001

医药卫生

达雷妥尤单抗注射液药物利用评价合理用药德尔菲法

Daratumumab injectionDrug use evaluationRational medicationDelphi method

《中国医院用药评价与分析》 2026 (3)

343-345,349,4

新疆维吾尔自治区自然科学基金资助项目(No.2021D01C178)新疆维吾尔自治区卫生健康委员会"天山英才"医药卫生高层次人才培养计划(No.TSYC202401B059)

10.14009/j.issn.1672-2124.2026.03.019

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