信迪利单抗药物利用评价标准的建立与应用

Establishment and application of drug use evaluation standard for sintilimab

目的建立信迪利单抗的药物利用评价(DUE)标准,评价信迪利单抗的临床应用情况,为临床合理用药提供参考依据。方法参考药品说明书、临床应用指南、指导原则、诊疗规范等,建立信迪利单抗DUE标准,设计点评表,对合肥市第一人民医院滨湖院区2020年7月~2021年6月应用信迪利单抗治疗出院患者进行合理性评价。结果信迪利单抗DUE标准根据用药指证、用药过程、用药结果的3个指标,分为13个子标准。符合标准的出院患者51例,共接受治疗205次。基线评估、用量、溶媒、给药途径、输注时间合理率100%,用药指征合理率21.57%,超适应证用药明显,给药顺序合理率68.62%,糖皮质激素治疗合理率96.08%,抗感染治疗合理率70.56%,不良反应记录率9.80%,不能真实有效反映免疫相关性不良反应的发生率,治疗有效率41.18%。结论利用信迪利单抗的DUE标准,发现和评价临床不合理用药问题,促进临床合理用药。

Objective To establish the drug use evaluation(DUE)standard of sintilimab to evaluate the clinical application of sintilimab,so as to provide reference basis for clinical rational drug use.Methods Referencing to the drug instructions,clinical application guidelines,guiding principles,diagnosis and treatment specifications,the due standard of sintilimab was established,and the date form was designed to evaluate the rationality of sintilimab in the treatment of discharged patients in our hospital from July 2020 to June 2021.Results The DUE standard of sintilimab is divided into 13 substandards according to the three indexes of medication indication,medication process and medication results.51 discharged patients met the criteria and received 205 treatments.The rational rate of baseline assessment,dosage,solvent,route of administration and infusion time was 100%,the rational rate of medication indication was 21.57%,off-label medication was obvious,the rational rate of administration order was 68.62%,the rational rate of glucocorticoid treatment was 96.08%,the rational rate of anti-infective treatment was 70.56%and the recorded rate of adverse reactions was only 9.80%,which could not truly and effectively reflect the incidence of immune related adverse reactions,The effective rate was 41.18%.Conclusions The DUE standard of sintilimab is used to detect and evaluate clinical irrational drug use and promote clinical rational drug use.