重组人胰岛素药物利用评价标准的建立

目的 :建立重组人胰岛素药物利用评价(DUE)标准,为临床合理用药提供参考。方法:基于中华医学会糖尿病学分会(CDS)制定的相关指南拟定重组人胰岛素DUE标准草案,形成专家咨询表,进行两轮专家咨询调查,通过相应的统计学分析对标准进行修订完善。结果:重组人胰岛素DUE标准分为用药指征、用药过程、用药结果三个部分。用药指征包括临床诊断标准、疾病诊断、禁忌证;用药过程包括给药途径、注射部位、血糖监测、给药剂量间隔与调整、联用其他降糖药情况、合用非降糖药情况、糖尿病教育;用药结果包括体征症状、控制目标、药品不良反应监测与处置。咨询专家的权威程度系数(Cr)>0.7,克朗巴赫系数(α)>0.6,说明专家权威性和指标体系内部一致性良好。结论:建立的重组人胰岛素DUE标准适用于医疗卫生机构开展DUE研究,同时也可为临床药师开展工作提供参考。

Establishment of DUE Criteria of Recombinant Human Insulin

OBJECTIVE： To establish DUE criteria of recombinant human insulin. METHODS： DUE criteria of recombinant human insulin was developed based on relevant instructions and guidance of Chinese Medical Association Diabetes Society （CDS）. Expert consultation questionnaire was formed and Delphi survey was conducted through two rounds of consulting and inquiry to revise and improve the DUE criteria. RESULTS： DUE criteria of recombinant human insulin contained three parts, including medication indications, medication process, medication results. Medication indications included clinical diagnostic criteria, disease diagnosis, contraindications; medication process included route of administration, site of injection, blood glucose monitoring, dose interval and adjustment, combined with other anti-diabetic drugs, combined with non-hypoglycemic, diabetes education; medication results included signs symptoms, objectives control, ADR monitoring and disposal. Authority consultants degree coefficient Cr were 〉 0.7, and Cronbach coefficient a were〉0.6, indicating that the expert authority and internal index system had good consistency. CONCLUSIONS： Established DUE criteria of recombinant human insulin not only are applied in drug utilization evaluation, but also provide reference for clinical pharmacists.