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作 者:程明霞 姑丽尼格尔·艾尼瓦尔 张源 盛梦迪 谢菡[3] 葛卫红[1] CHENG Mingxia;Gulinigeer·Ainiwaer;ZHANG Yuan;SHENG Mengdi;XIE Han;GE Weihong(Department of Pharmacy,Gulou Clinical Medical College,Nanjing University of Traditional Chinese Medicine,Nanjing 210008,China;Department of Pharmacy,China Pharmaceutical University Nanjing Drum Tower Hospital,Nanjing 210008,China;Department of Pharmacy,Nanjing Drum Tower Hospital Affiliated Hospital of Medical School,Nanjing University,Nanjing 210008,China)
机构地区:[1]南京中医药大学鼓楼临床医学院药学部,南京210008 [2]中国药科大学南京鼓楼医院药学部,南京210008 [3]南京大学医学院附属鼓楼医院药学部,南京210008
出 处:《医药导报》2025年第2期239-245,共7页Herald of Medicine
基 金:江苏省药品临床综合评价项目(苏卫办药政[2022]15号-3)。
摘 要:目的对国家1.1类新药艾瑞昔布适宜性和可及性进行评价,为临床合理用药提供参考。方法基于德尔菲法构建国家1.1类新药艾瑞昔布适宜性和可及性评价体系,通过调查问卷进行评价。结果经过2轮专家函询,专家权威系数为0.795,专家意见的三级指标变异系数为0.15,协调系数为0.244,最终确定非甾体抗炎药物适宜性和可及性评价指标体系,包括2个一级指标、8个二级指标和39个三级指标。共发放调研问卷173份,结果表明适宜性方面,艾瑞昔布在药品使用与药品技术特点方面都具有良好适宜性;可及性方面,艾瑞昔布价格水平较低,可负担性、可获得性与患者可接受性良好。结论该研究全方面评估国家1.1类新药艾瑞昔布的适宜性和可及性,为临床合理使用和监管决策提供参考依据。Objective To evaluate the suitability and accessibility of the national Class 1.1 new drug imrecoxib,and provided reference for rational use of drugs in clinical practice.Methods Constructing a suitability and accessibility evaluation system for the national Class 1.1 new drug imrecoxib based on the Delphi method and evaluated through a survey questionnaire.Results After two rounds of expert inquiries,the authority coefficient of the experts was 0.795,the coefficient of variation of the third level indicator of expert opinions was 0.15,and the coordination coefficient was 0.244.Finally,the evaluation index system for the suitability and accessibility of nonsteroidal anti-inflammatory drugs was determined.The evaluation index system including 2 primary indicators,8 secondary indicators,and 39 tertiary indicators.173 survey questionnaires were distributed in total.The results indicate that in terms of suitability,imrecoxib has good suitability in both drug use and drug technology characteristics;In terms of accessibility,the price level of imrecoxib is relatively low,and its affordability,accessibility,and patient acceptability are good.Conclusions This study comprehensively evaluated the suitability and accessibility of the national Class 1.1 new drug imrecoxib,provided a reference basis for clinical rational use and regulatory decision-making.
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