心力衰竭新型治疗药品的临床综合评价  

Clinical comprehensive evaluation of novel drugs for heart failure treatment

作　　者：高洁 张秀珍 丁静 张许 张厚莉 党和勤 陈文文 GAO Jie;ZHANG Xiuzhen;DING Jing;ZHANG Xu;ZHANG Houli;DANG Heqin;CHEN Wenwen(Department of Pharmacy,the Second Affiliated Hospital of Shandong First Medical University,Tai'an 271000,China)

机构地区：[1]山东第一医科大学第二附属医院药剂科,泰安271000

出　　处：《中国研究型医院》2025年第1期34-41,共8页Chinese Research Hospitals

基　　金：山东省中医药科技项目(M-2023295);山东省药学会医院合理用药天际健康中青年科研学术活动项目(hlyy2024-03);山东省医务系统职工科技创新计划入围项目(SDYWZGKCJHLH2023029);泰安市科技创新发展项目(2022NS347、2022ZC396、2022NS232、2023NS453、2023NS389)。

摘　　要：目的探索心力衰竭新型治疗药品的临床综合评价。方法成立临床综合评价项目研究小组,检索PubMed、Embase、中国知网、维普、万方等数据库,检索时间为数据库自建库至2024年4月,以心力衰竭,沙库巴曲缬沙坦,诺欣妥,维立西呱,唯可同,达格列净,安达糖等为检索关键词。采用德尔菲法构建药品临床综合评价指标体系,包括构建专家库、收集专家调查问卷、量化指标(指标重要程度、专家意见权威程度、专家意见集中程度、专家意见协调程度及专家积极系数)、指标权重及赋值。从安全性、有效性、经济性、适宜性、创新性、可及性及其他7个维度对心力衰竭新型治疗药品进行临床综合评价。结果临床综合评价指标体系专家库共纳入17名专家。本研究2轮调查问卷的有效回收率均为100%;专家权威系数为0.84,提示专家权威程度较高。第二轮问卷调查中,指标重要性赋值平均为(4.98±0.09)分,满分频率为41.2%~100.0%,表明专家意见集中程度较好。各指标变异系数分布于0~0.1,协调系数为0.39,表明专家意见协调程度较好。经专家讨论,临床综合评价指标体系修改后包括7项一级指标,27项二级指标以及衍生出的103项指标评分细则。本研究中心力衰竭新型治疗药品(沙库巴曲缬沙坦、维立西呱、达格列净、恩格列净)临床综合评价得分均>70.0分,达格列净评分最高(84.6分)。结论治疗心力衰竭新型药品中,沙库巴曲缬沙坦、维立西呱、达格列净、恩格列净具有较好的临床价值,推荐作为新型药物引进。Objective To explore the comprehensive clinical evaluation of novel therapeutic drugs for heart failure.Methods The research team of the clinical comprehensive evaluation program was established,and the databases of PubMed,Embase,CNKI,VIP,and WANFANG DATA were searched from the time of database self-construction to April 2024,and the keywords of heart failure,sakubutraviral sartorubicin,nociceptor,viliciciclovir,viktorubicin,daglitazone,andraglitazone,andraglitazone,were used for the search.The Delphi method was used to construct a comprehensive clinical evaluation index system for drugs,including the construction of an expert database,the collection of expert questionnaires,the quantification of indexes(the degree of importance of indexes,the degree of authority of experts'opinions,the degree of concentration of experts'opinions,the degree of coordination of experts'opinions and experts'positive coefficients),the weighting of indexes and the assignment of values.The clinical comprehensive evaluation of new heart failure treatment drugs was conducted in seven dimensions:safety,effectiveness,economy,appropriateness,innovation,accessibility and other dimensions.Results A total of 17 experts were included in the expert database of the clinical comprehensive evaluation index system.The effective recovery rate of the questionnaires in the 2 rounds of this study was 100%;The coefficient of expert authority was 0.84,suggesting a high degree of expert authority.In the second round of questionnaires,the mean of indicators assignment was(4.98±0.09)points,and the frequency of full scoreswas 41.2%-100.0%,suggesting a good degree of concentration of expert opinions.The variation coefficient of each indicator was distributed from 0 to 0.1,and the harmonization coefficient is 0.39,indicating that the degree of harmonization of expert opinions was good.After expert discussion,the clinical comprehensive evaluation index system was modified to include 7 first-level indexes,27 second-level indexes,and 103 index scoring rules deriv

关 键 词：心力衰竭 德尔菲技术 药品评价 

分 类 号：R54[医药卫生—心血管疾病]