基于德尔菲法的中草药肝毒性评估量表研制  

Research on Assessment Scale of Hepatotoxicity of Chinese Materia Medica Base on Delphi Method

作　　者：付丽红 张鑫[1] 吕烨 张伊婧 霍光远 高月求[1] FU Lihong;ZHANG Xin;LYU Ye;ZHANG Yijing;HUO Guangyuan;GAO Yueqiu(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203

出　　处：《中国中医药信息杂志》2023年第5期146-152,共7页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家自然科学基金(81673938、81874436);国家科技重大专项(2018ZX10725-504);上海市临床重点专科建设项目(中医专业)-中医肝病(shslczdzk01201);上海市教育委员会“曙光计划”(18SG39);上海市2020年度“科技创新行动计划”医学创新研究专项(20Z21900100)。

摘　　要：目的构建中草药肝毒性评估量表,对中草药及其相关制剂的肝毒性进行综合性证据评估。方法通过文献荟萃分析法结合专家访谈法收集国内外含有中草药肝毒性有效信息的数据库并进行遴选。制作专家咨询德尔菲问卷,采用德尔菲法进行2轮专家咨询,分析专家权威系数、意见集中度及一致性。根据专家意见进行修改和调整后计算指标条目权重,结合综合评价模型构建中草药肝毒性评估量表,并进行信效度测试。使用ROC曲线确定最佳诊断阈值。结果研究小组初步整理出9个相关因素,共涉及12个相关指标。经2轮咨询后,各指标条目咨询的专家共识度均不低于70%。第一、二轮咨询中Kendall协调系数W分别为0.162(χ^(2)=68.88,P<0.001)、0.246(χ^(2)=27.50,P<0.001)。最终形成包含8个条目的中草药肝毒性评估量表。量表的内容效度指数(I-CVI)>0.78,平均内容效度指数(S-CVI/Ave)=0.84,K^(*)=0.83,Cronbach’α系数为0.656。诊断模型ROC曲线下面积为0.906,Youden指数确定最佳阈值为0.99,灵敏度为95%,特异度为75%。根据四分位数法确定评分≥1.44(P75)者为高风险药物。结论初步建立了适合中草药肝毒性评估的工具量表,可用于评估中草药潜在的肝毒性,优化现有毒性药材评价体系,及时发现“高风险”“高警戒”中草药,为临床安全用药提供参考依据。Objective To construct the hepatotoxicity assessment scale of Chinese materia medica;To conduct comprehensive evidence assessment of hepatotoxicity of Chinese materia medica and its related preparations.Methods Through literature review and experts interview,databases containing effective information on hepatotoxicity of Chinese materia medica at home and abroad were collected and selected.Then,the expert consultation questionnaire of assessment scale was made.Two rounds of expert consultation were carried out using Delphi method,of which the expert authority coefficient,the concentration of opinions,and consistency of opinions were analyzed.According to expert opinions,the scale was modified and adjusted,and then the weight of indicator was calculated.Combined with the comprehensive evaluation model,the assessment scale of hepatotoxicity of Chinese materia medica was constructed,and the reliability and validity were tested.The ROC curve was used to determine the optimal diagnostic threshold of syndrome.Results The research team preliminarily sorted out a total of 9 related factors and 12 related indicators.After two rounds of consultation,the expert consensus degree of each indicator was≥70%.The Kendall W coefficients in the first and second rounds of consultation were 0.162(χ^(2)=68.88,P<0.001)and 0.246(χ^(2)=27.50,P<0.001),respectively.Finally,this assessment scale was formed with 8 indicators.Statistical results showed that the I-CVI>0.78,S-CVI/Ave=0.84,K*=0.83,and the overall Cronbach’sαcoefficient of the scale was 0.656.The area under ROC curve of this diagnostic scale was 0.906,and the optimal threshold determined by Youden index was 0.99.The optimal sensitivity was 95%,and the speci fi city was 75%of it.According to the quartile method,those with score≥1.44(P75)were identified as high-risk drugs.Conclusion A tool scale suitable for hepatotoxicity evaluation of Chinese materia medica and its related preparations has been preliminarily established,which can be used to evaluate the potential hepatot

关 键 词：中药药源性肝损伤 药物性肝损伤 德尔菲法 量表 药物不良反应 

分 类 号：R285[医药卫生—中药学]