HLA-B^(*)5801基因多态性检测用于预测别嘌醇相关重症药疹的快速卫生技术评估  

HLA-B^(*)5801 gene polymorphisms detection in prediction of severe drugeruption associated allopurinol:a rapid health technology assessment

作　　者：曹谨谨 凌亚 张倢 张晶晶[1] 朱建国[1] 曹秀芳[1] CAO Jinjin;LING Ya;ZHANG Jie;ZHANG Jingjing;ZHU Jianguo;CAO Xiufang(Department of Pharmacy,The First Affiliated Hospital of Soochow University,Suzhou 215006,Jiangsu Province,China)

机构地区：[1]苏州大学附属第一医院药学部,江苏苏州215006

出　　处：《药物流行病学杂志》2024年第9期1044-1053,共10页Chinese Journal of Pharmacoepidemiology

基　　金：江苏省药学会-奥赛康医院药学基金项目(A202314)。

摘　　要：目的对HLA-B^(*)5801基因多态性检测用于预测别嘌醇相关重症药疹的准确性、敏感度、特异度和经济性进行快速卫生技术评估,为临床决策提供循证依据。方法计算机检索PubMed、CochraneLibrary、WebofScience、Embase、WanFangData、CNKI数据库和卫生技术评估机构官方网站,搜集关于HLA-B^(*)5801基因多态性检测的卫生技术评估报告、系统评价/Meta分析和药物经济学研究,检索时限均从建库至2023年12月31日。由2名研究者独立筛选文献、提取资料和评价质量,对研究结果进行定性分析。结果共纳入文献16篇,包括系统评价/Meta分析5篇及药物经济学研究11篇。结果显示,出现重症药疹患者的HLA-B^(*)5801基因突变率显著高于别嘌醇耐受组(P<0.05)。2项研究报道了HLA-B^(*)5801基因多态性检测结果预测重症药疹的敏感度和特异度,敏感度分别为0.78、0.93,特异度分别为0.96、0.89。经济学研究显示,对于中国汉族、韩国、泰国等人群,在接受别嘌醇治疗前进行HLA-B^(*)5801基因多态性检测具有成本-效果优势,对于英国、美国(白种人或西班牙裔)、新加坡和马来西亚等人群则不具有成本-效果优势。结论我国汉族人群在接受别嘌醇治疗前进行HLA-B^(*)5801基因多态性检测并根据结果指导用药可以减少重症药疹风险,且能降低治疗成本。Objective To evaluate the accuracy,sensitivity,specificity and economy of HLA-B^(*)5801 gene polymorphisms detection in predicting allopurinol-related severe drug eruption before receiving allopurinol treatment using rapid health technology assessment(rHTA),to provide clinicians and policymakers with an efficient and convenient evidence-based basis.Methods PubMed,Cochrane Library,Web of Science,Embase,WanFang Data,CNKI databases and the official website of health technology assessment(HTA)agency were electronically searched to collect HTA reports,systematic reviews/Meta-analyses and pharmacoeconomic literature on the HLA-B^(*)5801 gene polymorphisms detection from inception to December 31,2023.Two reviewers independently screened studies,extracted data,assessed the included studies'quality,and analyzed and summarised the results.Results A total of 16 literature were included,of which 5 systematic reviews/Meta-analyses and 11 pharmacoeconomic studies.The results showed that the HLA-B^(*)5801 gene mutation rate was significantly higher in patients presenting with severe drug eruption than in the allopurinol-tolerant group(P<0.05).Two studies reported the sensitivity and specificity of the HLA-B^(*)5801 gene polymorphisms assay for predicting severe drug eruption,the sensitivity of 0.78,0.93,and specificity of 0.96,0.89,respectively.The economic study showed that HLA-B^(*)5801 gene polymorphisms detection before allopurinol treatment was cost-effective in Chinese Han,Korean,Thai populations,but not in British,American(Caucasian or Hispanic),Singaporean and Malaysian populations.Conclusion HLA-B^(*)5801 gene polymorphisms detection before allopurinol treatment and guiding drug use according to the screening results in Chinese Han population can reduce the risk of severe drug eruption and treatment costs.

关 键 词：别嘌醇 HLA-B^(*)5801基因检测 重症药疹 快速卫生技术评估 

分 类 号：R758.25[医药卫生—皮肤病学与性病学]