欧洲五维五水平量表在中国慢性乙型肝炎病毒感染者中的适用性调查  

Investigation on the Applicability of EQ-5D-5L in Chinese Patients with Chronic Hepatitis B

作　　者：贾元熙[1] 崔富强[2] 张栋梁[3,4] 张国民[2] 龚晓红[2] 王富珍[2] 郑徽[2] 吴振华[2] 缪宁[2] 孙校金[2] 张丽[5] 吕静静[5] 杨峰[6] 梁晓峰[2] 李黎[2] 

机构地区：[1]北京协和医学院公共卫生学院,北京102200 [2]中国疾病预防控制中心免疫规划中心,北京100050 [3]宁波市疾病预防控制中心,浙江宁波315010 [4]中国疾病预防控制中心现场流行病学培训项目,北京100050 [5]山东省疾病预防控制中心,济南250014 [6]青岛市疾病预防控制中心,山东青岛266033

出　　处：《中国疫苗和免疫》2013年第6期492-497,544,共7页Chinese Journal of Vaccines and Immunization

基　　金：国家科学技术艾滋病和病毒肝炎等重大传染病防治重大专项<我国乙型病毒性肝炎免疫预防策略研究>课题(编号:2012ZX10002001)

摘　　要：目的了解欧洲五维五水平量表(EQ-5D-5L)在中国慢性乙型肝炎(乙肝)病毒(Hepatitis B Virus,HBV)感染者中的适用性。方法采取整群抽样的方法,从山东省3家医院中连续调查HBV携带者、慢性乙肝(Chronic Hepatitis B,CHB)非活动期、CHB活动期、代偿性肝硬化(Compensated Cirrhosis,CC)、失代偿性肝硬化(Decompensated Cirrhosis,DC)和肝细胞癌(Hepatocellular Carcinoma,HCC)病人各至少100名。病人自填调查表。一周后对住院病人进行复查,询问医生了解病人病情的转归。采用日本模型获得不同病人的健康相关生命质量(Health-Related Quality of Life,HRQoL),进行效度、信度、敏感度和响应度的评价,使用多重线性回归进行影响因素分析。结果初次调查645人,复查183人。HBV携带者、CHB非活动期、CHB活动期、CC、DC和HCC病人的HRQoL均数分别为0.813、0.808、0.771、0.763、0.699和0.661;除HBV携带者与CHB非活动期、CHB活动期与CC外,不同HBV感染状态HRQoL的差异均有统计学意义;除CHB非活动期外,其他HBV感染状态的HRQoL与视觉模拟标尺均有较高的相关性。对病情稳定的各类病人,前后两次调查HRQoL的差异无统计学意义,且组内相关系数较高;量表存在一定程度的天花板效应;对病情好转的各类病人,第二次调查的HRQoL均显著升高。结论 EQ-5D-5L适用于我国慢性HBV感染人群,具有较好的效度、信度和响应度,但敏感度较低,对轻症病人有一定程度的天花板效应。Objective To know the applicability of the EQ-5D-SL in Chinese patients with chronic hepatitis B （CHB）. Methods Using the cluster sampling to select patients of six diseases from three hospitals in Shandong province, including hepatitis B virus （HBV） carriers, active CHB patients, inactive CHB patients, compensated cirrhosis （CC） patients, decompensated cirrhosis （DC） patients and hepatocellular carcinoma （HCC） patients. For each disease, at least 100 patients were investigated. Patients completed the questionnaires by themselves. A second interview was conducted one week later, and information on the progressions of their health status was obtained from doctors, The Japan model was used to obtain health-related quality of life （HRQoL）, and the EQ-5D-SL was evaluated by validity, reliability, sensitivity and responsiveness. Factors influences on HRQoL were analyzed by multiple liner regression （MLR）. Results For the first and second interiew, 645 and 183 patients were investigated,respectively. The means of HRQoL of HBV carriers, active CHB patients, inactive CHB patients, CC patients, DC patients and HCC patients were 0.813, 0.808, 0.771, 0.763, 0.699 and 0.661 respectively. There were significant differences on HRQoL between different diseases except for HBV carriers and inactive CHB, activeCHB and CC. Strong correlationwas found between HRQoL and the visual analog scale （VAS） in each disease except inactive CHB. For patients of each disease with stable health status, there was a high intraclass correlation coefficient （ICC） and no significant differences between the two interviews. Some ceiling effects were found. For patients of each disease with improved health status, there were significant differences between HRQoL obtained from^the two interviews. Conclusion The EQ-5D-5L was applicable in Chinese patients with chronic hepatitis B, with good validity, reliability and responsiveness, while the sensitivity was relatively low, there was some ceiling effects observed in mild

关 键 词：欧洲五维五水平量表 乙型肝炎病毒 健康相关生命质量 

分 类 号：R512.62[医药卫生—内科学]