Abstract: Background　The number of patients with chronic hepatitis B （CHB） in China ranks first in the world. Hepatitis B virus is harmful to the human body，and the health-related quality of life （QOL） in such patients is low. Hubei Provincial Hospital of Traditional Chinese Medicine，a determined key research base for liver diseases in the No. 23 Notice released by the State Administration of Traditional Chinese Medicine of the People's Republic of China in 2008，has developed and implemented key liver disease research programs，in order to develop new Chinese medicines with definite curative effect for liver diseases. Objective　To explore the health-related QOL and influencing factors in CHB patients based on a multicenter clinical study. Methods　611 CHB patients who participated in 13 research centers of key diseases in the National Clinical Research Base of Traditional Chinese Medicine （Hubei） from June 2012 to August 2016 were selected. All of them were treated with entecavir for 48 weeks and were followed up for 1 year. General data were collected. The severity of disease was assessed by the TCM Syndrome Scale （TCMSS），and health-related QOL was assessed by both Chronic Liver Disease Questionnaire （CLDQ） and 36-item Short Form Health Survey （SF-36） before and after treatment，respectively. Results　Except for 50 cases （8.2%） of dropouts/ terminators，the remaining 561 cases were included in the final analysis. The mean scores of abdominal symptoms，fatigue，systemic symptoms，activities，emotional function，anxiety，mean CLDQ total score，physical functioning，role physical，bodily pain，general health，vitality，social functioning，role emotional，mental health，physical component score （PCS），mental component score （MCS），and mean SF-36 total score after treatment were all much higher than those at baseline （P<0.05）.The total CLDQ score varied significantly by sex，marital status，comorbidity，and region （P<0.05）. The PCS score differed significantly by sex，comorbidity，and region（P<0.05）.The MCS score changed obviously according to comorbidity and region（P<0.05）.The total score of SF-36 differed significantly by comorbidity，treatment compliance and region（P<0.05）.Age，course of liver disease and TCMSS scores were negatively correlated with the total scores of CLDQ，PCS，MCS and SF-36 （P<0.05）.Multiple linear regression analysis showed that region was the influencing factor of the total scores of CLDQ，MCS and SF-36. The course of liver disease and TCMSS score were the influencing factors of the total scores of CLDQ，PCS，MCS and SF-36 （P<0.05）． Conclusion　Health-related QOL differed significantly by region in CHB patients. Moreover，it was negatively correlated with the duration of liver disease and TCMSS score，indicating that it decreased with the prolongation of duration of liver disease and increase of TCMSS score.

Key words: Hepatitis B, chronic；Liver diseases；Quality of life；Antiviral agents；Root cause analysis；TCM syndrome scale

摘要： 背景　我国慢性乙型肝炎（CHB）患者数量居世界首位，乙型肝炎病毒（HBV）对人体危害大，CHB患者生存质量（QOL）偏低。国家中医药管理局〔国中医药发（2008）23号〕确定湖北省中医院为肝病重点研究基地，为研制防治肝病疗效确切的中药新药，本院制定并实施了基地重点病种研究项目。目的　了解多中心临床研究中采用抗病毒治疗的CHB患者QOL及影响因素。方法　选取2012年6月—2016年8月参加国家中医临床研究基地（湖北）重点病种的13个研究中心的CHB患者611例，入组患者均采用恩替卡韦（ETV）治疗48周，并随访1年。收集患者的一般资料，于治疗前、治疗后分别采用中医症候量表评判患者疾病严重程度以及采用慢性肝病问卷（CLDQ）、健康状况调查简表（SF-36）评估患者QOL。结果　611例CHB患者中，脱落/中止50例（8.2%），共纳入561例。CHB患者治疗后腹部症状、乏力、全身症状、活动、情感功能、焦虑、CLDQ总分、生理机能、生理职能、躯体疼痛、一般健康状况、精力、社会功能、情感职能、精神健康、生理综合分（PCS）、心理综合分（MCS）、SF-36总分均高于治疗前（P<0.05）。不同性别、婚姻状况、合并症、地区的CHB患者治疗后CLDQ总分比较，差异均有统计学意义（P<0.05）；不同性别、合并症、地区的CHB患者治疗后PCS比较，差异均有统计学意义（P<0.05）；不同合并症、地区的CHB患者治疗后MCS比较，差异均有统计学意义（P<0.05）；不同合并症、依从性、地区的CHB患者治疗后SF-36总分比较，差异均有统计学意义（P<0.05）。CHB患者的年龄、病程、中医症候量表得分与CLDQ总分、PCS、MCS、SF-36总分均呈负相关（P<0.05）。多元线性回归分析结果显示，地区是CLDQ总分、MCS及SF-36总分的影响因素，病程、中医症候量表得分是CLDQ总分、PCS、MCS及SF-36总分的影响因素（P<0.05）。结论　不同地区CHB患者QOL存在差异，病程、中医症候量表得分与CHB患者QOL呈负相关，病程越长，中医症候量表得分越高，病情越重，QOL越低。

关键词: 乙型肝炎, 慢性；肝病；生活质量；抗病毒药；影响因素分析；中医症候量表