慢性乙型肝炎患者中医生存质量量表(测试版)的信效度检验

目的:对慢性乙型肝炎(CHB)患者中医生存质量量表(测试版)行信效度检验。方法:400例CHB患者通过慢性乙型肝炎患者中医生存质量量表(测试版)的问卷调查。结果:1CHB患者中医生存质量量表(测试版)信度检验:全卷分半信度系数为0.997(P0.01);内部一致性分析结果显示:量表总分、肝经领域、肝络领域、情志领域、部候领域得分的Cronbach alpha系数分别为0.958、0.874、0.887、0.918、0.856。2CHB患者中医生存质量量表(测试版)效度检验:维度相关性分析显示各条目得分与其所在维度得分之间相关性均较大。各维度与总量表分的P相关系数各维度之间的P相关系数,各维度得分与总分之间的P相关系数均在0.84以上(P均0.01);各维度之间的P相关系数在0.580~0.781之间(P均0.01),其中部候维度与情志维度相关性较大,肝经维度与肝络维度相关性较大(P均0.01)。3主成分因子分析:72条条目中,除条目50、57、69因子负荷0.4外,其余均0.4,每个因子的组成条目都能够被比较合理地解释。量表中的每个条目都在其所属的因子上有较高的负荷值,而在其他因子上的负荷值较低。结论:CHB患者中医生存质量量表(测试版)有较强的可行性;量表所测定的内容具有同源性,信度佳,各维度间有充分的内部一致性;该量表结构效度好,符合心理测量学的要求。     

建立慢性乙型肝炎患者中医生存质量量表的设想

慢性乙型肝炎（简称慢性乙肝）是一种严重危害人类健康的慢性传染病,目前尚无特效的根治方法,因而给患者带来了心理和经济上的双重压力,生存质量（quality of life,QOL）明显降低。“追求高质量的生活,不延长痛苦的生存”,这一观念正为越来越多的医生、患者及其家属所接受。     

慢性肝病量表在乙型肝炎肝硬化中的应用评价

目的 评价慢性肝病量表(CLDQ)在乙型肝炎肝硬化中应用的信度和效度.方法 将CLDQ用于297例乙型肝炎肝硬化患者的自评,同时评定患者肝功能Child分级,并以117例健康者为对照.通过条目分析、精密度分析、信度分析、探索性因子分析,以及反应度、区分度分析对量表进行总体评价.计数资料用x2检验,计量资料两组间比较用两独立样本t检验,多组间比较用单因素方差分析,两两比较用Scheffe法.内部一致性以Cronbach's α系数、Guttman分半系数考察,相关性分析用Pearson相关系数r或Spearman相关系数rs,方差分析考察区分度,结构效度检验用探索性因子分析的主成分法,并进行最大方差正交旋转. 结果 量表条目、量表整体及各维度无明显地板效应;条目的天花板效应大部分为30％ ～ 60％,腹部症状、活动和焦虑3个维度的天花板效应＜30％.总量表的内部一致性较好( Cronbach's α=0.905),不同维度的内部一致性(Cronbach's α)为0.442 ～0.848;总量表与各维度相关系数均＞0.6(P值均＜0.01).健康组量表总得分、各维度得分显著高于患者组(P值均＜0.01),患者组量表总得分和其中的4个维度得分在与不同肝功能分级之间呈现梯度变化,Child分级越重得分越低.探索性因子分析提取的7个公因子与原维度有中等的吻合度. 结论 CLDQ在乙型肝炎肝硬化中的应用具有较好的信度、内容效度、反应度和区分度,精密度和结构效度中等,可有效用于对乙型肝炎肝硬化患者的生活质量以及疗效的评价.     

慢性乙型肝炎患者抗病毒治疗后生存质量评估

目的了解慢性乙型肝炎（CHB）患者生存质量（QOL）状况,并通过抗病毒治疗对其QOL进行干预.方法采用横断面调查,选择2003年至2004年期间武汉大学人民医院感染科212例慢性乙型肝炎患者及健康人群185例,分别以健康状况问卷（SF-36）、医学应对问卷以及肝病特质问卷进行调查.结果与健康对照组比较,CHB患者除情感职能（RE）外,其他维度得分均明显低于健康对照者（P＜0.05）.CHB患者QOL与年龄、肝病特质问卷得分以及医学应对问卷中的屈服、面对因子分显著负相关（P＜0.01）.虽然不同抗病毒治疗方案对CHB患者QOL的影响差异无统计学意义,但完全应答组与无应答组比较,两组除社会功能（SF）（P＜0.05）以外其他维度的得分差异均有统计学意义（P＜0.01）;部分应答组与无应答组比较,仅RE、躯体疼痛（BP）及一般健康状况（GH）维度的得分差异有统计学意义（P＜0.05）.结论CHB患者QOL多个纬度均有受损.有效的抗病毒治疗能提高患者的QOL.     

慢性乙型肝炎患者远期生存质量研究

目的 对慢性乙型肝炎患者远期生存质量进行研究,为其预后判断,药物疗效的分析及药品经济学评估提供依据。 方法 采用补充修订的SF-36健康相关生存质量量表调查101例6～l 8年前经肝穿活组织检查诊断的慢性乙型肝炎和105例门诊体检的普通人群。 结果 慢性乙型肝炎患者在生理机能、生理职能、总体健康、精神健康、肝病特有症状5个方面的远期生存质量低于普通人群,差异有显著性(μ≥2.10,P<0.05)。 结论 慢性乙型肝炎患者远期生存质量差。     

慢性乙型肝炎患者健康相关生存质量分析

采用中文版SF-36量表测量慢性乙型肝炎(慢乙肝)患者的生存质量,并与文献报道的2 249例城乡居民生存质量资料作对照.结果与对照组比较,除机体疼痛、精神健康维度外,慢乙肝组其他维度得分均明显下降,多因素Logistic回归分析显示,性别、纳差、文化程度是影响患者生存质量的独立因素.提示慢乙肝患者生活质量明显下降,性别、纳差、文化程度是其独立影响因素.     

乙型肝炎肝硬化患者生存质量研究

慢性HBV感染是严重影响我国人民健康的传染病,容易发展为肝硬化、肝细胞癌等终末期肝病。国外研究显示,乙型肝炎肝硬化不仅严重影响患者的寿命,也给患者生活质量带来很大的影响。我们使用SF-36（36-item short form health survey）简明健康情况调查表（中文版）,对乙型肝炎肝硬化患者健康相关生存质量进行研究，分析其影响因素，并与慢性乙型肝炎患者和正常人群生存质量情况进行了比较。     

慢性乙型肝炎患者生存质量的测量与评价

目的测量并评价慢性乙型肝炎患者的生存质量(QOL).方法采用SF-36量表,对260例慢性乙型肝炎患者和260例正常对照进行QOL测量与评价,并对QOL的影响因素进行单因素分析和多因素逐步回归分析.结果慢性乙型肝炎患者的平均SF-36总评分及生理机能、角色生理状况、心理健康状况、角色心理状况、社会机能、活力、躯体疼痛和主观健康状况的平均评分分别为56±17、65±24、21±30、62±18、28±34、55±28、57±2、68±25和52±16,与对照组相比,差异有非常显著性(P均＜0.01).慢性乙型肝炎患者的平均生存质量指数评分(7.2±2.2)与对照组相比,差异有非常显著性(P＜0.01).慢性乙型肝炎患者SF-36总评分及其8个分项目相互之间的相关系数均具有显著性意义(P＜0.01).SF-36总评分与生存质量指数评分呈极显著性正相关(r=0.7841,P＜0.001);影响慢性乙型肝炎患者QOL的主要因素是临床分型、乏力、腹水、黄疸、脾肿大、血清ALT与总胆红素(TBil)升高、血浆白蛋白或(A/G)降低以及HBeAg、HBV-DNA持续阳性等.结论SF-36适用于我国慢性乙型肝炎患者QOL的测量.     

慢性乙型肝炎的中医体质规律研究

目的:探讨慢性乙型肝炎的中医体质规律。方法:运用问卷调查的方法,以王琦的《中医体质分类与判定表》为标准,对103例慢性乙型肝炎患者进行体质调查及中医体质判定。结果:103例慢性乙型肝炎患者,中医体质分布规律为湿热质占31.1%、气虚质占19.4%、气郁质占14.6%、痰湿质占12.6%、阴虚质占8.7%、阳虚质占4.9%、瘀血质占3.9%、平和质占2.9%、特禀质占1.9%。男性患者以湿热质、气虚质、痰湿质多见,分别占36.0%、16.0%、13.3%;女性患者以气郁质、气虚质、湿热质多见,分别占32.1%、28.5%、17.9%;中医体质与性别具有相关性,差异有显著性意义(P<0.05)。本组病例20～40岁年龄段患者占61.2%,以湿热质、气虚质、痰湿质多见;41～60岁年龄段占38.8%,以气虚质所占比例最高;中医体质与年龄具有相关性,差异有显著性意义(P<0.05)。中医体质类型与肝功能损害轻重程度之间无相关性(P>0.05)。结论:慢性乙型肝炎患者中医体质类型分布主要以湿热质、气虚质、气郁质最为多见。男性患者多见湿热质、气虚质、痰湿质,女性患者多见气郁质、气虚质、湿热质。湿热质、气郁质以青壮年为主要发病人群,而气虚质以年老体虚者居多。慢性乙型肝炎中医体质类型与肝功能损害轻重程度之间无相关性。     

慢性乙型肝炎患者生存质量评价及其中医辨证关系

目的评价慢性乙型肝炎患者的生存质量,并探讨中医各证型与生存质量的相关性。方法采用横断面调查,应用世界卫生组织生存质量测定简表(WHOQOL-BRIEF)和慢性肝病问卷(CLDQ)调查200例慢性乙型肝炎患者的生存质量,并与50例正常人进行比较。结果慢性乙型肝炎患者的生存质量较差,与正常对照组相比差异有统计学意义(P<0.01),且中医各证型间生存质量存在差异(P<0.05或P<0.01),以肝郁脾虚证患者生存质量最低(P<0.01)。结论慢性乙型肝炎患者生存质量较差,并与中医辨证分型具有相关性。     

Health-related quality of life in chronic hepatitis B patients

The relationship between stages of chronic hepatitis B liver disease and health-related quality of life (HRQoL) is an important aspect of the overall management of hepatitis B virus (HBV) infection, yet is not well characterized. Consequently we sought to examine HRQoL in HBV patients, stratified by disease severity, compared with normal controls and hypertensive patients, using the Short Form 36 Health Survey (SF-36) and the EQ-5D self-report questionnaire. Univariate and multivariate analyses were then performed. A total of 432 HBV (156 asymptomatic carriers, 142 chronic hepatitis B, 66 compensated cirrhosis, 24 decompensated cirrhosis, 22 hepatocellular carcinoma, and 22 post-liver transplant) patients, 93 hypertensive patients, and 108 normal controls participated in the study. Multivariate analysis showed that normal controls and asymptomatic carriers had similar SF-36 scores, which were better than those for hypertensive patients, but with development of chronic hepatitis B and compensated cirrhosis, showed a significant decrease in general health and the mental dimension, whereas those with advanced liver disease (decompensated cirrhosis and hepatocellular carcinoma) had significantly lower scores in all components (P < 0.05), indicating that the physical component deteriorates only with advanced liver disease. Similar results were obtained with EQ5D. Post-liver transplant patients had similar HRQoL to patients with decompensated cirrhosis and hepatocellular carcinoma, although there was a trend toward improvement. Conclusion: Our results showed that HRQoL in asymptomatic carriers is comparable to those of normal controls and better than hypertensive patients, but deteriorates with disease progression, initially in general health and mental dimensions, but with advanced disease all dimensions are affected.     

慢性肝病的生命质量量表评价

生命质量研究是随着人群健康改善情况逐渐发展起来的一种健康测量技术,作为患者躯体功能、心理状态、社会适应和环境因素指标的一种反映,能全面体现患者健康水平.生命质量正是在这种客观健康水平提高和主观健康观念更新的背景下应运而生的一套评价健康水平的指标体系.     

恩替卡韦治疗慢性乙型肝炎患者的临床疗效及其生存质量评价

目的:评价恩替卡韦对慢性乙型肝炎(CHB)患者临床疗效和生存质量(QOL)的影响。方法:对200例CHB患者进行前瞻性研究,采用美国医学结局研究组的普适性测定量表(SF-36)进行生存质量调查,根据患者的意愿分为对照组(常规用甘草酸二胺护肝治疗,77例)和恩替卡韦治疗组即试验组(在常规护肝基础上加用恩替卡韦抗病毒治疗,123例)。观察各组患者治疗前、治疗后26周、52周的临床症状、肝功能、HBV DNA、生存质量指数,并进行对照分析,综合评价恩替卡韦的疗效。结果:两组患者在基线时年龄、性别、肝功能、HBV DNA水平和生存质量指数等方面均无统计学差异(P>0.05)。与对照组相比,试验组在治疗后26周和52周的肝功能复常率(26周:90.08%Vs 28.95%,P=0.000;52周:97.44%Vs 26.03%,P=0.000)、HBV DNA阴转率(26周:68.60%Vs0.00%,P=0.000;52周:86.32%Vs 1.37%,P=0.000)均优于对照组,差异有显著性意义(P<0.05)。治疗26周后和52周后,试验组患者的QOL在除PF(躯体功能)、BP(肌体疼痛)以外的多个纬度的得分均高于治疗前(P<0.05);对照组患者的QOL在治疗26周和52周时与治疗前比较,未见明显改善。结论:恩替卡韦能改善CHB患者的临床客观指标,提高患者的生存质量。     

拉米夫定治疗慢性乙型肝炎生存质量评价

目的　评价拉米夫定治疗慢性乙型肝炎生存质量的改善状况。方法　分别于拉米夫定治疗前、治疗半年、1年采用SF 3 6量表测定 2 44例病人的生存质量评分。结果　与治疗前相比 ,拉米夫定治疗半年及 1年后在躯体角色RP( 9.6)、社会功能SF( 8.2 )、情绪角色RE( 11.8)和活力VT( 6.2 ) 4个领域得分有显著提高 (P <0 .0 5 ) ,主要集中在心理状态评分MCS( 3 .6)。结论　拉米夫定治疗慢性乙型肝炎病人能有效改善病人生存质量。     

Health-related quality of life in patients with chronic hepatitis B.

Although chronic hepatitis C (CH-C) has consistently been shown to impair patients' health-related quality of life (HRQL), the impact of chronic hepatitis B (CH-B) on HRQL has not been fully explored. AIM: Compare HRQL between patients with CH-B, CH-C, primary biliary cirrhosis (PBC) and healthy controls. Design: Three HRQL questionnaires [Chronic Liver Disease Questionnaire (CLDQ), Short Form 36 (SF-36) and the Health Utility Index (HUI Mark-2 and Mark-3)] were administered prospectively. Additional clinical and laboratory data and normative data for healthy individuals, were available. ANALYSIS: Scores were compared using analysis of variance and multiple regression. RESULTS: One hundred and forty-six patients with CH-B, CH-C and PBC were included [mean age 47.1 years (+/-11.6), 41% female, 33% cirrhosis]. CH-C and PBC patients scored the lowest on all CLDQ, SF-36 and HUI domains compared with CH-B patients and healthy controls. CH-B patients had scores similar to the healthy population, measured by most CLDQ and SF-36 scales. However, the HUI scores for CH-B patients showed more impairment than population norms. Having CH-B and not having cirrhosis were predictive of utility and HRQL scores in multivariate models. CONCLUSIONS: CH-B patients have better HRQL than CH-C, PBC and population norms. CH-B patients' overall utility scores are lower than population norms.     

Replication of clinical hepatitis B virus isolate and its application for selecting antiviral agents for chronic hepatitis B patients

AIM： To establish a cell model harboring replicative clinical hepatitis B virus （HBV） isolates and evaluate its application in individualized selection of anti-HBV agents for chronic hepatitis B （CHB） patients.
METHODS： The full-length HBV genomic DNA from 8 CHB patients was amplified by polymerase chain reaction （PCR）. All the patients were treated with lamivudine for at least seven months and finally became resistant to lamivudine. The amplified HBV DNA fragments were inserted into pHY106 vectors by Sap Ⅰ digestion. The recombinant plasmids containing 1.1 copies of HBV genome were transiently transfected into Huh7 cell line, and the levels of HBsAg, HBeAg and intercellular HBV replicative intermediates were determined by ELISA and Southern blot analysis, respectively, with or without lamivudine and adefovir treatment. The antiviral treatment with adefovir was administered to the patients and analyzed in parallel.
RESULTS： A total of 25 independent HBV isolates were obtained from the sera of 8 patients, each patient had at least two isolates. One isolate from each individual was selected and subcloned into pHY106 vector, including 5 isolates with YVDD mutation and 3 isolates with YIDD mutation. All recombinant plasmids harboring HBV isolates were transfected into Huh7 cells. The results indicated that HBV genome carried in HBV replicons of clinical HBV isolates could effectively replicate and express in Huh7 cells. Adefovir, but not lamivudine, inhibited HBV replication both in vitro and in vivo, and in vitro inhibition was dose-dependent.
CONCLUSION： The novel method described herein enables individualized selection of anti-HBV agents in clinic and is useful in future studies of antiviral therapy for CHB.     

Development and validation of a disease-targeted quality of life instrument in chronic hepatitis B: the hepatitis B quality of life instrument, version 1.0

Despite the increasing realization that health-related quality of life (HRQOL) is an important outcome in chronic HBV infection, there are no validated, disease-targeted instruments currently available. We sought to develop and validate the first disease-targeted HRQOL instrument in noncirrhotic HBV: the Hepatitis B Quality of Life instrument, version 1.0 (HBQOL v1.0). We established content validity for the HBQOL v1.0 by conducting a systematic literature review, an expert focus group, and cognitive interviews with HBV patients. We administered the resultant questionnaire to 138 HBV patients. We used factor analysis to test hypotheses regarding HRQOL domains and measured construct validity by comparing HBQOL v1.0 scores across several anchors, including viral response to treatment, SF-36 scores, and global health. Finally, we measured test-retest and internal consistency reliability. Content validation revealed that HBV affects multiple aspects of psychological, social, and physical health. The resultant questionnaire summarized this HRQOL impact with 31 items across six subscales: psychological well-being, anticipation anxiety, vitality, disease stigma, vulnerability, and transmissibility. Internal consistency and test-retest reliability were excellent. The HBQOL v1.0 discriminated between viral responders versus nonresponders and correlated highly with SF-36 scores and global health. CONCLUSION: Patients with chronic HBV infection attribute a wide range of negative psychological, social, and physical symptoms to their condition, even in the absence of cirrhosis or cancer. The HBQOL v1.0 is a valid and reliable measure that captures this HRQOL decrement. This instrument may be useful in everyday clinical practice and in future clinical trials.     

慢性乙型肝炎患者生存质量研究现状

本文就慢性乙型肝炎患者生存质量的现状、测评量表及影响因素和干预措施等方面进行综述,为提高该人群的生存质量提供依据,并指出制定特异性量表的重要性。