BACKGROUND/AIMS: The aim of this study was to measure health related quality of life (HRQOL) in patients with chronic viral hepatitis or cirrhosis and to determine factors associated with more severe impairment. METHODS: We conducted a cross-sectional study in which we documented patients' demographic and clinical characteristics and measured their HRQOL using the Korean version of Short Form-36. A total of 375 patients were enrolled in the study. We compared patients' HRQOL with that of 750 participants in a control group and assessed the association of HRQOL impairment with clinical parameters. RESULTS: In all except two domains (physical functioning, bodily pain) of SF-36, HRQOL scores were significantly lower in the patient group than in the control group (p<0.001). The difference was more prominent in those domains reflective of mental, rather than physical, health. When patient group was classified as noncirrhosis, Child A, B, or C according to modified Child-Pugh classification, severe liver disease was associated with a lower HRQOL score. Interestingly, scores of domains reflective of mental health were decreased from the early stage of disease (noncirrhosis or Child-Pugh A). Those of domains reflective of physical health, however, were decreased only in advanced stages of disease (Child-Pugh B or C). There are weak but significant correlations between SF-36 scores and age, serum albumin, serum bilirubin, and prothrombin time, but no correlation with histologic activity, transaminase level, disease duration, virus type (HBV or HCV) and HBV DNA level. CONCLUSIONS: Compared with the control group, patients with chronic viral hepatitis or cirrhosis showed substantial impairment of HRQOL, which is further affected by worsening disease severity. More concern about HRQOL should be warranted in the evaluation of health change due to disease progression or therapeutic trial.
Adult ; Female ; *Hepatitis B, Chronic/physiopathology/psychology ; *Hepatitis C, Chronic/physiopathology/psychology ; Humans ; Liver Cirrhosis/physiopathology/psychology ; Male ; Middle Aged ; *Quality of Life ; Questionnaires

Hepatitis B, Chronic ; physiopathology ; psychology ; Humans ; Liver ; physiopathology ; Stress, Psychological ; physiopathology

<b>OBJECTIVEb>To analyze the relationship of anxiety state with CD4(+) level and CD4(+)/CD8(+) ratio and to observe the effect of Chinese medicine (CM) treatment on anxiety in chronic hepatitis B (CHB) patients.

<b>METHODSb>The anxiety state of 120 CHB patients was evaluated based on Hamilton Anxiety Scale (HAMA) scoring. According to the scores, 63 patients with scores ≥14 were classified to anxiety and 57 patients with scores <14 to non-anxiety. The differences in CD4(+) cells and CD4(+)/CD8(+) ratio between patients with anxiety and non-anxiety were analyzed. Moreover, 63 patients with anxiety were randomized into two groups: 31 in the control group were treated with lamivudine (100 mg per day) alone and 32 in the observation group were given equal dosage lamivudine combined with CM treatment depending on syndrome differentiation, all for 12 weeks. The effects of treatment on anxiety state and T-lymphocyte subsets as well as its impact on some CHB-related indices were observed and compared.

<b>RESULTSb>The anxiety state of CHB patients was negatively correlated with CD4(+) and CD4(+)/CD8(+); the level of CD4(+) in patients with anxiety was significantly lower than that in non-anxiety patients (P<0.01 or P<0.05). After treatment, anxiety state in the observation group was significantly improved, with their HAMA scores significantly lowered (P<0.01), and the levels of CD4(+) and CD4(+)/CD8(+) were significantly higher than those in the control group (P<0.05 or P<0.01). Moreover, the alanine transaminase recovery rate and the HBV-DNA-negative conversion rate in the observation group were significantly higher than those in the control group, respectively (P<0.05).

<b>CONCLUSIONSb>The anxiety state of CHB patients was related to CD4(+) and CD4(+)/CD8(+) levels. CM treatment could improve the anxiety state and showed certain regulatory effect on the patients' immune system.

Anxiety ; immunology ; therapy ; CD4-CD8 Ratio ; Hepatitis B, Chronic ; immunology ; psychology ; therapy ; Humans ; T-Lymphocyte Subsets

BACKGROUND: False negative results have been reported in the immunodetection of hepatitis B virus (HBV) because of the existence of the various mutants of the virus, causing most suppliers to try to develop superior reagents by using highly sensitive and specific monoclonal or polyclonal antibodies. In this study, we evaluated the effectiveness of 3 newly developed reagents by major manufacturers by adopting automated methods with increased sensitivity and specificity in the detection and discrimination of native and recombinant mutant antigens. METHODS: We analyzed samples confirmed positive for hepatitis B surface antigen (HBsAg), high-risk samples from chronic hepatitis patients treated with antiviral agents, and samples from patients who had undergone liver transplantation and were treated with high-dose hepatitis B immunoglobulin (HBIG) by using reagents and systems newly developed by Abbott Laboratories (USA), Roche Diagnostics (Germany), and Siemens Healthcare Diagnostics (USA). Recombinant sample panels from these manufacturers with low and high concentrations were also analyzed for comparing the 3 reagents. RESULTS: There were no discrepant results among the various selected patient groups; however, for the recombinant mutant panels, all of the 3 reagents showed highly positive detection rates for their corresponding mutant panels, but showed relatively discrepant mutant detection rates when cross-tested with the other mutant panels. Detection rates of the HBsAg mutant panels were higher at a higher concentration of the mutant samples, but were lower for the same mutant receptor sites at a lower concentration. CONCLUSIONS: The 3 major detection methods seem to recognize the major native mutants commonly encountered in clinical practice. However, in the case of recombinant mutants, we believe that our data are not to be interpreted as a reference standard for any reagent, because the results can only be validated for the reagents' corresponding mutant panels; such results tend to be mutually exclusive, and the enough concentration of mutants was required to be adjusted for a comparative analysis.
Antibodies ; Antiviral Agents ; Delivery of Health Care ; Discrimination (Psychology) ; Hepatitis B ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Hepatitis, Chronic ; Humans ; Immunoassay ; Immunoglobulins ; Indicators and Reagents ; Liver Transplantation ; Sensitivity and Specificity ; Viruses

<b>OBJECTIVEb>To further verify the efficacy and safety of locally manufactured lamivudine on patients with chronic hepatitis B (CHB).

<b>METHODSb>2200 patients with CHB were recruited and received lamivudine orally 100 mg once daily for 12 months. The efficacy assessments included virologic response rate (defined by the absence of serum HBV DNA, HBeAg loss and HBeAg/HBeAb seroconversion), percentage of patients with normalization of alanine aminotransferase (ALT). Meanwhile improvement of quality of life (QOL) measured by mos SF-36 QOL questionnaire and liver histology evaluation were conducted in some patients. The safety assessments included adverse events, serious adverse events and laboratory abnormalities. All 2200 patients received at least one dose of medication and were all included in the safety population.

<b>RESULTSb>Ninety seven percent of patients (2137/2200) recruited were HBV DNA positive by dot blot (sensitivity GRT or equal to 1.0 pg/ml) at baseline. At the end of 12 months treatment, HBV DNA was undetectable in 80% patients (1538/1920) with HBV DNA positive before treatment. Among the 79%(1744/2200) of the patients recruited had positive HBV DNA accompanied abnormal ALT levels at baseline, 72% patients became ALT normal. And among the 84% (1843/2200) of the patients recruited were HBV DNA and HBeAg positive, anti-HBe negative, 16% (269/1650) patients achieved HBeAg/HBeAb seroconversion after 12 months of lamivudine treatment. The HBeAg/HBeAb seroconversion rate was positive correlation to the ALT level before treatment. A total of 304 patients completed the health-related QOL questionnaire. After 12 months treatment, lamivudine improved both their physical and mental health, especially for their mental health. 133 evaluable, paired liver biopsies were obtained for histological assessment, among whom 115 patients had abnormal ALT levels at baseline. Compared with pre-treatment most of their liver injury got alleviated (51.9%) or no further deterioration (36%), only 12% worsening. During the 12 months treatment, 9% patients withdrew from the study and 17% patients showed at least one adverse event, mild or moderate. There were no obvious difference between this study and the previously reported lamivudine Phase II or III study with regard to the kinds, incidence and severity of adverse events.

<b>CONCLUSIONb>The efficacy and safety profile of the locally manufactured lamivudine 100 mg tablets are similar with those of the previously reported available lamivudine tablets imported in treating Chinese chronic hepatitis B patients.

Adolescent ; Adult ; Aged ; Antiviral Agents ; therapeutic use ; Child ; DNA, Viral ; blood ; Hepatitis B e Antigens ; blood ; Hepatitis B, Chronic ; drug therapy ; psychology ; virology ; Humans ; Lamivudine ; adverse effects ; therapeutic use ; Liver ; pathology ; Middle Aged ; Quality of Life

PURPOSE: The purpose of this study was to identify the effects of the program to promote self management for patients with chronic hepatitis B. METHODS: The research was a quasi-experimental design using a non-equivalent control group pre-post test. The participants were 61 patients, 29 in the experimental group and 32 in the control group. A pretest and 2 posttests were conducted to measure main variables. For the experimental group, the self-management program, consisting of counseling-centered activities in small groups, was given for 6 weeks. Data were analyzed using chi2, t-test, and repeated measures ANOVA with PASW statistics program. RESULTS: There were statistically significant increases in knowledge, self-efficacy, active ways of coping, and self-management compliance but not in passive ways of coping in the experimental group compared to the control group over two different times. CONCLUSION: The results of this study indicate that the self-management program is effective in increasing knowledge, self-efficacy, active ways of coping, and self-management compliance among patients with chronic hepatitis B. Therefore, it can be usefully utilized in the field of nursing for patients with chronic disease as a nursing intervention for people with chronic hepatitis B.
Adaptation, Psychological ; Adult ; Demography ; Female ; Hepatitis B, Chronic/*psychology ; Humans ; Male ; Middle Aged ; *Program Development ; *Program Evaluation ; *Self Care ; Self Efficacy

PURPOSE: The purpose of this study was to explore the experiences of people with chronic hepatitis B (CHB) in Korea. The specific aim was to identify major problems that people with CHB face and strategies that they are dealing with. METHODS: A grounded theory method was utilized. The data were collected by individual in-depth interviews from 12 CHB patients from one of the major hospitals in Korea. RESULTS: After constant comparative analysis, a core category emerged as "illness management with self-reliance and will." Seven major strategies that were identified in dealing with the illness were maintaining receptive and positive attitudes; restraining excessive work and greed; searching for information; controlling illness information; adhering to practices for not spreading the viral disease; abstaining from alcohol and smoking and maintaining healthy eating habits; nd using alternative therapies. The outcomes that result from employing these strategies were identified as burden, depression and helplessness, stress for maintaining compliance, and dispirited interpersonal relationships. CONCLUSION: The results of this study suggest that most people with CHB in Korea have problems in psychosocial area. Thus health professionals need to provide not only informational support but also emotional one to improve quality of life of the people with CHB.
Adult ; Attitude to Health ; Female ; Hepatitis B, Chronic/etiology/*psychology ; Humans ; Interviews as Topic ; Korea ; Life Change Events ; Male ; Middle Aged ; Quality of Life ; *Sickness Impact Profile

PURPOSE: This ethnography was done to explore the meaning of illness in Korean Americans with chronic hepatitis B. METHODS: The participants were 6 patients with chronic hepatitis B and 6 general informants who could provide relevant data. Data were collected from iterative fieldwork with ethnographic interviews within Korean communities in two cities in the United States. Data were analyzed using causal chain analysis developed by Wolcott. RESULTS: The analyses revealed three meanings for the illness: hidden disease, intentionally hidden disease, and inevitably hidden disease. The contexts of meaning of illness included characteristics of the illness, social stigma, structure of health care system and communication patterns and discourse between health care providers and clients. CONCLUSION: The meaning of illness was based on folk illness concepts and constructed in the sociocultural context. Folk etiology, pathology and interpretation of one's symptoms were factors influencing illness behavior. These findings could be a cornerstone for culture specific care for Korean Americans with chronic hepatitis B.
Aged ; *Asian Americans ; Delivery of Health Care ; Female ; Health Personnel ; Hepatitis B, Chronic/*ethnology/etiology/psychology ; Humans ; Interviews as Topic ; Male ; Middle Aged ; Republic of Korea/ethnology ; Social Stigma

OBJECTIVE: To assess the quality of life of 3 types of chronic hepatitis B before and after the treatment of lamivudine, and to find an ideal way of medical treatment for chronic hepatitis B. METHODS: One hundred and fifty patients with chronic hepatitis B were investigated in this study, among whom 5 1 were in mild state illness, 53 were middle-range and the other 46 were severe. The quality of life of the patients was assessed by the quality of life questionnaire (SF-36). The marks of questionnaire were compared before and after the use of lamivudine to assess its comprehensive curative effect on chronic hepatitis B. RESULTS: The total score of SF-36, score of physical function, role-physical, mental health, social function, bodily pain and vitality were significant different before and after the treatment. Statistically significant differences were found among the 3 types of chronic hepatitis B before and after the treatment. CONCLUSION The quality of life of patients with chronic hepatitis B can be improved by using lamivudine. Assessment of quality of life may be taken as an important index in treating chronic hepatitis B.
Female ; Hepatitis B, Chronic ; drug therapy ; psychology ; Humans ; Lamivudine ; therapeutic use ; Male ; Quality of Life ; Reverse Transcriptase Inhibitors ; therapeutic use ; Surveys and Questionnaires

To report on the validity and reliability of the Chronic Liver Disease Questionnaire (CLDQ) for assessing subjects with posthepatitic B cirrhosis. The CLDQ was administered to 117 healthy volunteers and 297 patients with posthepatitic B cirrhosis. All posthepatic B cirrhosis patients were assessed for the Child-Pugh stage. The entire questionnaire and each individual item was analyzed for precision and reliability. Exploratory factor analysis, responsiveness, and discrimination validity were also assessed. No significant floor effects were detected, but a moderate ceiling effect (less than 30%) was found for the following subscales: abdominal symptoms (AS), activity (AC), and worry (WO). For most items, the ceiling effect was between 30% to 60%. The internal consistency (Cronbach's a) on total scale level was good (a = 0.905), and ranged from 0.442 to 0.848 for the different subscales. The correlation coefficients of the total scale with subscales were above 0.6 (P less than 0.01) for reliability. The CLDQ and subscale scores for healthy controls were higher than those for the patients (P less than 0.001), and were gradated from the patients with Child-Pugh A cirrhosis to those with Child-Pugh B or C cirrhosis. Increase in severity of liver disease was accompanied by lower scores by the CLDQ and 4 out 6 subscales. Exploratory factor analysis moderately reproduced the original factor structure. The CLDQ has good reliability, satisfactory content, responsiveness and discriminant validity, and moderate precision and construct validity. It is useful for effectively evaluating health-related quality of life and curative effect in patients with posthepatitic B cirrhosis.
Adolescent ; Adult ; Aged ; Case-Control Studies ; Chronic Disease ; Female ; Health Status ; Hepatitis B, Chronic ; psychology ; Humans ; Liver Cirrhosis ; psychology ; Male ; Middle Aged ; Pain ; physiopathology ; psychology ; Psychometrics ; Quality of Life ; psychology ; Reproducibility of Results ; Sensitivity and Specificity ; Severity of Illness Index ; Statistics as Topic ; Surveys and Questionnaires ; Young Adult