Guihua Zhuang

Antibody levels and immune memory 23 years after primary plasma-derived hepatitis B vaccination: Results of a randomized placebo-controlled trial cohort from China where endemicity is high

The duration of protection of hepatitis B vaccine remains incompletely understood. To assess the long-term protection provided by a primary vaccine series, the current study again recruited all subjects of a previous randomized placebo-controlled trial cohort 23 years after vaccination. Two hundred and sixty-one healthy children aged 5-9 years living in a highly HBV-endemic country were enrolled in the primary trial and received three doses of plasma-derived vaccine or placebo. The primary placebo receivers who did not receive any immunization against hepatitis B were used as non-vaccinated controls in the current study. After eliminating the interference of an early booster dose and vaccines outside the study, 48.1% (39/81) vaccinees still maintained anti-HBs titers ≥ 10 mI U/mL at Year 23, higher than 34.7% (26/75) in non-vaccinated controls (P=0.088). 75-100% of vaccinees with anti-HBs titer <10 mI U/mL at Year 23 in different sub-groups divided according to early immune backgrounds developed a rapid and robust antibody anamnestic response after a booster dose, highly significantly different from non-vaccinated controls who received the same dose of vaccine (7.5%, P<0.01). No case of clinically significant HBV infection was found in the primary cohort during the whole 23 years, but 10 transient HBsAg seroconversions in the primary placebo group and one in the primary vaccine group were determined. Anti-HBc positive rate obviously tended to be lower in vaccinees compared with non-vaccinated controls at Year 23. These results suggest a persisting immune memory and certain protection for 23 years after primary vaccination in children living in highly HBV-endemic areas. Clinically insignificant infections, which cannot be avoided and may often occur in vaccinees, play a positive role in the maintaining of immunity to HBV. Booster doses should be unnecessary for more than 20 years after a full primary immunization in children (as catch-up vaccination) and, also likely, in newborns living in highly HBV-endemic areas.

Significant impairment of health-related quality of life in mainland Chinese patients with chronic hepatitis B: a cross-sectional survey with pair-matched healthy controls

ObjectiveFew studies have evaluated health-related quality of life (HRQoL) of patients with chronic hepatitis B (CHB) in mainland China. We aimed at characterizing the impact of CHB on HRQoL in mainland Chinese and finding out factors associated with HRQoL.Methods460 CHB patients (323 with CHB only, 54 with compensated cirrhosis and 83 with decompensated cirrhosis) and 460 pair-matched healthy controls were recruited in Xi’an city. They answered a structured questionnaire including the Short Form 36 version 2 (SF-36v2), the Chronic Liver Disease Questionnaire (CLDQ) (only for patients), and questions on socio-demographic and clinical characteristics. A blood sample was collected from each of patients for liver function tests. SF-36v2 scores were compared between patients and controls overall and by groups by paired-samples t-test, and CLDQ scores and paired differences of SF-36v2 scores were compared among three patient groups by one-way ANOVA or Kruskal-Wallis test. Multi-variable linear regression analyses were performed to identify determinants of HRQoL in patients.ResultsPatients, overall and by groups had significantly lower SF-36v2 scores than controls on all summaries and domains, with differences higher than the suggested minimally important difference values. Both the SF-36v2 and the CLDQ showed that HRQoL of patients with cirrhosis further deteriorated, but compensated and decompensated cirrhosis patients had similar total HRQoL impairments. The gradually increasing impairment with disease progression was confirmed only on physical components. Impaired liver function and currently taken anti-viral treatment were associated with lower HRQoL. Education attainment and annual per capita household income had a positive effect on HRQoL.ConclusionsMainland Chinese CHB patients suffered significant HRQoL impairment on all health dimensions, and the impairment reached a high level on mental health at initial stage of illness and increased gradually on physical health with disease progression. Attention should be paid to the reduction of patients’ treatment cost burden and the provision of early health education accompanied with proper treatments.

The independent impact of newborn hepatitis B vaccination on reducing HBV prevalence in China, 1992–2006: A mathematical model analysis

OBJECTIVE To evaluate the independent impact of newborn hepatitis B vaccination on reducing HBV prevalence in China, from its introduction in 1992 to 2006. METHODS An age- and time-dependent discrete dynamic model was developed to simulate HBV transmission in China under the assumptions of no any change in interventions and only with newborn vaccination introduction, respectively. The initial conditions of the model were determined according to the national serosurvey in 1992. The simulated results were compared with the observed results of the national serosurvey in 2006, and the contribution rate of newborn vaccination on reducing HBV prevalence was calculated overall and by birth cohort. RESULTS The total HBV prevalence would remain stable through the 14-year period if no any change in interventions, but decrease year by year if only with newborn vaccination introduction. Newborn vaccination could account for more than 50% of the reduction of the total HBV prevalence, although the full 3-dose and timely birth dose vaccination coverage rates were low in the early years. The results by birth cohort showed that the higher the two coverage rates, the higher contribution rate on reducing HBV prevalence. For the 2005 birth cohort which had high levels in the two coverage rates, the contribution rate could reach more than 95%. CONCLUSION Newborn hepatitis B vaccination from 1992 to 2006 in China had played the most important role in reducing HBV prevalence. Newborn vaccination with high full 3-dose and timely birth dose coverage rates is the decisive factor in controlling hepatitis B in China.

Psychometrics of the Short Form 36 Health Survey Version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese Mainland Patients with Methadone Maintenance Treatment

Objective To test psychometrics of the Short Form 36 Health Survey version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese mainland patients with methadone maintenance treatment (MMT). Methods A total of 1,212 patients were recruited from two MMT clinics in Xi’an, China. Reliability was estimated with Cronbach’s α and intra-class correlation (ICC). Convergent and discriminant validity was assessed using multitrait-multimethod correlation matrix. Sensitivity was measured with ANOVA and relative efficiency. Responsiveness was evaluated by pre-post paired-samples t-test and standardized response mean based on the patients’ health status changes following 6-month period. Results Cronbach’s α of the SF-36v2 physical and mental summary components were 0.80 and 0.86 (eight scales range 0.73–0.92) and the QOL-DAv2.0 was 0.96 (four scales range: 0.80–0.93). ICC of the SF-36v2 two components were 0.86 and 0.85 (eight scales range: 0.72–0.87) and the QOL-DAv2.0 was 0.94 (four scales range: 0.88–0.92). Convergent validity was lower between the two instruments (γ <0.70) while discriminant validity was acceptable within each instrument. Sensitivity was satisfied in self-evaluated health status (both instruments) and average daily methadone dose (SF-36v2 physical functioning and vitality scales; QOL-DAv2.0 except psychology scale). Responsiveness was acceptable in the improved health status change (SF-36v2 except vitality scale; QOL-DAv2.0 except psychology and symptoms scales) and deteriorated health status change (SF-36v2 except vitality, social functioning and mental health scales; QOL-DAv2.0 except society scale). Conclusions The SF-36v2 and the QOL-DAv2.0 are valid tools and can be used independently or complementary according to different emphases of health-related quality of life evaluation in patients with MMT.

The doses of 10 μg should replace the doses of 5 μg in newborn hepatitis B vaccination in China: A cost-effectiveness analysis.

OBJECTIVE To identify whether Chinese current series of three 5 μg doses for newborn hepatitis B vaccination should be replaced by the series of three 10 μg doses. METHODS A cost-effectiveness analysis was conducted from the societal perspective based on the constructed decision tree-Markov model. Model parameters were estimated from published literatures, government documents and our surveys. The expected cost and effectiveness were compared between the 3-dose 5 μg series (the 5 μg strategy) and the 3-dose 10 μg series (the 10 μg strategy), and the incremental cost-effectiveness ratio (ICER, additional cost per quality-adjusted life-years gained) was calculated. Threshold values of the efficacy difference of the two series for the ICER=0, 1 and 3 times per capita gross domestic product were analyzed under different scenarios to understand whether the 10 μg strategy should replace the 5 μg strategy according to the recommendation of World Health Organization. RESULTS The 10 μg strategy would be cost-saving compared with the 5 μg strategy under the base-case scenario. Under keeping all the other parameters at the base-case values or further adjusting any one of them to the value most unfavorable to the 10 μg strategy, as long as the efficacy of 3-dose 10 μg series was slightly higher than that of 3-dose 5 μg series, the 10 μg strategy would be cost-effective, highly cost-effective, or even cost-saving. Even under the most pessimistic scenario, i.e. all the other parameters, but the discount rate, at the values most unfavorable to the 10 μg strategy, the 10 μg strategy would be cost-effective if the efficacy difference reached higher than 1.23 percentage point. CONCLUSION For newborn hepatitis B vaccination in China, the 10 μg strategy should be cost-effective, even more possibly highly cost-effective or cost-saving compared with the current 5 μg strategy. The doses of 10 μg should be considered to replace the doses of 5 μg in newborn hepatitis B vaccination in China.

Annual economic burden of hepatitis B virus-related diseases among hospitalized patients in twelve cities in China.

A nationwide survey of hepatitis B virus (HBV)‐associated economic burden has not previously been performed in China. The purpose of this study was to examine the direct, indirect, and intangible costs of HBV‐related diseases within the span of one year. A random sample was taken from specialty and general hospitals across 12 cities in six provinces of China. Intangible costs were estimated based on willingness to pay or open‐ended answers provided by patients. The results showed that 27 hospitals were enrolled, with a sample population of 4726 patients (77.7% response rate). The average annual costs were

Reliability, validity and sensitivity of the Chinese (simple) Short Form 36 Health Survey version 2 (SF‐36v2) in patients with chronic hepatitis B

4454.0 (direct),

Relationships between perceived social support and retention among patients in methadone maintenance treatment in mainland China

924.3 (indirect), and

Relative Contributions of Different Lifestyle Factors to Health-Related Quality of Life in the Elderly

6611.10 (intangible), corresponding to 37.3%, 7.7%, and 55.1% of the total costs, respectively. The direct medical fees were substantially greater than the non‐medical fees. Annual indirect costs were divided into outpatient (

Different associations of sufficient and vigorous physical activity with BMI in Northwest China

112.9) and inpatient (