| Background and Objectives:Globally, Hepatitis B is recognized as a major public health problem. It not only influences the health seriously and causes heavy burden to individuals and families, but also has a strong impact on social development. Evaluation study on disease burden and prevention and treatment strategy of Hepatitis B will contribute to the health policy planning on health management and resource allocation. The objectives of the study is to analyze disease burden of hepatitis B in Jiangsu province systematically, construct the model of neonatal hepatitis B vaccination strategy for long-term effects evaluation, carry out the economics analysis on screening immune and treatment for adult, which will provide a scientific basis for the prevention and treatment of hepatitis B in Jiangsu province.Methods:(1) The research on disease burden is to describe mainly through the epidemiology, economics and disability adjusted life years (DALYs). Epidemiological analysis of data comes from the health department of Jiangsu province, infectious diseases report information management system of the center for disease control and prevention in Jiangsu province, the death registration and monitoring system of the center for disease control and prevention in Jiangsu province. Through the sampling investigation, the retrospective investigation of hospital electronic medical records, the data of economic burden in patients with different types of hepatitis B-related diseases is obtained. SPSS 19.0 is used to do descriptive statistics and multivariate linear regression analysis. DALYs is to calculate the year of life lost (YLL) caused by the premature death through the death data of hepatitis B-related disease, use the loss of healthy life years (YLD) caused by the indirect method to estimate disability described in the study of the global burden of disease (GBD) and complete the calculation with Excel2007. (2) Neonatal immunization strategy evaluation is to evaluate the long-term clinical and economic effect by building decision tree-markov model that accords with Jiangsu’s reality. According to the project of neonatal immunization and the future trend in Jiangsu province, the hepatitis B vaccine immunization strategy multistage decision tree model is built, at the same time Markov model is established to simulate the outcome of process after infecting HBV. (3) The research on adult prevention and treatment strategy is to set three strategies-universal vaccination, the screening of the surface antibody vaccination and the screening of the surface antibody antigen vaccination in combination with the practical set of Jiangsu, and carry on the decision analysis through the application of TreeAge, WinBUGS software, according to the guide of Chinese adult hepatitis B immune prevention technology and the chronic hepatitis B prevention guide (2010 edition).Results:(1) The incidence of hepatitis B in Jiangsu province from 1990 to 2013 is between 14.26/100000 and 33.10/100000. The report incidence is fluctuating around 2004, while it was declining year by year after 2005, different from other demostic report-the overall rising trend. Male incidence is higher than female significantly. Male is between 19.61/100000 and 247.31/100000, while female is between 8.60/100000 and 18.66/100000. In 1990-2013 hepatitis B cases mainly concentrated in the 15 to 45 years old, which accounted for 69.36% of the total. The incidence on the people over 15 years old is much higher than the people under age 15. Hepatitis B mortality is 1.20/100000 in 2012. The death rate is increasing with the increase of age, and the male mortality is higher than female mortality. Liver cancer mortality rate is 30/100000 from 2002 to 2013, in which the male is significantly higher than female. With the increase of age the mortality is increasing gradually, liver cancer mortality has declining trend between different age groups among years. (2) Hospital survey results show that the outpatient rate is 8.60% monthly. The times of outpatient service is 6.5 per capita every year due to liver disease, and the hospitalization rate is 26.98% because of hepatitis B within a year. The direct medical costs of outpatient are 751.24 yuan, in which the medical expense accounted for 65.57%. The main influence factors of outpatient expense are medical expense, examination expense and antiviral treatment. The average hospitalization days for patients with hepatitis B-related diseases is 34 days, meanwhile the average hospitalization cost is 18312.62 yuan. In the hospitalization fee structure, the proportion of medical expense is the highest-63.77%. The hospitalization expenses account for 32.55% of household income, and account for 118% of the annual per capita income. The economic burden of inpatients is 28971 yuan, and direct economic burden is up to 68.7%. So the hospital stays, medicine proportion and age have regression relationship with the economic burden of hepatitis B-related patients in hospital. The annual medical costs per capita in patients with hepatitis B-related disease is 27575.68 yuan, and the annual economic burden per capita is 40791.95 yuan, in addition, there are differences in economic burden of patients with different disease. The intangible burden of the outpatient with Hepatitis B-related disease is 29319.3 yuan on average, and intangible burden of the liver cancer patients is the highest, while the one of chronic hepatitis B is the lowest. The intangible burden of in-patients is higher than that of outpatients by 36363.97 yuan on average, besides the intangible burden is heavier with hepatocellular carcinoma and hepatitis B cirrhosis compensatory period. (3) Through measuring hepatitis B virus (HBV) infection related disease healthy life years loss in Jiangsu province, it shows that male YLLs is higher than female in the hepatitis B, liver cirrhosis and liver cancer according to the disability adjusted life year (DALY) recommended by the world health organization, and the YLLs in the group aged 45 to 59 years old is the highest. The disability adjusted life years loss caused by HBV infection in Jiangsu province is 304510 in 2012 and 290072 in 2013, which is estimated by indirect method. (4) Through the simulation from decision tree-markov model, relative to the unvaccinated group, the clinical effect of neonatal immune shows that the vaccination in newborns of 2012 Birth cohort with 3 doses of 5μg recombinant hepatitis B vaccine can reduce the number of new infections by 17296, reduce one of chronic hepatitis by 3793 cases, reduce one of the liver cancer by 498 cases and reduce one of related death by 214729. While the vaccination with 3 doses of 10μg recombinant hepatitis B vaccine can reduce the number of new infections by 18257, reduce that of chronic hepatitis by 4003 cases, reduce that of the liver cancer by 526 cases and reduce one of related death by 226658. It can be seen that the clinical effect of vaccination in newborns with 3 doses of 10μg recombinant hepatitis B vaccine is better. It shows from economics evaluation results that the BCR of different neonatal immunization scheme is more than 1; therefore the neonatal direct vaccination with 3 doses of 10μg hepatitis B vaccine is the optimal strategy, which was adjusted in the last two years. The strategy of screening HBsAg for pregnant women is suboptimum. For newborns of HBsAg positive pregnant women, using 3 doses of 10μg hepatitis B vaccine, filling 1 dose of 100IU HBIG can be used as the alternatives of hepatitis B maternal and child block. Using one dimensional sensitivity analysis, the result shows that the more sensitive factors include protection rate of vaccine and vaccination rate among the parameters of the model. (5) According to the research on adult control strategy, it shows that the inoculation with 3 doses of 20μg for adults after screening surface antibody is the optimal strategy, and direct inoculation with 20μg recombinant hepatitis B vaccine is suboptimal solution. BCR is greater than 1 for direct inoculation and inoculation after screening surface antibody. We provide a line of nucleoside analogues treatment analysis on adult of surface antigen positive after screening on hepatitis B vaccine and needing treatment, from which we can draw a conclusion that BCR is less than 1, or the benefit is less than the cost. Probably because of antiviral drugs cost is higher and the curative effect is not significant. By item by item alternative method of sensitivity analysis, it has greater influence on the strategy-screening coverage rate for hepatitis B vaccine, the discount rate, vaccine protection rate, the rate of surface antibody positive. However the strategy has less sensitivity on the change of vaccination fee and screening fee. In our study, we also try to introduce quantitative method to estimate the sensitivity of model to the parameters; the result is that the impact of various parameters on model is in accordance with the one by item by item alternative method. Cost effectiveness ratio for entecavir is 18,036 which is lower than lamivudine 25675, cost-effectiveness ratio increases with age. Applying Bayesian methods to cost-effectiveness analysis, especially when using Markov Monte Carlo (MCMC), we get not only the average estimate of costs and benefits, but also the variation of the quantitative.Conclusions:(1) Hepatitis B virus infection brings heavy burden to patients and society, and it has achieved certain effect on hepatitis B prevention and control in Jiangsu province. (2) It is the more effective immune strategy to inoculate 3 doses of 10μg hepatitis B vaccine to newborns, which was adjusted currently. (3) It is the optimal strategy to inoculate 3 doses of 20μg to adult after screening surface antibody. Entecavir is a cost-effective strategy compared with lamivudine for CHB patients. (4) The benefit cost ratio of newborns immunity is far higher than that of adult. In practical work, close attention should be paid to the parameters that have greater influence on the strategy in the model. |
PDF Full Text Request