| Section 1Study on the carrying rate of hepatitis B virus in China in the past 5 years: a Meta-analysis[Background]Hepatitis B virus(HBV)infection is a major public health problem that seriously threatens national health and social development in China.Over a decade has passed since the last National Hepatitis Seroepidemiological Survey was conducted in 2006.The lack of updated seroepidemiological data on hepatitis B in China makes assessing the current prevalence and burden of the disease inadequate.[Objective]To evaluate the carrying rate of HBV in the past 5 years in our country,and to study and judge the prevalence of hepatitis B in China,so as to provide a basis for scientific evaluation and adjustment of hepatitis B prevention and control,especially vaccine immunization strategy.[Methods]A systematic search was conducted in international databases(Medline through Pub Med,EMBASE,Cochrane library)and national databases(CNKI,Wan Fang Data)to retrieve primary studies on the HBV carrying rate published between 2016 and 2020.Meta-analysis was used to summarize the data extracted form 19 studies that met the inclusion and exclusion criteria.Quality assessment,heterogeneity testing and publication bias assessment were also performed.[Results]Nineteen studies with a total sample size of 282166 were enrolled in this study.The results of Meta-analysis showed that the prevalence of HBV infection in the general population of China from 2016 to 2020 was 4.0%(95%CI:2.1%-5.9%).In addition,the subgroup analysis by region showed,the hepatitis B virus carrying rates of the general population in the western remote areas,the eastern coastal areas and the central inland areas were 4.1%(95%CI: 3.7%-4.5%),3.6%(95%CI: 0-7.2%)and 2.4%(95%CI: 0.5%-4.2%),respectively;the subgroup analysis by gender showed,the hepatitis B virus carrying rates of the general population in the male and female were4.1%(95%CI: 0.9%-7.3%)and 3.7%(95%CI: 2.0%-5.5%);the subgroup analysis by age showed,the hepatitis B virus carrying rates of the general population in the 0-4years old group,the 5-14 years old group,the 15-59 years old group and the ≥60 years old group were 0.5%(95%CI: 0.1-0.9%),1.0%(95%CI: 0.5%-1.5%),6.1%(95%CI:4.0%-8.1%)and 4.0%(95%CI: 2.3%-5.3%),respectively.[Conclusion]In the past five years,HBV infection in China has been effectively controlled,and has been transformed from a high prevalence area to a moderate prevalence area.The hepatitis B virus carrying rates of the general population in China has the following characteristics: the carrying rate of HBV in the western remote areas is the highest,followed by the eastern coastal areas,and the lowest in the central inland areas;male is higher than female;people over 15 years old are higher than children under 15 years old.Section 2 Study on the immune persistence of 60μg recombinant hepatitis B vaccine[Background] Hepatitis B is one of the needs of the emergency response to infectious disease in China,belongs to the statutory category B infectious disease in China.The efficacy and safety of hepatitis B vaccines have been widely proven since the introduction of bloodderived vaccines in 1981 and the introduction of recombinant gene vaccines in 1989.In 2010,60μg/1.0m L Recombinant Yeast-derived Hepatitis B Vaccine was approved and marketed by the China Food and Drug Administration for the vaccination of people aged 16 years and above who did not respond to the full vaccination of 10μg hepatitis B vaccine.It has been more than 10 years since the introduction of the 60μg hepatitis B vaccine,but few observations have been made on the immune persistence of the vaccine,and further studies are needed.[Objective] To observe the duration of immunization of 60μg Recombinant Yeast-derived Hepatitis B Vaccine.Provide the references for developing Hepatitis B vaccine immunization strategies.[Methods] This study contained two rounds of cross-sectional observations based on a phase 3 clinical trial conducted in China.The participants of this study were those whose serum antibody to Hepatitis B virus surface antigen(anti-HBs)turned positive(defined as anti-HBs≥10m IU/ml)after full immunization in the 60μg vaccine group of the original phase 3 study.After 6th(2014)and 11th(2019)years of full immunization,these vaccinees were re-recruited to participate in this study.Serum samples were collected to measure the concentration of anti-HBs.The participants who signed the informed consent form were investigated by questionnaire,and the venous blood was collected to quantitatively detect the concentration of serum anti-HBs.The database was set up by Epi Data 3.1 software and statistical analysis by SPSS 23.0 software.[Results] In two rounds of cross-sectional observations of immune persistence conducted in 2014 and 2019,the blood collection rates were 67.2%(276/411)and 58.2%(239/411),respectively.The HBV seropositive rate in 2008(the first month after full immunization),2014(the 6th years after full immunization)and 2019(the 11 th years after full immunization)were 96.0%(95%CI: 93.7-97.7),48.2%(95%CI: 42.1-54.3)and 40.6%(95%CI: 34.3-47.1),respectively;the anti-HBs GMC of seropositive individuals was 584.0m IU/ml(95%CI: 547.7-620.3m IU/ml),142.4m IU/ml(95%CI: 99.7-185.0m IU/ml),and 169.1m IU/ml(95%CI: 113.1-225.1m IU/ml),respectively.The difference of HBV seropositive rate(χ~2=286.723,P<0.0001)and anti-HBs GMC(H=213.982,P<0.0001)in the three time periods after full-course immunization was statistically significant,the serum HBV seropositive rate and anti-HBs GMC of the subjects in 2008 were significantly higher than those in 2014 and 2019;There were no statistical significance in the HBV seropositive rate(χ~2=2.996,P=0.249)and anti-HBs GMC(H=-8.451,P=1.000)between 2014 and 2019.The results showed that the level of anti-HBs induced by 60μg hepatitis B vaccine in Chinese non-responders aged 16-60 years old showed a decreasing trend with time.The level of anti-HBs 11 years after immunization was similar to the HBV seropositive rate in Chinese general population aged 15-59 years old,indicating that the level of serum anti-HBs decreased to a low level 11 years after full immunization with 60μg hepatitis B vaccine.[Conclusion] After 3 doses of 60μg hepatitis B vaccine were administered to non-responders aged 16 to 60 years in China,the state of low anti-HBs positive rate after 60μg hepatitis B vaccine immunizations would be long time,and the protective antibody persists about 11 years. |
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