本文選題：乙型肝炎疫苗　切入點(diǎn)：復(fù)種　出處：《浙江大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目的乙型肝炎是由乙型肝炎病毒(Hepatitis B Virus,HBV)感染引起的可能危及生命的肝臟感染性疾病,是一個(gè)嚴(yán)重的全球衛(wèi)生問題。我國(guó)自1992年乙肝疫苗納入免疫規(guī)劃后,在降低15歲兒童乙型肝炎表面抗原(Hepatitis B surface antigen,HBsAg)攜帶率方面取得了巨大的成就,但是成人HBsAg攜帶率仍然居高不下,成人已經(jīng)成為乙型肝炎病毒(HBV)新發(fā)感染的主要人群。目前,仍然有大量的成人未接種乙肝疫苗,同時(shí)成人乙肝疫苗接種后仍有一部分人無應(yīng)答。成人初次接種乙肝疫苗無應(yīng)答可能和年齡、性別、(肥胖)BMI≥25 kg/m2、成人伴隨疾病等有關(guān),而關(guān)于成人無應(yīng)答人群復(fù)種效果及影響因素的獨(dú)立研究不多。本研究通過對(duì)浙江省德清縣開展成人乙肝疫苗接種,觀察乙肝疫苗初次免疫效果,分析無應(yīng)答的影響因素,評(píng)價(jià)成人無應(yīng)答人群復(fù)種1劑次60μg重組乙型肝炎疫苗后的抗體產(chǎn)生水平及疫苗安全性,探討復(fù)種效果的影響因素。為今后制定更加合理的成人乙肝疫苗免疫政策和無應(yīng)答人群復(fù)種措施提供依據(jù)。研究方法選取德清縣西部莫干鎮(zhèn)、中部乾元鎮(zhèn)和東部新安鎮(zhèn)三個(gè)鄉(xiāng)鎮(zhèn),每個(gè)鄉(xiāng)鎮(zhèn)各選2個(gè)村,選擇年齡為16～49周歲,既往未接種過乙肝疫苗者為調(diào)查對(duì)象。在取得當(dāng)事人書面知情同意后,由經(jīng)統(tǒng)一培訓(xùn)的鄉(xiāng)鎮(zhèn)防保人員按照統(tǒng)一的調(diào)查表對(duì)調(diào)查對(duì)象進(jìn)行詢問調(diào)查,主要內(nèi)容包括性別、出生年月和乙肝暴露情況等。調(diào)查對(duì)象采靜脈血5 mL,分離血清后,置低溫保存、送檢,檢測(cè)血清乙肝病毒表面抗原(HBsAg)、乙肝病毒表面抗體(抗-HBs)、乙肝病毒核心抗體(抗-HBc)。HBsAg和抗-HBs兩項(xiàng)均陰性者納入為初種對(duì)象。研究對(duì)象分三組進(jìn)行乙肝疫苗初次免疫,分別采用:A組0、1、3月免疫程序,B組0、1、6月免疫程序和C組0、1、12月免疫程序,研究對(duì)象按免疫程序在上臂三角肌處肌內(nèi)注射3劑次重組(酵母)乙型肝炎疫苗(簡(jiǎn)稱10 μg乙肝疫苗),在第3劑次乙肝疫苗接種后一個(gè)月,采靜脈血5 mL檢測(cè)抗-HBs。乙肝疫苗初次全程接種后1個(gè)月檢測(cè)抗-HBs滴度10.00 mIU/mL者判定為免疫無應(yīng)答。在知情同意的前提下,初次免疫無應(yīng)答者納入為復(fù)種研究對(duì)象。復(fù)種對(duì)象在初次免疫完成后一年,在上臂三角肌處肌內(nèi)注射1劑次60 μg重組乙型肝炎疫苗(釀酒酵母)(簡(jiǎn)稱60μg乙肝疫苗),并在接種現(xiàn)場(chǎng)測(cè)量復(fù)種對(duì)象的身高和體重,接種后1個(gè)月采集復(fù)種研究對(duì)象外周靜脈血3ml,檢測(cè)抗-HBs。乙肝疫苗由浙江省疾病預(yù)防控制中心提供,血清-20℃冷凍保存送至杭州市艾迪康醫(yī)學(xué)檢驗(yàn)中心檢測(cè),采用化學(xué)發(fā)光法定量檢測(cè),應(yīng)用美國(guó)ABBOTT公司ARCHITETi2000化學(xué)發(fā)光免疫分析儀。血清學(xué)檢測(cè)判定標(biāo)準(zhǔn):HBsAg≥0.05 mIU/mL為陽性,抗-HBs≥10.00 mIU/mL為陽性,乙肝核心抗體(抗-HBc)≥1.00 mIU/mL為陽性。采用EPiData軟件建立數(shù)據(jù)庫,雙錄入數(shù)據(jù),應(yīng)用SPSS 19.0統(tǒng)計(jì)軟件對(duì)數(shù)據(jù)進(jìn)行處理和分析,率的比較采用χ2檢驗(yàn),如果其中有格子的期望頻數(shù)5采用Fisher精確檢驗(yàn)。兩組的風(fēng)險(xiǎn)采用多元logistic回歸計(jì)算OR值及其95%CI來評(píng)價(jià)。幾何平均滴度(geometric means of titer,GMT)比較采用非參數(shù) Mann-Whitney U 檢驗(yàn),GMT趨勢(shì)檢驗(yàn)采用Pearson相關(guān)分析;無應(yīng)答危險(xiǎn)因素分析采用非條件Logistic回歸分析。研究結(jié)果1、乙肝疫苗初次免疫完成初次全程免疫接種689人,抗-HBs陽轉(zhuǎn)率為82.29%(567/689),無應(yīng)答122人,無應(yīng)答率17.71%,抗-HBs GMT為75.19 mIU/mL。男女性陽轉(zhuǎn)率分別為82.33%和82.27%,差異無統(tǒng)計(jì)學(xué)意義(χ2=0.001,P=0.982),男女性的GMT分別為 82.44 mIU/mL 和 70.52 mIU/mL,差異無統(tǒng)計(jì)學(xué)意義(Z=-0.02,P=0.988)。不同年齡組16～歲、25～歲、30～歲、35～歲、40～49歲抗-HBs陽轉(zhuǎn)率分別為83.02%、85.42%、81.36%、79.69%和81.43%,各年齡組陽轉(zhuǎn)率差異無統(tǒng)計(jì)學(xué)意義(χ2=1.76,P=0.780);GMT 分別為 107.43 mIU/mL、122.60 mIU/mL、61.48 mIU/mL、53.94mIU/mL、48.67mIU/mL,隨著年齡的增高GMT有隨之下降的趨勢(shì)(r=-0.13,P0.001)。多因素Logistic回歸分析顯示,C組發(fā)生乙肝疫苗無應(yīng)答的危險(xiǎn)性是B組的2.09倍(95%CI:1.26～3.46,P=0.004),單項(xiàng)乙肝核心抗體(抗-HBc)陽性發(fā)生初次免疫無應(yīng)答是抗-HBc陰性者的1.73倍(95%CI:1.07～2.80,P=0.026),有手術(shù)史發(fā)生無應(yīng)答的危險(xiǎn)性是無手術(shù)史的1.56倍(95%CI:0.96～2.53,P=0.070)。2、乙肝疫苗復(fù)種初次免疫無應(yīng)答者122人,剔除外出或不愿意接種人群,最終有89人完成1劑次60μg乙肝疫苗接種和免疫后采血。復(fù)種1個(gè)月后,抗-HBs陽轉(zhuǎn)率為95.51%(85/89),抗-HBs GMT 為 585.39 mIU/mL。其中抗-HBs 滴度≥100 mIU/mL 者占74.16%(66/89)。經(jīng)χ2檢驗(yàn)分析發(fā)現(xiàn),成人再次免疫無應(yīng)答與BMI有關(guān)(P=0.029),BMI≥25kg/m2是危險(xiǎn)因素。多因素Logistic回歸分析,隨著BMI的增加,復(fù)種無應(yīng)答風(fēng)險(xiǎn)有隨之增加的趨勢(shì),OR值為1.20(P=0.133)。結(jié)論成人3劑次10μg乙肝疫苗初次接種可獲得較好的免疫應(yīng)答,但隨著年齡的增高GMT有隨之下降的趨勢(shì)。抗-HBc單陽性者初次接種乙肝疫苗免疫應(yīng)答水平低于抗-HBc陰性人群,復(fù)種可以提高其抗體應(yīng)答率;成人乙肝疫苗接種0、1、3月程序和0、1、6月程序陽轉(zhuǎn)率高于0、1、12月程序,其長(zhǎng)期效果需進(jìn)一步隨訪。成人常規(guī)乙肝疫苗免疫無應(yīng)答者復(fù)種1劑次60μg重組乙型肝炎疫苗,可獲得良好的免疫應(yīng)答,控制體重可能會(huì)提高乙肝疫苗的復(fù)種免疫效果。
[Abstract]:Hepatitis B is caused by the hepatitis B virus (Hepatitis B, Virus, HBV) infection caused by potentially life-threatening liver infection is a serious global health problem. Since 1992 China's hepatitis B vaccine into immunization programs, 15 year old children in reducing hepatitis B surface antigen (Hepatitis B surface antigen, HBsAg) carrying rate has made great achievements, but the adult HBsAg carrying rate is still high, has become the adult hepatitis B virus (HBV) infection of the main population. At present, there are still a lot of adults without inoculation of hepatitis B vaccine, and adults after hepatitis B vaccination remains a part of non responders. Adult primary inoculation of hepatitis B no vaccine response may and age, gender, BMI = 25 kg/m2 (obesity), with adult diseases, and the effect on adult population and non response cropping due to not many independent research elements. Based on the study of Zhejiang in Deqing County province to carry out adult hepatitis B vaccine, immune effect of hepatitis B vaccine first, analysis of influence factors of non response, and the level of vaccine safety evaluation of adult non response group multiple antibody 1 doses of 60 g after Recombinant Hepatitis B Vaccine, to investigate the factors affecting the effect of cropping. And provide evidence for developing adult hepatitis B vaccination policy more reasonable and non response measures. Methods of multiple cropping populations in Western Deqing County Mo Zhen, Gan Yuan Zhen central and Eastern Xin'an town three townships, each township 2 village, aged 16~49 years of age, who had not been vaccinated with hepatitis B vaccine as the subjects. In obtaining written informed consent after the parties and by the trained personnel of township to survey questionnaire according to the questionnaire, the main contents include gender, year of birth April and exposure. The survey of hepatitis B 5 mL venous blood, serum separation after the cryopreservation, inspection, detection of serum hepatitis B virus surface antigen (HBsAg), hepatitis B virus surface antibody (anti -HBs), hepatitis B virus core antibody (anti -HBc) and anti.HBsAg -HBs two were negative into early the object of study. Subjects were divided into three groups of hepatitis B vaccine immunization, immunization programs were carried out: A group 0,1,3 month, 0,1,12 month B immunization program immunization program and C group 0,1,6 group, the research object according to the immune program in the upper arm deltoid intramuscular injection of 3 doses of heavy group (yeast) hepatitis B vaccine (referred to as 10 g, a month) of hepatitis B vaccine in third doses of hepatitis B vaccine, venous blood 5 mL detection of anti -HBs. vaccine of hepatitis B vaccination in 1 months after the initial detection of anti -HBs titer of 10 mIU/mL were judged as no immune response. On the premise of informed consent, without immunization The respondents included as the research object. The object in multiple cropping a year after the completion of the first immunization, 1 doses of 60 g Recombinant Hepatitis B Vaccine injection in the upper arm deltoid muscle (Saccharomyces cerevisiae) (referred to as 60 g of hepatitis B vaccine), and height and weight measurements in multiple cropping object inoculation site, venous blood 3ml after inoculation of 1 collected cropping on peripheral -HBs., detection of anti hepatitis B vaccine provided by the Zhejiang Provincial Center for Disease Control and prevention, serum -20 C cryopreservation to ADICON clinical laboratories in Hangzhou detected by chemiluminescence quantitative detection, using the United States ABBOTT company ARCHITETi2000 chemiluminescence immunoassay analyzer. Standard serological detection: HBsAg = 0.05 mIU/mL positive anti -HBs was greater than 10 mIU/mL positive, hepatitis B core antibody (anti -HBc) for more than 1 mIU/mL respectively. The database was established by EPiData software, the double input data, using SPSS 19 .0 statistical software for data processing and analysis, were compared by the 2 test, if the expected frequency which has 5 lattice using Fisher's exact test. The risk of the two groups using multivariate logistic regression to calculate the value of OR and 95%CI. To evaluate the geometric mean titer (geometric means of titer, GMT) compared with non parametric Mann-Whitney U GMT test, trend test analysis using Pearson correlation analysis; Logistic regression analysis of risk factors of non response. Results: 1, hepatitis B vaccine immunization completed the initial vaccination of 689 people, the anti -HBs positive seroconversion rate was 82.29% (567/689), no response in 122, no response rate 17.71%, anti -HBs GMT 75.19 mIU/mL. and seroconversion rates were 82.33% and 82.27%, the difference was not statistically significant (2=0.001, P=0.982), and GMT were 82.44 mIU/mL and 70.52 mIU/mL, there was no statistically significant difference (Z=-0.0 2, P=0.988). Different age groups aged 16 ~ 25 years old, 30 years old ~ ~, ~ 35 years old, 40~49 years old, anti -HBs positive rates were 83.02%, 85.42%, 81.36%, 79.69% and 81.43%, the seroconversion rate of each age group showed no significant difference (2=1.76, P=0.780); GMT = 107.43 mIU/mL, 122.60 mIU/mL, 61.48 mIU/mL, 53.94mIU/mL, 48.67mIU/mL, GMT increased with age has decreased trend (r=-0.13, P0.001). Logistic regression analysis showed that C group had no response to hepatitis B vaccine risk is 2.09 times more than that of B group (95%CI:1.26 3.46, P= 0.004), single hepatitis B core antibody (anti -HBc) positive primary immune non response is 1.73 times the anti -HBc negative (95%CI:1.07 - 2.80, P=0.026), a history of operation risk of non response is 1.56 times of surgery (95%CI:0.96 - 2.53,.2, P=0.070) without response to hepatitis B vaccine in immunization in 122 people, excluding out or Not willing to receive the crowd, the final 89 people completed the 1 dose 60 g of hepatitis B vaccination and immune blood. In 1 months after the anti -HBs positive seroconversion rate was 95.51% (85/89), anti -HBs GMT 585.39 mIU/mL. the titer of anti -HBs was greater than 100 mIU/mL accounted for 74.16% (66/89) by 2. The analysis showed that the adult again no immune response associated with BMI (P=0.029), BMI = 25kg/m2 are risk factors. Multivariate Logistic regression analysis, with the increase of BMI, multiple non response to be increased risk, the value of OR was 1.20 (P=0.133). Conclusion the adult 3 doses of hepatitis B vaccine at 10 g vaccination can obtain better immune response, but with the increase of age GMT has decreased trend. Anti -HBc positive initial inoculation of hepatitis B vaccine immune response level was lower than that of anti -HBc negative population, multiple cropping can improve the antibody response rate; adult hepatitis B vaccination program 0,1,3 months and 0,1,6 months The positive conversion rate of program is higher than that of 0,1,12 month program, and its long-term effect needs further follow-up. Adults with routine hepatitis B vaccine immunization and non responders revaccination 1 doses of 60 g g can get good immune response. Controlling body weight may improve the immune effect of multiple vaccination of hepatitis B vaccine.

【學(xué)位授予單位】：浙江大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R186

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