【摘要】：背景我國是全球首個研制出甲型H1N1流感疫苗并上市進行人群大規(guī)模接種的國家,疫苗上市前僅有血清學的實驗性數(shù)據(jù),需要在上市后進行以疾病為研究終點的流行病學保護效果評價。我國流感哨點監(jiān)測網(wǎng)絡(luò)具有病原學檢測的功能,對哨點醫(yī)院監(jiān)測門診的流感樣病例進行流感病原學檢測和分型,具備開展基于流感哨點監(jiān)測網(wǎng)絡(luò)的觀察性流行病學流感疫苗效果評價性研究的基礎(chǔ)。江蘇省2009年11月份開始該省在重點人群推廣接種甲型H1N1流感疫苗。該省流感監(jiān)測系統(tǒng)顯示,2009年第48周(11月30日至12月6日)甲型H1N1流感流行強度達到峰值,流感病毒陽性率為68.46%,其中98.35%為甲型H1N1流感病毒,通過該監(jiān)測系統(tǒng)能在較短時間內(nèi)獲得有實驗室檢測結(jié)果的研究對象,可以進行甲型H1N1流感疫苗效果的快速評價。 目的快速評價甲型H1N1流感疫苗減少發(fā)生流感癥狀就診的甲型H1N1流感病例的效果,為下一步甲型H1N1流感防控工作提供科學依據(jù),并分析影響本研究所得甲型H1N1流感效果真實性的影響因素,為今后開展類似研究提供參考。 方法本研究采用巢式病例對照研究方法,研究對象定義為2010年1月至3月,因流感樣癥狀在江蘇省哨點醫(yī)院監(jiān)測門診就診,并進行鼻/咽拭子采樣檢測的就診者,且該就診者應屬于甲型H1N1流感疫苗適宜接種人群,沒有甲型H1N1流感疫苗禁忌癥。監(jiān)測門診醫(yī)生使用《哨點醫(yī)院流感樣病例調(diào)查問卷》對研究對象進行回顧性調(diào)查,對發(fā)病時間、甲型H1N1流感疫苗接種與否、接種時間、年齡、性別、基礎(chǔ)性疾病、過去一年就診次數(shù)、其中甲型H1N1流感檢測陽性者作為病例,對照分為流感檢測均為陰性和其他類型流感陽性兩類,并根據(jù)接種至發(fā)病間隔時間長短定義不同類型的接種者,通過分層分析和多因素分析明確和控制可能的影響因素,計算甲型H1N1流感疫苗的獨立RR值,根據(jù)疫苗效果VE公式獲得甲型H1N1流感疫苗減少發(fā)生流感癥狀就診的甲型H1N1流感的保護效果。 結(jié)果2010年1月5日至2010年3月31日,29所哨點醫(yī)院共完成有效問卷2764份。研究對象發(fā)病時間以2010年第2周至第8周為主,以鎮(zhèn)江(14.8%)及南京(11.8%)的調(diào)查人數(shù)較多,年齡范圍為6月～95歲,中位數(shù)為23歲,職業(yè)主要為學生(31.4%),其次為幼托兒童(11.9%)、工人(11.7%)、散居兒童(11.5%)。研究對象中甲型H1N1陽性為191例(6.9%),其他類型流感陽性為786例(28.4%),流感檢測陰性為1784例(64.5%)301人(10.8%)接種過甲型H1N1流感疫苗。 甲型H1N1流感的單因素分析OR值為0.95(0.59-1.54)。經(jīng)分層和多因素分析發(fā)現(xiàn),甲型H1N1流感流行強度的時間變化和地區(qū)差異、研究對象過去1年非外科原因就診次數(shù)、發(fā)病至就診間隔天數(shù)為可能的影響因素。將研究對象限制為發(fā)病日期所在周在2010年第6周之前,接種者定義為接種至發(fā)病間隔≥14天者,對照組由其他類型流感檢測陽性組成時,疫苗效果最接近真實值,RR值點估計值為0.49,甲型H1N1流感疫苗效果VE為51%(CI：7%-75%)。其中兒童青少年甲型H1N1流感疫苗RR值為0.43(CI：0.19-0.95),效果VE為57%(CI：5%-81%)。 該疫苗效果的可信區(qū)間過于寬泛以及成人甲型H1Nl流感疫苗RR值沒有統(tǒng)計學意義提示存在樣本量明顯不足的情況。對于RR值點估計值推算的疫苗保護率(51%),低于其他國家的研究結(jié)論,考慮可能受到幾種偏倚的影響,造成對疫苗效果的低估。 結(jié)論甲型H1N1流感疫苗效果VE為51%(CI：7%-75%),其中兒童青少年為57%(CI：5%-81%),該結(jié)果可能受到研究樣本量較小的影響,并可能存在多種偏倚,偏倚的主要方向是低估疫苗效果。
[Abstract]:Background China is the first country in the world to develop influenza A (H1N1) vaccine for mass vaccination. There are only serological experimental data before the vaccine is launched. It is necessary to evaluate the effect of epidemiological protection with disease as the end point after the vaccine is launched. Influenza-like cases in outpatient surveillance clinics of sentinel hospitals were screened and typed for influenza pathogens, which provided the basis for evaluating the effectiveness of an observational epidemiological influenza vaccine based on the influenza sentinel surveillance network. Influenza surveillance system in Jiangsu Province began to promote the vaccination of influenza A (H1N1) among key populations in November 2009. The epidemic intensity of influenza A (H1N1) reached its peak in the 48th week of 2009 (November 30 to December 6). The positive rate of influenza A (H1N1) virus was 68.46%, of which 98.35% was influenza A (H1N1).
Objective To rapidly evaluate the efficacy of influenza A (H1N1) vaccine in reducing the number of cases of influenza A (H1N1) with influenza symptoms, and to provide a scientific basis for the prevention and control of influenza A (H1N1), and to analyze the influential factors affecting the authenticity of influenza A (H1N1) efficacy, so as to provide a reference for similar studies in the future.
Methods A nested case-control study was conducted in Jiangsu Sentinel Hospital from January to March 2010. The patients with influenza-like symptoms were selected from the surveillance clinic of Jiangsu Sentinel Hospital and tested by nasal/pharyngeal swabs. The patients should be suitable for influenza A (H1N1) vaccination without contraindication of influenza A (H1N1) vaccine. Surveillance clinic doctors used the "Sentinel Hospital Influenza-like Case Questionnaire" to conduct a retrospective survey of the subjects. The onset time, vaccination time, age, sex, basic diseases, the number of visits in the past year, including influenza A H1N1 positive patients as a case, the control group was divided into influenza detection. They were both negative and other influenza-positive. Different types of vaccinators were defined according to the interval between vaccination and onset. The independent RR values of influenza A vaccine were calculated by stratified analysis and multi-factor analysis to identify and control the possible influencing factors. The influenza A vaccine was reduced according to the VE formula of vaccine efficacy. The protective effect of influenza a H1N1 influenza.
Results A total of 2764 valid questionnaires were completed from January 5, 2010 to March 31, 2010 in 29 sentinel hospitals. The onset time of the subjects was mainly from the 2nd week to the 8th week of 2010. The number of the investigated persons was more in Zhenjiang (14.8%) and Nanjing (11.8%). The age ranged from June to 95, the median age was 23 years, the occupational age was mainly students (31.4%) and the children in kindergartens (11.8%). Among the subjects, 191 (6.9%) were positive for influenza A (H1N1), 786 (28.4%) were positive for other types of influenza, and 1 784 (64.5%) were negative for influenza testing and 301 (10.8%) were vaccinated against influenza A (H1N1).
The OR of univariate analysis of influenza A (H1N1) was 0.95 (0.59-1.54). Hierarchical and multivariate analysis revealed temporal and regional variations in the epidemic intensity of influenza A (H1N1). The number of non-surgical visits in the past year and the interval between onset and treatment were the possible influencing factors. Before the 6th week of 2010, the vaccinators were defined as those who had been vaccinated for more than 14 days. When the control group was positive for other types of influenza, the vaccine effect was the closest to the true value, with an estimated RR value of 0.49 and a vaccine effect of 51% (CI: 7% - 75%) for influenza A (H1N1) in children and adolescents. The RR value of the influenza A vaccine for children and adolescents was 0.43 (CI: 0.19 - 75%). 0.95), the effect of VE is 57% (CI:5%-81%).
The confidence interval for vaccine efficacy is too broad and the RR value of adult influenza A (H1Nl) vaccine is not statistically significant, suggesting that there is a significant shortage of samples. Estimate.
Conclusion The efficacy of influenza A (H1N1) vaccine was 51% (CI: 7% - 75%) with 57% (CI: 5% - 81%) in children and adolescents. The results may be affected by the small sample size and may have multiple bias. The main direction of bias is to underestimate the effectiveness of the vaccine.
【學位授予單位】：中國疾病預防控制中心
【學位級別】：碩士
【學位授予年份】：2011
【分類號】：R186

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