基于流感哨点监测网络的甲型H1N1流感疫苗效果评估
发布时间：2018-09-18 12:11
【摘要】：背景我国是全球首个研制出甲型H1N1流感疫苗并上市进行人群大规模接种的国家,疫苗上市前仅有血清学的实验性数据,需要在上市后进行以疾病为研究终点的流行病学保护效果评价。我国流感哨点监测网络具有病原学检测的功能,对哨点医院监测门诊的流感样病例进行流感病原学检测和分型,具备开展基于流感哨点监测网络的观察性流行病学流感疫苗效果评价性研究的基础。江苏省2009年11月份开始该省在重点人群推广接种甲型H1N1流感疫苗。该省流感监测系统显示,2009年第48周(11月30日至12月6日)甲型H1N1流感流行强度达到峰值,流感病毒阳性率为68.46%,其中98.35%为甲型H1N1流感病毒,通过该监测系统能在较短时间内获得有实验室检测结果的研究对象,可以进行甲型H1N1流感疫苗效果的快速评价。 目的快速评价甲型H1N1流感疫苗减少发生流感症状就诊的甲型H1N1流感病例的效果,为下一步甲型H1N1流感防控工作提供科学依据,并分析影响本研究所得甲型H1N1流感效果真实性的影响因素,为今后开展类似研究提供参考。 方法本研究采用巢式病例对照研究方法,研究对象定义为2010年1月至3月,因流感样症状在江苏省哨点医院监测门诊就诊,并进行鼻/咽拭子采样检测的就诊者,且该就诊者应属于甲型H1N1流感疫苗适宜接种人群,没有甲型H1N1流感疫苗禁忌症。监测门诊医生使用《哨点医院流感样病例调查问卷》对研究对象进行回顾性调查,对发病时间、甲型H1N1流感疫苗接种与否、接种时间、年龄、性别、基础性疾病、过去一年就诊次数、其中甲型H1N1流感检测阳性者作为病例,对照分为流感检测均为阴性和其他类型流感阳性两类,并根据接种至发病间隔时间长短定义不同类型的接种者,通过分层分析和多因素分析明确和控制可能的影响因素,计算甲型H1N1流感疫苗的独立RR值,根据疫苗效果VE公式获得甲型H1N1流感疫苗减少发生流感症状就诊的甲型H1N1流感的保护效果。 结果2010年1月5日至2010年3月31日,29所哨点医院共完成有效问卷2764份。研究对象发病时间以2010年第2周至第8周为主,以镇江(14.8%)及南京(11.8%)的调查人数较多,年龄范围为6月～95岁,中位数为23岁,职业主要为学生(31.4%),其次为幼托儿童(11.9%)、工人(11.7%)、散居儿童(11.5%)。研究对象中甲型H1N1阳性为191例(6.9%),其他类型流感阳性为786例(28.4%),流感检测阴性为1784例(64.5%)301人(10.8%)接种过甲型H1N1流感疫苗。 甲型H1N1流感的单因素分析OR值为0.95(0.59-1.54)。经分层和多因素分析发现,甲型H1N1流感流行强度的时间变化和地区差异、研究对象过去1年非外科原因就诊次数、发病至就诊间隔天数为可能的影响因素。将研究对象限制为发病日期所在周在2010年第6周之前,接种者定义为接种至发病间隔≥14天者,对照组由其他类型流感检测阳性组成时,疫苗效果最接近真实值,RR值点估计值为0.49,甲型H1N1流感疫苗效果VE为51%(CI：7%-75%)。其中儿童青少年甲型H1N1流感疫苗RR值为0.43(CI：0.19-0.95),效果VE为57%(CI：5%-81%)。 该疫苗效果的可信区间过于宽泛以及成人甲型H1Nl流感疫苗RR值没有统计学意义提示存在样本量明显不足的情况。对于RR值点估计值推算的疫苗保护率(51%),低于其他国家的研究结论,考虑可能受到几种偏倚的影响,造成对疫苗效果的低估。 结论甲型H1N1流感疫苗效果VE为51%(CI：7%-75%),其中儿童青少年为57%(CI：5%-81%),该结果可能受到研究样本量较小的影响,并可能存在多种偏倚,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.
【学位授予单位】：中国疾病预防控制中心
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：R186
本文编号：2247869
[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.
【学位授予单位】：中国疾病预防控制中心
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：R186
【参考文献】
相关期刊论文 前5条
1 叶冬青;巢式病例对照研究的设计及分析[J];疾病控制杂志;2001年01期
2 汤奋扬;嵇红;祁贤;李亮;祖荣强;霍翔;许可;朱凤才;孟繁岳;;江苏省2009年甲型H1N1流感流行病学及病原学特征分析[J];江苏预防医学;2010年01期
3 许可;李亮;祖荣强;霍翔;嵇红;汤奋扬;;江苏省甲型H1N1流感暴发疫情的流行特征和影响因素分析[J];江苏预防医学;2010年01期
4 霍翔;李亮;祖荣强;孟繁岳;许可;嵇红;朱凤才;汤奋扬;;流感样病例监测在甲型H1N1流感大流行中的早期预警效果分析[J];江苏预防医学;2010年01期
5 叶方立,夏金山;病例对照研究评价疫苗效力的样本含量[J];中国卫生统计;2001年02期
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