组群随机试验在伤寒疫苗效果观察中的应用研究

董柏青; 杨进; 唐振柱; 杨宏徽; 曾竣; 张杰; 王鸣柳; 梁贵臣; 司国爱; 李翠云; 梁大斌; 廖和壮; RionLeonOchiai; AliMohammad; CamiloJAcosta; JohnClemens

Abstract

董柏青,杨进,唐振柱,杨宏徽,曾竣,张杰,王鸣柳,梁贵臣,司国爱,李翠云,梁大斌,廖和壮,RionLeonOchiai,AliMohammad,CamiloJAcosta,JohnClemens.组群随机试验在伤寒疫苗效果观察中的应用研究[J].Chinese journal of Epidemiology,2005,26(2):97-100

组群随机试验在伤寒疫苗效果观察中的应用研究

Application of cluster randomization method on typhoid Vi vaccine trails

Received:July 02, 2004

DOI：

KeyWord: 伤寒疫苗组群随机试验效果观察

English Key Word: Typhoid Vi vaccine Cluster randomized trial Vaccine trial

FundProject:国际疫苗研究所资助项目(DOMITyphoidT-3)

Author Name	Affiliation
DONG Bai-qing	530021 南宁,广西壮族自治区疾病预防控制中心
YANG Jin	530021 南宁,广西壮族自治区疾病预防控制中心
TANG Zhen-zhu	530021 南宁,广西壮族自治区疾病预防控制中心
YANG Hong-hui	530021 南宁,广西壮族自治区疾病预防控制中心
ZENG Jun	530021 南宁,广西壮族自治区疾病预防控制中心
ZHANG Jie	530021 南宁,广西壮族自治区疾病预防控制中心
WANG Ming-liu	530021 南宁,广西壮族自治区疾病预防控制中心
LIANG Gui-chen	河池市金城江区卫生防疫站
SI Guo-ai	河池市金城江区卫生防疫站
LI Cui-yun	530021 南宁,广西壮族自治区疾病预防控制中心
LIANG Da-bin	530021 南宁,广西壮族自治区疾病预防控制中心
LIAO He-zhuang	530021 南宁,广西壮族自治区疾病预防控制中心
Rion Leon Ochiai	International Vaccine Institute,Korea
Ali Mohammad	International Vaccine Institute,Korea
Camilo J Acosta	International Vaccine Institute,Korea
John Clemens	International Vaccine Institute,Korea

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Abstract:

目的　用组群随机试验实现伤寒Vi疫苗效果观察的研究设计和实施应用。方法　采用组群随机试验方法确定试验组和对照组所需样本量,并组织实施大规模疫苗接种,在试验组接种伤寒Vi疫苗、对照组接种流脑疫苗。结果　根据组群随机试验方法计算共需要观察对象为 96 12 1人,分为 10 8个组群。根据组群大小、地理位置 (城乡 )及性质 (学校、机关、厂矿、人口特征 )分层配对,确定试验组分为 5 3个组群共 4 4 0 5 4人,对照组为 5 4个组群共 4 84 2 2人。对两组间各主要混杂因子 (年龄、性别、居住地点、主要人群的经济收入、受教育程度、主要职业 )等进行分析,发现两组之间总体相差不大,具有较好的均衡性与可比性。结论　组群随机抽样法应用于大规模疫苗效果观察试验,能较好地控制组间混杂因子,使干预的实际效果得到科学的评价;实施也比较简单,被干预对象容易接受,可行性高。

English Abstract:

Objective To describe the design and application of cluster randomized controlled method on typhoid Vi vaccine trial,and to assess the effect of implementation. Methods Simple size calculation of cluster-randomized trial was used to determine the sample size of the two groups and a vaccination campaign was conducted. The study group was given typhoid Vi vaccine and the control group was given meningococcal A vaccine. Results According to sample size calculation,a total sample of 96 121 participants was required and the study areas were divided into 108 clusters. In practice,53 study clusters with 44 054 participants and 54 control clusters with 48 422 participants were stratified and matched according to size,location (urban or rural),characteristics (school,department,factory,demography) were randomized respectively. Confounding factors of two groups including age,sex,resident area,income,level of education were compared. It was found that the ratio of all confounding factors between the two groups were comparable and balanced. Conclusion Confounding factors can be better controlled between study group and the control group by applying cluster-randomized method on vaccine trail which enabled the intervention to be more scientifically evaluated; The implementation of cluster randomization trial was simple and easy to be accepted.

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