增强免疫力保健食品人体试食试验人群筛选标准的探讨

Screening Criteria:A Study of Human Feeding Trials for Boosting-immunity Health Food

背景随着经济的发展和社会竞争的日趋激烈,机体免疫力下降逐渐成为现代人的一大隐忧.具有增强免疫力作用的保健食品有着庞大家族和广泛的消费人群,因此,探索更好的评价保健食品的方法迫在眉睫.目的 本研究作为某增强免疫力保健食品人体试食试验的一部分,旨在探讨更好的人群筛选标准.方法选择2011年3-5月在新浜镇社区卫生服务中心体检的6 033例农（居）民为调查对象,制定人群初筛方法和复筛方法,总结增强免疫力保健食品人体试食试验的人群筛选标准.结果根据初筛标准,最初纳入的6 033例村（居）民中45～69岁者4 242例,为初筛人群.根据复筛标准,拟定一个主工作区和一个副工作区,共包括919例农（居）民,为复筛人群.结合本研究设定的白细胞计数＜4.2×109/L的标准,最终纳入该保健食品人体试食试验的农（居）民共133例.结论 45～69岁可作为增强免疫力保健食品人体试食试验的人群初筛标准,白细胞计数＜4.2×109/L可作为增强免疫力保健食品人体试食试验的人群复筛标准,同时需考虑相同区域内生活状况、生态环境等因素的影响.

Backgrounds Immunity descent has gradually become a secret worry with the development of economy and the increasing social competition. Large groups are consuming health food with boosting - immunity functions. herefore better methods for evaluating health food are needed imminently. Objective To explore better screening criteria for human feeding tri- als for boosting - immunity health food. Methods A total of 6 033 rural （urban） residents who had physical examinations in CHC of Xin bang Town from March to May 2011 were enrolled in this study. Preliminary screening or rescreening methods were made to summarize screening criteria. Results A total of 6 033 rural （urban） residents including 4 242 aged 45 - 69 years were enrolled, according to preliminary screening criteria, as preliminary - screening group ; a main working area and a deputy were made based on rescreening criteria, 919 rural （urban） residents enrolled as rescreening group. Combined with the criteria of leukocyte count （ 〈4. 2 109/L） made by this study, a total of 133 rural （urban） residents were at last enrolled in the hu- man feeding trials for boosting - immunity health food. Conclusion Ages of 45 - 69 years can be used as a relatively reliable preliminary screening criterion for human feeding trials for boosting - immunity health food, leukocyte count （ 〈 4. 2 109/L） as a reliable rescreening criterion, and living conditions, environment in the same district should be considered simultaneously.