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    基于随机对照试验的铁皮枫斗颗粒改善亚健康人群免疫力的作用研究

    Study on the Effect of Tiepi Fengdou Granules on Improvement of Immunity in Sub-healthy People Based on Randomized Controlled Trial

      摘要
    • 摘要:
      目的  评价铁皮枫斗颗粒(Tiepi Fengdou granules，TFG)对亚健康人群免疫力的改善效果。
      方法 采用随机对照试验，在杭州、湖州两地纳入111名40~65岁的亚健康人群为研究对象，随机分为观察组(服用TFG)和对照组，干预时间为3个月，在干预前后通过问卷调查一般健康情况，采集外周静脉血测量免疫相关生物指标；采用logistic线性回归模型，调整年龄、性别、疾病史、疫苗接种和身体质量指数(body mass index，BMI)等后，比较TFG干预对免疫相关生物指标的影响。
      结果 本研究共纳入观察组56人，对照组55人，2组在年龄、性别、疾病史、疫苗接种等方面均无统计学差异；经调整年龄、性别、BMI后，干预后的观察组白细胞、中性粒细胞、淋巴细胞的绝对值和补体C3、C4的浓度均显著高于对照组(P˂0.05)。
      结论 TFG通过加强细胞免疫和补体系统改善亚健康人群的免疫力。

       

      Abstract:
      OBJECTIVE  To evaluate the improvement effect of Tiepi Fengdou granules(TFG) on the immunity of sub-healthy people.
      METHODS  A randomized controlled trial was conducted, a total of 111 sub-healthy people(40−65 years old) in Hangzhou and Huzhou were included in the study and randomly divided into observation group(eating TFG) and placebo group. The intervention time was 3 months. Before and after the intervention, the general health condition was investigated by questionnaire, and peripheral blood was collected to measure immune-related biological indicators. The logistic linear regression model was used to compare the effects of TFG intervention on immune-related biological indicators after adjusting for age, gender, disease history, and vaccination, and body mass index(BMI).
      RESULTS  A total of 56 people in the observation group and 55 people in the placebo group were included in this study, and there were no statistically significant differences in age, gender, disease history, and vaccination between the two groups. After adjusting for age, gender and BMI, the absolute values of white blood cells, neutrophils, lymphocytes and the concentrations of complement C3 and C4 in observation group after treatment were significantly higher than those in placebo group(P˂0.05).
      CONCLUSION  TFG improves the immunity of sub-healthy people by strengthening cellular immunity and complement system.

       

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