芦荟胶囊通便功能的人体试食研究

Assessment of Aloe Capsule's Facilitating Feces Excretion Function in Human Feeding Trials

[目的]观察芦荟胶囊的通便功能。[方法]采用双盲法将120例受试者按其便秘症状随机分为试食组和对照组,试食样品组服用受试样品,对照组服用与受试样品外观相似的安慰剂,连续服用7d后,观察两组排便次数、排便状况和粪便性状的变化。[结果]对照组试食前后排便次数分别为2.13和2.11次/周,排便状况积分分别为1.56和1.58分,粪便性状积分分别为1.79和1.64分,差别均无统计学意义;试食样品组试食前后排便次数分别为2.13和4.09次/周,排便状况积分分别为1.57和0.61分,粪便性状积分分别为1.83和0.63分,差别均有统计学意义(P<0.01);试食后试食样品组与对照组的排便次数、排便状况和粪便性状差别均有统计学意义(P<0.01)。对照组和试食样品组试验前后未见不良反应,各项安全性指标均未见异常。[结论]芦荟胶囊对人体具有明显通便功能,且对机体健康无不良影响。

[Objective]To observe the facitating feces excretion function of Aloe Capsule. [Methods]The 120 volunteers were assigned to the trial group and the control group randomly based on their constipation symptoms. The trial group was given aloe while the control group was given placebo for seven days continuously. Then the defecation frequency,condition and excrement character were observed. [Results]In the control group the defecation frequency was 2.13 and 2.11, the integral of defecation condition was 1.56 and 1.58,the integral of excrement character was 1.79 and 1.64 before and after administration respectively. In the trial group the above corresponding indices were 2.13 and 4.09,1.57 and 0.61,1.83 and 0. 63, respectively. The defecation frequency of the trial group was higher than that of the control group（ P〈0.01）, the defecation condition and excrement character increased significantly（ P〈0.01） in the trial group. No Adverse effect was observed and every safe index was normal during the experiment. [Conchlsion]Aloe Capsule could improve human feces excretion function and had no negative effects.