乳果糖溶液通便功能人体试食试验研究

目的观察乳果糖溶液的通便功能。方法采用双盲法将127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，对照组不进行任何处理。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均为0.3次／d，排便状况积分均为1.7分／便次，粪便性状积分均为1.1分／便次，差别无统计学意义；试食样品组试食前后排便次数分别为0.3次／d和0.7次／d，排便状况积分分别为1．7和0.5分／便次，粪便性状积分分别为1．1和0.4分／便次，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）。试验前后对照组和试食组均未见不良反应，各项安全性指标均未见异常。结论乳果糖溶液对人体具有明显通便功能，且对机体健康无不良影响。

Assessment of Lactulose solution''''s facilitating feces excretion function in human feeding trials

Objective To observe the faeitating feces excretion function of laetulose solution. Methods The 127 volunteers were assigned to the trial group and the control group randomly based on their constipation symptoms. The trial group was given laetulose solution while the control group was given nothing for seven days continuously. Then the defecation frequency, condition and excrement character were observed. Results In the control group the defecation frequency, the inte- gral of defecation condition and the integral of excrement character was 0.3, 1.7, 1.4 respectively, no matter before and after administration. In the trial group the above corresponding indices were 0.3 and 0. 7, 1.7 and 0.5, 1.1 and 0.4, respective; ly. 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. Conclusion Lactulose solution could improve human feces excretion function and had no negative effects.