【摘要】 目的 :观察和评价人体对肠乐康散剂的耐受性和安全性 ,推荐临床用药剂量。方法 :将 30例健康受试者随机均分为 0 .5 ,1.0和 2 .0 g 3个剂量组 ,po ,bid ,共 10d。试验前后作肠道菌群培养分析。 结果 :除肠乐康散剂 4.0 g·d-1剂量组使食欲增加外 ,未见异常反应。肠道菌群培养结果表明有益菌有增加趋势。结论 :肠乐康散剂安全性大 ,耐受性好 ,推荐Ⅱ期临床使用剂量为 po,1.0～ 1.5 g ,bid。更多还原

【Abstract】 Objectives:To evaluate the tolerance and safety of changlekang(CLK) and to determine its dose.Methods:30 healthy volunteers were randomly and equally divided to receive twice daily oral dose of 0.5g,1.0g,or 2.0g of CLK powder for 10d.The colonies in intestinal tract were cultured and analyzed before and after treatment.Results:The appetite of volunteers in group of twice daily dose of 2.0g was increased and no abnormal reactions were observed.It was indicated that the beneficial bacteria in intestinal tract tend to be increased after culture.Conclusion:CLK powder is tolerable and safe with a recommended twice daily oral dose of 1.0～1.5g.更多还原