国产微生态制剂金双歧片治疗急性腹泻的随机对照研究

金双歧是一种由双歧杆菌、乳杆菌和嗜热链球菌组成的三联活菌制剂 ,它能有效地调整肠道菌群 ,抑制肠道病原微生物的定植和生长。为考察金双歧片的临床疗效和安全性 ,本研究以培菲康胶囊 (上海信宜制药厂生产的一种活菌制剂 )为对照药 ,进行了双盲双模拟随机对照试验。结果表明 ,金双歧治疗急性腹泻时 ,对各种症状、体征及化验检查异常均有较好的治疗作用 ,临床有效率为 86 1% ,与培菲康治疗组相似 ( 91 6 % ,P >0 0 5 )。经治疗后两组病原菌均被清除。金双歧治疗组 2例恶心 ,培菲康治疗组有 3例恶心 ,均能耐受至疗程结束后 2天自行消失 ,未发现其它不良反应 ,不良反应发生率为 5 6 %和 8 3 %。表明金双歧是一种治疗急性腹泻安全有效的药物

A Double Blind Randomized Control Study of the Domestic Microecologic Agents Golden Bifido for Treatment to Acute Diarrhea

Golden Bifidobacterium(Golden Bifido)is a domestic microecologic agents consisted of Bifidobacterium longum,Lactobacillus and Streptococcus thermophilus.The agents can effectively balance the gut microflora,and inhibit the pathogenic organism to colonize and growth in gut.To evaluate the clinical efficacy and safety,Golden Bifido was administrated to treat for acute diarrhea of 36 patients compared with Pe Fei Kang(another microecologic agents,manufactured by Xing Yi Pharmaceutic factory fo Shanghai)in double blind randomized control study.The result showed that the Golden Bifido possessed good effectiveness in treatment to acute diarrhea,including releasing the symptoms,signs and improvement of the abnormal laboratory findings.The rate of clinical efficacy for Golden Bifido and Pe Fei Kang were 86 1%(31/36)and 91 6%(33/36)separately.There were no significant difference between the two groups( P >0 05).After treatment,the pathogenic organisms were eradicated in both of the two groups.There were appeared that two and three patients in Golden Bifido and Pe Fei Kang treatments felt nausea,respectively.The tolerated nausea could disappeared automatically in two days of the therapy process ending.No other adverse reactions was found.The rate of the adverse reaction were 5 6%(2/36)and 8 3%(3/36)in two groups respectively.From these results,Golden Bifido is a variety of safety and effective agents for treatment to acute diarrhea.