宝乐安散剂治疗急慢性腹泻61例随机双盲双模拟对照试验

Baolean Powder in Treatment of 61 Patients with Acute and Chronic Diarrhea:A Randomized Double-blind Double-dummy,Controlled Trial

目的观察宝乐安散剂治疗急慢性腹泻的临床疗效和安全性。方法采用多中心随机双盲、双模拟对照试验。宝乐安散剂61例,po,1.0g(10×108cfu),tid;对照药米雅片65例,po,0.7g(7.0×108cfu),tid。疗程急性腹泻3～7d,慢性腹泻14～21d。结果宝乐安散剂治疗急性腹泻有效率为100.0%(29/29),慢性腹泻有效率为100.0%(32/32);对照药米雅片分别为100.0%(32/32)和100.0%(33/33)。两药疗效间差异均无显著性(χ2=0.0,P>0.05),均未出现不良反应。结论宝乐安散剂是治疗急性、慢性腹泻安全有效的微生态制剂,其疗效和安全性均相当于进口药米雅片。

Objective To observe the efficacy and safety of baolean powder （including clostridium butyricum） in treatment of acute and chronic diarrhea. Methods A randomized double-blind double-dummy,multi-center and controlled trials were adopted in the studies. 126 patients were divided to receive three times daily baolean powder of 1.0 g（ 10 × 10^8 cfu ） ,or three times daily miya tablet of 0.7 g（7.0 × 10^8 cfu） for 3 - 7 d or 14 -21 d. Results For treatment of acute and chronic diarrhea,the effective rate of baolean powder was 100.0% （29/29） and 100.0% （32/32） respectively,and miya tablet was 100.0% （ 32/32 ） and 100.0% （ 33/33 ）, respectively. No significant differences （ x^2 = 0.0, P 〉 0. 05 ） were observed between boolean powder and the control drug （ miya tablet） in studies. Conclusion Baolean powder is an effective agent in treatment of acute and chronic diarrhea,the efficacy and safety of baolean powder are similar to those of miya tablet.