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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 clinical efficacy and safety of Bailean powder in the treatment of acute and chronic diarrhea. Methods A multicenter, randomized, double-blind, double-dummy, controlled trial was used. Bao Luan powder in 61 cases, po, 1.0g (10 × 108cfu), tid; control drug Miya film 65 cases, po, 0.7g (7.0 × 108cfu), tid. Treatment of acute diarrhea 3 ~ 7d, chronic diarrhea 14 ~ 21d. Results The effective rate of BaoLuan Powder in the treatment of acute diarrhea was 100.0% (29/29) and that of chronic diarrhea was 100.0% (32/32). The control drug Miya Pills was 100.0% (32/32) and 100.0% 33/33). No significant difference between the two drugs (χ2 = 0.0, P> 0.05), no adverse reactions. Conclusion Baolian powder is a safe and effective preparation for the treatment of acute and chronic diarrhea. Its efficacy and safety are equivalent to the imported medicine Miya Pills.