利福昔明治疗急性感染性腹泻111例临床疗效及安全性

Evaluation of clinical effect and safety of rifaximin in treating 111 patients with acute infectious diarrhea

目的:评价利福昔明治疗急性感染性腹泻的临床疗效及安全性.方法:采用多中心、随机、双盲双模拟、阳性药物平行对照研究.入选急性感染性腹泻240例,完成227例,其中利福昔明组111例,男性52例,女性49例,年龄(30±s 11) a,入组d 1,服用利福昔明300 mg和左氧氟沙星安慰剂1片,po,tid,d 2～5,利福昔明400 mg和左氧氟沙星安慰剂1片,po,bid;左氧氟沙星组116例,男性57例,女性59例,年龄(30±11) a,入组d 1,服用左氧氟沙星100 mg和利福昔明安慰剂3片,po,tid, d 2～5,左氧氟沙星100 mg和利福昔明安慰剂4片,po,bid.2组疗程均为3～5 d.观察2组疗效和不良反应.结果:利福昔明组痊愈率和有效率分别为84.7 %和100 %,左氧氟沙星组痊愈率和有效率分别为77.6 %和100 %.2组疗效无统计学差异(P>0.05).利福昔明组和左氧氟沙星组细菌清除率分别为100 %和99 %, 2组无统计学差异( P>0.05).2组均未出现不良反应.结论:利福昔明治疗急性感染性腹泻具有明显疗效,未见不良反应.

AIM：To evaluate the efficacy and safety of rifaximin in treating acute infectious diarrhea. METHODS： A multi-center randomized, doubleblind with double dummy under positive drug parallel controlled investigation clinical trial was carried out. Two hundred and forty patients were enrolled with only 227 patients finished the trial and divided into two groups in the end. Rifaximin group of 111 patients （ M 52,F 59; age（30 ±s 11） a） took： thed 1, rifaximin 300 mg and 1 levofloxacin consoled tablets, po, rid; from d 2-5, rifaximin 400 mg and 1 levofloxacin consoled tablets ,po, bid. Levofoxacin group of 116 pa- tients（M 57, F59; age（30 ±11） a ）took： the d 1, levofloxacin 100 mg and 3 rifaximin consoled tablets, po, tid; from d 2-5, levofloxacin 100 mg and 4 rifaxicin consoled tablets ,po, bid. The period of treatment for each groups was 5 d. RESULTS： After 5 d of treatment, the recovery rate and the effective rate of rifaximin were 84.7 % and 100 % ,those of levofloxacin were 77.6 % and 100 % ; outcoming with no statistical that difference between the two groups （ P 〉 0. 05 ）. The bacteritcal eliminating rate of rifaximin was 100 %, that of levofloxacin was 99 % ; also with no statistical difference between the two groups （P 〉 0.05）, including no occurrence of adverse reaction. CONCLUSION： Rifaximin is safe and effective in treating acute infectious diarrhea.