利福昔明胶囊治疗急性肠道感染随机双盲双模拟多中心疗效观察

Randomized controlled double-blind double dummy multicenter clinical trial on the effects of rifaximin capsula on acute infectious entercolitis

目的:评价利福昔明治疗急性肠道感染的有效性和安全性。方法:采用随机双盲双模拟试验方法,完成可供评估病例216例,其中试验组109例,对照组107例。试验组用药利福昔明胶囊(200mg/次,每6h1次)+氧氟沙星胶囊模拟胶囊(2粒,每日3次),对照组用药氧氟沙星胶囊(每次200mg,每日3次)+利福昔明胶囊模拟胶囊(2粒,每6h1次),疗程3天。结果:在治疗急性肠道感染中,利福昔明和氧氟沙星在止泻时间、大便常规复常率、细菌清除率、主要症状复常率等方面差异无显著性。两组的总有效率分别为95.41%和95.33%,不良反应发生率分别为3.64%、2.75%。利福昔明和氧氟沙星的疗效和安全性在统计学上差异无显著性。结论:利福昔明胶囊治疗急性肠道感染安全、有效。

Objective： To evaluate the clinical efficacy and safety of rifaximin capsula for acute infectious entercolitis. Methods： A total of 216 patients with acute infectious entercolitis entered a randomized controlled double-blind double dummy muhicenter clinical trial. Patients were divided into two groups treated with rifaximin capsula（200 mg, per 6 h）＋Oflxacin dummy capsula（2^#, 3 times per day） as a treated group and Oflaxaxin（200 mg, three times per day）＋ rifaxicin dummy capsula（2s, per 6 h） as a control for three days, respectively. 109 patients were enrolled in rifaximin group and 107 patients were enrolled in control group. Results： The rate and time of diarrhea, the normalization rate of stool routine, the clearance of bacteria and the relieve rate of symptoms were similar in the two groups. The total efficacy rates were 95.41% and 95.33%in the treatment and controlled group, respectively. The incidence of adverse reaction was 3.64% and 2.75% in the two groups. There werer no significant differences between the two groups in total efficacy and incidence of adverse reaction. Conclision：Rifaximin is effective and safe in the treatment of acute infectious entercolitis.