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目的 评价国产利福昔明治疗细菌感染性腹泻的疗效和安全性。方法 采用多中心、随机、单盲对照试验 ,以国产环丙沙星作对照 ,研究利福昔明治疗细菌感染性腹泻的效果。利福昔明第一日每次 0 .4 g,一日三次 ,第二日起每日 0 .4 g,一日二次 ;环丙沙星第一日每次 0 .2 5 g,一日三次 ,第二日起每次 0 .2 5 g,一日二次 ,疗程均为 3～ 7d。治疗前、后查血、尿、大便常规 ,肝、肾功能和血生化 ,心电图用于安全性评价。结果 利福昔明组 10 0例 ,环丙沙星组 10 5例 ,其临床有效率和临床痊愈率分别为 10 0 %和 93.0 0 % ,98.0 9%和 92 .38% ,两组临床有效率和痊愈率无统计学差异。 2 0 5例中有 137例治疗前分离到病原菌 ,细菌阳性率 6 6 .83%( 137/ 2 0 5 )。细菌清除率分别为 10 0 % ,97.10 %。两组不良反应发生率分别为 10 .4 8%和 5 .36 % ( 6 / 112 ) ,经统计学处理无显著性差异。结论 利福昔明片治疗细菌感染性腹泻 ,临床疗效肯定 ,不良反应少 ,可在细菌感染性腹泻治疗中应用
Objective To evaluate the efficacy and safety of domestic rifaximin in the treatment of bacterial diarrhea. Methods A multicenter, randomized, single-blind, controlled trial of ciprofloxacin was used as a control to study the effect of rifaximin in the treatment of bacterial diarrhea. Rifaximin 0.4g on the first day, three times a day, from the second day of daily 0. 4g, twice a day; ciprofloxacin on the first day each 0. 25g, a Three times a day, from the second day of each 0. 25g, twice a day, treatment are 3 ~ 7d. Before treatment, check blood, urine, stool routine, liver, kidney function and blood biochemistry, electrocardiogram for safety evaluation. Results 10 cases of rifaximin group, ciprofloxacin group 105 cases, the clinical and clinical cure rate was clinically 10.0% and 93.0 0%, 98.0 9% and 92.38%, two groups of clinical No significant difference in efficiency and cure rate. Among 205 cases, 137 cases were isolated from pathogens before treatment, and the positive rate of bacteria was 66.38% (137/250). Bacterial clearance rates were 100% and 97.10% respectively. The incidence of adverse reactions in both groups were 10.48% and 5.36% (6/112), respectively, and there was no significant difference by statistical analysis. Conclusions Rifaximin tablet treatment of bacterial diarrhea, positive clinical efficacy, adverse reactions, can be used in the treatment of bacterial diarrhea