利福昔明片治疗急性感染性腹泻的多中心临床研究

A multicenter,randomized,and controlled clinical study of rifaximin tablets in treatment of acute infectious diarrhea

目的:观察利福昔明片治疗急性感染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平行对照方法,以环丙沙星片作为对照。253例急性感染性腹泻患者被随机分成试验组(127例)和对照组(126例)。试验组给利福昔明片,d1为0.4g,po,tid,d2起改为0.4g,bid。对照组给环丙沙里片,d1为0.5g,po,tid,d2起改为0.5g,bid。疗程3-7d。结果:试验组和对照组疗效分别为90.40％和93.55%;无显著性差异(P>0.05)。试验组发生不良反应1例1次,发生率为0.79％;对照组5例7次,发生率为3.79%(其中1例因不良事件导致脱落)。结论:利福昔明片是治疗急性感染性腹泻有效且安全的口服制剂,不良反应发生率低于环丙沙星片。

Objective:To observe the efficacy and safety of rifaximin tablets in treatment of a-cute infectious diarrhea. Methods: 253 patients with acute infectious diarrhea were enrolled into the study. They were randomly divided to receive oral 40 mg rifaximin tablets 3 times daily at the 1st day and then twice daily from the second on ( n =127) or oral 50 mg ciprofloxicin 3 times daily for the 1st day and then twice daily from the second day on (n=126) for 3-7 days. Results:The effective rate was 90.40 % for the active group and 93.55 % for the control group and there was no significant dif ference between groups (P>0.05).The incidence of adverse events was 0.79% for the active group and 3.79 % for the control group. Conclusion: Rifaximin tablet is an effective and safe oral agent for treatment of acute infectious diarrhea.