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利福昔明治疗急性细菌性肠道感染临床试验
Efficacy and Safety of Rifaximin in the Treatment of 237 Cases of Acute Intestinal Bacterial Infections
投稿时间:2006-11-27  修订日期:2006-12-18
DOI:
中文关键词:  利福昔明  环丙沙星  肠道感染,急性  有效性和安全性
英文关键词:Rifaximin,Ciprofloxacin,Intestinal infection,Efficacy,Safety
基金项目:
吴亮  杨道锋  张蓓  田德英
华中科技大学同济医学院附属同济医院感染科 武汉430030(吴亮,杨道锋,田德英)
,华中科技大学同济医学院附属同济医院检验科 武汉430030(张蓓)
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中文摘要:
      目的:评价利福昔明治疗急性肠道细菌感染性痰病的疗效和安全性。方法:采用多中心随机双盲双模拟阳性药物平行对照试验。急性细菌性肠道感染患者237例,随机分为:①治疗组118例,给予利福昔明0.2g,po,q6h,同时给予盐酸环丙沙星模拟片1片,bid,疗程5d,②对照组119例,给予环丙沙星0.25g,po,bid,同时给予利福昔明模拟片2片,po,q6h,疗程5d。结果:治疗组肠道感染的治愈率和显效率分别是79.49%,17.09%,总有效率96.58%;对照组分别是79.49%,16.24%,总有效率95.73%,两组差异无统计学意义。利福昔明和环丙沙星的细菌清除率分别是96.55%,100%。经确认与药物有关的不良反应发生率为2.54%和3.36%。各项结果的差异无统计学意义(P>0.05)。结论:利福昔明治疗肠道感染具有较好的疗效,该药有疗效高、起效快、疗程短、不良反应发生率低等优点,是临床治疗急性肠道细茵感染的一种安全有效的抗菌药。
英文摘要:
      Objective:To evaluate the efficacy and safety of nation-made rifaximin in the treatment of acute intes- final bacterial infections.Method:A muhicentre,random,parallel control,double-blind and double-dummy positive-drug protocol was employed in this trial.A total of 234 cases with acute intestinal infections were divided into a therapeutic group and a controlled group.118 cases received rifaximin 0.2 g,po,q6h and ciprofloxacin dummy tablet (Group A).119 ca- ses received ciprofloxacin,0.25 g,po,bid and rifaximin dummy tablet.The duration in both groups was 5 days.Result: The overall efficacy rates in the rifaximin group and the ciprofloxacin group were 96.58% and 95.73%,whereas the cure rates in the two groups were 79.49% and 79.49%.The bacterial clearance rates in both groups were 96.55% and 100%. The incidences of adverse effects in both groups were 2.54% and 3.36%.There was no statistical significance between them.Conclusion:Compared with ciprofloxacin,rifaximin has the same effect and safety in the treatment of acute intestinal infections,and their adverse effects are few and mild.
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