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。
Objective： To evaluate the efficacy and safety of nation-made rifaximin in the treatment of acute intestinal bacterial infections. Method- A multicentre, 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 cases 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.
出处
《药物流行病学杂志》
CAS
2007年第2期65-68,共4页
Chinese Journal of Pharmacoepidemiology
