Prulifloxacin the treatment of acute bacterial infections of the multi-center double-blind double-dummy randomized controlled clinical study.docVIP

 PAGE \* MERGEFORMAT 12 Prulifloxacin the treatment of acute bacterial infections of the multi-center double-blind double-dummy randomized controlled clinical study 【Abstract】 Objective To evaluate the efficacy and Prulifloxacin treatment of mild to moderate acute bacterial infection of the clinical efficacy and safety. Methods A multi-center, double-blind double-dummy, parallel randomized controlled trial designed to levofloxacin as the control drug, Prulifloxacin group 200mg, levofloxacin group of 200mg, twice daily treatment was 7 ~ 10d. The results of this study included 278 cases, Prulifloxacin levofloxacin group and 139 cases of each group, of which Prulifloxacin Group FAS analysis of 130 cases, PP analysis of 123 cases; analysis of levofloxacin group FAS 126 cases, PP analysis of 119 cases. The end of treatment, FAS analysis Prulifloxacin group and levofloxacin group cure rates were 53.85% and 65.04%, PPS analysis of cure rates of the two groups were 55.56% and 67.23%; FAS analysis of the two groups are effective rates were 86.92% and 91.06%, PPS analysis of the efficiency of the two groups were respectively 89.68% and 94.12%, two groups of bacterial clearance rates were 90.43% and 87.10%. These results compare the two groups between the two groups there was no significant difference. The incidence of adverse reactions the two groups were 5.15% and 6.57%, mainly nausea, diarrhea, and elevated serum transaminase and so on. Both groups were no serious adverse events. Conclusion Domestic Prulifloxacin injection in treatment of mild to moderate bacterial infections curative effect, security is good. Keywords: Prulifloxacin levofloxacin in acute bacterial infection, double-blind double-dummy, multi-center clinical trial A multicenter double blind double dummy randomized controlled clinical study ABSTRACT Objective To evaluate the clinical efficacy and safety of prulifloxacin for the treatment of slight and moderate acute bacterial