Multi-center clinical studies on pazufloxacin sodium chloride injection in treatment for acute bacterial infections / 中华全科医师杂志

ABSTRACT

Objective To evaluate efficacy and safety of locally-produced pazufloxacin mesilate sodium chloride injection in the treatment of bacterial infections of respiratory and urinary tract.Methods A multi-center double-blind randomized controlled clinical trial was carried out to evaluate efficacy and safety of pazufloxacin mesilate sodium chloride in treatment for acute bacterial infection, as compared to those of levofloxacin hydrochloride and glucose injection as control treatment.A total of 244 patients with acute bacterial infection of respiratory and urinary tract were enrolled in the studies.120 in trial group and 120 in control group, with four withdrawals.Pazufloxacin mesilate and levofloxacin were administered intravenously by drip at a dose of 300 mg and 200 mg, every 12 hours for 7 to 14 days for trial and control groups, respectively.Resuits Overall efficacy of pazufloxacin mesilate was 77.0 percent and 93.5 percent in treatment for acute bacterial infections of respiratory and urinary tract.respectively, and that of levofloxacin was 80.6 percent and 89.6 percent, respectively.Overall bacterial clearance rate WaS 91.5 percent for pazufloxacin mesilate, 89.6 percent for respiratory tract infection and 94.1 percent for urinary tract infection, respectively.and 93.4 percent for levofloxacin, 97.3 percent for respiratory tract infection and 89.7 percent for urinary tract infection, respectively.No significant difference in adverse drug reactions between the two groups(P＞0.05)was found, with 4.88 percent and 7.44 percent for trial and control groups, respectively.Conclusions Pazufloxacin mesilate sodium chloride injection produced locally is a safe and effective antibiotic in treatment for acute infections of respiratory and urinary tract.