Objective To assess the effectiveness and safety of prulifloxacin in the treatment of urinary tract infection.
Methods The double-blind, double dummy and randomized controlled method was adopted. One hundred and forty-four patients were randomized to the treatment group (prulifloxacin , 4 tablets, bid) and the control group (levofloxacin, 4 tablets, bid). The randomization code was produced by computer. The treatment duration for both groups was from 7 to 10 days.
Results Data were analyzed on the basis of full analysis sets (FAS) and per-protocol (PP) analysis. The total improvement rates of the trial and control groups were 85.07% and 88.52% respectively by FAS analysis, and 90.48% and 91.53% respectively by PP analysis. There was no significant difference between the two groups in improvement rates (P gt;0.05). Bacterial negative rates in the trial and control groups were 93.75% and 93.88% respectively by FAS analysis and 97.83% and 97.87% respectively by PP analysis. The results showed no statistical significance difference between the two groups in bacterial negative rates (P gt;0.05). The adverse events in the prulifloxacin and levofloxacin groups were 2.80% and 5.60% respectively.
Conclusion Prulifloxacin has the same clinical effectiveness as levofloxacin with a few toxic adverse effects in the treatment of urinary tract infection.
Citation： QIU Hongyu,CAI Yongning,FU Ping,ZHENG Li,WU Xiaohou,LENG Jing,ZHANG Guifa,ZHONG Hui,SHA Zhaohui,LI Zi,MI Xuhua,DAI Qiang,LU Ding. Prulifloxacin in the Treatment of Urinary Tract Infection: A Double-Blind, Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2006, 06(6): 399-403. doi: Copy