Prulifloxacin versus levofloxacin in the treatment of respiratory and urinary
tract infections: a multicentre, double-blind, randomized controlled clinical
trial.
Author(s): Chen Y, Yang H, Lu G, Wu X, Huang W, Wu Y, Lv X, Wu G, Zhang G, Li Q, Sun Y.
Affiliation(s): Southwest Hospital of the Third Military Medical University, Chongqing, China.
zwmcyc@163.com
Publication date & source: 2012, Chemotherapy. , 58(3):249-56
BACKGROUND: Prulifloxacin is a promising fluoroquinolone antibiotic. A
multicentre, double-blind, randomized clinical study was designed to evaluate its
efficacy and safety compared to that of levofloxacin for the treatment of
respiratory and urinary infections of Chinese patients.
METHODS: A total of 267 patients were enrolled and each was randomly assigned to
either the treatment or the control group. Prulifloxacin 264.2 mg (equivalent to
ulifloxacin 200 mg) b.i.d. or levofloxacin hydrochloride 200 mg b.i.d. was
administered orally for 5-14 days according to a patient's condition. The
clinical response, bacterial eradication and incidence of adverse events were
evaluated.
RESULTS: Two hundred and forty-three patients completed the study. For the
modified intention-to-treat population, the cure and effective rates were 45.53
and 82.93% in the prulifloxacin group and 49.18 and 83.61% in the levofloxacin
group. For the per-protocol analysis population, the cure and effective rates
were 45.90 and 83.61% in the prulifloxacin group and 49.59 and 83.47% in the
levofloxacin group. The bacterial eradication rates were 96.59 and 95.35%, and
the drug-related adverse event rates were 7.87 and 5.51% in the prulifloxacin and
levofloxacin group, respectively. The cure rate and efficacy rate of respiratory
and urinary tract infections of the levofloxacin group were better than those of
the prulifloxacin group. However, the difference between the 2 groups was not
statistically significant (p > 0.05).
CONCLUSION: Prulifloxacin is as effective and well tolerated as levofloxacin in
the treatment of respiratory and urinary tract infections.
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