Southwest Hospital of the Third Military Medical University, Chongqing, China.
Chemotherapy. 2012;58(3):249-56. doi: 10.1159/000339718. Epub 2012 Aug 9.
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.
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.
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).
Prulifloxacin is as effective and well tolerated as levofloxacin in the treatment of respiratory and urinary tract infections.
普卢利沙星是一种很有前途的氟喹诺酮类抗生素。本研究采用多中心、双盲、随机对照临床试验，旨在评价其疗效和安全性，并与左氧氟沙星治疗中国患者呼吸道和泌尿道感染进行比较。
共纳入 267 例患者，按随机数字表法分为治疗组和对照组，每组各 133 例。根据患者病情，分别予普卢利沙星 264.2 mg（相当于左氧氟沙星 200 mg），每日 2 次；或盐酸左氧氟沙星 200 mg，每日 2 次，口服治疗 5~14 天。评价临床疗效、细菌清除率及不良反应发生率。
243 例患者完成研究。意向性治疗分析集（mITT）人群中，普卢利沙星组和左氧氟沙星组的痊愈率和有效率分别为 45.53%和 82.93%、49.18%和 83.61%；符合方案集（PP）人群中，分别为 45.90%和 83.61%、49.59%和 83.47%。细菌清除率分别为 96.59%和 95.35%，不良反应发生率分别为 7.87%和 5.51%。左氧氟沙星组呼吸道和泌尿道感染的痊愈率和有效率优于普卢利沙星组，但差异无统计学意义（P > 0.05）。
普卢利沙星治疗呼吸道和泌尿道感染的疗效与左氧氟沙星相当，安全性良好。
