注射用帕珠沙星治疗细菌性感染111例的临床随机对照研究

目的:评价国产注射用帕珠沙星治疗细菌性感染的疗效和安全性。方法:采用多中心、随机、单盲、平行对照试验设计。选择细菌性感染病人227例,其中呼吸系统感染113例,泌尿系统感染114例。所有病人随机分为试验组111例,给予帕珠沙星0.3g,iv,gtt,bid;对照组116例,给予左氧氟沙星0.2g,iv,gtt,bid;疗程均为7～10d。结果:2组人口学指标差异无统计学意义,资料具有可比性。临床综合疗效试验组和对照组的痊愈率分别为72.6%和67.8%,有效率分别为97.4%和91.5%(P>0.05)。细菌清除率分别为99%和98.0%(P>0.05)。试验组与对照组的不良反应发生率分别为12.0%和12.6%(P>0.05),主要表现为恶心、静脉炎等。结论:注射用帕珠沙星治疗呼吸系统和泌尿系统细菌性感染疗效好,使用安全。

A clinical randomized controlled trial of pazufloxacin injection in treatment of bacterial infection in 111 patients

AIM: To evaluate the efficacy and safety of domestic pazufloxacin for injection in the treatment of bacterial infections. METHODS: A multi-center, single blind, parallel-group, randomized controlled study of pazufloxacin was conducted among 227 individuals with bacterial infections (113 with respiratory tract infections, 114 with urinary tract infections). They were randomized either to treatment group (111 patient, treated with pazufloxacin, 300 mg, iv, gtt, bid, for 7-10 d) or control group (116 patient, treated with levofloxacin, 200 mg, iv, gtt, bid, for 7-10 d). RESULTS: The toltal clinical effective rate was 97.4 % (110/113) in treatment group and 91.5 % (108/118) in control group. There was no significant difference of recovery rate(72.6 % vs 67.8 %, P>0.05), efficacy rate(97.4 % vs 91.5 %, P>0.05) and bacterial eradication rate( 99 % vs 98.0 %, P>0.05) between two groups. The incidence rate of adverse reactions was 12.0 % in the treatment group and 12.6 % in the control group (P>0.05). No severe adverse reactions were found. CONCLUSION: Pazufloxacin for injection is an effective and safe antibiotic in the treatment of bacterial infections in respiratory tract and urinary tract.