帕珠沙星治疗急性泌尿系统感染的多中心随机对照临床研究

A multicenter randomized controlled clinical study of pazufloxacin versus levofloxacin in the treatment of acute urinary tract infections

目的评价国产帕珠沙星注射液治疗急性泌尿系统感染的疗效和安全性。方法采用多中心、单盲、区组随机、平行对照试验设计，以左氧氟沙星注射液为对照药，帕珠沙星每次静滴300mg，左氧氟沙星每次静滴200mg，两药均每日用药2次，疗程7～10d。结果本研究共纳入117例，帕珠沙星组和左氧氟沙星组分别为58例和59例，其中帕珠沙星组1例因细菌培养为耐药大肠埃希菌生长而剔除，故两组进行全分析集（FAS）和符合方案分析集（PPS）分析的病例数均分别为57例和59例。疗程结束时帕珠沙星组与左氧氟沙星组的痊愈率和有效率分别为71．9％与67．8％和93．0％与83．1％，细菌清除率和阴转率均分别为97．6％与93．8％，两组比较差异无显著性。帕珠沙星组和左氧氟沙星组的不良反应发生率分别为12．1％和15．3％，差异无显著性，均主要表现为恶心、腹泻、局部刺激及血清转氨酶增高等。两组均未见严重不良事件发生。结论国产帕珠沙星注射液与左氧氟沙星注射液治疗泌尿系统中、重度急性细菌性感染均疗效确切，安全性较好。

Objective To evaluate the clinical efficacy and safety of domestic injectable pazufloxacin for the treatment of moderate and severe acute bacterial urinary tract infections. Methods A multicenter randomized controlled clinical study was conducted to compare the efficacy and safety of pazufloxacin with levofloxacin. Pazufloxacin and levofloxacin were administered intra venously at the dose of 300 mg and 200 mg twice daily for 7 to 10 days respectively. Results One hundred and seventeen （117） patients were enrolled in the study, 58 in pazufloxacin group and 59 in levofloxacin group. Only 1 patient withdrew from pazu floxacin group due to bacterial resistance. In general, 57 cases in pazufloxacin group and 59 in levofloxacin group were assessable for clinical efficacy by full analysis set（FAS） analysis and per-protocol set（PPS） analysis. At the end of the treatment, the total cure rates and effective rates were 71.9% and 93.0% in pazufloxacin group, and 67.8% and 83.1 % in levofloxacin group respectively. The bacterial eradication rates were 97.6% and 93.8% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 12. 10% and 15.3% of patients in the two groups, mainly nausea, diarrhea, dizziness, local stimulation and elevated transaminases. No serious adverse event was reported in any group. Conclusions Domestic injectable pazufloxacin is as effective and safe as levofloxaein in the treatment of moderate and severe acute bacte- rial urinary tract infections.