注射用甲磺酸帕珠沙星治疗急性细菌性感染的随机对照多中心临床研究

A multiple center randomized controlled clinical study of pazufloxacin mesylate for injection in treatment of patients with acute bacterial infections

目的评价注射用甲磺酸帕珠沙星治疗呼吸系统和泌尿系统急性细菌性感染的临床疗效和安全性。方法采用多中心、随机单盲、平行阳性对照试验方法。试验组给予注射用甲磺酸帕珠沙星500mg，iv gtt，bid；对照组给予注射用盐酸左氧氟沙星200mg，iv gtt，bid，疗程7～14d。观察和记录受试者与感染有关的症状和体征变化情况、疗效、细菌清除率和不良事件发生情况。结果纳入全分析集（FAS）进行安全性分析251例，试验组和对照组分别为126例和125例；纳入符合方案集（PPS）进行疗效分析共240例，两组各120例；共分离符合PPS的临床致病菌164株。试验组和对照组总有效率分别为92．5％和94．2％，总痊愈率分别为60．0％和60．8％，细菌清除率分别为94％（79／84）和95％（76／80），不良反应发生率分别为4．8％（6／126）和4．0％（5／125），组间均无显著差异（均P〉0．05）。结论注射用甲磺酸帕珠沙星治疗呼吸系统和泌尿系统急性细菌感染，临床疗效明显，安全性较好，与左氧氟沙星相当。

AIM To evaluate the efficacy and safety of pazufloxacin mesylate for injection in the treatment of patients with acute bacterial infections of respiratory tract and urinary-reproductive tract. METHODS It was a randomized, single-blind, parallel controlled and multiple center trial design. The treatment group were treated with pazufloxacin mesylate for injection （500 mg, iv gtt, bid for 7 - 14 d）, and control group were given levofloxacin hydrochloride for injection （200 mg, iv gtt, bid for 7 - 14 d）. The infection symptoms and signs of change, curative effects, bacterium clearance rates and adverse events were observed and recorded. RESULTS There were 251 patients in the full analysis set （FAS） for security analysis, 126 patients in the treatment group and 125 patients in the control group respectively; there were 240 patients in the perprotocal set （PPS） for efficacy analysis, 120 patients in each of the two groups; there were 164 strains of pathogenic bacterium separated with PPS clinical analysis. The total effective rate of the treatment and the control group was 92.5% and 94.2%, and the recovery rate was 60.0% and 60.8%, respectively; the bacterial clearance rate was 94% （79/84） and 95% （76/80） respectively, and the adverse reaction rate was 4.8% （6/126） and 4.0% （5/ 125） respectively. There were no significant differences between the two groups （P 〉 0.05）. CONCLUSION Pazufloxacin mesylate for injection is effective and safe in the treatment of patients with acute infections of respiratory tract and urinary-reproductive tract, which is equal to levofloxacin.