国产甲磺酸帕珠沙星氯化钠注射液治疗急性细菌感染性疾病的多中心临床研究

目的评价国产甲磺酸帕珠沙星氯化钠注射液治疗呼吸道感染和泌尿道感染的临床疗效和安全性。方法采用多中心随机、双盲、阳性药物平行对照设计。共入选244例，脱落4例。试验组120例，使用甲磺酸帕珠沙星氯化钠注射液，每次300mg，每日2次静脉滴注；对照组120例，使用盐酸左氧氟沙星葡萄糖注射液，每次200mg，每日2次静脉滴注；疗程均为7-14d。安全性评价244例。结果试验组和对照组呼吸道感染治疗的临床总有效率分别为77.0％和80．6％，泌尿道感染治疗的总有效率分别为93．5％和89．6％。试验组总细菌清除率为91．5％，其中呼吸道感染及泌尿道感染细菌清除率分别为89．6％和94．1％。对照组总细菌清除率为93．4％，其中呼吸道感染及泌尿道感染细菌清除率分别为97．3％和89．7％。试验组和对照组不良反应率分别为4．88％和7．44％，差异无统计学意义（P〉0．05）。结论国产甲磺酸帕珠沙星氯化钠注射液治疗呼吸道感染和泌尿道感染安全、有效。

Multi-center clinical studies on pazufloxacin sodium chloride injection in treatment for acute bacterial infections

Objective To evaluate efficacy and safety of locally-produced pazufloxacin mesilate sodium chloride injection in the treatment of bacterial infections of respiratory and urinary tract.Methods A multi-center double-blind randomized controlled clinical trial was carried out to evaluate efficacy and safety of pazufloxacin mesilate sodium chloride in treatment for acute bacterial infection, as compared to those of levofloxacin hydrochloride and glucose injection as control treatment.A total of 244 patients with acute bacterial infection of respiratory and urinary tract were enrolled in the studies.120 in trial group and 120 in control group, with four withdrawals.Pazufloxacin mesilate and levofloxacin were administered intravenously by drip at a dose of 300 mg and 200 mg, every 12 hours for 7 to 14 days for trial and control groups, respectively.Resuits Overall efficacy of pazufloxacin mesilate was 77.0 percent and 93.5 percent in treatment for acute bacterial infections of respiratory and urinary tract.respectively, and that of levofloxacin was 80.6 percent and 89.6 percent, respectively.Overall bacterial clearance rate WaS 91.5 percent for pazufloxacin mesilate, 89.6 percent for respiratory tract infection and 94.1 percent for urinary tract infection, respectively.and 93.4 percent for levofloxacin, 97.3 percent for respiratory tract infection and 89.7 percent for urinary tract infection, respectively.No significant difference in adverse drug reactions between the two groups(P＞0.05)was found, with 4.88 percent and 7.44 percent for trial and control groups, respectively.Conclusions Pazufloxacin mesilate sodium chloride injection produced locally is a safe and effective antibiotic in treatment for acute infections of respiratory and urinary tract.