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目的:评价甲磺酸帕珠沙星氯化钠注射液治疗急性细菌性感染包括呼吸道感染、泌尿道感染以及皮肤软组织的安全性和有效性。方法:采用区组随机化、盲法对照、多中心临床试验的设计方法,选用左氧氟沙星作为对照药,其中皮肤软组织感染病例采用开放性试验设计方法。结果:在本次随机临床试验中共入选257例使用帕珠沙星或其对照药左氧沙星治疗急性呼吸系统、泌尿系统感染的病例,有243例进入PP分析,其临床总痊愈率分别为65.3%和66.4%,总有效率分别为93.2%和96.0%,细菌清除率分别为87.1%和90.6%,相关不良反应发生率分别为10.3%和7.6%,两组间的临床疗效、细菌清除率和不良反应发生率比较均无显著差异,另外入选30例使用帕珠沙星治疗皮肤软组织感染的开放病例,有29例进入PP分析,其临床痊愈率为51.7%,临床有效率为86.2%,细菌清除率为95.8%,不良反应发生率为3.3%。结论:甲磺酸帕珠沙星是治疗常见急性细菌性呼吸道感染、泌尿系统感染及皮肤软组织感染较为安全、有效的抗菌药物。
OBJECTIVE: To evaluate the safety and efficacy of pazufloxacin mesylate sodium chloride injection in the treatment of acute bacterial infections, including respiratory infections, urinary tract infections and skin and soft tissues. Methods: Block randomized, blind control, multicenter clinical trial design method, the selection of levofloxacin as a reference drug, in which cases of skin and soft tissue infections using open-label design. Results: Of the 257 randomized clinical trials using pazufloxacin or its reference drug, levofloxacin, for the treatment of acute respiratory and urinary tract infections, 243 patients entered the PP analysis. The total clinical cure rates were 65.3% and 66.4% respectively. The total effective rates were 93.2% and 96.0% respectively. The bacterial clearance rates were 87.1% and 90.6% respectively. The incidences of adverse reactions were 10.3% and 7.6% respectively. The clinical efficacy and bacterial clearance Rate and adverse reactions were no significant difference in the other 30 cases were treated with pazufloxacin treatment of skin and soft tissue infections in open cases, 29 cases entered the PP analysis, the clinical cure rate was 51.7%, the clinical effective rate was 86.2% , Bacterial clearance rate was 95.8%, the incidence of adverse reactions was 3.3%. Conclusion: Pazufloxacin mesylate is a safe and effective antimicrobial agent for the treatment of common acute bacterial respiratory infections, urinary tract infections and skin and soft tissue infections.