摘要
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 efficacy and safety of pazufloxacin and levofloxacin in the treatment of bacterial infections. METHODS A randomized multieenter clinical trial was conducted for the treatment of patients with respiratory tract and urinary tract infection,While an opened trial was conducted for skin soft-tissue infections. RESULTS In randomized study, 243 patients were enrolled in Per-Protocol analyse,The results showed that the overall cure rates were 65.25% for pazufloxaein group and 66. 40% for levofloxacin group, the efficacy rates were 93. 22% and 96.00%, respectively. The incidence of adverse reaction was 10. 32% and 7.63%, respectively. The results showed that there was no statistical difference between the two groups （P〉0.05）; In opened study,29 patients were enrolled in Per-Protocol analyse,The overall cure rates and efficacy rates were 51.72% and 86. 21%. The incidence of adverse reaction was 3. 33%. CONCLUSION Pazufloxacin injection is effective and safe for the treatment of bacterial infections.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2007年第2期178-182,共5页
Chinese Journal of Hospital Pharmacy
