帕珠沙星注射液治疗呼吸和泌尿系统细菌性感染的单盲随机对照试验  

A single-blind randomized controlled trial of pazufloxacin injection in treatment of bacterial infections of respiratory and urinary tracts

作　　者：王婷[1] 乔华[1] 梁莉[1] 张虹[1] 

机构地区：[1]兰州大学第一医院,甘肃兰州730000

出　　处：《中国新药与临床杂志》2005年第8期633-637,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:评价帕珠沙星注射液治疗呼吸系统和泌尿系统急性细菌感染的有效性和安全性。方法:用随机单盲对照试验设计,试验组予帕珠沙星注射液,300mg,iv,gtt,bid,对照组予左氧氟沙星注射液,200mg,iv,gtt,bid,2组疗程均为7～14d。结果:试验组可评价病例为31例,对照组可评价病例为33例,试验组临床总有效率和痊愈率分别为94%和58%,细菌清除率为100%;对照组临床总有效率和痊愈率分别为94%和67%,细菌清除率为100%。试验组和对照组药物不良反应发生率分别为10%(3/31)和39%(13/33)。2组比较除不良反应发生率差异有显著意义外,其余差异均无显著意义(P>0.05)。结论:帕珠沙星注射液治疗呼吸系统和泌尿系统急性细菌感染疗效确切,使用安全、方便。AIM：To evaluate the clinical efficacy and safety of pazufloxacin injcction for the treatment of moderate to severe respiratory and urinary tracts acute bacterial infections. METHODS： A single-blind randomized controlled clinical trial was conducted including the treatment and the control groups. Pazufloxacin was used as 300 mg twice daily intravenously for each of the for mer and levofloxacin 200 mg twice daily intravenously was given to each of the latter, with 7-14 d, as a course for both groups. RESULTS ： Thirty-one and 33 patients were evaluable in treatment group and control group respectively. The overall efficacy rates and cure rates were 94% and 58% for the treatment group, 94 % and 67 % for the control group,whereas both the bacterial clearance rates reached 100 %. The adverse drug reaction rates were 10 % （3/31） and 40 % （13/33） for the treatment and control groups with no statistical significance in other items （ P 〉 0.05 ）. CONCLUSION ： Pazufloxacin injection is effective, tolerable and safe for the treatment of acute bacterial infections.

关 键 词：帕珠沙星 呼吸道感染 泌尿道感染 细菌感染 随机对照试验 左氧氟沙星 

分 类 号：R978[医药卫生—药品] R691.3[医药卫生—药学]