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国产司帕沙星治疗急性呼吸道感染的多中心临床对照试验
引用本文:胡必杰,张新.国产司帕沙星治疗急性呼吸道感染的多中心临床对照试验[J].中国抗生素杂志,1999,24(6):449-452.
作者姓名:胡必杰  张新
作者单位:上海市倍特司帕沙星临床研究协作组
摘    要:司帕沙星(sparfloxacin)是一广谱长效的新型氟喹诺酮类抗菌药。本试验采取多中心随机对照方法,评价了司帕沙星治疗呼吸系统感染的有效性与安全性,选用环丙沙星为对照。两组共治疗患者124例,其中司帕沙星组65例,环丙沙星组59例。结果显示:司帕沙星对呼吸系统感染的疗效明显优于环丙沙星,统计学有显著性差异(P= 0.033),司帕沙星组与环丙沙星组的有效率分别为92.3% 和83.1% ;两组清除率分别为92% 和78.3% ;不良反应发生率分别为7.7% (5/65)和13.6% (8/59)。试验表明:司帕沙星是一抗菌谱广、抗菌活性强、临床疗效好、不良反应发生少而轻微、服用方便的抗菌药物,对呼吸系统感染疗效肯定确切。

关 键 词:司帕沙星  呼吸道感染  临床疗效  安全性

A multiple centre randomized controlled clinical study of sparfloxacin in the acute respiratory tract infections
Hu Bijie,Zhang Xin and He Lixian.A multiple centre randomized controlled clinical study of sparfloxacin in the acute respiratory tract infections[J].Chinese Journal of Antibiotics,1999,24(6):449-452.
Authors:Hu Bijie  Zhang Xin and He Lixian
Institution:Shanghai Beite Sparfloxacin Clinical Studies Group
Abstract:Sparfloxacin is a new flruoroquinolone antibacterial agent. A multiple centre randomized controlled clinical trial method was employed to evaluate the efficacy and safety of sparfloxacin against the treatment of acute respiratory tract infections. Ciprofloxacin was selected as the control drug. A total of 124 patient included in both groups, 65 cases in sparfloxacin group and 59 cases in ciprofloxacin group. Results showed that the efficacy rates of sparfloxacin group and ciprofloxacin group were 92.3%and 83.1% respectively, the therapeutic efficacy of sparfloxacin group was superior to ciprofloxacin group against the infection of respiratory tract systems, there were significant difference between the two groups ( P <0.05). the bacterial clearance rates of both groups were 92% and 78.3% respectively. The adverse reaction rates of sparfloxacin and ciprofloxacin were 7.7% and 13.6% respectively. The finding indicated that sparfloxacin is a antibacterial drug of broad spectrum, with potent antibacterial activities, excellent clinical efficacy, little and/or mild adverse reaction, convenientty administrered and had definitive efficacy against the respiratory tract system infections.
Keywords:Sparfloxacin  Respiratory tract infections  Multiple centre  Clinical efficacy  Safety
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