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

A multiple centre randomized controlled clinical study of sparfloxacin in the acute respiratory tract infections

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。

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.