口服加替沙星与左氧氟沙星治疗下呼吸道和尿路感染的前瞻性多中心随机对照研究

目的：评价加替沙星片治疗下呼吸道感染及尿路感染的疗效与安全性。方法：以左氧氟沙星片为对照药，在248例下呼吸道和尿路感染中进行疗效和安全性的多中心随机对照观察。加替沙星组125例，其中下呼吸道感染50例，尿路感染75例；左氧氟沙星组123例，其中下呼吸道感染54例，尿路感染69例。给药方案分别为治疗下呼吸道感染加替沙星片400mg1次／d口服，左氧氟沙星片200mg2次／d口服，疗程均为7—14d；肾盂肾炎、复杂性尿路感染及反复发作性尿路感染加替沙星片400mg1次／d口服，左氧氟沙星200mg2次／d口服，疗程均为7—14dl急性单纯性下尿路感染加替沙星片200mg1次／d口服，左氧氟沙星片100mg2次／d口服，疗程均为5d。结果：加替沙星组125例和左氧氟沙星组123例的临床有效率分别为95．2％(119／125)和91．9％(113／123)，临床痊愈率分别为68．8％(86／125)和63．4％(78／123)；细菌清除率分别为89．3％(100／112)和89．5％(94／105)；不良反应发生率分别为25．3％(40／158)和18．6％(30／161)，实验室检查异常发生率为14．7％(22／150)和15．8％(24／152)。上述结果经统计学处理，差异均无显性。结论：本研究结果显示加替沙星片治疗下呼吸道及尿路感染的疗效和安全性与左氧氟沙星片相仿。

A randomized, patient-blind, multicenter comparison of gatifloxacin versus levofloxacin in the treatment of lower respiratory tract infections and urinary tract infections

Objective: This study compared the clinical and bacteriological efficacy and tolerability of gatifloxacin versus levofloxacin in adult patients with lower respiratory tract infections(LRTI) and urinary tract infections(UTI). Methods: In this randomized, patient blind, multicenter, comparable study 248 patients were evaluable, 125 in gatifloxacin group with 50 cases of LRTI and 75 UTI;123 in levofloxacin group with 54 cases of LRTI and 69 UTI. Dosage regimen used: gatifloxacin 400?mg once daily or levofloxacin 200?mg twice daily for 7-14 days in patients with LRTI and UTI, gatifloxacin 200?mg once daily or levofloxacin 100?mg twice daily for 5 days in patients with uncomplicated UTI. Results: Clinical cure rates and total effective rates were 68.8%(86 /125), 95.2%(119 /125) in the gatifloxacin group, and 63.4%(78 /123), 91.9%(113 /123) in the levofloxacin group; the corresponding bacterial eradication rates were 89.3%(100 /112) and 89.5%(94 /105) respectively. The clinical adverse reaction rates were 25.3%(40 /158) and 18.6%(30 /161) and abnormal laboratory tests were 14.7%(22 /150) and 15.8%(24 /152) in two groups respectively. No significant difference in the above figures between the two groups. Conclusion: Gatifloxacin is as effective and safe as levofloxacin in the treatment of lower respiratory tract infection and urinary tract infection.