甲苯磺酸托氟沙星与司帕沙星双盲双模拟多中心临床与实验研究

Multi-center, double-blind, double-simulated, randomized-controlled clinical trial and laboratory study on tosufloxacin tosilate versus sparfloxacin

目的 本研究以司帕沙星为对照药 ,对国产二类新药甲苯磺酸托氟沙星进行临床研究 ,以评价后者的安全性与有效性。方法 采用前瞻性、双盲双模拟、多中心区组随机试验设计。托氟沙星胶囊 15 0mgtid ,餐后服用 ,司帕沙星胶囊 3 0 0mg ,qd ,疗程均为 7～ 14d。结果 试验组完成 10 0例、对照组 10 4例。两组各病种的临床有效率分别为 88.0 0 %与 87.5 0 %;细菌清除率分别为 88.5 1%与 86.5 9%。试验组与对照组各对应指标差异无统计学意义 (P >0 .0 5 )。体外抗菌活性研究结果表明 ,托氟沙星的抗菌活性与司帕沙星、氧氟沙星、环丙沙星相似 ,对革兰氏阳性菌的抗菌活性明显优于阿奇霉素。甲苯磺酸托氟沙星可引起轻微的消化道症状、短暂中枢兴奋症状及皮疹 ,其不良反应发生率为 12 .0 0 %;司帕沙星可引起短暂中枢兴奋症状、轻微消化道症状、光敏反应及实验室肝功的异常 ,不良反应发生率为 16.3 5 %。各对应指标差异无统计学意义 (P>0 .0 5 ) ,试验期间未出现严重不良反应。结论 甲苯磺酸托氟沙星作为一种广谱抗菌药物 ,抗菌活性较强 ,合理使用可安全有效地治疗由敏感菌引起的轻。

Objective: To evaluate the efficacy and safety of domestic tosufloxacin tosilate versus sparfloxacin. Method: A multi center,double blind, double simulated, block randomized, parallel controlled clinical trials on patients with acute bacterial infections were conducted. A total of 100 patients enrolled in tosufloxacin group (150mg tid for 7～14 days), 104 patients enrolled in sparfloxacin group (300mg qd for 7～14 days). Results The efficacy rate in trial and control group were 88.00% and 87.50%, respectively; the bacterial eradication rate were 88.51% and 86.59%, respectively ( P > 0.05 ). The results of in vitro susceptibility test showed that tosufloxacin possess similar antibacterial activity to sparfloxacin, ofloxacin and ciprofloxacin, and is more active against gram positive cocci than azithromycin. The adverse reactions of tosufloxacin involved in central nervous system, digestive tract, rash and ALT elevation (12.00%). That of sparfloxacin included photosensitivity and others similar with tosufloxacin (16.35%). Conclusion The results suggested that tosufloxacin tosilate with wide antibacterial spectrum, satisfactory activity, is an effective and safe antibacterial agent in treatment of mild to moderate acute bacterial infections.