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采用司帕沙星与洛美沙星随机对照治疗急性细菌感染多中心临床研究。 112例接受司帕沙星 2 0 0 mg每日 1次 ,重症感染 40 0 mg每日 1次 ;111例接受洛美沙星 2 0 0 mg每日 2次 ,或 2 0 0 mg每日 3次 ,疗程为 5～ 14d。两组的痊愈率与有效率分别为 75 .89%、6 3.37% (P=0 .2 95 8)与 91.96 %、88.2 9% (P=0 .3790 )。试验组和对照组细菌阳性率、清除率及阴转率分别为 88.39%、85 .5 8% (P=0 .5 5 6 5 ) ,90 %和 91.6 7% (P=0 .2 435 ) ,95 .96 %、91.5 8(P=0 .2 436 )。临床分离的 196株致病菌对司帕沙星、洛美沙星、氧氟沙星、环丙沙星和依诺沙星的高敏率分别为89.2 9%、81.6 3%、87.75 %、87.75 %和 73.46 %。 MIC结果提示司帕沙星对金葡球菌、大肠埃希氏菌及肺炎克雷伯氏菌的 MIC90 均低于其他 4种喹诺酮类药物 ,对其他革兰氏阳性及阴性菌的 MIC比后 4种氟喹酮类药物略低或相似。两组不良反应发生率分别为 7.14%和 7.2 1% ,经统计学处理无显著性差异 (P=0 .80 92 )。该研究结果提示 ,司帕沙星为一抗菌谱广、抗菌活性强、治疗各种敏感菌所致的急性感染安全有效的药物。
Randomized controlled clinical trial of sparfloxacin versus lomefloxacin in the treatment of acute bacterial infections. 112 cases received sparfloxacin 200 mg once daily and severe infection 40 0 mg once daily; 111 patients received lomefloxacin 200 mg twice daily or 200 mg three times daily , Treatment for 5 ~ 14d. The cure rate and effective rate of the two groups were 75.89%, 63.37% (P = 0.958) and 91.96%, 88.29% (P = 0.3790) respectively. The positive rate, clearance rate and negative conversion rate of bacteria in the test group and the control group were 88.39%, 85.58% (P = 0.5555), 90% and 91.6% (P = 0.2343) , 95.96%, 91.58 (P = .2 436). The high sensitivity of 196 pathogenic bacteria isolates to sparfloxacin, lomefloxacin, ofloxacin, ciprofloxacin and enoxacin were 89.29%, 81.63%, 87.75%, 87.75% And 73.46%. MIC results suggest that the MIC90 of sparfloxacin against Staphylococcus aureus, Escherichia coli and Klebsiella pneumoniae are lower than the other four quinolones, MIC against other Gram-positive and -negative bacteria after 4 Fluoroquinone drugs slightly lower or similar. The incidence of adverse reactions in both groups were 7.14% and 7.21%, respectively, and there was no significant difference between the two groups (P = 0.8092). The results suggest that sparfloxacin antibacterial broad spectrum, strong antibacterial activity, the treatment of acute infections caused by various sensitive bacteria safe and effective drug.