司帕沙星与洛美沙星随机对照治疗急性细菌性感染多中心研究

Multicenter evaluation on efficacy and safety of sparfloxacin versus lomefloxacin in the treatment of acute bacterial infections

采用国产司帕沙星 (sparfloxacin)与洛美沙星 (lomefloxacin)随机对照治疗呼吸道、泌尿道、皮肤软组织急性细菌性感染及淋球菌性尿道炎。共 2 0 2例 ,试验组 10 2例 ,对照组 10 0例 ,司帕沙星 2 0 0 mg,每日 1次 ,洛美沙星 2 0 0 mg或 30 0 mg每日 2次 ,疗程 5～ 14d。两组的痊愈率与有效率分别为 79.41%与 91.18%及6 8.0 0 %与 84.0 0 % ;两组细菌阳性率、清除率及阴转率分别为 95 .1%、93%、92 .7%及 94%、86 .45 %、87.2 3% ,以上结果经统计学处理均无显著性差异。临床分离的 196株致病菌对司帕沙星、洛美沙星、氧氟沙星、环丙沙星及依诺沙星的高敏率分别为 86 .77%、79.5 9%、79.0 8%、83.16 %及 6 1.2 2 % ,司帕沙星与后四者比较 ,除与依诺沙星有显著性差异 (P<0 .0 5 )外 ,与其余 3种无显著性差异 (P>0 .0 5 )。以上 5种抗菌药物对196株致病菌的 MIC结果提示 :司帕沙星对金葡球菌及大肠埃希氏菌的 MIC5 0 及 MIC90 低于其他 4种喹诺酮类抗菌药物 ,对其他革兰氏阳性菌及阴性菌的 MIC值较其他 4种喹诺酮类抗菌药略低或相似。两组的不良反应发生率分别为 4.85 %和 3.96 % ,经统计学处理差异无显著性。以上结果提示司帕沙星抗菌谱广、抗菌活性强、安全有效、使用简便。

An open, multicentre, randomised study was carried out to assess the efficacy and safety of sparfloxacin versus lomefloxacin in the treatment of bacterial infections of hospitalized patients. 202 patients with respiratory tract infection, urinary tract infection and skin structure infections were enrolled. 102 patients received sparfloxacin 200mg once daily and 100 patients received lomefloxacin 200mg twice daily for 5~14 days. The efficacy rate were 91.18% and 84% respectively in two groups, with no statistically singificant difference ( P = 0.1386 ). The bacteriological eradication rates were 93% and 86.45% respectively ( P =0.2326). The adverse reactions were five (4.85%) cases in sparfloxacin group and four (3.96%) cases in lomefloxacin group, most of them were nausea, vomiting. One patient had to withdraw from sparfloxacin group due to severe vomiting and nausea. There was no photosenstivity reaction. In conclusion, the results showed that sparfloxacin is well tolerated and as effictive as lomefloxacin but more convenicence.