摘要
目的 评价国产司帕沙星片治疗急性细菌性感染的临床疗效与安全性。方法 以国产洛美沙星片为对照药进行随机对照研究,共治疗各种细菌性感染231例,其中司帕沙星组117例、洛美沙星组114例。司帕沙星200～300mg,每日1次口服,疗程 5～14d;洛美沙星300mg,每日2次口服,疗程5～14d。结果 司帕沙星组与对照组的痊愈率和有效率分别为84.62％与74.56％和94.87％与92.98％。细菌清除率分别为94.28％和92.02％。组间比较差异无显著性(P>0.05)。两组的不良反应发生率分别为7.69％和11.40％(P>0.05),反应多呈轻度,勿需处理可自行缓解。结论 司帕沙星抗菌谱广,抗菌活性强,为治疗中、轻度急性细菌性感染安全有效的口服抗菌药物。
Objective To evaluate the clinical efficacy and safety of domestic sparfloxacin in the treatment of acute bacterial infections.Methods A multicenter randomized controlled clinical trial was conducted. 117 patients were treated with domestic sparfloxacin 200 - 300 mg qd for 5 - 14 days and 114 patients were treated with domestic lomefloxacin 300 mg bid for 5- 14 days.Results The cure rates and the efficacy rates in each group were 84.62% , 74.56% and 94.87% , 92.98% ,respectively.The bacterial clearance rates were 94.28% and 92.02% .respectively. Adverse drug reactions rates were 7.69 % and 11.40 % , most of them were mild. There were no significant differences of above results between the two groups (P > 0.05 ) . Conclusions The results suggest that sparfloxacin with wide antibacterial spectrum, satisfactory activity, is an effective and safe antibacterial agent in treatment of mild to moderate acute bacterial infections.
