司帕沙星注射液与氧氟沙星注射液随机对照临床试验  

A randomized controlled clinical study on sparfloxacin for injection versus ofloxacin for injection

作　　者：王丽春[1] 吕晓菊[1] 杨尧[1] 冯萍[1] 俞汝佳[1] 

机构地区：[1]四川大学华西医院,成都610041

出　　处：《中国抗生素杂志》2002年第7期423-426,共4页Chinese Journal of Antibiotics

摘　　要：目的　评价司帕沙星注射液治疗急性细菌性感染的有效性与安全性。方法　采取随机对照及开放试验 ,以氧氟沙星注射液做对照 ;司帕沙星剂量 2 0 0 mg qd或 q12 h,氧氟沙星剂量 2 0 0 mg q12 h,疗程为 5～14 d。结果　共治疗患者 76例 ,试验组 39例 ,对照组 2 0例 ,开放组 17例。大针剂组 (GI) :试验组、对照组与开放组的有效率分别为 84 .2 1%、85 .0 0 %与 88.89% ;小针剂组 (MI) :各组有效率分别为 85 .0 0 %、85 .0 0 %与10 0 % ,在 GI组中试验组、对照组、开放组的细菌清除率分别为 92 .86 %、87.5 0 %、10 0 % ,在 MI组分别为80 .0 0 %与 87.5 0 %、10 0 % ,试验组与对照组之间的差异无计学意义 (P>0 .0 5 )。试验组的不良反应发生率为15 .0 0 % (GI)、10 .0 0 % (MI) ,对照组为 10 .0 0 % ,无统计学差异 (P>0 .0 0 5 )。开放组的不良反应发生率为0 .0 0 % (GI)与 12 .5 0 % (MI)。结论　司帕沙星注射液抗菌谱广、抗菌活性强 ,为一治疗中、重度急性细菌性感染安全有效的注射用药物。Objective: To evaluate the efficacy and safety of sparfloxacin for the treatmeat of acute bacterial infection. Methods: A randomized controlled and open clinical trial was carried out. Ofloxacin was served as the controlled drug. The regimen for sparfloxacin was 200mg intravenous qd or q12h, and ofloxacin was 200mg intravenous q12h for 5～14 days. Results: A total of 76 patients were enrolled in the study, 39 patients in trial group, 20 in control group and 17 in open group. Giant injection (GI) group: the effective rate were 84.21%, 85.00% and 88.89% in trial, control and open group respectively; Minor injection (MI) group: the effective rate were 85.00%, 85.00% and 100.00%. The bacterial clearance rates were 92.86%, 87.50%, 100.00% in GI group and 80.00%, 87.50%, 100.00% in MI group respectively. The difference between the trial group and the control group was not statistically significant ( P >0.05). The adverse drug reaction rates were 15.00% (GI), 10.00% (MI) in trial group and 10.00% in control group. There were no statical differences ( P >0.05). In open group the adverse drug reaction rates were 0.00% (GI) and 12.50% (MI). Conclusion: Sparfloxacin for injection has broad antibacterial spectrum and potent antibacterial activity, and it is safe and effective in the treatment of moderate or severe bacterial infections.

关 键 词：司帕沙星 氧氟沙星 随机对照 临床试验 

分 类 号：R969.4[医药卫生—药理学] R978.1[医药卫生—药学]