司帕沙星注射液与氧氟沙星注射液多中心随机对照治疗细菌性感染  

Multi-center,Randomized-controlled Clinical Trial on Sparfloxacin Injection Versus Ofloxacin Injection in Bacterial Infetions

作　　者：吕晓菊[1] 冯萍[1] 王丽春[1] 俞汝佳[1] 张晋琳[2] 祝彪[2] 毛伯勤[3] 王晓霞[3] 

机构地区：[1]四川大学华西医院感染科,四川成都610041 [2]四川省人民医院,四川成都610072 [3]四川省成都市第三人民医院,四川成都610033

出　　处：《华西医学》2002年第2期196-198,共3页West China Medical Journal

摘　　要：目的 :本研究以司帕沙星注射剂与氧氟沙星注射剂进行随机对照临床研究 ,评价司帕沙星注射液的安全性与有效性。方法 :采用前瞻性、非盲法多中心区组随机平行试验设计。司帕沙星 10 0mg或 2 0 0mg ,直接静脉滴注 ,Qd ,疗程 5～ 14天。氧氟沙星 2 0 0mg ,静脉滴注 ,Q12h ,疗程 5～ 14天。结果 :试验组 5 9例、对照组 6 0例 ,两组不同病种感染者的临床有效率为 86 4 4%与 81 6 7%,细菌清除率为 93 6 2 %与 88 0 0 %。试验组与对照组各对应指标差异无统计学意义 (P >0 0 5 )。司帕沙星注射液可引起短暂中枢兴奋症状、轻微消化道症状、皮疹及短暂肝肾功能异常 ,其不良反应发生率为 6 6 7%。氧氟沙星注射液可引起轻微消化道症状、头昏、肝功能异常及血小板减少 ,不良反应发生率为 8 33%,两组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及光敏反应。结论 :司帕沙星注射液作为一种广谱抗菌药物 ,抗菌活性强 ,使用方便 ,可有效治疗中、重度细菌性感染。Objective:To evaluate the efficacy and safty of domestic sparfloxacin injection versus ofloxacin.Method:A multi-center,block randomized,parallel controlled,open labeled clinical trials on patients with acute bacterial infections were conducted.59 patients enrolled in sparfloxacin trial group,and received sparfloxacin 200mg intravenous drop QD for 5～14 days.Results:The efficacy rate in T and C group were 86.44% and 81.67% respectively,bacterial eradication rate were 93.62% and 88.00% respectively.There were no significant differences between two groups(P>0.05).The adverse reactions of sparfloxacin include central nervous system,digestive tract,rash and ALT or BUN elevation(6.67%).That of ofloxacin is similar with sparfloxacin(8.33%)?Conclusion:The results suggested that sparfloxacin,with wide antibacterial spectrum,satisfactory activity,is an effective and safe antibacterial agent in treatment of moderate to severe acute bacterial infections.

关 键 词：司帕沙星注射液 氧氟沙星注射液 多中心随机对照治疗 细菌性感染 

分 类 号：R453[医药卫生—治疗学]