司帕沙星注射液治疗急性细菌性感染随机对照临床研究  

A Randomized Controlled Clinical Study of Sparfloxacin Injection in the Treatment of Acute Bacterial Infections

作　　者：苗佳[1] 蔡永宁[1] 郑莉[1] 沈奇[1] 徐楠[1] 梁德荣[1] 

机构地区：[1]华西医科大学附属第一医院临床药理研究所,四川成都610041

出　　处：《华西医学》2001年第4期418-421,共4页West China Medical Journal

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 :采用随机对照试验设计 ,将 41例急性细菌性感染患者随机分入试验组 (2 0例 )和对照组 (2 1例 ) ,分别接受司帕沙星和氧氟沙星注射液治疗 ,另有 2 0例患者进入开放试验组接受司帕沙星注射液治疗 ,疗程均为 7～ 14天。结果 :随机对照试验组与对照组的临床痊愈率和有效率分别为 30 0 0 %与 47 6 2 %、 80 0 0 %与 86 71% ,细菌清除率分别为 77 78%与76 47% ,不良反应发生率分别为 2 0 0 0 %和 2 3 81% ,以上结果两组比较差异均无统计学意义 (P >0 0 5 )。开放试验组的临床痊愈和有效率分别为 30 0 0 %和 80 0 0 % ,细菌清除率为 75 0 0 % ,不良反应发生率为 2 5 0 0 %。对临床分离的 5 1株致病菌纸片敏试测定结果表明 ,司帕沙星的敏感率与氧氟沙星相近 ,略高于环丙沙星 ,稍低于头孢三嗪和阿米卡星 ,但五者比较差异均无统计学意义 (P >0 0 5 )。结论 :司帕沙星注射液临床疗效确切 ,可有效地治疗敏感菌所致急性细菌性感染。但其制剂的溶解性和稳定性尚需进一步改进。Objective:To evaluate the clinical efficacy and safety of sparfloxacin injection on patients with acute bacterial infection.Methods:41 patients were randomly divided into test group(20 patients)and control group(21 patients).Sparfloxacin or ofloxacin injection were given respectively for 7～14 days.Other 20 patients involved in open group received sparfloxacin injection for 7～14 days.Results:The clinical cured rates and effective rates of test and control group were 30 00% and 47 62%,80 00% and 86 71% respectively.The bacterial eradication rates of two groups were 77 78% and 76 47%.The ADRs rates were 20 00% and 23 81% respectively.There were no significant differences between the two groups( P >0 05).The clinical cured rate and effective rate of open group were 30 00% and 80 00%,the bacterial eradication rate was 75 00% and the ADRs rate was 25 00%.The sensitive test showed the sensitive rate of sparfloxacin to 51 strains was equal to ofloxacin,little higher than ciprofloxacin,little lower than cefetriacxon and amikacin.But there were also no significant differences among the five antibiotics ( P >0 05).Conclusion:Sparfloxacin injection is an effective antibiotic for treating acute bacterial infections.

关 键 词：司帕沙星注射液 氧氟沙星注射液 急性细菌性感染 随机对照 抗生素 

分 类 号：R969[医药卫生—药理学]