国产司帕沙星注射液治疗急性细菌性感染的多中心临床评价  

Multicenter Evaluation on the Efficacy and Safety of Sparfloxacin in the Treatment of Acute Bacterial Infections

作　　者：蔡永宁[1] 梁德荣[1] 徐楠[1] 苗佳[1] 邱焞功[2] 文崇林[3] 

机构地区：[1]四川大学华西医院国家药品临床研究基地,成都610041 [2]四川省人民医院感染科 [3]成都市第三人民医院

出　　处：《华西医科大学学报》2002年第2期291-293,325,共4页Journal of West China University of Medical Sciences

摘　　要：目的　评价国产司帕沙星 (sparfloxacin)注射液治疗急性细菌性感染的有效性和安全性。方法　以氧氟沙星 (ofloxacia)注射液为对照 ,对国产司帕沙星注射液进行了多中心随机对照临床试验。司帕沙星组 5 8例 ,采用司帕沙星 2 0 0 mg每日 1次静滴 ;氧氟沙星组 6 1例 ,采用氧氟沙星 2 0 0 mg每日 2次静滴。两组疗程均为 7～ 14天。结果　两组的痊愈率分别为 44 .83%和 42 .6 2 % (P>0 .0 5 ) ,有效率分别为 87.93%和 81.97% (P>0 .0 5 ) ;两组细菌清除率分别为 86 .0 0 %和 84.6 2 % (P>0 .0 5 )。两组不良反应发生率分别为 13.79%和 2 2 .5 8% (P>0 .0 5 ) ,本研究中未见光敏感反应发生。结论　国产司帕沙星注射液是治疗各种急性细菌性感染的安全。Objective To evaluate the efficacy and safety of domestic sparfloxacin. Methods A multicentre randomized controlled clinical trial was conducted to compare sparfloxacin versus ofloxacin in the treatment of acute bacterial infections. 58 patients received 200mg of sparfloxacin once daily intravenous drip and 61 patients received 200mg of ofloxacin twice daily intravenous drip. Both durgs were given for 7-14 days. Results The clinical cure rates of sparfloxacin group and ofloxacin group were 44.83% and 42.62%, and the efficacy rates were 87 93% and 81.97%, respectively; no significant differences were noted between the two groups (P>0.05). The bacterial eradication rates were 86.00% and 84.62% respectively (P>0.05). The adverse reactions in the two groups were 13.79% and 22.58% (P>0.05). Photosensitivity reaction was not observed in this study. Conclusion Domestic sparfloxacin is effective and safe in treating acute bacterial infections.

关 键 词：随机对照研究 司帕沙星注射液 治疗 急性细菌性感染 多中心 临床评价 

分 类 号：R453.2[医药卫生—治疗学]