盐酸左氧氟沙星注射液随机对照治疗细菌性感染临床试验研究  

A randomized controlled clinical study on levofloxacin versus ciprofloxacin in the treatment of bacterial infections

作　　者：郑波[1] 李家泰[1] 吕媛[1] 陈扬[1] 林江涛[2] 苏楠[2] 何洁[2] 林桂秋[2] 顾俊明[3] 王慧玲[3] 霍莉[3] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100083 [2]中日友好医院,北京100029 [3]大连医科大学附属二院,大连116023

出　　处：《中国抗生素杂志》2002年第6期365-368,共4页Chinese Journal of Antibiotics

摘　　要：目的 :以环丙沙星注射液作为对照药 ,进行随机对照临床试验 ,评价山西芮城制药厂生产的盐酸左氧氟沙星注射液治疗细菌性感染的安全有效性。方法 :本试验采用随机对照试验设计方法 ,完成可评估病例 12 4例 ,其中试验组 61例 ,对照组 63例。剂量均为每次 0 .10 .2g ,每日二次 ,疗程 714d。结果 :临床有效率试验组为 90 .16%,对照组为 80 .95 %,各种致病菌清除率试验组为 94.5 5 %,对照组为 89.5 9%,药物不良反应率分别为 4.92 %和 7.94%。两组统计学处理差异无显著性 (P >0 .0 5 )。结论 :表明采用盐酸左氧氟沙星治疗急性细菌性感染安全。Objective: To evaluate the safety and efficacy of levofloxacin in the treatment of bacterial infections, a randomized controlled clinical study of levofloxacin versus ciprofloxacin was conducted. Method: A total of 124 patients was enrolled in the study. 61 patients received levofloxacin and 63 patients received ciprofloxacin were assessable for clinical efficacy. The regimen of the two groups were 0.1～0.2g, twice daily, 7～14d. Result: The result showed that the overall efficacy rates were 90.16% for the levofloxacin group and 80.95% for the ciprofloxacin group, whereas the bacterial clearance rates were 94.55% and 89.59%, respectively. The adverse drug reaction rate were 4.92% and 7.94%, respectively. Conclusion: Results showed that levofloxacin was effective and safe for the treatment of bacterial infections. There were no statistical differences between the two groups ( P >0.05).

关 键 词：盐酸左氧氟沙星注射液 随机对照 细菌性感染 临床试验研究 环丙沙星 

分 类 号：R515[医药卫生—内科学] R978.19[医药卫生—临床医学]