普卢利沙星片治疗急性细菌性感染随机双盲对照临床研究  

Double-blind randomized controlled multicenter clinical trial of prulifloxacin in the treatment of acute bacterial infections

作　　者：苏雪松[1] 周光宇[1] 李德天[1] 边晓慧[1] 刘勇[1] 陈萍[2] 左巍[2] 段蕴铀[3] 王晓波[4] 刘颖[5] 王东亮[5] 孙艺[6] 

机构地区：[1]中国医科大学附属盛京医院肾内科,沈阳110004 [2]中国人民解放军沈阳军区总医院,沈阳110003 [3]中国人民解放军海军总医院,北京100036 [4]中国人民解放军第二一零医院,辽宁大连116011 [5]中国人民解放军第二零二医院,沈阳110001 [6]沈阳医学院奉天医院,沈阳110006

出　　处：《中国临床药理学杂志》2009年第1期6-10,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价普卢利沙星片(第4代喹诺酮类抗生素)治疗临床常见细菌性感染的安全性和有效性。方法采用多中心、随机、双盲、平行对照试验设计,共入选病例255例,进入PP(符合方案集)分析249人,其中:试验组124例,对照组125例。口服普卢利沙星片和左氧氟沙星片均每次200 mg,每日2次,疗程7-14天。结果试验组和对照组临床痊愈率分别为90.32%和85.60%,总有效率分别为95.97%和95.20%,细菌清除率分别为100%和98.98%;药物不良反应发生率分别为6.25%和3.94%。结论普卢利沙星片治疗急性呼吸和泌尿系统感染安全、有效。Objective To evaluate the efficacy and safety of prulifloxacin in the treatment of clinical common bacterial infections. Methods A doubleblind randomized , controlled, open, multicenter clinical trial was conducted for treatment of 255 patients with respiratory tract and urinary tract infections. The total number of subjects for per - protocol （PP） analysis was 249 , 124 cases in trial group while 125 cases in control group. Both prulifloxacin and levofloxacin were taken orally 200 mg respectively, twice daily. The treatment duration for both groups was from 7 to 14 days . Results The cure rate for prulifloxacin and levofloxacin was 90.32% and 85.60%. The clinical efficacy rate for prulifloxacin and levofloxacin was separately 95.97% and 95.20%. The bacterial eradication rate for prulifloxacin and levofloxacin was 100% and 98.98% , respectively. The incidence of drug adverse reaction was 6. 25% and 3. 94% , respectively. Conclusion Prulifloxacin had an excellent clinical efficacy and good safety pofile in treating patients with acute respiratory and urinary bacterial infections.

关 键 词：普卢利沙星 左氧氟沙星 细菌性感染 

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