普卢利沙星片治疗呼吸和泌尿系统急性感染的有效性和安全性研究  

Efficacy and safety of prulifloxacinin treatment of acute bacterial infections

作　　者：于佳[1] 修清玉[2] 方正[2] 于锋[1] 

机构地区：[1]中国药科大学药学院,南京210009 [2]上海长征医院呼吸内科,上海200000

出　　处：《药学与临床研究》2009年第3期249-253,共5页Pharmaceutical and Clinical Research

摘　　要：目的：评价国产普卢利沙星片治疗呼吸系统和泌尿系统急性细菌感染的安全性和有效性。方法：采用多中心、随机、双盲双模拟、阳性药平行对照试验设计，以左氧氟沙星为对照药，普卢利沙星组264mg，左氧氟沙星组200mg，每日两次，疗程5—14天，视病情和病种而异。结果：本研究共纳入265例，普卢利沙星组132例，左氧氟沙星组133例。疗程结束时，两系统感染的FAS分析，对照组和试验组痊愈率分别为67．67％和73．48％，总有效率对照组和试验组分别为89．47％和90．91％。PP分析与FAS分析结果一致。对照组细菌清除率为94．06％（95／101）；试验组细菌清除率为95．96％（95／99）。两组以上比较均无统计学差异。两组的不良反应发生率分别为5．26％（7／133）和3．79％（5／132），包括恶心、头痛、腹胀、腹泻等，其程度均为轻度，疗程结束后均消失或恢复正常。两组不良反应比较差异无统计学意义。结论：国产普卢利沙星片同左氧氟沙星相比，其治疗急性呼吸道和泌尿道感染的安全性和有效性相当。Objective： To evaluate the clinical efficacy and safety of prulifloxacin in patients with acute bacterial infections of respiratory system and urinary system. Methods：A multieenter randomized double blind double dummy controlled clinical study was conducted to compare the efficacy and safety of prulifloxacin and levofloxaein. Prulifloxacin group was administered at the dose of 264 mg and levofloxacin group of 200 rag, twice daily for 5 to 14days. Results：Two hundred and sixty five patients were enrolled in the study, 132 in prulifloxaein group and 133 in levofloxacin group. At the end of the treatment, in FAS analysis the total cure rates and effective rates were 67.67% and 89. 47% in levo- floxaein group ,73.48% and 90. 91% in prulifloxacin group;in PPS analysis the total cure rates and effective rates were the same. The bacterial resistance rates were 94. 06% （95/101） and 95.96% （95/ 99 ）respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed to be 5.26% （7/133）and 3.79% （5/132） of patients in the two groups, mainly nausea, headache, abdominal distention and diarrhea, which were all slight and disappear or became normal as the treatment was over. The differences were not statistically significant. Gonclusions： Prulifloxacin is as effective and safe as levofloxacin in patients with acute bacterial infections of respiratory system and urinary system.

关 键 词：普卢利沙星 左氧氟沙星 急性细菌感染 II期临床试验 

分 类 号：R969.4[医药卫生—药理学]