加替沙星治疗急性细菌性呼吸道和泌尿道感染的有效性与安全性评价  

Gatifloxacin Oral Administration for the Treatment of Acute Bacterial Respiratory and Urinary Tract Infection

作　　者：孟琨[1] 岳英明[1] 王素秋[1] 

机构地区：[1]首都医科大学附属北京天坛医院呼吸内科

出　　处：《首都医科大学学报》2005年第3期319-323,共5页Journal of Capital Medical University

摘　　要：目的评价国产加替沙星治疗急性细菌性呼吸道和泌尿道感染的有效性与安全性.方法采用随机、双盲双模拟、平行对照研究,用加替沙星(治疗组)与左氧沙星(对照组)(均为每次200 mg口服,每12 h给药1次,疗程5～14 d)治疗急性细菌性呼吸道和泌尿道感染.实际入组51例,揭盲后显示,治疗组25例,对照组26例.结果加替沙星和左氧沙星治疗急性细菌性呼吸道和泌尿道感染临床有效率分别为100%(25/25)和96.2%(25/26),2组细菌清除率分别为94.4%(17/18)和89.5%(17/19),不良反应发生率分别为0与3.8%,上述结果经2组间比较差异无统计学意义.结论加替沙星对临床常见的敏感细菌引起的呼吸道、泌尿道感染是安全、有效的抗菌药物.Objective To evaluate the efficacy and safety of domestic-manufacture gatifloxacin tablet in the treatment of acute bacterial respiratory and urinary tract infections. Methods A randomized and controlled clinical trial was conducted to compare the gatifloxacin and levofloxacin for the treatment of patients with acute bacterial respiratory and urinary tract infections. The dose of both agents was 200 mg twice daily per os. The duration of the therapy was 5 to 14 d in both groups. Results Forty-three patients were enrolled in this study after excluding 1 case of negative bacterial culture, 1 case with incomplete CRF. The patients were divided into gatifloxacin group(n=25) or levofloxacin group (n=26). The overall effective rates and bacterial clearance rates were 100% and 94.4% in gatifloxacin group, 96.2% and 89.5% in levofloxacin group, respectively whereas the adverse drug reaction rates were 0 and 3.8%, respectively. No statistical significances were found in above data. Conclusion Gatifloxacin and levofloxacin were effective and safe for the treatment of acute bacterial respiratory and urinary tract infections.

关 键 词：泌尿道感染 急性细菌性 加替沙星 呼吸道 安全性评价 不良反应发生率 左氧沙星 双盲双模拟 细菌清除率 对照研究 临床常见 抗菌药物 对照组 治疗组 有效率 统计学 

分 类 号：R691.3[医药卫生—泌尿科学] R697.33[医药卫生—外科学]