CAJ | 학술논문

目的:比较帕珠沙星与环丙沙星治疗肺部铜绿假单胞菌感染的临床疗效与安全性.方法:采用随机对照方法,试验组用甲磺酸帕珠沙星注射液300 mg,Q12h静脉滴注一次;对照组用左氧氟沙星400 mg,Q12h静脉滴注一次,疗程均为(7~10)d,病情严重者可延长至14d.结果:共纳入144例患者,帕珠沙星与环丙沙星每组各72例,符合方案分析集130例,安全性分析集144例.结果显示:帕珠沙星组与环丙沙星组痊愈率分别为80.3%与71.8%,总有效率分别为93.9%和87.5%;两组细菌清除率分别为93.9%(62/66),84.4%(54/64),差异均无显著性意义(P>0.05);药敏试验结果显示,帕珠沙星与环丙沙星对铜绿假单胞菌的敏感率最高,分别为94.1%,91.8%,优于头孢他啶及左氧氟沙星,且差异存在统计学意义(P<0.05);另,两组不良事件发生率相似(P>0.05),主要以局部刺激及消化道反应为主,症状轻微,停药后自行恢复.结论:帕珠沙星治疗肺部铜绿假单胞菌感染疗效确切,并与环丙沙星相当,安全性好.
목적:비교파주사성여배병사성치료폐부동록가단포균감염적림상료효여안전성.방법:채용수궤대조방법,시험조용갑광산파주사성주사액300 mg,Q12h정맥적주일차;대조조용좌양불사성400 mg,Q12h정맥적주일차,료정균위(7~10)d,병정엄중자가연장지14d.결과:공납입144례환자,파주사성여배병사성매조각72례,부합방안분석집130례,안전성분석집144례.결과현시:파주사성조여배병사성조전유솔분별위80.3%여71.8%,총유효솔분별위93.9%화87.5%;량조세균청제솔분별위93.9%(62/66),84.4%(54/64),차이균무현저성의의(P>0.05);약민시험결과현시,파주사성여배병사성대동록가단포균적민감솔최고,분별위94.1%,91.8%,우우두포타정급좌양불사성,차차이존재통계학의의(P<0.05);령,량조불량사건발생솔상사(P>0.05),주요이국부자격급소화도반응위주,증상경미,정약후자행회복.결론:파주사성치료폐부동록가단포균감염료효학절,병여배병사성상당,안전성호.
Objective:To evaluate the validity and safety of Pazufloxacin Mesilate in the treatment of Pulmonary Pseudomonas aeruginosa Infection.Methods: Arandomized controlled clinical study was conducted, pazufloxacin group was administered at a dose of 300mg twice daily for 7 to 10 days ,and levofloxacin group 400mg twice daily during the same period.Results:144 patients were divided into pazufloxacin group(n=99)and ciprofloxacin group(n=99) randomly. In general, 130 cases were assessable for per-protocol set(PPS) analysis and 144 cases for (Safety analysis Set, SAS). The total cure rates and effective rates were 93.9%and 80.3%in pazufloxacin group, and 87.5%and 71.8%in ciprofloxacin group respectivel; the bacterial eradication rates were 93.9% and 87.5% respectively ;there were no significant differences between two groups(P>0.05).The sensitivity of Pseudomonas aeruginosa to Pazufloxacin and ciprofloxacin were significantly higher than other antibitics which were 94.1%, 91.8% respectively. No significant difference in adverse drug reactions between the two groups(P>0.05)was found. Conclution:Pazufloxacin Mesilate is as effective and safe as levofloxacin in the treatment of Pulmonary Pseudomonas aeruginosa Infection