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哌拉西林/他唑巴坦与替卡西林/棒酸随机对照治疗细菌性感染临床评价

A RANDOMIZED, CONTROLLED CLINICAL TRIAL ON PIPERACILLIN/TAZOBACTAM VERSUS TICARCILLIN/CLAVULANIC ACID FOR THE TREATMENT OF BACTERIAL INFECTIONS

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【作者】 侯芳李家泰高磊陈扬

【Author】 HOU Fang, LI Jia-Tai, GAO Lei, CHEN Yang(1st Affiliated Hospital, Institute of Clinical Pharmacology, Beijing Medical University, Beijing, 100034)

【机构】 北京医科大学第一医院北京医科大学临床药理研究所

【摘要】 哌拉西林/他唑巴坦(piperacilin/tazobactam)是美国HomeProducts公司Lederle实验室研制的复方制剂,对产β-内酰胺酶致病菌有较强抗菌作用。为评价其安全有效性,我们以替卡西林/棒酸为对照药,进行随机对照试验治疗细菌性感染124例。剂量用法:哌拉西林/他唑巴坦4.5g,q8h,静脉点滴;替卡西林/棒酸,3.2g,q8h,静脉点滴。疗程均为7-14d。哌拉西林/他唑巴坦组及替卡西林/棒酸组可评价临床疗效例数分别为63例和61例,总有效率分别为90.5%和88.5%,治疗各种致病菌感染有效率分别为90.2%和88.0%,本组临床试验所分离致病菌101株,产酶阳性率为77.2%,细菌清除率分别为90.2%和92.0%。两组安全性评价例数分别为65例和62例,不良反应发生率分别为7.69%和8.06%,以上结果经统计学处理无显著性差异(P>0.05)。

【Abstract】 A randomized, open-label, controlled study was conducted for the treatment on 124 hospitalized patients with lower respiratory tract infection and urinary tract infections to compare the efficacy and safety of two β-lactamase inhibitor combinations, piperacillin-tazobactam and ticarcillin-clavulanic aicd .63 patients received piperacillin-tazobactam(4g·(500mg)-1) every 8 hours by intravenous infusion and 61 patients received ticarcillin/clavulanic acid(3g·(200mg)-1) every 8 hours by intravenous infusion. The duration was 7-14 days in two groups. 63 of 79 cases received piperacillin/tazobactam and 61 of 84 cases received ticarcillin/clavulanic acid were assessable for clinical efficacy. The overall effcacy rates were 90.5% for the piperacillin/tazobactam group and 88.5% for the ticarcillin /clavulanic acid group, whereas the bacterial eradication rates were 90.2% and 92.0%, respectively. 78 (77.2%) of 101 strains isolated from patients produced β-lactamase.The adverse drug reaction was evaluated in 65 cases of piperacillin/tazobactam group and 62 cases of ticarcillin/clavulanic acid group, the adverse drug reaction rates were 7.69%(5/65) and 8.06%(5/62), respectively. The results showed that there were no statistical differences between these two groups.(P>0.05) .

  • 【文献出处】 中国临床药理学杂志 ,THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY , 编辑部邮箱 ,1998年01期
  • 【分类号】R978
  • 【被引频次】7
  • 【下载频次】97
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