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）。
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) .
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
1998年第1期7-13,共7页
The Chinese Journal of Clinical Pharmacology
关键词
哌拉西林
他唑巴坦
替卡西林
细菌性感染
おiperacillin/tazobactam
ticarcillin/clavulanic acid
randomized controlled clinical trial
bacterial infections
