Dela Pena Arturo S, Asperger Walter, Köckerling Ferdinand, Raz Raul, Kafka Reinhold, Warren Brian, Shivaprakash Malathi, Vrijens France, Giezek Hilde, DiNubile Mark J, Chan Christina Y
Philippine General Hospital, Manila, Philippines.
J Gastrointest Surg. 2006 Apr;10(4):567-74. doi: 10.1016/j.gassur.2005.06.015.
Complicated intra-abdominal infections usually mandate prompt surgical intervention supplemented by appropriate antimicrobial therapy. The aim of this study was to demonstrate that ertapenem was not inferior to piperacillin-tazobactam for the treatment of community-acquired intra-abdominal infections. A randomized open-label active-comparator clinical trial was conducted at 48 medical centers on four continents from December 2001 to February 2003. Adult patients with intra-abdominal infections requiring surgery were randomized to receive either ertapenem 1 g daily or piperacillin/tazobactam 13.5 g daily in 3-4 divided doses. The primary analysis of efficacy was the clinical response rate in clinically and microbiologically evaluable patients at the test-of-cure assessment 2 weeks after completion of therapy. All treated patients were included in the safety analysis. Patient demographics, disease characteristics, and treatment duration in both treatment groups were generally similar. The most commonly isolated pathogens at baseline were E coli (greater than 50% of cases in each group) and B fragilis ( approximately 9%). Favorable clinical response rates were 107/119 (90%) for ertapenem recipients and 107/114 (94%) for piperacillin/tazobactam recipients. The frequencies of drug-related adverse events, most commonly diarrhea and elevated serum alanine aminotransferase levels, were similar in both treatment groups. Six of 180 ertapenem recipients (3%) and two of 190 piperacillin/tazobactam recipients (1%) had serious drug-related adverse experiences. In this study, ertapenem and piperacillin/tazobactam were comparably safe and effective treatments for adult patients with complicated intra-abdominal infections.
复杂腹腔内感染通常需要迅速进行手术干预，并辅以适当的抗菌治疗。本研究的目的是证明厄他培南在治疗社区获得性腹腔内感染方面不劣于哌拉西林-他唑巴坦。2001年12月至2003年2月，在四大洲的48个医学中心进行了一项随机开放标签活性对照临床试验。需要手术治疗的腹腔内感染成年患者被随机分为两组，分别接受每日1 g厄他培南或每日13.5 g哌拉西林/他唑巴坦（分3 - 4次给药）。疗效的主要分析指标是治疗结束2周后治愈评估时临床和微生物学可评估患者的临床反应率。所有接受治疗的患者均纳入安全性分析。两个治疗组的患者人口统计学特征、疾病特点和治疗持续时间总体相似。基线时最常分离出的病原体是大肠杆菌（每组病例中超过50%）和脆弱拟杆菌（约9%）。厄他培南治疗组的良好临床反应率为107/119（90%），哌拉西林/他唑巴坦治疗组为107/114（94%）。两个治疗组药物相关不良事件的发生率相似，最常见的是腹泻和血清丙氨酸转氨酶水平升高。180例接受厄他培南治疗的患者中有6例（3%）、190例接受哌拉西林/他唑巴坦治疗的患者中有2例（1%）出现严重的药物相关不良事件。在本研究中，厄他培南和哌拉西林/他唑巴坦对于患有复杂腹腔内感染的成年患者而言，安全性和有效性相当。
