The Efficacy and Safety of Tigecycline for the Treatment of Complicated Intra-Adominal Infections The European Experience
The Efficacy and Safety of Tigecycline for the Treatment of Complicated Intra-Adominal Infections The European Experience
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DOI：
10.1179/joc.2008.20.supplement-1.12
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发表时间：
2008-10-01
影响因子：
1.8
通讯作者：
Tellado, J.
中科院分区：
文献类型：
--
作者：
Fomin, P.;Koalov, S.;Tellado, J.
复杂的腹内感染的多菌性使这些感染的治疗特别具有挑战性。因此，最初选择抗菌药物治疗是非常重要的。不适当的经验性抗菌治疗已被证明延迟临床缓解，增加住院时间，并增加死亡风险。此外，耐药菌株(如超广谱β-内酰胺酶；[ESBLS])从患者体内恢复的频率越来越高，这要求经验性抗菌疗法涵盖这些难以治疗的生物体。在此，我们评估了一种新的抗菌剂替格环素的疗效。这是对参与两个第111阶段双盲试验的欧洲网站的数据的综合分析，以评估替格环素与亚胺培南/西司他丁在成人复杂腹部感染中的疗效和安全性。患者接受替吉环素(起始剂量为100 mg，随后每12小时静脉注射50 mg)或亚胺培南/西司他丁(500/500 mg，每6小时静脉注射)，疗程5-14天。主要终点是在联合初级微生物学评估(ME)和微生物学改良的治疗意向(m-MITT)人群中，在治疗试验访问(治疗后12-44天)时的临床反应。ME组临床治愈率替环素为92.4%(219/237)，亚胺培南/西司他丁为88.8%(198/223)(95%CI=-2.2，9.4)。在治疗试验访问中，m-mitt人群的临床治愈率替环素为87.3%(247/283)，亚胺培南/西司他丁为83.5%(228/273)(95%CI=-2.5，10.0)。同时测定治疗前对替吉环素和亚胺培南/西司他丁基线分离株的体外抗菌活性。替吉环素对最常见的需氧菌和厌氧菌的MIC90平均值为
The polymicrobial nature of complicated intra-abdominal infections makes these infections particularly challenging to treat. The initial selection of antimicrobial therapy is therefore extremely important. Inappropriate empiric antimicrobial therapy has been shown to delay clinical resolution, increase length of hospital stay, and increase the risk of mortality. In addition, the increasing frequency with which resistant isolates (e.g., extended spectrum beta-lactamases; [ESBLs]) are recovered from patients mandates that empiric antimicrobial therapy covers these difficult-to-treat organisms.Here, we assessed the efficacy of a new antimicrobial agent, tigecycline. This is a combined analysis of data from the European sites that participated in two Phase 111, double-blind trials to evaluate the efficacy and safety of tigecycline, versus that of imipenem/cilastatin, in adults with complicated intra-abdominal infections. Patients received either tigecycline (initial dose of 100 mg, followed by 50 mg intravenously every 12 hours) or imipenem/cilastatin (500/500 mg intravenously every 6 hours) for 5-14 days. The primary end point was the clinical response at the test-of-cure visit (12-44 days after therapy) in the co-primary microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations. For the ME group, clinical cure rates at the test-of-cure visit were 92.4% (219/237) for tigecycline versus 88.8% (198/223) for imipenem/cilastatin (95% CI = -2.2, 9.4). Clinical cure rates for the m-mITT populations were 87.3% (247/283) for tigecycline versus 83.5% (228/273) for imipenem/cilastatin (95% Cl = -2.5, 10.0) at the test-of-cure visit. Pretherapy in vitro activity against baseline isolates for tigecycline and imipenem/cilastatin were also determined. The mean MIC 90 for tigecycline against the most commonly isolated aerobes and anaerobes was