Tellado Jose, Woods Gail L, Gesser Richard, McCarroll Kathleen, Teppler Hedy
CGI, H.G.U. Gregorio Maranon, Madrid, Spain.
Surg Infect (Larchmt). 2002 Winter;3(4):303-14. doi: 10.1089/109629602762539535.
Anaerobes are an important component of many serious, deep tissue infections, especially complicated intra-abdominal (IAI), complicated skin and skin structure (SSSI), and acute pelvic (PI) infections. This study compares the efficacy of ertapenem, 1 g once a day, in the treatment of adults with anaerobic IAI, SSSI, and PI to piperacillin-tazobactam, 3.375 g every 6 hours.
Three randomized, double-blind trials comparing ertapenem to piperacillin-tazobactam for treatment of IAI, SSSI, and PI were conducted. This subgroup analysis included 623 patients, whose baseline culture grew one or more anaerobic pathogens, from these three studies.
Anaerobes most commonly isolated were Bacteroides fragilis group (IAI) and peptostreptococci (SSSI and PI). The median duration of ertapenem and piperacillin-tazobactam therapy, respectively, in these subgroups was 6 and 7 days for IAI, 7 and 8 days for SSSI, and 4 and 5 days for PI. Cure rates for all evaluable patients with anaerobic infection were 89.3% (242/271) for ertapenem and 85.9% (220/256) for piperacillin-tazobactam (95% CI for the difference, adjusting for infection, -2.6% to 9.3%), indicating that the two treatments were equivalent. Cure rates by infection, for ertapenem and piperacillin-tazobactam, respectively, were as follows: IAI, 86.4% (133/154) and 82.4% (117/142); SSSI, 84.4% (27/32) and 82.4% (28/34); PI, 96.5% (82/85) and 93.8% (75/80). The frequency and severity of drug-related adverse experiences were comparable in both treatment groups.
In this subgroup analysis, ertapenem was as effective as piperacillin-tazobactam for treatment of adults with moderate to severe anaerobic IAI, SSSI, and PI, was generally well tolerated, and had a similar safety profile.
厌氧菌是许多严重深部组织感染的重要组成部分,尤其是复杂性腹腔内感染(IAI)、复杂性皮肤及皮肤结构感染(SSSI)和急性盆腔感染(PI)。本研究比较了每天1克厄他培南与每6小时3.375克哌拉西林-他唑巴坦治疗成人厌氧性IAI、SSSI和PI的疗效。
进行了三项比较厄他培南与哌拉西林-他唑巴坦治疗IAI、SSSI和PI的随机双盲试验。该亚组分析纳入了这三项研究中623例基线培养出一种或多种厌氧性病原体的患者。
最常分离出的厌氧菌为脆弱拟杆菌属(IAI)和消化链球菌(SSSI和PI)。在这些亚组中,厄他培南和哌拉西林-他唑巴坦治疗的中位持续时间,IAI分别为6天和7天,SSSI分别为7天和8天,PI分别为4天和5天。所有可评估的厌氧感染患者的治愈率,厄他培南为89.3%(242/271),哌拉西林-他唑巴坦为85.9%(220/256)(差异的95%置信区间,校正感染因素后为-2.6%至9.3%),表明两种治疗方法等效。按感染类型划分的治愈率,厄他培南和哌拉西林-他唑巴坦分别如下:IAI为86.4%(133/154)和82.4%(117/142);SSSI为84.4%(27/32)和82.4%(28/34);PI为96.5%(82/85)和93.8%(75/80)。两个治疗组药物相关不良事件的频率和严重程度相当。
在该亚组分析中,厄他培南治疗成人中重度厌氧性IAI、SSSI和PI的疗效与哌拉西林-他唑巴坦相当,总体耐受性良好,且安全性相似。