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阿莫西林/克拉维酸与头孢噻肟用于腹部手术抗菌预防的随机对照试验

Amoxicillin/clavulanic acid versus cefotaxime for antimicrobial prophylaxis in abdominal surgery: a randomized trial.

作者信息

Tonelli F, Mazzei T, Novelli A, Mazzoni P, Ficari F

机构信息

Dipartimento di Fisiopatologia Clinica, Università degli Studi di Firenze, Italy.

出版信息

J Chemother. 2002 Aug;14(4):366-72. doi: 10.1179/joc.2002.14.4.366.

DOI:10.1179/joc.2002.14.4.366
PMID:12420854
Abstract

Amoxicillin/clavulanic acid (amoxicillin 2 g/clavulanic acid 200 mg) has been administered in comparison to cefotaxime (2 g) for antimicrobial prophylaxis in 476 evaluable patients undergoing abdominal surgery at high risk of septic complications. Both antibiotics were administered as a single infusion. 205 evaluable patients (110 in amoxicillin/clavulanic acid group and 95 in cefotaxime group) underwent upper gastrointestinal surgery (including gastroduodenal and biliary surgery). The wound infection rate was 4.5% for amoxicillin/clavulanic acid and 7.4% for cefotaxime, with no significant differences. Intra-abdominal abscesses were observed in 3 patients in the amoxicillin/clavulanic acid group and in 1 patient in the cefotaxime group. 271 evaluable patients (135 in amoxicillin/clavulanic acid group and 136 in cefotaxime group) underwent lower gastrointestinal surgery (including colorectal surgery). The wound infection rate was 11% for amoxicillin/clavulanic acid and 13% for cefotaxime, with no significant differences. A purulent discharge was present in 3 patients in both groups. Intra-abdominal abscesses were observed in 3 patients in the amoxicillin/clavulanic acid group and in 4 patients in the cefotaxime group. No serious adverse events and no cases of diarrhea were observed. In conclusion, in our experience amoxicillin/clavulanic acid proved to be as effective as cefotaxime in protecting patients from surgical infections in abdominal surgery. Its use in surgical prophylaxis may help decrease the cost of treatment and reduce the risk of resistance to antibiotics and superinfections.

摘要

在476例有发生感染性并发症高风险的接受腹部手术的可评估患者中,对阿莫西林/克拉维酸(阿莫西林2克/克拉维酸200毫克)与头孢噻肟(2克)进行了抗菌预防比较。两种抗生素均采用单次输注给药。205例可评估患者(阿莫西林/克拉维酸组110例,头孢噻肟组95例)接受了上消化道手术(包括胃十二指肠和胆道手术)。阿莫西林/克拉维酸组的伤口感染率为4.5%,头孢噻肟组为7.4%,无显著差异。阿莫西林/克拉维酸组有3例患者发生腹腔内脓肿,头孢噻肟组有1例。271例可评估患者(阿莫西林/克拉维酸组135例,头孢噻肟组136例)接受了下消化道手术(包括结直肠手术)。阿莫西林/克拉维酸组的伤口感染率为11%,头孢噻肟组为13%,无显著差异。两组均有3例患者出现脓性分泌物。阿莫西林/克拉维酸组有3例患者发生腹腔内脓肿,头孢噻肟组有4例。未观察到严重不良事件和腹泻病例。总之,根据我们的经验,在腹部手术中,阿莫西林/克拉维酸在保护患者免受手术感染方面与头孢噻肟同样有效。其用于手术预防可能有助于降低治疗成本,并降低对抗生素耐药和二重感染的风险。

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