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氨曲南与头孢哌酮治疗复杂性尿路感染的对照研究

[Well-controlled comparative study on aztreonam and cefoperazone in the treatment of complicated urinary tract infections].

作者信息

Ohmori H, Kumon H, Kumamoto Y, Sakai S, Niijima T, Kishi H, Ohkoshi M, Kawamura N, Naide Y, Nishiura T

出版信息

Jpn J Antibiot. 1986 Jan;39(1):24-56.

PMID:3517407
Abstract

A well-controlled comparative study was conducted in order to evaluate the efficacy, safety and usefulness of the monobactam antibiotic aztreonam (AZT) in complicated urinary tract infections (UTI) using cefoperazone (CPZ) as the control drug. Patients with complicated UTI due to Gram-negative bacteria were examined. However, in polymicrobial infections, the cases caused by Gram-negative and Gram-positive bacteria were also examined. Both drugs were administered 1 g, twice a day by intravenous drip infusion for 5 days. Overall clinical efficacy was evaluated by the criteria proposed by the UTI committee in Japan. Of the total 394 cases, the clinical efficacy was evaluated for 152 cases in the AZT group and 143 cases in the CPZ group excluding 99 cases of exclusion or dropout. There was no statistically significant difference in the back ground characteristics between the 2 groups. The overall clinical efficacy rate was 55.3% for AZT and 55.2% for CPZ with difference not significant. As for clinical efficacy, in the monomicrobial infection after postprostatectomy (G-2), AZT was superior to CPZ (P less than 0.05), whereas in the polymicrobial infection without indwelling catheter (G-6), CPZ was superior to AZT (P less than 0.1). The overall bacteriological eradication rate was 77.2% for AZT and 74.5% for CPZ. For Gram-negative bacteria only the eradication rate for AZT (83.2%) was superior to that for CPZ (74.6%). This was probably due to the stability of AZT to beta-lactamase. Side effects were observed in 3 cases out of 201 in the AZT group and 5 cases out of 189 in the CPZ group. No severe abnormal laboratory finding was observed in any group; there was no significant difference between the 2 groups. Consequently, AZT was judged to be an antibiotic with clinical usefulness equal to, or even superior to that of CPZ.

摘要

为了评估单环β-内酰胺类抗生素氨曲南(AZT)在复杂性尿路感染(UTI)中的疗效、安全性和实用性,以头孢哌酮(CPZ)作为对照药物进行了一项严格对照的比较研究。对革兰氏阴性菌引起的复杂性UTI患者进行了检查。然而,在混合感染中,由革兰氏阴性菌和革兰氏阳性菌引起的病例也进行了检查。两种药物均通过静脉滴注给药,剂量为1g,每日两次,共5天。根据日本UTI委员会提出的标准评估总体临床疗效。在总共394例病例中,排除99例排除或退出病例后,对AZT组的152例和CPZ组的143例进行了临床疗效评估。两组的背景特征在统计学上无显著差异。AZT的总体临床有效率为55.3%,CPZ为55.2%,差异不显著。至于临床疗效,在前列腺切除术后的单一微生物感染(G-2)中,AZT优于CPZ(P<0.05),而在无留置导管的混合微生物感染(G-6)中,CPZ优于AZT(P<0.1)。AZT的总体细菌清除率为77.2%,CPZ为74.5%。仅对于革兰氏阴性菌,AZT的清除率(83.2%)优于CPZ(74.6%)。这可能是由于AZT对β-内酰胺酶的稳定性。AZT组201例中有3例出现副作用,CPZ组189例中有5例出现副作用。两组均未观察到严重的实验室异常结果;两组之间无显著差异。因此,AZT被判定为一种临床实用性与CPZ相当甚至优于CPZ的抗生素。

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