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[诺氟沙星在大肠杆菌对氟喹诺酮类耐药率为10%的地区治疗急性膀胱炎的疗效:一项比较性随机研究]

[Norfloxacine efficacy in acute cystitis in the region with 10% resistance of E. coli to fluoroquinolones: a comparative randomized study].

作者信息

Rafal'skiĭ V V, Malev I V, Derevitskiĭ A V, Kozlov S N, Galkin V V

出版信息

Urologiia. 2009 May-Jun(3):18-21.

Abstract

We have conducted a clinicomicrobiological study the first stage of which consisted in collection of information on uropathogens resistance to fluoroquinolones in 89 females with uncomplicated urinary infections (UI). Sensitivity to antibacterial drugs was determined by the agar dilution test (CLSI, 2007). At stage two of the study we made a prospective multicenter randomized trial including 108 females aged 18-55 years with acute uncomplicated cystitis. The patients were randomized into two groups: group 1 (n = 55) received norfloxacin (400 mg twice a day for 3 days); group 2 (n = 53) received phosphomycin (a single 3.0 g dose). Clinical and microbiological assessment of efficacy and safety was performed before the treatment, on treatment day 5, 10 and 28. Isolation of E. coli strains in the region highly and moderately resistant to cyprofloxacine was rather high--10 and 1.1%, respectively. Before the treatment E. coli was isolated from the urine in 82.4% cases, E. faecalis--5.9%, S. saprophyticus--3.9%, Staphylococcus spp--2.0%, others--< 1%. No significant differences by bacteriological and clinical efficacy were found between the groups. Eradication of the agent and persistent bacteriological response were seen in 100 and 95.2%, 95.8 and 100% patients of groups 1 and 2, respectively. Complete and partial responses were registered in 68.5 and 76%, 76 and 98% patients of groups 1 and 2, respectively. Thus, treatment with norfloxacin in a dose 400 mg twice a day for 3 days and with phosphomycin in a 3.0 g single dose have high clinical and microbiological efficacy in uncomplicated cystitis. Norfloxacin retains clinical and microbiological efficacy in acute uncomplicated cystitis even in conditions of 10% prevalence of fluoroquinolone-resistant strains. We think that there are reasons for revision of criteria of interpretation of uropathogens sensitivity to fluoroquinolones in the treatment of uncomplicated UI.

摘要

我们开展了一项临床微生物学研究,其第一阶段包括收集89例单纯性泌尿系统感染(UI)女性患者尿路病原体对氟喹诺酮类药物耐药性的信息。采用琼脂稀释法(CLSI,2007年)测定对抗菌药物的敏感性。在研究的第二阶段,我们进行了一项前瞻性多中心随机试验,纳入108例年龄在18至55岁之间的急性单纯性膀胱炎女性患者。患者被随机分为两组:第1组(n = 55)接受诺氟沙星(400 mg,每日2次,共3天);第2组(n = 53)接受磷霉素(单次剂量3.0 g)。在治疗前、治疗第5天、第10天和第28天进行疗效和安全性的临床及微生物学评估。该地区对环丙沙星高度和中度耐药的大肠杆菌菌株分离率相当高,分别为10%和1.1%。治疗前,82.4%的病例尿液中分离出大肠杆菌,粪肠球菌为5.9%,腐生葡萄球菌为3.9%,葡萄球菌属为2.0%,其他为<1%。两组之间在细菌学和临床疗效方面未发现显著差异。第1组和第2组分别有100%和95.2%、95.8%和100%的患者病原体根除且细菌学反应持续。第1组和第2组分别有68.5%和76%、76%和98%的患者有完全和部分反应。因此,每日2次服用400 mg诺氟沙星共3天以及单次服用3.0 g磷霉素治疗单纯性膀胱炎具有较高的临床和微生物学疗效。即使在氟喹诺酮耐药菌株患病率为10%的情况下,诺氟沙星在急性单纯性膀胱炎中仍保持临床和微生物学疗效。我们认为有理由修订单纯性UI治疗中尿路病原体对氟喹诺酮类药物敏感性的解读标准。

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