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[硝羟喹啉治疗膀胱炎——NitroxWin:前瞻性、多中心、非干预性研究及微生物耐药性监测]

[Therapy of cystitis with nitroxoline-NitroxWin : Prospective, multicenter, non-interventional study and microbiological resistance surveillance].

作者信息

Wagenlehner Florian, Kresken Michael, Wohlfarth Esther, Bahrs Christina, Grabein Beatrice, Strohmaier Walter Ludwig, Naber Kurt G

机构信息

Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie, Justus-Liebig-Universität, Gießen, Deutschland.

Antiinfectives Intelligence GmbH, Köln, Deutschland.

出版信息

Urologie. 2023 Nov;62(11):1186-1192. doi: 10.1007/s00120-023-02167-5. Epub 2023 Aug 31.

Abstract

BACKGROUND

According to German AWMF S3 guideline nitroxoline is recommended as one of the first-choice antibiotics for treatment of acute uncomplicated cystitis (UC) in women. Under real-world conditions the clinical efficacy of nitroxoline should be checked in a noninterventional, prospective and multicenter study (NIS) and the prevalence of nitroxoline resistance in E. coli be monitored.

MATERIALS AND METHODS

Female patients with UC treated with nitroxoline (recommended dosage 250 mg tid for 5 days) were included by urologists, general practitioners (GPs), and internists in family medicine throughout Germany from April-December 2022 and followed for 21-28 days. The diagnosis and course of therapy were judged by the Acute Cystitis Symptom Score (ACSS) questionnaire and laboratory investigations (leukocyturia etc). Separately, a nationwide resistance surveillance was performed during 2019-2020 in collaboration with 23 laboratories to collect urinary E. coli isolates and test their susceptibility to nitroxoline.

RESULTS

Of the 316 patients with mean (SD) age of 57.2 (±20.4 [median 62.5]) years who were included in the NIS, 193/248 (86.3%) in the per-protocol group and in 193/263 (81.44%) in the intention-to-treat group were clinically successful. Furthermore, 96% of the patients rated the tolerability of nitroxoline as "very good" or "good". All 272 E. coli isolates tested were susceptible to nitroxoline.

CONCLUSIONS

Nitroxoline showed very good clinical results in the NIS, and 100% of the tested E. coli urine isolates were susceptible to nitroxoline. Nitroxoline can still be recommended as one of the first-choice antibiotics for treatment of UC in women.

摘要

背景

根据德国AWMF S3指南,硝羟喹啉被推荐为治疗女性急性单纯性膀胱炎(UC)的首选抗生素之一。在现实世界条件下,应通过一项非干预性、前瞻性多中心研究(NIS)来检验硝羟喹啉的临床疗效,并监测大肠杆菌中硝羟喹啉耐药性的流行情况。

材料与方法

2022年4月至12月期间,德国各地的泌尿科医生、全科医生(GPs)和家庭医学内科医生纳入了接受硝羟喹啉治疗(推荐剂量250mg,每日三次,共5天)的UC女性患者,并随访21至28天。通过急性膀胱炎症状评分(ACSS)问卷和实验室检查(白细胞尿等)来判断诊断和治疗过程。另外,在2019年至2020年期间,与23个实验室合作进行了一项全国性耐药性监测,以收集尿液大肠杆菌分离株并检测它们对硝羟喹啉的敏感性。

结果

纳入NIS的316例患者,平均(标准差)年龄为57.2(±20.4[中位数62.5])岁,按方案组中193/248(86.3%)以及意向性治疗组中193/263(81.44%)临床治疗成功。此外,96%的患者将硝羟喹啉的耐受性评为“非常好”或‘好’。所有检测的272株大肠杆菌分离株均对硝羟喹啉敏感。

结论

在NIS中,硝羟喹啉显示出非常好的临床效果,并且100%的检测尿液大肠杆菌分离株对硝羟喹啉敏感。硝羟喹啉仍可被推荐为治疗女性UC的首选抗生素之一。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da51/10630225/8cac8e574e69/120_2023_2167_Fig1_HTML.jpg

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