每日一次口服500毫克奈诺沙星治疗急性下尿路感染的临床效用：一项前瞻性开放标签多中心研究
Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study.
作者信息
Du Zhen, Zheng Bo, Chen Shan, Cui Liang, Wu Huilin, Gao Zhan, Yang Jin, Cui Gang, Wang Jiajing, Shu Tiehuan, Feng Ninghan, Qiao Ludong
机构信息
Department of Urology, Beijing Tongren Hospital, Capital Medical University, No 1. Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China.
Institute of Clinical Pharmacology, Peking University First Hospital, Peking University, Beijing, 100034, China.
出版信息
BMC Infect Dis. 2025 Apr 10;25(1):501. doi: 10.1186/s12879-025-10915-5.
BACKGROUND
Urinary tract infection (UTI) is one of the most common infectious diseases requiring convenient and appropriate treatment. Nemonoxacin is active against the common pathogens of UTIs. However, more clinical data are required to further support the utility of 500 mg nemonoxacin once daily in treatment of acute lower UTI.
METHODS
We conducted a prospective, single-arm, open-label, multicenter clinical trial in outpatients with acute lower UTI, including uncomplicated UTI (uUTI), recurrent UTI (rUTI), and complicated UTI (cUTI). The patients were prospectively enrolled to take 500 mg nemonoxacin capsules once daily for 3 days (uUTI and rUTI) or 14 days (cUTI). The baseline data, clinical symptoms, laboratory and microbiological tests were analyzed to evaluate the efficacy and safety of nemonoxacin. The clinical and microbiological efficacy were evaluated using the modified intent-to-treat (mITT) set and microbiologically modified intent-to-treat (m-mITT) set, respectively. The comprehensive efficacy and safety were assessed using microbiologically evaluable (ME) set and safety set (SS), respectively.
RESULTS
A total of 404 patients were enrolled. Majority (90.1%) of the patients were females. More than half (66.3%) of the patients were 20 to 40 years of age, and 19.1% were elderly patients (≥ 60 years). Most (83.2%) of the patients reported two or more urinary tract symptoms. The overall clinical efficacy rate of nemonoxacin was 83.9% (292/348) in mITT set, specifically, 83.9% (186/224) in uUTI, 84.4% (81/96) in rUTI and 89.3% (25/28) in cUTI. The overall microbiological efficacy rate was 76.8% (119/155) in m-mITT set. The overall comprehensive efficacy rate was 73.4% (102/139) in ME set. The incidence of clinical adverse reactions was 7.2% (29/404) in the safety set. Most of the adverse events were mild and transient, including pruritus, nausea, dizziness, and headache. No drug-related serious adverse events were observed.
CONCLUSIONS
Nemonoxacin capsules 500 mg once daily is effective, safe, and well-tolerated for treatment of mild-to-moderate acute lower UTIs in adult outpatients.
TRIAL REGISTRATION
Chinese Clinical Trial Registry (ChiCTR2100046585). Registered on May 22, 2021.
背景
尿路感染（UTI）是最常见的需要便捷且适当治疗的传染病之一。奈诺沙星对UTI的常见病原体具有活性。然而，需要更多临床数据来进一步支持每日一次500mg奈诺沙星治疗急性下尿路感染的效用。
方法
我们对急性下尿路感染的门诊患者进行了一项前瞻性、单臂、开放标签、多中心临床试验，包括单纯性尿路感染（uUTI）、复发性尿路感染（rUTI）和复杂性尿路感染（cUTI）。患者前瞻性入组，每日一次服用500mg奈诺沙星胶囊，疗程3天（uUTI和rUTI）或14天（cUTI）。分析基线数据、临床症状、实验室和微生物学检查结果，以评估奈诺沙星的疗效和安全性。分别使用改良意向性治疗（mITT）集和微生物学改良意向性治疗（m-mITT）集评估临床和微生物学疗效。分别使用微生物学可评估（ME）集和安全性集（SS）评估综合疗效和安全性。
结果
共纳入404例患者。大多数患者（90.1%）为女性。超过一半（66.3%）的患者年龄在20至40岁之间，19.1%为老年患者（≥60岁）。大多数患者（83.2%）报告有两种或更多尿路症状。在mITT集中，奈诺沙星的总体临床有效率为83.9%（292/348），具体而言，uUTI中为83.9%（186/224），rUTI中为84.4%（81/96），cUTI中为89.3%（25/28）。在m-mITT集中，总体微生物学有效率为76.8%（119/155）。在ME集中，总体综合有效率为73.4%（102/139）。在安全性集中，临床不良反应发生率为7.2%（29/404）。大多数不良事件为轻度且短暂，包括瘙痒、恶心、头晕和头痛。未观察到与药物相关的严重不良事件。
结论
每日一次500mg奈诺沙星胶囊治疗成年门诊患者轻至中度急性下尿路感染有效、安全且耐受性良好。
试验注册
中国临床试验注册中心（ChiCTR2100046585）。于2021年5月22日注册。
Zotero 插件