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左氧氟沙星500mg片日1次治疗下呼吸道感染和泌尿道感染的非对照、开放、多中心临床研究 预览 被引量:23

An open-label,uncontrolled,multicenter study to evaluate the efficacy and safety of oral levofloxacin 500 mg once daily in patients with lower respiratory tract infections or urinary tract infections
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摘要 目的评价左氧氟沙星500mg片剂日1次的治疗方案对轻中度社区获得性下呼吸道感染和尿路感染的疗效与安全性。方法本研究为前瞻性、非对照、开放、多中心临床试验,以左氧氟沙星片剂500mg日1次口服,不同疗程治疗社区获得性肺炎、慢性支气管炎急性发作、急性单纯性下尿路感染、急性肾盂肾炎、反复发作性尿路感染与复杂性尿路感染患者,观察其临床征象、实验室检查、影像学改变及微生物学检查等,评价该治疗方案的安全性和疗效。结果共入选病例1266例,其中全分析集1245例,符合方案集1082例,安全性分析集1245例。在符合方案集中左氧氟沙星治疗各类感染结束后7~14d的疗效评价中,社区获得性肺炎、慢性支气管炎急性发作、急性单纯性下尿路感染、急性肾盂肾炎、反复发作性尿路感染和复杂性尿路感染的临床有效率分别为96.8%(306/316)、96.0%(360/375)、93.7%(74/79)、98.7%(76/77)、94.9%(93/98)和96.0%(24/25);微生物学有效率分别为98.4%(120/122)、95.1%(136/143)、97.6%(41/42)、94.1%(48/51)、92.3%(24/26)和81.3%(13/16);综合疗效有效率分别为91.7%(289/315)、87.2%(328/376)、93.5%(72/77)、89.7%(70/78)、86.7%(85/98)和69.2%(18/26)。临床不良反应发生率为17.3%(215/1245),主要有头晕、恶心和失眠等;与药物相关的实验室异常发生率为15.7%(191/1213),主要有白细胞计数减少和肝酶升高等。不良反应多呈轻度和一过性,因不良反应中停者为2.7%,未发生与药物相关的严重不良事件。结论左氧氟沙星500mg片日1次不同疗程的给药方案治疗社区获得性下呼吸道感染与尿路感染患者获良好疗效,不良反应轻微,耐受性良好。 Objective To evaluate the efficacy and safety of oral levofloxacin 500 mg once daily in the treatment of patients with community acquired lower respiratory tract infections (LRTIs) or urinary tract infections (UTIs),a prospective,uncontrolled,open-label,multi-center study was conducted.Methods Patients with community acquired pneumonia (CAP),acute exacerbation of chronic bronchitis (AECB),acute uncomplicated lower urinary tract infection (LUTI),acute pyelonephritis (APN),recurrent urinary tract infection (UTI) or complicated UTI were treated by levofloxacin 500 mg tablet once daily.Results Among the 1 266 patients enrolled,1 245 were included in full analysis set (FAS) and 1 082 were included in the per protocol set (PPS).The safety analysis population was identical to the FAS population.At test of cure (day 7-14 after the end of treatment) among the PPS population,the clinical efficacy rates of CAP,AECB,LUTI,APN,recurrent UTI and complicated UTI were 96.8% (306/316),96.0% (360/375),93.7% (74/79),98.7% (76/77),94.9% (93/98) and 96.0% (24/25),respectively.The bacteriological efficacy rates were 98.4% (120/122),95.1% (136/143),97.6% (41/42),94.1% (48/51),92.3% (24/26) and 81.3% (13/16),respectively.The overall efficacy rates were 91.7% (289/315),87.2% (328/376),93.5% (72/77),89.7% (70/78),86.7% (85/98) and 69.2% (18/26),respectively.The incidence of drug-related adverse reactions (ADRs) was 17.3% (215/1 245).The most common ADRs were dizziness,nausea and insomnia.The incidence of drug-related laboratory abnormalities was 15.7% (191/1 213) with 'WBC decreased','ALT increased' and 'AST increased' being the most frequent.Most events were mild and transient.Only 2.7% of the patients withdrew from the study due to ADRs.No drug-related serious adverse events (SAE) were found.Conclusions The dosing regimen of levofloxacin 500 mg once daily is effective and tolerable for the treatment of LRTIs and UTIs.
作者 黄海辉 张婴元 任振义 郑红光 俞云松 吕晓菊 肖祖克 杨惠芬 修清玉 陈宝元 岳红梅 郝青林 黄健安 马惠 肖伟 郭东阳 司彬 孙圣华 张伟 李其皓 沈华浩 段建 李华茵 姚婉贞 顾俊明 夏前明 应可净 刘翱 杨和平 施敏骅 孙铁英 丁国华 吴国明 HUANG Haihui; ZHANG Yingyuan; REN Zhenyi; ZHENG Hongguang; YU Yunsong; L Xiaoju; XIAO Zuke; YANG Huifen; XIU Qingyu; CHEN Baoyuan; YUE Hongmei; HAO Qinglin; HUANG Jianan; MA Hui; XIAO Wei; GUO Dongyang; SI Bin; SUN Shenghua; ZHANG Wei; LI Qihao; SHEN Huahao; DUAN Jian; LI Huayin; YAO Wanzhen; GU Junming; XIA Qianming; YING Kejing; LIU Ao; YANG Heping; SHI Minhua; SUN Tieying; DING Guohua; WU Guoming.(Institute of Antibiotics; Huashan Hospital; Fudan University; Shanghai 200040; China);
出处 《中国感染与化疗杂志》 CAS 2010年第4期,共10页 Chinese Journal of Infection and Chemotherapy
关键词 左氧氟沙星 下呼吸道感染 尿路感染 levofloxacin lower respiratory tract infection urinary tract infection
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