个人中心| | 帮助
高级检索
当前位置： 首页 > 详情页

Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial

| 认领 | 导出 | |

文献详情

资源类型：
WOS体系：
Pubmed体系：

收录情况： ◇ SCIE

作者：
Yuan, Jinyi[1,2] * ; Mo, Biwen[3] ; Ma, Zhuang[4] ; Lv, Yuan[5] ; Cheng, Shih-Lung[6] ; Yang, Yanping[7] ; Tong, Zhaohui[8] ; Wu, Renguang[9] ; Sun, Shenghua[10] ; Cao, Zhaolong[11] ; Wu, Jufang[1,2] ; Zhu, Demei[1,2] ; Chang, Liwen[12] ; Zhang, Yingyuan[1,2,*1] ; Zhao, Li[13] ; Wang, Xiongbiao[14] ; Wang, Xuefen[15] ; Wang, Dexi[16] ; Li, Xiangyang[17] ; Peng, Yiqiang[18] ; Liang, Yongjie[19] ; Liu, Hua[20] ; Xiao, Zuke[21] ; Lv, Xiaoju[22] ; Wu, Shiman[23] ; Dai, Yuanrong[24] ; Huang, Yijiang[25] ; Hu, Zhenghong[26] ; Qiu, Chen[27] ; Li, Xi[28] ; Zhang, Suiyang[29] ; Li, Wenpu[30] ; Liu, Shuang[31] ; Shi, Yi[32] ; Xiong, Chang[33] ; Kuang, Jiulong[34] ; Xiu, Qingyu[35] ; Cui, Shehuai[36] ; Li, Jianguo[37] ; Lin, Qichang[38] ; Huang, Wenxiang[39] ; Wan, Yixin[40] ; Li, Qimangu[41] ; Shen, Ce[42] ; Xiao, Yi[43] ; Wu, Xiaoju[44] ; Chuang, Yin Ching[45] ; Perng, Wann Cherng[46] ; Tsao, Shih-Ming[47] ; Hsu, Jeng-Yuan[48] ; Wang, Chin-Chou[49] ; Wang, Jen-Hsien[50] ; Yeh, Pen-Fang[51] ; Lin, His-Hsun[52] ; Kuo, P. H.[53] ; Lin, Ming-Shian[54] ; Su, Wei-Juin[55] ;
机构： [1]Fudan Univ, Huashan Hosp, Inst Antibiot, 12 Middle Wulumuqi Rd, Shanghai 200040, Peoples R China [2]Minist Hlth, China Key Lab Clin Pharmacol Antibiot, Shanghai, Peoples R China [3]Guilin Med Univ, Dept Resp Med, Affiliated Hosp, Guangxi, Peoples R China [4]Gen Hosp Shenyang Mil Area Command, Dept Resp Med, Shenyang, Liaoning, Peoples R China [5]Peking Univ, Inst Clin Pharmacol, Hosp 1, Beijing, Peoples R China [6]Far Eastern Mem Hosp, Dept Internal Med, New Taipei, Taiwan [7]Cent Hosp Jinan, Dept Resp Med, Jinan, Shandong, Peoples R China [8]Capital Med Univ, Beijing Chao Yang Hosp, Dept Resp Med, Beijing, Peoples R China [9]Cheng Ching Gen Hosp, Dept Chest Med, Taichung, Taiwan [10]Cent S Univ, Xiangya Hosp 3, Dept Resp Med, Changsha, Hunan, Peoples R China [11]Peking Univ, Dept Resp Med, Peoples Hosp, Beijing, Peoples R China [12]TaiGen Biotechnol Co Ltd, Taipei, Taiwan [13]China Med Univ, Shengjing Hosp, Dept Resp Med, Shenyang, Liaoning, Peoples R China [14]Shanghai Univ Tradit Chinese Med, Putuo Hosp, Dept Resp Med, Shanghai, Peoples R China [15]Zhejiang Univ, Affiliated Hosp 1, Dept Resp Med, Zhejiang, Peoples R China [16]Guangzhou Red Cross Hosp, Dept Resp Med, Guangzhou, Guangdong, Peoples R China [17]Fudan Univ, Dept Resp Med, Huadong Hosp, Shanghai, Peoples R China [18]Cent Hosp Changsha, Dept Resp Med, Changsha, Hunan, Peoples R China [19]Tongji Univ, East Hosp, Dept Resp Med, Shanghai, Peoples R China [20]Gansu Prov Peoples Hosp, Dept Resp Med, Lanzhou, Gansu, Peoples R China [21]Jiangxi Prov Peoples Hosp, Dept Resp Med, Nanchang, Jiangxi, Peoples R China [22]Sichuan Univ, West China Hosp, Ctr Infect Dis, Chengdu, Sichuan, Peoples R China [23]Shanxi Med Univ, Affiliated Hosp 1, Dept Resp Med, Taiyuan, Shanxi, Peoples R China [24]Wenzhou Med Univ, Affiliated Hosp 2, Dept Resp Med, Wenzhou, Zhejiang, Peoples R China [25]Hainan Prov Peoples Hosp, Dept Resp Med, Haikou, Hainan, Peoples R China [26]Wuhan Gen Hosp Guangzhou Command, Dept Resp Med, Wuhan, Hubei, Peoples R China [27]Peoples Hosp Shenzhen, Dept Resp Med, Shenzhen, Guangdong, Peoples R China [28]Hainan Med Univ, Affiliated Hosp, Dept Resp Med, Haikou, Hainan, Peoples R China [29]Second Artillery Gen Hosp, Dept Resp Med, Beijing, Peoples R China [30]Hunan Prov Peoples Hosp, Dept Resp Med, Changsha, Hunan, Peoples R China [31]Capital Med Univ, Dept Resp Med, Beijing Anzhen Hosp, Beijing, Peoples R China [32]Nanjing Gen Hosp, Dept Resp Med, Nanjing, Jiangsu, Peoples R China [33]Hubei Univ Med, Taihe Hosp, Dept Resp Med, Shiyan, Hubei, Peoples R China [34]Nanchang Univ, Dept Resp Med, Affiliated Hosp 2, Nanchang, Jiangxi, Peoples R China [35]Changzheng Hosp, Dept Resp Med, Shanghai, Peoples R China [36]Third Mil Med Univ, Daping Hosp, Dept Resp Med, Chongqing, Peoples R China [37]Zhongshan Univ, Affiliated Hosp 2, Dept Resp Med, Zhongshan, Guangdong, Peoples R China [38]Fujian Med Univ, Affiliated Hosp 1, Dept Resp Med, Fuzhou, Fujian, Peoples R China [39]Chongqing Med Univ, Dept Infect Dis, Affiliated Hosp 1, Chongqing, Peoples R China [40]Lanzhou Univ, Affiliated Hosp 2, Dept Resp Med, Lanzhou, Gansu, Peoples R China [41]Xinjiang Med Univ, Affiliated Hosp 1, Dept Resp Med, Xinjiang, Peoples R China [42]Shanghai Jiao Tong Univ, Affiliated Peoples Hosp 6, Dept Resp Med, Shanghai, Peoples R China [43]Peking Union Med Coll Hosp, Dept Resp Med, Beijing, Peoples R China [44]Wuhan Univ, Peoples Hosp, Dept Resp Med, Wuhan, Hubei, Peoples R China [45]Chi Mei Med Ctr, Dept Med Res, Tainan, Taiwan [46]Triserv Gen Hosp, Dept Internal Med, Div Pulm Med, Taipei, Taiwan [47]Chung Shan Med Univ Hosp, Dept Internal Med, Div Chest, Taichung, Taiwan [48]Taichung Vet Gen Hosp, Dept Internal Med, Taichung, Taiwan [49]Kaohsiung Chang Gung Mem Hosp, Div Pulm & Crit Care Med, Dept Internal Med, Kaohsiung, Taiwan [50]China Med Univ Hosp, Dept Internal Med, Div Infect Dis, Taipei, Taiwan [51]Cheng Hsin Gen Hosp, Taipei, Taiwan [52]E Da Hosp, Sect Infect Dis, Dept Med, Kaohsiung, Taiwan [53]Natl Taiwan Univ Hosp, Dept Internal Med, Taipei, Taiwan [54]Ditmanson Med Fdn, Dept Internal Med, Chia Yi Christian Hosp, Chiayi, Taiwan [55]Taipei Vet Gen Hosp, Dept Chest Med, Taipei, Taiwan
出处：
DOI： 10.1016/j.jmii.2017.07.011
ISSN：

关键词： Clinical outcome Community-acquired pneumonia Levofloxacin Nemonoxacin Randomized controlled trial Safety

摘要：
Background/Purpose: Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin in patients with CAP. Methods: A phase 3, multicenter, randomized (2:1) controlled trial was conducted in adult CAP patients receiving nemonoxacin 500 mg or levofloxacin 500 mg orally once daily for 7-10 days. Clinical, microbiological response and adverse events were assessed. Non-inferiority was determined in terms of clinical cure rate of nemonoxacin compared with that of levofloxacin in a modified intention-to-treat (mITT) population. NCT registration number: NCT01529476. Results: A total of 527 patients were randomized and treated with nemonoxacin (n = 356) or levofloxacin (n = 171). The clinical cure rate at test-of-cure visit was 94.3% (300/318) for nemonoxacin and 93.5% (143/153) for levofloxacin in the mITT population [difference (95% CI), 0.9% (-3.8%, 5.5%)]. The microbiological success rate was 92.1% (105/114) for nemonoxacin and 91.7% (55/60) for levofloxacin in the bacteriological mITT population [difference (95% CI), 0.4% (-8.1%, 9.0%)]. The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) (P > 0.05). Conclusion: Nemonoxacin 500 mg once daily for 7-10 days is as effective and safe as levofloxacin for treating adult CAP patients in terms of clinical cure rates, microbiological success rates, and safety profile. identifier: NCT01529476. Copyright (C) 2018, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC.

基金：
Major Research and Development Project of Innovative Drugs under the auspices of Ministry of Science and Technology of China [2008ZX09312-010, 2012ZX09303004-001]; TaiGen Biotechnology Co., Ltd.
语种：
外文
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2018]版：
大类 | 3 区 生物
小类 | 3 区 传染病学 3 区 微生物学 4 区 免疫学
最新[2025]版：
大类 | 3 区 医学
小类 | 3 区 免疫学 3 区 传染病学 3 区 微生物学
JCR分区：
出版当年[2017]版：
Q3 INFECTIOUS DISEASES Q3 MICROBIOLOGY Q4 IMMUNOLOGY
最新[2023]版：
Q1 INFECTIOUS DISEASES Q1 MICROBIOLOGY Q2 IMMUNOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

第一作者：
第一作者机构： [1]Fudan Univ, Huashan Hosp, Inst Antibiot, 12 Middle Wulumuqi Rd, Shanghai 200040, Peoples R China [2]Minist Hlth, China Key Lab Clin Pharmacol Antibiot, Shanghai, Peoples R China
通讯作者：
通讯机构： [1]Fudan Univ, Huashan Hosp, Inst Antibiot, 12 Middle Wulumuqi Rd, Shanghai 200040, Peoples R China [2]Minist Hlth, China Key Lab Clin Pharmacol Antibiot, Shanghai, Peoples R China [*1]Institute of Antibiotics, Huashan Hospital, Fudan University, 12 Middle Wulumuqi Road, Shanghai 200040, China.
推荐引用方式(GB/T 7714)：
Yuan Jinyi,Mo Biwen,Ma Zhuang,et al.Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial[J].JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION.2019,52(1):35-44.doi:10.1016/j.jmii.2017.07.011.
APA：
Yuan, Jinyi,Mo, Biwen,Ma, Zhuang,Lv, Yuan,Cheng, Shih-Lung...&Su, Wei-Juin.(2019).Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial.JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION,52,(1)
MLA：
Yuan, Jinyi,et al."Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial".JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION 52..1(2019):35-44

相关文献

[1]XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial [2]Effects of Juhongtanke oral solution on alleviating the symptoms of community-acquired pneumonia: A multicenter, prospective, randomized controlled trial [3]麒麟丸治疗特发性少弱精子症的多中心、随机双盲对照研究 [4]Establishing Classifiers With Clinical Laboratory Indicators to Distinguish COVID-19 From Community-Acquired Pneumonia: Retrospective Cohort Study. [5]三种中成药在左氧氟沙星基础上辅助治疗社区获得性肺炎(非重症,成人)的成本效果分析 [6]穴位贴敷联合耳穴压豆在社区获得性肺炎的应用研究 [7]温灸刮痧改善社区获得性肺炎的咳嗽症状的临床疗效观察 [8]ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial. [9]Suppression effect and safety of acupuncture on colonic spasm during colonoscopy: a randomized controlled trial [10]宣白承气汤加味治疗老年社区获得性肺炎的临床研究

资源点击量：2018 今日访问量：0 总访问量：645 更新日期：2024-07-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 广东省中医院 技术支持：重庆聚合科技有限公司 地址：广州市越秀区大德路111号