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学科主题: 临床医学
题名:
A Phase II Study of Antofloxacin Hydrochloride, a Novel Fluoroquinolone, for the Treatment of Acute Bacterial Infections
作者: Wang, Jin1; Xiao, Yonghong1; Huang, Wenxiang2; Xu, Nan3; Bai, Chunxue4; Xiu, Qingyu5; Mei, Changlin6; Zheng, Qingshan7
关键词: Antofloxacin hydrochloride ; Levofloxacin hydrochloride ; Acute exacerbation of chronic bronchitis ; Acute pyelonephritis
刊名: CHEMOTHERAPY
发表日期: 2010
DOI: 10.1159/000317581
卷: 56, 期:5, 页:378-385
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology ; Pharmacology & Pharmacy
研究领域[WOS]: Oncology ; Pharmacology & Pharmacy
关键词[WOS]: DOUBLE-BLIND ; CHRONIC-BRONCHITIS ; ACUTE EXACERBATIONS ; MALE-VOLUNTEERS ; PHARMACOKINETICS ; PYELONEPHRITIS ; CIPROFLOXACIN ; GATIFLOXACIN ; LEVOFLOXACIN
英文摘要:

Aims: To evaluate the clinical and bacterial efficacies and the safety of antofloxacin hydrochloride tablets in the treatment of acute exacerbations of chronic bronchitis (AECB) and acute pyelonephritis (AP). Patients and Methods: A randomized, controlled, multicenter, double-blind, double-dummy clinical trial was conducted at 6 hospitals in China. The patients in the investigational group took an oral 400-mg loading dose of antofloxacin on the first day followed by 200 mg daily. Control group patients took 200 mg of levofloxacin orally twice daily for 7-14 days. Results: A total of 284 patients were enrolled into the study, including 140 cases of AECB and 144 cases of AP; 141 patients were in the antofloxacin group and 143 patients were in the levofloxacin group. Two hundred fifty-four patients completed the entire treatment and follow-up and comprised the per-protocol analysis data set; 30 patients were excluded because of informed consent withdrawal, loss to follow-up, protocol violations, or adverse drug events. Treatment was ceased in 3 patients in the antofloxacin group and in 1 patient in the levofloxacin group because of skin rashes, dizziness, or adverse gastrointestinal effects. At the end of the 2-regimen treatment, the observed effectiveness rates for AECB were 90.3 and 87.7% for the treatment and control groups, respectively, and 96.9 and 92.1% for AP. The overall bacterial eradication rates were 95.9 and 92.4%, and drug-related adverse events were observed in 13.1 and 10.1% of patients, respectively. There were no severe adverse effects. No statistical differences in drug efficacy and safety were detected between the 2 treatment groups (p > 0.05). Conclusions: Antofloxacin hydrochloride is an effective and well-tolerated new fluoroquinolone that demonstrates clinical and bacteriological efficacies similar to levofloxacin for the treatment of AECB and AP. Copyright (C) 2010 S. Karger AG, Basel

语种: 英语
项目资助者: Anhui Huanqiu Pharmaceutical Co., Ltd., Bengbu, China
WOS记录号: WOS:000283553700005
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/61421
Appears in Collections:北京大学第一临床医学院_临床药理研究所_期刊论文

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作者单位: 1.Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China
2.Drug Clin Evaluat Ctr Anhui Prov, Wuhu, Peoples R China
3.Sichuan Univ, W China Hosp, Chengdu 610064, Peoples R China
4.Peking Univ, Inst Clin Pharmacol, Hosp 1, Beijing 100191, Peoples R China
5.Chongqing Univ Med Sci, Affiliated Hosp 1, Chongqing, Peoples R China
6.Second Mil Med Univ, Changzheng Hosp, Shanghai, Peoples R China
7.Zhongnan Univ, Xiangya Hosp 3, Changsha, Hunan, Peoples R China

Recommended Citation:
Wang, Jin,Xiao, Yonghong,Huang, Wenxiang,et al. A Phase II Study of Antofloxacin Hydrochloride, a Novel Fluoroquinolone, for the Treatment of Acute Bacterial Infections[J]. CHEMOTHERAPY,2010,56(5):378-385.
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