IR@PKUHSC  > 北京大学第一临床医学院  > 临床药理研究所
学科主题临床医学
A Phase II Study of Antofloxacin Hydrochloride, a Novel Fluoroquinolone, for the Treatment of Acute Bacterial Infections
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
2010
DOI10.1159/000317581
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
资助者Anhui Huanqiu Pharmaceutical Co., Ltd., Bengbu, China ; Anhui Huanqiu Pharmaceutical Co., Ltd., Bengbu, China
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
资助者Anhui Huanqiu Pharmaceutical Co., Ltd., Bengbu, China ; Anhui Huanqiu Pharmaceutical Co., Ltd., Bengbu, China
WOS记录号WOS:000283553700005
引用统计
被引频次:9[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/61421
专题北京大学第一临床医学院_临床药理研究所
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
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GB/T 7714
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.
APA Wang, Jin.,Xiao, Yonghong.,Huang, Wenxiang.,Xu, Nan.,Bai, Chunxue.,...&Zheng, Qingshan.(2010).A Phase II Study of Antofloxacin Hydrochloride, a Novel Fluoroquinolone, for the Treatment of Acute Bacterial Infections.CHEMOTHERAPY,56(5),378-385.
MLA Wang, Jin,et al."A Phase II Study of Antofloxacin Hydrochloride, a Novel Fluoroquinolone, for the Treatment of Acute Bacterial Infections".CHEMOTHERAPY 56.5(2010):378-385.
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