a randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis:一项随机,双盲研究比较5天口服吉米沙星患者7天口服左氧氟沙星治疗慢性支气管炎急性发作.pdfVIP
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a randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis:一项随机,双盲研究比较5天口服吉米沙星患者7天口服左氧氟沙星治疗慢性支气管炎急性发作
ARTICLE IN PRESS
Respiratory Medicine (2004) 98, 697–707
A randomized, double-blind study comparing 5 days
oral gemifloxacin with 7 days oral levofloxacin
in patients with acute exacerbation of
chronic bronchitis $
S. Sethia,*, C. Fogartyb, A. Fulambarkerc
aPulmonary and Critical Care Medicine, University at Buffalo, State University of New York,
Buffalo, NY, USA
bSpartanburg Pharmaceutical Research, 126 Dillon Drive, Spartanburg, SC, USA
cDivision of Pulmonary Medicine, Chicago Medical School/Finch University of Health Sciences,
3001 Green Bay Road, North Chicago, IL, USA
Received 13 February 2004; accepted 17 March 2004
KEYWORDS Summary Objective: To demonstrate that 5 days of treatment with a new
Gemifloxacin; fluoroquinolone, gemifloxacin, is at least as effective as 7 days of treatment with
Acute exacerbation of levofloxacin in adult patients with acute exacerbation of chronic bronchitis (AECB).
chronic bronchitis; Design: Randomized, double-blind, double dummy, multicentre, parallel group study
Setting: Sixty different medical centers in US, UK and Germany.
Clinical trial;
Material and methods : A total of 360 adults ( 440 years of age) with AECB were
Levofloxacin;
randomly assigned to receive gemifloxacin 320 mg once daily for 5 days or
Respiratory tract infection levofloxacin 500 mg once daily for 7 days. The primary efficacy parameter was a
clinical response at follow-up (Days 14–21).
Results: In total, 335/360 patients completed the study (93.1%). Seven patients
receiving gemifloxacin withdrew from the study compar
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