Efficacy and safety of cefditoren pivoxil for exacerbations of chronic obstructive pulmonary disease: A prospective multicenter interventional study |
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Authors: | Taiga Miyazaki Kiyoyasu Fukushima Kohji Hashiguchi Yuichi Inoue Tomo Mihara Toyomitsu Sawai Naofumi Suyama Tsutomu Kobayashi Akira Kondo Yuichi Fukuda Yosuke Harada Eisuke Sasaki Norihito Kaku Shotaro Ide Takahiro Takazono Tomomi Saijo Kosuke Kosai Yoshitomo Morinaga Hiroshi Mukae |
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Affiliation: | 1. Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan;2. Department of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan;3. Division of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Isahaya, Japan;4. Department of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan;5. Department of Respiratory Medicine, Aino Memorial Hospital, Unzen, Japan;6. Department of Respiratory Medicine, Izumikawa Hospital, Minamishimabara, Japan;7. Department of Respiratory Medicine, Nagasaki Harbor Medical Center, Nagasaki, Japan;8. Department of Respiratory Medicine, Sasebo Chuo Hospital, Sasebo, Japan;9. Department of Respiratory Medicine, JCHO Isahaya General Hospital, Isahaya, Japan;10. Department of Respiratory Medicine, Sasebo City General Hospital, Sasebo, Japan;11. Department of Respiratory Medicine, National Hospital Organization Ureshino Medical Center, Ureshino, Japan;12. Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan |
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Abstract: | Oral antibiotic therapy for patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) usually involves an aminopenicillin with clavulanic acid, a macrolide, or a quinolone. To date, however, the clinical efficacy and safety of the oral cephalosporin cefditoren pivoxil has not been evaluated in Japanese patients with acute exacerbations of COPD. We conducted a prospective, multicenter, single arm, interventional study from January 2013 to March 2017 to determine the efficacy and safety of oral administration of 200 mg cefditoren pivoxil three times daily for 7 days in a cohort of 29 eligible patients from 15 hospitals. The mean age (SD) of participants was 73.1 (8.1) years and 28 had a smoking history (the mean [SD] of smoking index, 1426.7 [931.7]). The primary efficacy endpoint was clinical response (cure rate) at test of cure, which was set at 5–10 days after treatment ceased. Of the 23 patients finally analyzed, cure was achieved in 15 (65.2%), while 8 (34.8%) remained uncured. Previous experience of acute exacerbations significantly affected the cure rate: none of the three patients who had at least two prior exacerbations were cured, while 15 of the 20 patients with one or fewer prior exacerbations were cured (p = 0.032). The microbiological eradication rate was 88.9% at test of cure. During treatment, mild pneumonia was reported as an adverse event in one patient (3.4%) but resolved within 10 days of onset. We conclude that cefditoren pivoxil represents a viable alternative for antibiotic therapy in patients with few prior exacerbations. |
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Keywords: | Corresponding author. Department of Respiratory Medicine, Nagasaki University Hospital, Department of infectious diseases, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan. Chronic obstructive pulmonary disease Cefditoren pivoxil COPD exacerbation COPD chronic obstructive pulmonary disease CRP C-reactive protein EOT end of treatment forced expiratory volume in 1 s FVC forced vital capacity M mucous P purulent PM purulent-mucous TOC test of cure WBC white blood cell |
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