Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Enterococcus faecalis Pseudomonas aeru- ginosa, Enterobacter cloacae, Citrobacter freun- Fig.
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1 Key words : cefluprenam, seven days therapy, respiratory tract infection
2 Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Enterococcus faecalis Pseudomonas aeru- ginosa, Enterobacter cloacae, Citrobacter freun- Fig. 1 Chemical structure
3
4 4) Granule-colony stimulating factor (G- streptomycin, kanamycin, rifampicin, enviomycin, lividomycin, ca- CSF)
5
6 Table 1 Items and schedule of laboratory tests
7 Table 2 An evaluation criterion for pathogenecity of a bacterium isolated from a clinical specimen (A modified evaluation criterion based on the proposal by Dr. Masatoshi Konno at the urgent seminor in the 42th gereral meeting of Japan Society of Chemotherapy)
8 Fig. 2 Case disposition Table 3 Reasons for exclusion from the evaluation
9 Table 4 Baseline characteristics of the cases
10 Table 5 Clinical efficacy by type of infection and severity 1) 95% confidence interval for efficacy rate : 84.8 `98.3% 2) 95% confidence interval for efficacy rate : 86.8 `99.5% Efficacy rate= excellent+good/ no. of cases Table 6 Clinical efficacy in chronic respiratory infections by diagnosis Efficacy rate= excellent+good/ no. of cases
11 Table 7 Clinical efficacy by causative organisms Efficacy rate= excellent+good/ no. of cases Table 8 Bacteriological response by causative organisms Eradication rate= eradicated/ no. of strains
12 Table 9 Adverse drug reactions Table 10 Laboratory findings Table 11 Safety Safety rate= no problem/ no. of cases Table 12 Usefulness Usefulness rate= very useful+useful/ no. of cases
13 Table 13 Recurrence rate by type of infection Table 14 Recurrence rate on cases where any oral antibiotic was used for assuring clinical efficacy with CFLP after finishing the administration of CFLP
14 Table 15 Reasons for use of antibiotics after finishing the administration of CFLP
15
16 1) Watanabe N, Hiruma R, Katsu K : In vitro evaluation of E1077, a new cephalosporin with a broad antibacterial apectrum, Antimicrob. Agents Chemother, 1992, 36 : ) Hata K, Otsuki M, Nishino T : In vitro and in vivo antibacterial activities of E1077, a novel parenteral cephalosporin with a broad antibacterial spectrum, Antimicrob. Agents Chemother, 1992, 36 : ) Toyosawa T, Miyazaki S, Tsuji A, Yamaguchi K, Goto S : In vitro and in vivo antibacterial activities of E1077, a novel parenteral cephalosporin. Antimicrob. Agents Chemother
17 Usefulness of 7 Day Therapy with Cefluprenam in the Management of Respiratory Tract Infections Kaoru SHIMADA Department of Internal Medicine, Tokyo Senbai Hospital Mitsuhide OHMICHI & Hiroko SASAKI Department of Respiratory Diseases, Sapporo Hospital of Hokkaido Railway Company Akira WATANABE Department of Respiratory Medicine, Institute of Department, Aging and Cancer, Tohoku University Kazuo SATO Department of Internal Medicine, Sato Hospital Kosaku NAGAI Department of Internal Medicine, Furukawa City Hospital Kazuki KONISHI Department of Internal Medicine, Sendai Open Hospital Takashi OHTA & Yoshifumi MATSUURA Department of Respiratory Diseases, Ohta General Medical School, Ohtanishinouchi Hospital Hideki IKEDA Department of Internal Medicine, Nagai City General Hospital Kenichi IGARASHI Second Department of Internal Medicine, Niigata University School of Medicine Fumihide IWATA Department of Internal Medicine, Sado General Hospital Koichi WADA & Michio MARUYAMA Department of Internal Medicine, National Sanatorium Nishi-Niigata Central Hospital Shigeyuki HOSHINO & Akira IWASHIMA Department of Internal Medicine, Koseiren Nagaoka Central General Hospital Yasutoshi SUZUKI & Osamu SEKINE Department of Internal Medicine, Suibarago Hospital Nobuki AOKI Department of Internal Medicine, Shinrakuen Hospital Saburo IZUMI Department of Internal Medicine, Toyama Prefectural Central Hospital Toshio NAKAMURA & Toshiki IWABUCHI Department of Internal Medicine, St.Marianna University School of Medicine, Yokohama City Seibu Hospital Harumi SHISHIDO & Shoko TANOUE Department of Respiratory Diseases, National Sanatorium Tokyo Hospital Yuko KOMASE Department of Internal Medicine, St.Marianna University School of Medicine, Toyoko Hospital Iwao SAKURAI Department of Internal Medicine, Kanagawa Prefecture Midwives and Nurses Training School Hospital Kenji KASAI, Hiroyuki TERAWAKI, Michihiro TSUKUI, Keita HIRANO & Hiroyuki TANIGUCHI Department of Internal Medicine, Fuji City Central Hospital Junya IKUTA, Akira YAMAGISAWA & Kunihiko GOTOH Division of Respiratory Diseases, Tosei Public Hospital
18 Masashi YAMAMOTO, Mitsuo SATO & Akihisa KUMASAWA Department of Internal Medicine, Nagoya Ekisaikai Hospital Takashi SONODA Department of Internal Medicine, Ashiya Municipal Hospital Jiro OKIMOTO, Mak oto KIMURA, Hirohide YONEYAMA, Takayuki KARINO, Kazue FUJITA & Hideo OHBA Department of Internal Medicine, Kawasaki Medical School, Kawasaki Hospital Takashi TSUYA & Akimasa OHUNE Department of Respiratory Diseases, Chugoku Rosai Hospital Kohya SHIBA Second Department of Internal Medicine, The Jikei university, School of Medicine Akira SAITOH College of Medical Technology, Hokkaido university Hiroyuki KOBAYASHI The First Department of Internal Medicine, Kyorin university, School of Medicine Toshiharu MATSUSHIMA Division of Respiratory Diseases, Kawasaki Medical university Shigeru KOH NO Department of Internal Medicine, Nagasaki university, School of Medicine Efficacy and safety of a newer injectable cephalosporin, cefluprenam (CFLP) on cases with bacterial pneumonia and chronic respiratory tract infections were evaluated at a dose of 1g (potency), d.i.d for 7 days. 1. Of 130 cases in total, 116 cases were enrolled for the clinical efficacy evaluation. The efficacy rate (excellent and good responses) was 94.8% (110/116). The efficacy rate was 93.8% (60/64) for cases with bacterial pneumonia, and 96.2% (50/52) for cases with chronic respiratory tract infections. The recurrence was noted in 1.2% (1/82). The bacteriological response rate was 100.0% (32/32) for gram possitive cocci, 93.8% (15/16) for gram negative rods and 97.9% (47/48) in total. 2. Adverse drug reactions were noted in 3.9% (5/129), consisting of 2 cases with skin rash, 1 case with drug fever, 1 case with skin rash and skin itching and 1 case with drug fever and headache. The abnormal laboratory changes were noted in 23.6% (30/127), mainly containing the elevation in GPT and GOT, and eosinophylia. The safety rate (no problem evaluation) was 74.8% (95/127). 3. The usefulness rate (very useful and useful evaluations) was 93.1% (108/116). As suggested by the evaluation on the secondary endpoint in the phase III comparative studies with both bacterial pneumonia and chronic respiratory tract infections, it was confirmed that the 7 day therapy of CFLP was promising for treatment of moderate bacterial pneumonia and chronic respiratory tract infectons, because the high clinical efficacy was obtained and also the incidence of allergic reactions with CFLP was almost the same as that of ceftazidime (CAZ) evaluated highly safe. Based on these results, it was concluded that CFLP was useful in the management of moderate respiratory tract infections and also the recommended therapeutic period with CFLP was within 7 days.
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