CHEMOTHERAPY
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- ねんたろう ひろもり
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1
2 CHEMOTHERAPY
3 VOL.40 S-3
4 CHEMOTHERAPY
5 Table 1. No.of patients studied
6 CHEMOTHERAPY Table 2. Age of patients Minimum age: 16 years old Maximum age: 93 years old Table 3. Severity of illness of patients Table 4. Daily dose and treatment duration
7
8 CHEMOTHERAPY MAY 1992 Table 7. Relation of severity of illness to clinical efficacy classified by daily dose Excellent+good/no. of patients
9 VOL.40 S-3 Table 8. Relation of diagnosis with or without underlying disease and complication to clinical efficacy * Excellent+good/no. of patients ~100
10 CHEMOTHERAPY MAY 1992 Table 9. Clinical efficacy in respiratory tract infection classified by causative organisms * Excellent+good/no. of patients ~100
11 VOL.40 S-3 Table 10. Clinical efficacy in urinary tract infection classified by causative organisms * Excellent+good/no. of patients ~100 Table 11. Relation of daily dose to clinical efficacy (Granule) Excellent+good/no. of patients
12 CHEMOTHERAPY MAY 1992 Table 12. Bacteriological efficacy in respiratory tract infection classified by causative organisms 1) Eradication rate: eradicated+replaced/(no. of patients-unknown) ~100 (Excluded patients in whom bacteriological examination was not done or causative organism(s) could not be identified.) 2) Including 2 patients with normal flora at beginning of treatment and organisms appeared after treatment
13 VOL.40 S-3 Table 13. Bacteriological efficacy in urinary tract infection classified by causative organisms * Eradicated+replaced/(no. of patients-unknown) ~100
14 CHEMOTHERAPY MAY 1992 Table 14. Relation between MIC and bacteriological response in respiratory tract infection No. of strains eradicated / no. of strains isolated Table 15. Organisms appearing after treatment in respiratory tract infection
15 VOL.40 S-3 Table 16. Clinical adverse reactions Incidence in tablet: 3.4% (13/386), granule: 5.9% (4/68), total: 3.7% (17/454)
16 CHEMOTHERAPY MAY 1992 Table 17. Abnormal laboratory findings * According to the draft of criteria proposed by Japan Society of Chemotherapy
17 VOL.40 S-3 Table 18. Usefulness * Markedly useful+useful/no. of patients ~100
18 CHEMOTHERAPY MAY ) Atarashi S, Yokohama S, Yamazaki K, Sakano K, Imamura M, and Hayakawa I: Synthesis and antibacterial activities of optically active ofloxacin and its fluoromethyl derivative. Chem Pharm Bull 35: , ) Une T, Fujimoto T, Sato K, and Osada Y: In vitro activity of DR- 3355, an optically active ofloxacin. Antimicrob Agents Chemother 32: , ) Nakashima M, Uematsu T, Kanamaru M, Okazaki 0, Hashimoto S, and Tachizawa H: Pharmacokinetics of DR-3355, a new quinolone, in healthy volunteers. Program Abstr 28th ICAAC, abst. no. 951, 1988
19 CLINICAL STUDY ON LEVOFLOXACIN IN THE FIELD OF INTERNAL MEDICINE Atsushi Saito, Yoshiteru Shigeno, Yuei Irabu and Hiroshi Fukuhara The First Department of Internal Medicine, School of Medicine, University of the Ryukyus, 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa , Japan Akira Saito, Masumi Tomizawa and Ichiro Nakayama College of Medical Technology, Hokkaido University and Affiliated Hospitals Yohmei Hiraga and Mitsuhide Ohmichi Department of Respiratory Diseases, Sapporo Hospital of Hokkaido Railway Company, Sapporo, Japan Kazuo Takebe The Third Department of Internal Medicine, Hirosaki University School of Medicine Masashi Tamura, Kazuki Konishi, Yoshiaki Mori Akio Mizuno and Akiho Obara The Third Department of Internal Medicine, School of Medicine, Iwate Medical University Tamotsu Takishima and Yasuo Tanno The First Department of Internal Medicine, School of Medicine, Tohoku University Jun-ichi Masakichi Motomiya, Kotaro Oizumi#, Akira Watanabe, Yushi Nakai Saito, Kiyoshi Konno, Satoshi Shindo, Kosaku Nagai and Kazunao Niizuma Department of Internal Medicine, Research Institute for Chest Diseases and Cancer, Tohoku University and Affiliated Hospitals (*The First Department of Internal Medicine, Kurume University, School of Medicine) Masataka Katsu, Hiroshi Hirose and Masatoshi Ishii Department of Internal Medicine, Kasumigaura National Hospital Jingoro Shimada# #, Kohya Shiba, Masaki Yoshida and Osamu Sakai The Second Department of Internal Medicine, The Jikei University School of Medicine (##Department of Microbiology and Institute of Medical Science, St. Marianna University School of Medicine)
20 CHEMOTHERAPY Hiroichi Tanimoto and Kazuo Ohara The Fourth Department of Internal Medicine, The Jikei University School of Medicine Kihachiro Shimizu, Kyoichi Totsuka and Junichi Katahira Department of Internal Medicine, Tokyo Women's Medical College Kaoru Shimada, Hazime Goto, Shinichi Oka, Yoshihisa Ogata, Takashi Inamatsu, Yoshishige Masuda, Hiroshi Sakamoto, Fumiko Kojima, Makoto Kodaira, Yasuyuki Sano and Yasufumi Miyamoto Department of Infectious Disease, Institute of Medical Science, University of Tokyo and Affiliated Hospitals Hiroyuki Kobayashi The First Department of Internal Medicine, School of Medicine, Kyorin University Hideo Ikemoto, Takeshi Mori and Masayoshi Inagaki Department of Internal Medicine, Juntendo University School of Medicine Koichiro Nakata, Yoshitaka Nakamori and Tatsuo Nakatani Devision of Respiratory Diseases, Toranomon Hospital Takeshi Kawai and Mitsuo Honma Department of Internal Medicine, School of Medicine, Keio University Junzaburo Kabe, Koichiro Kudo and Hitoshi Arioka Department of Respiratory Disease, National Medical Center Hospital Masaru Koyama Department of Internal Medicine, Tokyo Kyosai Hospital Harumi Shishido Department of Respiratory Diseases, Tokyo National Chest Hospital Norio Kikuchi and Hidetoshi Igari Department of Internal Medicine, Chiba Kaihin Municipal Hospital Hiroshi Tabeta Department of Internal Medicine, Funabashi Municipal Medical Center Shigeki Odagiri, Kaneo Suzuki, Hiroshi Takahashi, Kenichi Takahashi, Yasuhiko Ashikari, Eri Hagiwara, Yasutsugu Amano and Akira Shohji Department of Respiratory Diseases, Kanagawa Prefectural Circulatory and Respiratory Diseases Center
21 Fumio Matsumoto and Takero Imai Department of Internal Medicine, Kanagawa Prefectural Midwives and Nurses Training School Hospital Shoichiro Irimajiri, Yasuo Matsuoka and Mitsuo Obana Department of Internal Medicine, Kawasaki Municipal Hospital Masaaki Arakawa, Kouichi Wada, Hiroki Tukada and Takashi Kawashima The Second Department of Internal Medicine, Niigata University, School of Medicine Osamu Sekine, Yasutoshi Suzuki and Katsuji Uno Department of Internal Medicine, Suibarago Hospital Nobuki Aoki Department of Internal Medicine, Shinrakuen Hospital Atsuhiko Sato, Masatoshi Iwata, Kingo Chida, Izumi Shichi, Hirokazu Okano, Masahiko Okano and Masami Taniguchi The Second Department of Internal Medicine, Hamamatsu University, School of Medicine and Affiliated Hospitals Tatsuo Satake, Kenzo Takagi, Kenichi Yamaki and Hiroyuki Miyatake The Second Department of Internal Medicine, Nagoya University School of Medicine Toshiyuki Yamamoto, Kanzo Suzuki, Satoru Adachi and Toru Matsuura Department of Internal Medicine, Nagoya-shi Koseiin Geriatric Hospital Fumiyuki Kuze, Tatsuyoshi Ikeue, Katsuhiro Suzuki, Kenji Bando, Masaru Chiba, Yoshinori Hasegawa, Ryuhei Nawata, Nobuo Inaba, Akira Kagioka and Mitsuo Hase The First Clinic of Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals Eiro Tsubura###, Masaru Nakagawa, Susumu Kishimoto, Nakaaki Osawa, Iwao Igarashi, Kiyoshi Komuta, Keiji Maeda, Mitsunori Sakatani, Toshio Sone, Yasutake Takahashi, Tatsuya Okada, Mitsumasa Ogawara, Kazuya Higashino and Takashi Nakano Department of Internal Medicine, Toneyama National Hospital and Affiliated Hospitals (### Osaka Hospital, Anti-Tuberculosis Association Osaka Branch) Fumio Miki Department of Internal Medicine, Tane General Hospital Shigenori Nakashima, Atsushi Yasukawa The Fourth Department of Internal Medicine, Kinki University School of Medicine
22 CHEMOTHERAPY Nobuhiro Narita, Masayoshi Sawaki and Keiichi Mikasa The Second Department of Internal Medicine, Nara Medical College Rinzo Soejima, Niro Okimoto and Masaru Sumi Division of Respiratory Disease, Department of Medicine, Kawasaki Medical School Toshiharu Matsushima and Yoshihiko Tano The Second Department of Medicine, Kawasaki Medical School Kawasaki Hospital Takao Sasaki, Yukio Matsumoto and Yuji Sugimoto The Third Department of Internal Medicine, Tottori University, School of Medicine Michio Yamakido and Kenji Hasegawa The Second Department of Internal Medicine, Hiroshima University, School of Medicine Osamu Kurimura Department of Internal Medicine, Kure National Hospital Yoshiro Sawae, Koji Takagi and Nobuyuki Shimono School of Health Science, and First Department of Internal Medicine, Faculty of Medicine, Kyushu University Atsushi Shinoda, Tsuneo Ishibashi and Masahiro Takamoto Department of Internal Medicine, Ohmuta National Hospital Hozumi Yamada, Osamu Kato, Yosuke Aoki and Shigetaka Kuroki Department of Internal Medicine, Saga Medical School Kohei Hara, Hironobu Koga, Kiyoyasu Fukushima, Hisasuke Nakamura, Tetsuro Kanda, Miyako Ishiguro, Takakazu Kiya and Shiro Kusano The Second Department of Internal Medicine, School of Medicine, Nagasaki University and Affiliated Hospitals Keizo Matsumoto, Hironori Masaki and Hirofumi Tanaka Department of Internal Medicine, Institute of Tropical Medicine, Nagasaki University Masaru Nasu, Yoichiro Goto, Hiroyuki Nagai, Toru Yamasaki and Takayoshi Tashiro The Second Department of Internal Medicine, Medical College of Oita Shinobu Takenaka and Kiyoshi Shima Department of Internal Medicine, Kumamoto Municipal Hospital Mitsuo Kaku, Kazuyuki Sugawara and Keizo Yamaguchi # # # # Clinical Laboratory, Nagasaki University Hospital
23 Levofloxacin (LVFX), an optical isomer of ofloxacin (OFLX), is twice as potent as OFLX against gram-positive and gram-negative bacteria such as Haemophilus influenzae, Streptococcus pneumoniae and Pseudomonas aeruginosa, while it has been shown to be as safe as OFLX in animal experiments. Phase 1 study showed that the pharmacokinetics of LVFX were similar to those of OFLX. We carried out a multicenter collaborative trial at 69 institutions to determine the clinical efficacy and safety of LVFX in the field of internal medicine, mainly in the treatment of respiratory tract infections. LVFX was orally administered to 463 patients in daily doses of 200 mg to 600 mg for 7 to 14 consecutive days. Out of the total patients enrolled, the clinical efficacy was evaluated in 423 patients and was 84.9% (321/378) against respiratory tract infections, 78.8% (26/33) against urinary tract infections, 100% (9/9) against infectious enteritis and 100% (3/3) against other infections. As for respiratory tract infections, the efficacy rate was 90.6% (77/85) for pharyngitis and tonsillitis, 80.2% (174/217) for infectious exacerbation of chronic respiratory disease and 91.8% (67/73) for pneumonia. The efficacy rate, as a function of the daily dose, was 79.2% (38/48) with 100mg b.i.d., 85.5% (253/296) with 100mg t.i.d., 87.7% (50/57) with 200mg t.i.d., and 81.8% (18/22) with other dose regimens. The bacteriological response was evaluated in 179 patients and showed an eradication rate of 77.4% (123/159) for monomicrobial infections and 40.0% (8/20) for polymicrobial infections. The MIC was determined for 78 strains, and the eradication rate was 78.9% (56/71) for strains with an MIC value of 1.56 pg/ml or lower and 0.0% (0/7) for strains with an MIC value of 3.13,ug/ml or higher. Out of 454 patients, clinical adverse reactions were recorded in 17 (3.7%), consisting of gastrointestinal disorder in 9, neurogenic symptoms in 7 and other symptoms in 1. Abnormal laboratory findings were recorded in 41 (10.0%) out of 409 patients, the main item being elevation of the eosinophil count and the transaminase level. None of them were serious. Based on the above results, we concluded that LVFX is a useful antibacterial agent for the treatment of infections in the field of internal medicine, mainly respiratory tract infections.
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