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3 Table 1 The list of collaborator clinics
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6 Table 5 Distribution by body weight Table 4 Distribution by age and sex groups Sex : N. S. Age : N. S.
7 Table 6 Diagnosis classified by committee members Table 7 Backgrounds of patients
8 CHEMOTHERAPY 2940 Table Table 9 Comparison 8 Comparison of severity of initial among DEC.1977 symptoms and signs two Fig.1 groups Comparison two groups of clinical judged by committee two groups や や 有 効11例(23.9%),無 1例(2.2%)で among 効10例(21.7%),判 あ り,SBPC投 effectiveness members among 定不能 与 群 に 著効 が や や 多 く, 無 効 が や や 少 い 成 績 を 得 た が,有 意 差 は 認 め られ な か っ た 患 者 を重 症 度別,治 値,起 療 前 の 発 熱 の 有 無,治 療 前 の 赤 沈 炎菌 が Pseudomonas か 混 合 感 染 か,あ で あ るか 否 か,単 一 菌 感 染 る い は ま た 起 炎 菌 の感 受 性 で層 別 し て,両 薬 剤 の効 果 の 比較 を 実 施 し た が,Table に 示 す と お り,い ず れ の層 に お い て も両 薬 剤間 に臨 床 効 果 の 有 意 差 は 認 め られ なか っ た d. 細菌学的効果 薬 剤 投 与 前 の喀 痰 検 査 に よ り起 炎菌 を 決 定 し 得 た78
9 Table 10 Comparison of causative bacteria among two groups (1) Table 11 Comparison of causative bacteria among two groups (2) Table 12 Comparison of MIC against causative bacteria Table 13 Duration of treatment Table 14 Cause of discontinuance of medication
10 Table 15 Clinical effectiveness classified by initial severity Table 16 Clinical effectiveness classified by initial body temperature
11 Table 17 Clinical effectiveness classified by initial ESR Table 18 Comparison of clinical effectiveness in the infections caused by Pseudomonas Table 19 Comparison of clinical effectiveness in the infections caused by bacteria other than Pseudomonas Table 20 Comparison of clinical effectiveness in the single infection
12 Table 21 Comparison of clinical effectiveness in the mixed infection Table 22 Clinical effectiveness classified by initial MIC against causative organisms Table 23 Comparison of bacteriological effectiveness (Figures in the parenthesis indicate percentage.)
13 Table 24 Comparison of bacteriological effectiveness against Hemophilus Table 25 Comparision of bacteriological effectiveness against Pseudomonas (Figures in the parenthesis indicate percentage.) Table 26 Comparison of bacteriological effectiveness against bacteria other than Pseudomonas (Figures in the parenthesis indicate percentage.) Table 27 Comparison of bacteriological effectiveness in the single infection (Figures in the parenthesis indicate percentage.)
14 Table 28 Comparison of bacteriological effectiveness in the mixed infection (Figures in the parenthesis indicate percentage.) Table 29 Comparison of bacteriological effectiveness classified by initial MIC (1) Table 30 Comparison of bacteriological effectiveness classified by initial MIC (2)
15 Fig. 2 Degree of improvement of body temperature
16 Fig. 3 Degree of improvement of cough
17 Fig. 4 Degree of improvement of volume of sputum Fig. 5 Degree of improvement of property of sputum
18 Fig. 6 Degree of improvement of dyspnea Fig. 7 Degree of improvement of chest pain
19 Fig. 8 Degree of improvement of rales Fig. 9 Degree of improvement of cyanosis
20
21 Fig. 12 Degree of improvement of WBC counts
22 Fig. 13 Degree of improvement of ESR
23 Fig. 14 Degree of improvement of CRP Fig. 15 Clinical effectiveness judged by doctors in charge among two groups
24 Table 31 Side effects (Cases adopted by committee members)
25 1) STAPLEY, E. O. ; D. HENDLIN, J. M. MATA, M. JACKSON, H. WALLICK, S. HERNANDEZ, S. MOCHALES, S. A. CURRIE & R. M. MILLER : Phosphonomycin. I. Discovery and in vitro biological characterization. Antimicr. Agents & Chemoth : , ) HENDLIN, D. ; B. M. FROST, E. THIELE, H. KROPP, M. E. VALIANT, B. PELAK, B. WEISS- BERGER, C. CORNIN & A. K. MILLER : Phosponomycin. III. Evaluation in vitro. Antimicr. 3) KESTLE, D. G. & WILLIAM, M. M. KIRBY : Clinical pharmacology and in vitro activity
26 6) SIEGEL, S. : Nonparametric statistics for the behavioral sciences. p , McGraw-Hill, Kogakusha 7) SIEGEL, S. : Nonparametric statistics for the behavioral sciences. p , McGraw- Hill, Kogakusha 8) SIEGEL, S. : Nonparametric statistics for the COMPARATIVE TEST OF THE EFFECTIVENESS OF FOSFOMYCIN Na AND SULBENICILLIN Na ON CHRONIC RESPIRATORY TRACT INFECTION BY SINGLE BLIND METHOD FUMIO MIKI, MICHIHIDE KAWAI, KENJI KUBO and KENZO SHIOTA The First Department of Internal Medicine, Osaka City University Medical School YASUMICHI KATO, MASUMI TOMIZAWA, ICHIRO NAKAYAMA, AKIRA SAITO and KIYOBUMI ISHIKAWA The Second Department of Internal Medicine, Hokkaido University, School of Medicine and Related Hospitals FUMIO NAGAHAMA, TAKEHITO NAKABAYASHI, SHINYA YASUDA, TETSUSHI KOROKU and MASASHI YAMAMOTO Department of Respiratory Disease, Sapporo National Hospital KIYOSHI KONNO and IZUMI HAYASHI Division of Internal Medicine, The Research Institute for Tuberculosis and Cancer, Tohoku University KIHACHIRO SHIMIZU Department of Internal Medicine, University of Tsukuba TEPPEI KUMADA Department of Internal Medicine, Tokyo Women's Medical College KEIMEI MASHIMO, OTOHIKO KUNII and KAZUFUTO FUKAYA Department of Internal Medicine, Institute of Medical Science, University of Tokyo YASUSHI UEDA, FUMIO MATSUMOTO and ATSUSHI SAITO The Second Department of Internal Medicine, The Jikei University, School of Medicine KEIICHI NAKAGAWA, JUNZABURO KABE and KENTARO WATANABE Department of Internal Medicine, Tokyo Kyosai Hospital
27 HIROICHI TANIMOTO and HIDEAKI KAMATA Chest Clinic of Toranomon Hospital HIDEO IKEMOTO and KAZUYOSHI WATANABE Department of Internal Medicine, Juntendo University, School of Medicine KOKICHI FUKUSHIMA, AKIRA ITO and RYUICHIRO YAMAZAKI The First Department of Internal Medicine, Yokohama City University, School of Medicine IPPEI FUJIMORI, SACHU SHIMADA and NOBUYUKI GONDA Department of Internal Medicine, Kawasaki Municipal Hospital MASATAKA KATSU and HISASHI TAKIZUKA Department of Internal Medicine, Kasumigaura National Hospital TOMOKO KABASAWA, SHIRO KAWASHIMA, YASUTOSHI SUZUKI, MORITO IWANAGA, MASATOSHI NIWAYAMA, HAJIMU TAKEDA, FUSANOSUKE YAMASAKU and YASUTAMI KINOSHITA The Second Department of Internal Medicine, Niigata University, School of Medicine OSAMU SEKINE, YOSHIMARU USUDA, NOBUKI AOKI and NOBUHITO WAKABAYASHI Department of Internal Medicine, Shinrakuen Hospital KATSUYUKI KITAHARA and MASANAGA TAKATO Department of Internal Medicine, Nagaoka Chuo Hospital KAORU OYAMA, MASAKI MATSUDA and RYUSAKU SHIMIZU Department of Internal Medicine, Toyama Prefectural Central Hospital TOSHIYUKI YAMAMOTO and SABURO KITAURA The First Department of Internal Medicine, Nagoya City University, School of Medicine HIROSHI OKUBO and YURUKO OKAMOTO The First Department of Internal Medicine, Kansai Medical University NATSUO NISHIZAWA, YUZO KAWAMORI, SHOICHI KAWAMURA and HIROSHI ETO Department of Internal Medicine, Senboku National Hospital and Related Hospital TAKEHIRO TSUJIMOTO and SAKIMORI YAMAGUCHI Department of Internal Medicine, Hoshigaoka Koseinenkin Hospital MICHIAKI KAWANO, MASAO NISHIYAMA, KATSUHITO KOHZAI and EIRO TSUBURA The Third Department of Intertal Medicine, Tokushima University, School of Medicine RINZO SOEJIMA and YOSHIHIKO TANO Division of Respiratory Diseases of Internal Medicine, Kawasaki Medical School KOJI SHINAGAWA Department of Internal Medicine, Chugoku Chuo Hospital KOHEI HARA, MASARU NASU, MASAO NAKATOMI, ATSUSHI SAITO and NOBUOKI MORI The Second Department of Internal Medicine, Nagasaki University, School of Medicine KEIZO MATSUMOTO, YOSHIO UZUKA, YUKIO NOGUCHI and MAKOTO IMAOKA Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University
28 In order to compare the therapeutic effects and side effects of fosfomycin Na (FOM) with those of sulbenicillin Na (SBPC), a comparative clincal trial has been carried out in 115 patients with chronic respiratory tract infections at 25 institutions in Japan. Each of the patients was assigned to either of the drugs at random. Both drugs were administered as intravenous infusions at a dosage of 2g twice daily for 14 days. In each patient, on the basis of detailedly recorded subjective and objective symptoms, laboratory test results and chest X-ray film findings, committee members consisting of several physicians who had not been informed of the drug actually given to each patient made an assessment on the severity, therapeutic results, and presence or absence of side effects. Subsequently, the key code for the drug abministered to each patient was opened and statistical analysis was carried out by making a comparison between the two groups (one received FOM and the other SBPC) with respect to background factors, clinical effectiveness, bacteriological effectiveness, degree of improvement and observed side effects. Out of the 115 cases originally admitted to the trial, 13 cases were excluded because of failure to observe the treating regimen initially established, leaving 102 cases (56 from FOM group and 46 from SBPC group) for analysis. It was indicated that regarding background factors there was no significance between the two groups except that more cases of SBPC group had highly accelerated ESR value and that there were more cases in FOM group which had infections due to Pseudomonas and mixed infections, both with significance. The clinical effectiveness were classified as excellent in 5 and 7 cases in FOM and SBPC group, respectively, as good in 22 and 17 cases ; as fair in 8 and 11 cases, as poor in 21 and 14 cases ; and as undecided in 0 and 1 case, respectively, with no significance. In the bacteriological effectiveness and the degree of improvement, there was no significance which is of importance in a comparison of both drugs. In regard to the incidence of side effects no significance was observed.
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