CHEMOTHERAPY
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1 CHEMOTHERAPY
2 CHEMOTHERAPY
3 VOL.32 S-3 CHEMOTHERAPY 1063 Fig. 1 Chemical structure of AT ethyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)- 1, 8-naphthyridine-3-carboxylic acid sesquihydrate
4 AT Fig. 2 Package of AT-D (AT or PPA) Group PPA Morning Noon Evening Night Group Morning Noon Evening Night
5 VOL.32 S-3 CHEMOTHERAPY 1065
6 CHEMOTHERAPY 1) Evaluation should be made on day 3 and 7 (at the end of the study) after initiation of treatment. 2) Parameters evaluated for acute and chronic suppurative otitis media are as follows. The severity of each parameter is rated on the rating scale shown Table 1 Criteria for efficacy evaluation 4) The improvement rate on day 3 or 7 after initiation of treatment is assessed as follows (Acute and chronic otitis media are evaluated in the same manner.). in parentheses. [Acute] Otalgia:+++ ++(2),+(1),-(0), Feeling of ear obstruction:+++ ++(2),+(1),- (0) Redness of tympanic membrane and/ or mucosa of tympanic cavity:+++(3),++(2),+(1),-(0) Volume of otorrhea:+++(3),++(2),+(1),-(0) [Chronic] Feeling of ear obstruction:+++ ++(2),+(1), Redness of tympanic membrane and/ or mucosa of tympanic cavity:+++(3),++(2),+(1),-(0) Volume of otorrhea:+++(3),++(2),+(1),-(0) Property of otorrhea:+++(3),++(2),+(1),-(0) 3) The rate of improvement on day 3 or 7 (at the end of the study) is calculated according to the following equations applying the differences between scores on day 0 of treatment and on day 3 or 7 (at the end of the study)after initiation of treatment. [Acute] Sum of difference scores for otalgia, feeling of ear obstruction and redness of tympanic membrane Number of positive parameters +Difference score for volume of otorrhea [Chronic] Sum of difference scores for feeling of ear obstruction, redness of tympanic membrane and mucosa of tympanic cavity, and property of otorrhea +Difference Number of positive parameters score for volume of otorrhea 5) Final overall improvement is assessed on the basis of assessments on day 3 and 7 as follows (Acute and chronic otitis media are evaluated in the same manner.). [Note] i) If all symptoms evaluated have disappeared on day 7 after initiation of treatment, the result is rated excellent. ii) It otorrhea has disappeared on day 7 after initiation of treatment the result is rated good regardless of the presence of other symptoms to be evaluated.
7 VOL.32 S-3 CHEMOTHERAPY 1067 Table 2 Criteria for bacteriological evaluation Table 3 Patients studied Table 4 Reason for exclusion (): No. of cases evaluated partially for clinical efficacy Table 5 Reason for drop out
8 CHEMOTHERAPY Table 6 Background characteristics (1) (): No. of cases evaluated partially for clinical efficacy
9 VOL.32 S-3 CHEMOTHERAPY 1069 Table 7 Background characteristics (2) ( ): No. of cases evaluated partially for clinical efficacy
10 Table 8 Organism isolated from otorrhea before treatment ( ): No. of cases evaluated partially for clinical efficacy
11 VOL.32 S-3 CHEMOTHERAPY 1071 Fig. 3 Sensitivity distribution of clinical isolates Table 9 Sensitivity distribution of clinical isolates Inoculum size 106 cells/ml
12 CHEMOTHERAPY Table 10 Clinical effectiveness evaluated by physicians Excellent+ Good / Evaluated patients
13 CHEMOTHERAPY Table 11 Clinical effectiveness evaluated by committee members
14 CHEMOTHERAPY
15 VOL.32 S-3 CHEMOTHERAPY 1075 Table 13 Bacteriological responce
16 CHEMOTHERAPY Table 14 Utility * Markedly satisfactory + satisfactory / Evaluated patients
17 CHEMOTHERAPY Table 15 Degree of improvement of symptoms
18 CHEMOTHERAPY Table 16 Global improvement rating Table 17 Overall safety rating Table 18 Side effects
19 VOL.32 S-3 CHEMOTHERAPY 1079 Table 19 L boratory test
20 CHEMOTHERAPY 1) KOUNO, K.; M. INOUE,& S. MITSUHASHI: In vitro and in vivo antibacterial activity of AT Antimicr. Agents& Chemoth. 24: 78 `84, 1983 A COMPARATIVE DOUBLE BLIND STUDY OF AT WITH PIPEMIDIC ACID IN THE TREATMENT OF SUPPURATIVE OTITIS MEDIA SHUNKICHI BABA, HARUJI KINOSHITA, YOSHITO MORI Nagoya City University, School of Medicine TAKEHIKO IWASAWA HISAKAZU SUGIMORI TAKUJI TOMURA Sapporo Teishin Hospital Sapporo National Hospital Sapporo Railway Hospital JIRO KURITA St. Franciscan Tenshi Hospital TOHRU SASAKI Asahikawa Municipal Hospital YASUYA NOMURA, ISUZU KAWABATA, TAKASHI FUKAYA Faculty of Medicine, University of Tokyo TOHRU KIKAWADA HIROSHI TANAKA HIRONORI WATANABE SHOZO KAWAMURA Matsudo City Hospital Kameda General Hospital Takeda General Hospital Juntendo University, School of Medicine RINYA SUGITA YUTAKA FUJIMAKI MIKIO TANAKA Doai Memorial Hospital Hanawa Hospital Seibo Hospital
21 CHEMOTHERAPY MASASHI WADA Tokyo Rosai Hospital HIROSHI WATANABE Taketani Hospital TOSHIO UCHIDA Koto Hospital HIROSATO MIYAKE, MAKOTO SAKAI, KAZUYOSHI FUJII, ATSUSHI SIIINKAWA Tokai University, School of Medicine TAKASHI KAWAI, KANETAKA MURAI Ichinomiya City Hospital MASAO TSUKIYAMA Tokai Teishin Hospital TAKESHI MARUO Showa Hospital KENJI WADA Kamo Hospital TSUTOMU HATANO Toyohashi City Hospital TAKASHI MATSUSHITA Nagoya City Josai Hospital OSAMU MIZUKOSHI, HITOSHI SAITO, MASAYOSHI TACHIBANA Kyoto Prefectural University of Medicine TAKESHIGE NISHIMURA, AKIRA SAITO, MIWA HYUGA Kyoto First Red Cross Hospital KAZUHARU OHKAWA, AKIMASA NAKAMURA Kyoto Second Red Cross Hospital NOBUKAZU TADAKI, SABURO MIMAKI, SUSUMU NAKAE Kyoto City Hospital SATORU TAKENOUCHI Health Insurance Kuramaguchi Hospital HIDEKI MATSUOKA, KATSUHISA KAMITANI Social Insurance Kobe Central Hospital SEIICHI KOMIYA, TOMIROU TERASONO Maizuru National Hospital SEIJI INOUE Inoue E. N. T. Clinic TOMOHIRO YASUNO Yasuno E. N. T. Clinic TAKASHI MATSUI Matsui E. N. T. Clinic MICHIYA HIRAYAMA, ITARU YAMAMICHI, NORIKO YOSHIOKA Matsushita Hospital TOHRU MATSUNAGA, MINORU ISHIDA Osaka University, Medical School
22 CHEMOTHERAPY AKIRA IIO Ohtemae Hospital ETSUKO TANAKA, HIROKO NAKAHARA Izumiotsu City Hospital ICHIRO OKAWACHI Higashi Osaka City Central Hospital KUNIO SAKAI Kansai Rosai Hospital KINICHI INATOME Seo E. N. T. Clinic HARUHIRO HAYASHI Tondabayashi Hospital YASUO HARADA, KOJI YAJIN, MICHINORI KUROKAWA Hiroshima University, School of Medicine MASARU OHYAMA, KENJI KATSUTA, KATSUNORI FUKUDA Kagoshima University, School of Medicine TAKUMI YANAIDANI Miyanojo National Hospital RYUJI KIYOTA Kagoshima Prefectural Hokusatsu Hospital NORIKO HASHIMOTO Kimotsukigun Ishikairitsu Hospital MAKOTO YAMAMOTO Kagoshima Prefectural Ohshima Hospital YASUICHI OHBORI Ichihino Onsen Hospital TSUNEO TANAKA Department of Health Administration, School of Health Science, Faculty of Medicine, University of Tokyo KOICHI DEGUCHI Tokyo Clinical Research Center The efficacy, safety and utility of AT (AT) 600mg/ day(in 3 divided doses) were compared with those of pipemidic acid (PPA) 200mg/ day (in 4 divided doses) by the double- blind method in the treatment of 330 patients with acute suppurative otitis media, chronic suppurative otitis media or acute exacerbation of chronic suppurative otitis media. In the evaluation of clinical efficacy by the doctor in charge, the efficacy rate in acute exacerbation of chronic suppurative otitis media was 56.1%(46/ 82) for the AT group and 41.3%(31/ 75) for the PPA group. The AT group showed the higher rate than PPA group(p< 0.1). In evaluation on the basis of the criteria by the committee, the efficacy rate in acute exacerbation of chronic suppurative otitis media was 53.7%(44/ 82) for the AT group and 37.3%(28/ 75) for the PPA group. The higher efficacy rate of AT group than PPA group was shown(p< 0.1). As regards clinical response by causative organism, out of cases in which gram-positive organisms were detected, the result was judged to be effective in 60.0% of the AT group and 46.4% of the PPA group. AT group showed the higher rate than PPA group(p< 0.1). As for bacteriological response, the elimination rate was 54.3% in the AT group and 50.4% in the PPA group. There was no significant difference between the two groups. However, in acute exacerbation of chronic suppurative
23 CHEMOTHERAPY otitis media, the elimination rate was 54.7% for the AT group and 41.2% for the PPA group, and thus, the AT group showed the higher rate than PPA group(p< 0.1). As to safety, side effects occurred in 7 (4.4%) of 159 cases in the AT group and 13 (8.0%) of 162 cases in the PPA group. There was no significant difference between the two groups. In utility evaluation, the acceptability rate covering "satisfactory" and "very satisfactory" was 55.9% for the AT group and 50.7% for the PPA group. There was no significant difference between the two groups. These results indicate that AT is a highly useful drug for the treatment of suppurative otitis media and is expected to be as effective as or more effective than PPA at approximately 1/ 3 of the PPA dose level.
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