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Table 1 Classification of female patients with vealcal irritating symptom by their signs Urination pain with other vesical irritability or not

Table 2 Serum levels of DL-8280 after a single oral administration (Mine healthy volunteers and outpatients with urinary tract infections In Sample was not collected. Case No. 1, 2, 3: Volunteers, Case No. 4, 5, 6: Outpatients Table 3-(1) Urinary levels of DL-8280 after a single oral administration (100mg) in healthy volunteers and outpatients with urinary tract infections (1) Urine volume was corrected to 1ml/min. Retention time (min) of urine in bladder Case No. 1, 2: Urine was collected in time schedule. Case No. 3, 4, 5: Urine was collected free. Table 3-(2) Urinary levels of DL-8280 after a single oral administration (100mg) in healthy volunteers and outpatients with urinary tract infections (2) Urine volume was corrected to lml/min. Retention time (min) of urine in bladder

534 CHEMOTHERAPY FEB. 1984 Table 5-(1) Distribution of clinical sings before treatment in cases of Group I

Table 5-(2) Distribution of clinical sings before treatment in cases of Group II

Table 5-(3) Distribution of clinical sings before treatment in cases of Group III

Table 5-(4) Distribution of clinical sings before treatment in cases of Group IV

CHEMOTHERAPY FEB. 1984 Table 5-(5) Distribution of clinical signs before treatment in cases of Group V

Table 6 Distribution of strains isolated before DL-8280 treatment 4) SATO, K.; Y. MATSUURA, M. INOUE, T. UNE, Y. OSADA, H. OGAWA & S. MITSURASHI: In vitro and in vivo activity of DL-8280, a new oxazine derivative. Antimicr. Agents & Chemoth. 22: 548-553, 1982

Fig. 1-(1) Susceptibility of E. coli isolated before M-8280 treatment Fig. 2-(1) Susceptibility of gram rods except E. coli iso fore DL-8280 treatment Fig. 1-(2) Susceptibility of E. coil isolated before DL-8280 treatment Fig. 2-(2) Susceptibility of gram rods except E. coli ieola fore DL-8280 treatment

Fig. 3-(1) Susceptibility of grain positive cocci isolated before DL-8280 treatment Fig. 4-(1) Correlograma of MIC between DL-8280 and NFLX, PPA and NA: E. coil Fig. 3-(2) Susceptibility of gram positive cocci isolated before DL-8280 treatment

Fig. 4-(2) Correlograma of MIC between DL-8280 and NFLX, PPA and NA: S. fascalis Fig. 4-(3) Corr.lograms of MIC between DL-8280 and NFLX, PPA and NA: gram nega

CHEMOTHERAPY FEB. 1984 Table 7-(2) Bacteriological response to DL-8280 in acute simple cystitis fitting for criteria of UTI committee (78 cases) Table 842) Bacteriological response of Dli-8280 in acute simple cystitis unfitting for criteria of UTI committee (93 cases) -Group I: 3rd or 4th day judgement- * Regardless of bacterial count * Regardless of bacterial count Poly-microbial infection * Table 8-(1) Overall clinical efficacy of DL-8280 in acute simple cystitis unfitting for criteria of UTI committee Group - I: 3rd or 4th day judgement-

Table 9 Results of DL-8280 treatment 3rd or 4th day judgement- - Table 11-(1) Bacteriological response of DL-8280 in Group II (23 cases) -3 rd or 4th day judgement- Table 10 Relation of judgements between the original and UTI committee's criteria -3rd or 4th day judgement- Regardless of bacterial count Poly-microbial infection

Table 11-(2) Bacteriological response of DL-8280 in Group III (11 cases) -3rd or 4th day judgement- Table 12 Bacteriological response of DL-8280 in all cases (131 cases) - 3rd or 4th day judgement- Strains* appearing after treatment Regardless of bacterial count Table 11-(3) Bacteriological response of DL-8280 in Group IV (4 cases) - 3rd or 4th day judgement- Strains* appearing after treatment Strains* appearing after treatment Regardless of bacterial count Poly-microbial infection Regardless of bacterial count Poly-microbial infection

Table 13 Side effects Incidence of side effects: 10/167 (6.0%) Table 14 MIC50 and MICH values of E. coli, gram positive cocci and other gram negative rods isolated before DL-8280 treatment

COMPARATIVE STUDIES ON CLINICAL EFFICACY OF DL-8280 (100 MG/DAY, 3 DAYS TREATMENT) IN VARIOUS TYPES OF FEMALE ACUTE SIMPLE CYSTITIS YOSHIAKI KUMAMOTO, SHIGERU SAKAI, TSUGUO UMEHARA and Department of Urology, Sapporo Medical College TAKAOKI HIROSI SHOGO SHIMAMURA Department of Urology, Sapporo Teishin Hospital TAKAHIRO TAMIYA, KEIJI TAKATSUKA and SHINICHI MIYAMOTO Department of Urology, Sunagawa Municipal Hospital AKIO HONMA and TATSUO AOYAMA Department of Urology, Japan Red Cross Asahikawa Hospital SEIJI FURUYA and EIJI YOKOYAMA Department of Urology, Japan Red Cross Kitami Hospital CHOSHO ENATSU Department of Urology, Tomakomai Oji General Hospital HITOSHI TANDA and SHUJI KATO Department of Urology, Higashi Sapporo Sanjukai Hospital5 TSUNEAKI TORII and MASATAKA FUJITA Department of Urology, Hakodate Goryokaku Hospital KATSUYUKI MITOBE and AKIRA NISHIO Department of Urology, Sakata Municipal Hospital DL-8280, a new pyridone-carboxylic acid type synthetic antimicrobial agent for oral use, was studied fundamentally and clinically and the following conclusions were obtained. 1) The MICs of DL-8280 against clinical isolates were determined. The MICs against 80% of GNR and 30% of GPC were 0.10 pg/ml and less than 0.39 j g/ml, respectively. 2) The urinary concentration during 22-24 hours after a single oral administration at the dose of 100 mg was over 10 Đg/ml and this result suggested DL-8280 was the long-acting drug. 3) Clinical effect and side effect in female patients with acute simple cystitis including the urethral syndrome treated with 100 mg for 3-17 days orally were evaluated. A new original criteria was established for judgement of cases unfitting for criteria of UTI committee. 4) The clinical response in 78 female patients with acute simple cystitis fitting for criteria of UTI committee was excellent in 64 cases, moderate in 14 cases, and clinical efficacy rate was 100%. 5) All cases were divided to group I, II, III, IV and V and therapeutic effect was evaluated in each group. No significant difference in clinical efficacy was observed among all groups, except cases having only subjective symptoms group V by the new original criteria. 6) As to side effects, eruption, itching, lip swelling and gastrointestinal disturbance were observed in 10 cases and rate of appearance was 6.0%. But those were not severe.

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