To study the prevalence of Staphylococcus aureus on both the throat and nasal vestibles, samples were taken from 25 healthy medical staff members and 25 inpatients at 7 hospitals in P. R. China and at a hospital in Tokyo in 1996 and 1997. Isolated S. aureus were examined by coagulase typing, enterotoxin typing, and drug susceptibility against 23 antimicrobials.
The results were as follows;
1) S. auerus was isolated from 4% to 25% of all sublects examined at 7 hospitals in P. R. China, showing a significantly lower rate than 42.5% at a hospital in Tokyo.
2) More S. aureus were isolated from healthy people, especially medical staff members than from inpatients.
3) The most prevalent coagulase type of S. aureus isolated in P. R. China, 1996 and 1997 was type VII, but their enterotoxin types were variable, indicating different sources of infections agents existing at the in hospitals. On the other hand, strains of coagulase type II with enterotoxin type C were the most prevalent at a hospital in Tokyo, showing the cross infections in a hospital.
4) S. aureus isolated in P. R. China were the most susceptible to imipenem and panipenem, and they were the least susceptible to tetracycline, erythromycin, roxithromycin and adithromycin. There were no strains of MRSA. On the other hand, 17 strains of S. aureus (40.8%) were MRSA ata hospital in Tokyo and those strains were susceptible to arbekacin and vancomycin.
There was a great difference between drug susceptibility against strains from P. R. China and those from Tokyo. This difference seems to come from the difference in infectious diseases, the treatments, and the medical care systems in the respective countries. However, since China is rapidly introducing Wewstern medicine, this report will serve as basic data for understanding fututre of drigresistance.

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In order to detect β-lactamases in sputum directly, we developed a method todetermine β-lactamase activity for Pseudomonas aeruginosa isolated from sputum specimens. The extraction procedures from sputum were carried out within 30 minutes. A satisfactory linear relationship was obtained when extracts from sputum containing P. aeruginosa (10⁶cfu/ml) were added to 100 μ M nitrocefin solution and absorbance was measured for 5 minutes at 37° C. On theother hand, β-lactamase activity was not identified with samples of Enterococcus faecalis (10⁵cfu/ml). Subsequently, we examined the detection limit using samples with different bacterial quantities and found as a result that β-lactamase activity could be detected with samples of P. aeruginosa of 10⁶cfu/ml and above. In addition, the K_mvalue of sputum containing penicillinase-producing Escherichia coli (10⁷cfu/ml) was as high as 127 μM and significantly differed from those values for cephalosporinase-roducing P. aeruginosa. These results suggested that this newly developed method was able to detect β-actamase activity in sputum samples quickly, conveniently and sensitively.

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We evaluated gatifloxacin (GFLX, AM-1155), a new fluoroquinolone to determine it's clinical usefulness and penetration into sputum samples from three patients with bronchiectasis and one patient with old pulmonary tuberculosis. GFLX was given orally at a dose of 200 mg twice daily for 6-7 days. The maximum range of concentrations of GFLX in serum and sputum were 0.72-3.65 μg/ml and 3.81-7.11 μg/ml, respectively. The penetration rate of this drug into sputum samples were 171-625%. Clinical effects were excellent in one patient, good in one, fair in one, and also poor in one. The causative pathogens were Pseudomonas aeruginosa in three cases, and Haemophilus influenzae and Moraxella catarrhalis in one case. Although H. influenzae and M. catarrhalis were eradicated rapidly after oral administration of GFLX, three strains of P. aeruginosa were not eradicated. Adverse effects and abnormalities on laboratory findings in these patients were not observed. These data support that GFLX is a useful oral fl uoroquinolone for the treatment of chronic respiratory tract infections.

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Pharmacokinetic and clinical studies were carried out with gatifloxacin (GFLX) in otorhinolaryngological infections. The results were as follows:
1. In the middle ear mucosa, the concentration of GFLX ranged from undetectable levels (ND) to 0.66/μg at 120 to 165 minutes after oral administration of 100 mg, and from ND to 1.11 μg/g at 140 to 510 minutes after oral administration of 200 mg, and the penetration ratio (tissue/serum) ranged from 0.23 to 6.00. In the paranasal sinus mucosa, the concentration of GFLX ranged from 1.06 to 1.91 μg/g at 120 to 170 minutes after oral administration of 100 mg, and from 1.79 to 4.29 μg at 110 to 160 minutes after oral administration of 200 mg, and the penetaration ratio ranged from 1.41 to 2.20. In the paroid gland, the concentraion of GFLX ranged from 0.34 to 2.52 μg at 150 to 350 minutes after oral administration of 100mg, and the penetration ratio ranged from 1.82 to 7.20.
2. The clinical efficacy rate was 75.7%(28/37) for otitis media, 88.2%(15/17) for paranasal sinusitis, 85.2%(23/27) for tonsillitis, 81.8%(9/11) for pharyngolaryngitis, 86.7%(13/15) for otitis externa, and 4/4 for suppurative sialadenitis. The overall clinical efficacy was excellent in 39, good in 53, fair in 14, and poor in 5, with the efficacy rate of 82.9%(92/111).
3. The elimination rate was 87.0%(67/77) for gram-positive aerobes, 90.9%(30/33) for gram-negative aerobes, and 100%(8/8) for anaerobes, and resulted in the overall rate of 89.0%(105/108).
4. Although adverse reactions were observed in 5 of 115 cases (4.3%) and abnormal laboratory test findings were recorded in 4 of 92 cases (4.3%), none were serious.
These results indicate that GFLX is a very useful drug for the treatment of otorhinolaryngological infections.

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In a multicenter open study, the efficacy, safety and usefulness of gatifloxacin (GFLX), a newly developed fluoroquinolone antibacterial drug, were evaluated in patients with ocular infections.
1) The clinical response was excellent in 38 cases, good in 36 cases and fair in 5 cases, with a efficacy rate of 93.7%(74/79).
2) In bacteriological efficacy, the eradication rate was 98.1%(51/52) for 52 cases.
3) Side effects were observed in 5 of 94 cases, and included diarrhea, nausea, constipation, enlarged feelings of abdomen. The frequency of side effects was 5.3%(5/94). Abnormal laboratory findings were observed in 2 of 64 cases, and included elevation of AL-P and bilirubin, and the frequency of abnormal laboratory findings was 3.1%(2/64).
4) Usefulness was observed in 81 cases at a rate of 91.4%(74/81).
These results suggest that GFLX is useful for the treatment of ocular infections.

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To objectively evaluate the clinical value of gatifloxacin (GFLX), a new 8-methoxyquinolone derivative, in the treatment of complicated urinary tract infections, we performed a prospective randomized doubleblind comparative study using levofloxacin (LVFX) as a control drug. Only patientswithout indwelling catheters, who had at least 5 WBCs/hpf pyuria, at least 10⁴CFU/mL bacteriuria, and an identifiable underlying urinary tract disease were admitted to the study. Patients were randomly assigned to receive Committee were used to evaluate clinical efficacy in a total of 248 patients: 97 patients in the GFLX group and 98 patients in the LVFX group. There were no significant differences in the background characteristics of the patients in these two groups. Excellent and moderate responses were obtained in 93.8% of the 97 patients who received GFLX and in 86.7% of the 98 patients who received LVFX. This difference was not statistically signifiicant, and the clinical equivalence of GFLX to LVFX was verified (as Δ=10%). The overall bacteriological eradication rate was 93.2% of 148 strains in the GFLX group and 91.2% of 147 strains in the LVFX group, with no significant difference. The number of strains appearing after treatment was 8 (in 8 patients, 8.2%) in the GFLX group and 16 (in 14 patients, 14.3%) in the LVFX group, with no significant difference. The incidence of clinical adverse reactions was 7.3% for both of GFLX and LVFX, and the incidence of laboratory adverse reactions was 5.4% for GFLX and 3.6% for LVFX, the differences not being statistically significant. None of the adverse reaction findings were serious. Nor were there any significant differences between the two groups in overall safety rating or clinical value. Based on the results of this study, we conclude that GFLX (200 mg b.i.d.) is as useful as LVFX (100 mg t.i.d.) for the treatment of complicated urinary tract infections.

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We evaluated the clinical value of gatifloxacin (GFLX), a new 8-methoxy quinolone antibacterial agent, in the treatment of complicated urinary tract infections associated with indwelling catheters. Forty-seven patients, 20 to 80 years old, with pyuria of at least 5WBCs/hpf and bacteriuria of at least 10⁴CFU/mL were enrolled in the study and orally treated with GFLX at doses of 200 mg b. i. d.(200mg group) or 300 mg b. i. d.(300mg group) for 7 days. Clinical efficacy was evaluated according to the criteria of the Japanese UTI Committee. The overall clinical efficacy rate (excellent and moderate) was70.0% among the 20 patients in the 200mg group and 68.8% among the16patients in the 300mg group. The overall bacteriological eradication rate was 88.3% of 60 strains in the 200mg group and 88.9% of 36 strains in the 300mg group. The incidence of clinical adverse reactions was 7.7%(2/26 cases) in the 200mg group and 9.5%(2/21 cases) in the300mg group, and the incidence of laboratory adverse reactions was 0%(0/26 cases) in the 200mg group and 12.5%(2/16 cases) in the 300mg group. None of the adverse reactions were serious. The overall safety rating was 96.2%(25/26 cases) in the 200mg group and 88.9%(16/18 cases) in the 300 mg group. Based on the above results, we conclude that GFLX is safe and effective in the treatment of complicated urinary tract infections associated with indwelling catheters, and that 200 mg b. i. d. is a sufficient dosage of GFLX.

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