In the present study, we used the envelope method to divide patients with respiratory infections into two groups: a monotherapy group given imipenem/cilastain sodium (IPM/CS) and a combination therapy group given imipenem/cilastatin sodium plus amikacin sulfate (AMK). We then compared the clinical efficacy and safety between groups.
1. Safety was evaluated in 83 patients in the IPM/CS group and 88 in the IPM/CS+AMK group while clinical efficacy was evaluated in 77 and 80 patients in the respective groups.
2. The overall efficacy rate was 84.4% in the IPM/CS group. Among the main infections, the efficacy rates were 82.7% in 52 cases of pneumonia (including lung abscess), 100% in cases of infected bronchiectasis, 66.7% in six cases of secondary infection of chronic respiratory disease, and 100% in four cases of chronic bronchitis.
The overall efficacy rate was 83.8% in the IPM/CS+AMK group. Among the main infections, the efficacy rates were 88.1% in 59 cases of pneumonia (including lung abscess), 83.3% in 12 cases of infected bronchiectasis, and 60.0% in five cases of secondary infection of chronic respiratory disease. No significant differences in efficacies were seen between groups.
3. In the IPM/CS group, the efficacy rates were 92.3% for patients without prior antibiotic therapy in the IPM/CS group and 68.0% for those with prior therapy; in the IPM/CS+AMK group, the respective rates were 83.7% and 83.9%. In the IPM/CS group, there was a significant difference in the responses of patients with and without prior antibiotic therapy (P<0.05).
4. Side effects were observed in six patients in the IPM/CS group (7.2%) and two patients in the IPM/CS+AMK group (2.3%). Abnormal laboratory test results were noted in 5 patients in the IPM/CS group (6.0%) and in 10 in the IPM/CS+AMK group (11.4%). There was no significant difference in the incidence of side effects between groups and no severe adverse reactions in either group.
These results indicate that IPM/CS alone produces of good response in moderate to severe respiratory infections while IPM/CS combined with AMK is useful in intractable respiratory infections.

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In 34 hospitals in Kyushu area, the clinical effects and safety of fluconazole (FLCZ) against pulmonary mycosis were studied.
To a total of 108 patients with respiratory diseases was FLCZ administrated.
The results were as follows.
1. Sixty-six cases were evaluable for the clinical efficacy of FLCZ. In 8 cases of pulmonary cryptococcosis, the clinical efficacy rate was 100% (8/8). In 58 cases of pulmonary aspergillosis, it was 43.1% (25/38). Overall, the clinical efficacy rate was 50% (33/66).
2. Fungi were eliminated in 3 of 6 cases in which Cryptococcus was detected, and were eliminated in 8 and reduced in 4 of 30 cases in which Aspergillus spp. including A. fumigatus were detected.
3. Side effects were observed in 5 of 87 cases (5.7%), none of them was serious, however.
Abnormal results of laboratory tests that might be related to the FLCZ administration were observed in 5 cases (5.7%).
4. From these results, fluconazole appears to be a potent antifungal agent for treatment of pulmonary mycosis.

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In order to evaluate antimicrobial activity of ciprofloxacin (CPFX), minimum inhibitory concentrations (MICs) of CPFX and other drugs were determined against clinical isolates that were obtained in our laboratory from January to December of 1991, and of 1993.
The results are summarized as follows:
1. CPFX-resistant strains were on the increase in various strains, compared to those in the early 1980s. However, many of CPFX-resistant strains were multi-drug resistant including β-lactams. In addition, they showed cross resistance to other fluoroquinolone agents.
2. MIC distribution of other drugs suggested that there were increased frequencies of benzylpenicillin ( PCG)-insensitive Streptococcus pneumoniae (PISP) and CEPs-resistant Escherichia coll. However, MIC distribution of CPFX to these resistant strains were in a relatively low range.
3. When isolates of 1991 were compared to those of 1993, we confirmed that CPFX-resistant strains decreased among certain bacteria such as Staphylococcus aureus. Also we confirmed that fewer CPFX-resistant strains were found among bacteria that may be highly related to infections encountered in daily medical care.

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In order to examine antimicrobial activities of fosfomycin (FOM), the minimum inhibitory concentrations (MICs) of FOM and those of control drugs were determined against Streptococcus pneumoniae and Haemophilus influenzae isolated from sinusitis patients from September to November, 1993, and the following results were obtained.
1. Among 50 S. pneumoniae strains tested, there were 10 strains (20.0%) of benzylpenicillin (PCG)-insensitive S. pneumoniae (PISP) and 2 strains (4.0%) of PCG-resistant S. pneumoniae (PRSP); but the MIC distributions of FOM among the PISPs and the PRSPs were almost identical to those among the PCG-susceptible S. pneumoniae (PSSP).
2. There were 12 strains (24.0%) of β-lactamase producing strains among 50 strains of H. influenzae tested, but the FOM's MIC distribution among these strains was almost identical to that among β-lactamase non-producing strains.
3. The results obtained on the MIC₉₀s of FOM against S. pneumoniae and H. influenzae suggest that the nebulization treatment with FOM nasal preparation satisfies the condition “above the MIC”.

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[in Japanese]

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In 28 patients with hematologic malignancy, the clinical effect and the safety of sulbactam/ cefoperazone (SBT/CPZ) were studied on 45 episodes during granulocytopenic stage after anti-neoplastic chemotherapy.
The overall efficacy rate obtained with SBT/CPZ in combination with other drugs was 62%. The rates for sepsis, suspected sepsis and pneumonia were 67%, 94% and 38%, respectively.
The efficacy in those cases that showed granulocyte count less than 300/μl during the course of administration of SBT/CPZ was 53%, and in those cases that showed granulocyte counts recovery to more than 300/μl was 73%. Prior antimicrobiological treatments had no influence on the efficacy of SBT/CPZ.
SBT/CPZ showed an activity spectrum covering frequently isolated microorganism including Acinetobacter calcoaceticus, Pseudomonas aeruginosa, Enterobacter cloacae and Staphylococcus aureus.
Mild adverse effect were observed in 4 episodes (8.8%).
These result suggested that SBT/CPZ was thought to be a useful drug for empirical therapy in granulocytopenic patients with hematologic malignancies.

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The clinical efficacy was examined for the newly developed oral cephem antibiotic, cefpodoxime proxetil(CPDX-PR)dry syrup, in the treatment of various acute infections in the field of pediatrics.
CPDX-PR dry syrup was administered at 10 mg/kg/day in 3-divided doses to 535 children at 21 institutions, including Tottori University Hospital and its related hospitals.
The efficacy rate of this drug was determined to be 80.8%. Among isolates, Staphylococcus, aureus and Streptococcus sp. were highly susceptible to the drug, whereas Haemophilus influenzae showed relatively poor susceptibility.
Side effects were observed in 2.80% of all of the patients, and abnormal laboratory findings were detected in 1.87%.
The low incident of side effects demonstrated its high safety, and this drug was considered to be very useful for such pediatric infections as acute tonsillitis, acute pharyngitis and acute bronchitis.

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Chorioamnionitis as a complication of threatened abortion and preterm labor and preterm PROM were treated with ceftazidime (CAZ) and aspoxicillin (ASPC) as a primary therapy. The following results were obtained.
1. Cases of threatened abortion and preterm labor (n=25) and preterm PROM (n=5) were treated with 2-4g CAZ/day alone (n=14) or in combination with 4g ASPC/day (n=16) along with a uterine contraction inhibitor (ritodrine hydrochloride etc. n=28) and clinical evaluation was made.
2. In the cases of threatened abortion and preterm labor the efficacy ratio was 24/25 (96%). In the cases of preterm PROM, the latent period-delaying effect was observed in five out of the five patients. Upon analysis of the tocolysis index in the group of threatened abortion and pretermlabor, the index values≥5 were observed in 12 out of 25 (60%), and the delivery incidence before the 35th week of gestation was 4/25 (16%). In all patients, the incidence of delivery after the 36th week of gestation was 24/30 (80%)
3. Bacteriological examinations showed a high detection rate for Gram-positive bacteria, and the combination effect between ASPC and CAZ was demonstrated against all 9 isolates examined.
The above results indicated a high efficacy as well as safety of the combination of CAZ and ASPC as a primary therapeutic means against chorioamnionitis.

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We carried out clinical and bacteriological studies on sultamicillin (SBTPC) in pediatric sinusitis at 10 general practice settings. The results are summarized as follows.
1. The major isolated organisms from purulent nasal discharges were Streptococcus pneumoniae 27.5%, Haemophilus influenzae 32.4%and Moraxella catarrhalis9.9%. Similar results were observed for the major isolates from nasopharynx.
2. 33%of the isolated S. pneumoniae were penicillin-insensitive S. pneumoniae (PISP) against which the MICs were equal to or higher than 0.1μg/ml.
3. PISP was isolated from 14% of all cases.
4. The clinical efficacy rate was 77.5%and was deemed satisfactory.
5. In the bacteriological study, persistance rate of PISP was38.5%among the PISP from purulent nasal discharge and60.0%among the PISP from nasopharynx which and these values were significantly higher than persistance rates of PSSP, H. influenzae and M. catarrhalis.
6. Adverse reactions were observed in 21.5%of all cases, involving diarrhea and loose stool.

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To objectively evaluate the clinical efficacy and safety in acute tonsillitis, flomoxef (FMOX) was examined for the distribution of sensitivity of clinical strains to it and for its clinical usefulness.
1. The 80% minimum inhibitory concentration of 11 clinical strains of Gram-positive bacteria, 6 of Gram-negative bacteria and 5 of anaerobic bacteria was 0.39μg/ml. FMOX showed the strongest, most comprehensive antibacterial action among the drugs tested.
2. Thirty patients received FMOX. Clinical effectiveness was evaluated in 28 patients, and clinical usefulness and safety in 30.
3. The clinical efficacy rate (‘excellent’ and ‘good’) was 75% (21/28).
4. As for bacteriological response, bacterial elimination rates were 67% for Gram-positive bacteria, 100% for Gram-negative bacteria, 100% for anaerobic bacteria and 100% for mixed infections.
5. Side effects occurred in 2 (6%) patients: drug eruption and diarrhea in 1 patient each. These symptoms improved rapidly after discontinuation of the drug.
6. Although abnormal clinical test results were found in 7 (23%) patients, i. e., increases in GOT and GPT in 2, in GPT in 4 and in BUN in 1, they were transient.
7. The usefulness of FMOX was assessed in light of its efficacy and safety. It was highly satisfactory in 14 patients, satisfactory in 11, relatively satisfactory in 1, unsatisfactory in 2 and highly unsatisfactory in 2, and rate of usefulness was 83%. FMOX is considered to be highly useful for the treatment of severe acute tonsillitis.

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[in Japanese]

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