In this study the antibacterial activities of various antibiotics against penicillin-resistant or intermediate Streptococcus pneumoniae (PRSP or PISP) in the presence of a sulfonated human immunoglobulin (SHG) preparation were investigated. The MICs of the antibiotics were found to decrease in the presence of 1, 5, 10 and 20 μg/ml of SHG. High concentrations of SHG (5 mg/ml) led to a decrease in the MIC of penicillin G (PCG) against PR (I) SP. The addition of SHG to β-lactams, especially PCG, significantly increased the synergistic effect against PR (I) SP compared to vancomycin. The agglutination titers of SHG to some PR (I) SP increased 2, 0 48-fold, however, there was no relationship between the agglutination titers and the synergistic effect. These results suggest SHG are synergically effective with β-lactams and may enhance the chemotherapy during serious PR (I) SP infections when used in association with antibiotics.

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[Purpose] To determine the efficacy and toxicity of combined therapy of low-dose cisplatin (CDDP) and protracted infusion 5-fluorouracil (5-FU) with radiotherapy (RT) in patients strictly diagnosed as having stage N esophageal cancer.[Patients and Methods] Patients, who were diagnosed as having either T 4, N 4 or M 1 by TNM classification and with measurable lesions, were eligible for this study. Low-dose CDDP was administered intravenously at a dose of 7 mg/m²/day over 1 hour, followed by RT at a dose of 2 Gray (Gy)/fraction/day on days 1-5, 8-12, 15-19, 22-26. Protracted intravenous infusion of 5-FU was performed at a dose of 200 mg/m²/day for 28 days. After one week of rest, RT boost was given to the locoregional area 5 days a week over 2 weeks. The cumulative dose of radiation was 60 Gy (LDFPX regimen).[Results] Fourteen patients were enrolled in this study, and all of them were assessable for response and toxicity. There were one CR (complete response) and 8 PR (partial response) out of 14 patients, with a resulting the response rate of 64%. The median time to progression and the median duration of response were 10 and 8 months, respectively. The median overall survival was 7. 5 months, and the survival rate at one year was 26. 8%. The major side effects were leukopenia and neutropenia.[Conclusions] LDFPX therapy seems to be as active as other therapies previously reported for advanced esophageal cancer. The adverse events were found to be less toxic both hematologically and nonhematologically than other therapies. These results suggest that LDFPX therapy is useful, especially for patients with poor performance status.

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Clinical and bacteriological studies were performed in infants and children with acute purulent otitis media caused by Streptococcus pneumoniae between September 1997 and August 1998. A total of 334 strains were isolated from 284 patients. Benzylpenicillin-sensitive S. pneumoniae accounted for 35.0%, benzylpenicillin-insensitive S. pneumoniae for 49.5%, and benzylpenicillin-resistant S. pneumoniae for 15.6%. The most frequently isolated strains were benzylpenicillin-insensitive and resistant S.pneumoniae especially in children aged 3 years and under. Ages ranged from 5 months to 12 years 11 months, and the average age was 3 years 7 months. The rate of resistant S. pneumoniae was higher in the city than in the country. The resistant strains consisted of serotypes 23 (90.9%), 19 (86.2%), 3 (83.3%), and 6 (74.2%). High resistance (MIC, ≥4.0μg/ml) to benzylpenicillin was recognized in 6, 19, 23 types. The MIC₈₀ of the oral β-lactam antibiotics showed that cefditoren pivoxil had the strongest effect (MIC₅₀: 0.5μg/ml) against S. pneumoniae. The MICK, of oral β-lactam antibiotics revealed that benzylpenicillin, cefditoren pivoxil, and cefteram pivoxil all had the same effect (MIC₉₀: 1.0μg/ml) on S. pneumoniae.Clindamycin showed the strongest antimicrobiological effect, on some strains of S. pneumoniae (71.3%), however, other strains (28.1%) were resistant to clindamycin (MIC: over 16.0 μg/ml). Effective clinical treatment was achieved in 81.4% of the patients with a combination of oral antibiotics and operative treatment (myringotomy), however, special operative treatment (insertion of a tympanotomy tube) was necessary or ear discharge persisted in 18.4% of the patients. In conclusion, we wish to emphasize that it is important to prepare guidelines for the antimicrobiological treatment of S. pneumoniae.

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We conducted a drug use evaluation study on Carbenin^® according to the “Guidelines on the Testing Methods for Evaluating the Use of New Drug Products, etc. in Applying for Drug Reexamination ”, based on the Revised GPMSP issued April 1994. Our study was conducted using the repeated testing method under actual treatment conditions. This drug use evaluation was made over a period of about 3 years lasting until March 1997, including the pilot study that started in February 1994. Among the 17, 872 cases reports collected, we examined the 17, 748 cases eligible for safety analysis, excluding the 124 cases disqualified due to reasons such as their being recorded outside the designated time period. The resulting ADR (including abnormal laboratory values) incidence was 9. 34%(1, 658 out of 17, 748 cases), showing no elevation tendency compared to the 16. 97%(443 out of 2, 611 cases) at the time of approval. Also, no significant deviation was noted in the schematic proportions. Though both safety and efficacy were examined in our study, we are reporting only the test results on safety because this drug is presently under reexamination (October 1, 1993-September 30, 1999).

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