A prospective study was carried out to evaluate the efficacy and safety of cefpirome (CPR) in treating infections associated with hematological diseases.
1) CPR was administered alone to one hundred patients in the study, and 77 of them were evaluted for efficacy.
2) CPR was effective or markedly effective in 45 of the 77 patients (efficacy rates 58.4 %). In septicemia and suspected septicemia, the efficacy rates were 25%(1/4) and 59. 7%(37/62), respectively.
3) The efficacy rate depended on the neutrophil count before and after antimicrobial treatment. As the counts increased, the efficacy rates rose.
4) In patients with a neutrophil count under 500/μl before CPR administration and over 500/μl after CPR, the efficacy rates for treatment with CPR alone and in combination with G-CSF were 25%(1/4) and 80.0%(8/10), respectively. The efficacy rates were higher in patients receiving CPR plus G-CSF, suggesting that G-CSF is likely to be of value in the treatment of infections.
5) Adverse effects of CPR in the 100 patients consisted of nausea in one patient (1.0%) and abdonormal laboratory values (mainly elevation of GOT, GPT and AL-P) in 11 patients. None of the adverse effects were serious and all resolved after completion of treatment with CPR.

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Isolation of Pseudomonas aeruginosa from sites of infection after surgery for colon cancer has been tending to increase. Tow regimens have been established to prevent such infections. The first regimen is rokitamycin (RKM) plus astromicin (ASTM) preoperatively and sulbactam/cefoperazone (SBT/CPZ) postoperatively, and second is ofloxacin (OFLX) preoperatively and cefmetazole (CMZ) or alternatively, flomoxef (FMOX) postoperatively. A total of 40 patients were enrolled in this trial to test the effect of prevention for postoperative infections by P. aeruginosa in April 1993. The subjects were divided into two groups of 20 patients each by the controlled envelope method. The results were: only one and two patients has postoperative infections on the first and second regimen, respectively. The organisms isolated from them were Staphylococcus aureus, S. aureus+Enterococcus faecalis, and Staphylococcus epidermidis+E. faecalis, respectively, not P. aeruginosa. We think that the low incidence 7.5 % (3/40) of postoperative infection was due to the anti-Pseudomonas agents used in either pre- or post-operatively.

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Grepafloxacin (GPFX), a new fluoroquinolone, and ofloxacin (OFLX) were compared in a multicenter, double-blind, double-placebo study in the treatment of skin and skin structure infections. Patients with deep-seated hair follicle infections (furuncles, furunculosis, and carbuncles) and deep-seated diffuse infections (cellulitis and erysipelas) were enrolled after their informed consent was obtained. Patients assigned to the GPFX group received one 200-mg tablet of GPFX once a day after breakfast and two placebo OFLX tablets after meals (t. i. d.). Patients assigned to the OFLX group received one placebo tablet of GPFX once a day after breakfast and two 100 mg OFLX tablets after meals (t. i. d.). The patients were treated for 7 days. Patients were evaluated in terms of efficacy, safety, and bacteriologic response. Efficacy was evaluated on day 4 (3-5) and on day 7 (6-8). Two hundred twenty-seven patients (GPFX group, 114 patients; OFLX group, 113 patients) were enrolled. The clinical efficacy rates were 90.5%(95/105) in the GPFX group and 88.5%(92/104) in the OFLX group. The overall improvement rates on day 4 were 73.9 %(65/88) in the GPFX group and 77.9%(67/86) in the OFLX group. The safety rates were91.7%(100/109) in the GPFX group and 85.5%(94/110) in the OFLX group. The usefulness rates were 87.7%(93/106) in the GPFX group and 83.5%(91/109) in the OFLX group. Adverse reactions were seen in 6.4% of patients treated with GPFX and in 9.1% of patients treated with OFLX. The main adverse reactions were of gastrointestinal origin. None of them were severe. Abnormal laboratory findings were all minor (2.2% in the GPFX group and 7.6% in the OFLX group). The bacteriologic response rates were 89.0% for the GPFX group and 90.9% in the OFLX group. These differences were not statistically significant. These results suggest that GPFX at a dose of 200 mg once a day is as effective and safe as OFLX at a dose of 200 mg three times a day in the treatment of skin and skin structure infections.

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We conducted a double-blind comparative study of grepafloxacin (GPFX), a new oral quinolone antimicrobial agent, in order to evaluate its clinical efficacy, safety, and usefulness in patients with obstetric and gynecological infections, and used ofloxacin (OFLX) as the reference drug. GPFX and OFLX were administered orally to the patients at doses of 300 mg q. d. and 200 mg t. i. d., respectively, for consecutive 7 days.
1) Clinical efficacy
Of the 244 patients treated with GPFX or OFLX, 201 were included in the evaluation of clinical efficacy. The efficacy rate [(excellent+good)/total] was 98.0%(98/100) in the GPFX group and 93.1%(94/101) in the OFLX group and the difference between the groups not significant. The 90% confidence level for the difference in efficacy ranged from 0.2% to 9.7%. These results domonstrate that the efficacy of GPFX and OFLX is equivalent.
2) Bacteriological effect
The bacteriological effects of GPFX and OFLX were evaluatedin 118 patients. The eradication rates were 89.7%(52/58) and 95.0%(57/60), respectively, showing no significant difference between the groups.
3) Adverse events and abnormal laboratory values
The incidence of adverse events was 7.6%(9/119) in the GPFX group and 6.0%(7/117) in the OFLX group. The incidence of abnormal laboratory valueswas 4.8%(5/104) in the GPFX group and 0.9%(1/108) in the OFLX group. No significant difference was observed between the groups.
4) Safety
The safety rates (safe/total) were 86.8%(92/106) in the GPFX group and 92.7%(101/109) in the OFLX group, showing no significant difference between the groups.
5) Usefulness
The usefulness rates [(very useful+useful)/total] were 91.4%(85/93) in the GPFX group and 90.5%(86/95) in the OFLX group, showing no significant differences between these groups. The 90% confidence level ranged from-6.0% to 7.7%. These results demonstrate that the usefulness of GPFX and OFLX was equivalent.
These above findings confirmed that the clinical usefulnessof GPFX 300 mg q. d. and OFLX 200 mg t. i. d. is equivalent in patients with obstetric and gynecological infections.

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