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[Clinical evaluation on the usefulness and safety of norfloxacin in a twice-a-day regimen against upper respiratory tract infections].

Sixty-six patients with tonsillitis or pharyngolaryngitis received oral norfloxacin (NFLX) 200 mg b.i.d. or 300 mg b.i.d. for not less than 3 days in general at School of Medicine, Yokohama City University, and 6 related hospitals. The results are summarized as follows: 1. Ten patients were excluded from the study because 4 patients did not present at the follow-up visits, 4 patients did not follow the protocol and 2 patients had unclear infections. Thus, 56 patients were evaluated. 2. The fifty-six evaluable patients were classified as follows: Twenty patients were with tonsillitis and 36 were with pharyngolaryngitis. Thirty-eight patients were treated with 200 mg b.i.d. while 18 patients received 300 mg b.i.d. Thirty-two patients were male and 24 patients were female. Three patients were inpatients and 53 patients were outpatients. Most of patients were light or moderate cases, and the 26 patients had mild underlying disorders. 3. Clinical improvements were observed in 11 of 15 patients (73.3%) with tonsillitis and 25 of 30 patients (83.3%) with pharyngolaryngitis (80.0% overall) within 7 days administration. 4. Clinical improvements were observed in 15 of all 20 patients (75.0%) with tonsillitis and 30 of all 36 patients (83.3%) with pharyngolaryngitis (80.4% overall). 5. Bacteriologically, "eradication", "decrease" and "replacement" were observed in 6, 2 and 1 patients, respectively. 6. As for adverse effects, nausea and headache were observed in 1 patient and abnormal changes in laboratory findings were noted in 1 patient (slight elevations of GOT and GPT). 7. Oral NFLX 200 mg b.i.d. or 300 mg b.i.d. was as almost equally effective as 200 mg t.i.d. in tonsillitis or pharyngolaryngitis. Thus NFLX 200 mg b.i.d. or 300 mg b.i.d. appears to give sufficient clinical efficiency. 8. When antibacterial activity and serum half-life of NFLX are considered, twice daily administration was confirmed to be sufficiently effective in the clinical application.