Clinical evaluation of grepafloxacin in the treatment of various infectious diseases in the field of internal medicine. The clinical usefulness of grepafloxacin (GPFX), a new quinolone synthesized as an oral antibacterial agent, in various infections in the field of internal medicine was investigated by collaborative research at 62 institutions nationwide. GPFX was administered primarily to patients with respiratory tract infections (RTI), mostly at daily doses of 100~300 mg once or in 2 divided doses. Clinical efficacy was evaluated in 509 of a total of 525 patients for analysis and efficacy was observed in 443 (87.0%) of the 509, including 432 (87.1%) of 496 patients with RTI and 11 (84.6%) of 13 patients with urinary tract infections (UTI). In RTI by disease, clinical efficacy was observed in 19 (86.4%) of 22 patients with pharyngolaryngitis or pharyngitis, 17 (94.4%) of 18 with tonsillitis, 53 (91.4%) of 58 with acute bronchitis, 104 (87.4%) of 119 with pneumonia, 17 (89.5%) of 19 with mycoplasmal pneumonia, 5 (100%) of 5 with atypical pneumonia, 117 (87.3%) of 133 with chronic bronchitis, 48 of 63 with bronchiectasis, 17 (89.5%) of 19 with diffuse panbronchiolitis, and 35 (87.5%) of 40 with secondary infection with chronic respiratory disease. Bacteriological efficacy in RTI was evaluated in 233 patients. Bacteriological eradication was observed in 154 (78.2%) of 197 patients with monomicrobial infection and 22 (61.1%) of 36 with polymicrobial infection. For monomicrobial infection, bacteriological efficacy was higher in patients infected with gram-positive bacteria (48 of 53, 90.6%) than in patients infected with gram-negative bacteria (105 of 142, 73.9%). The MIC80 of GPFX was 0.39 μg/ml in 115 strains of causative organisms in which the MIC80 was determined in RTI, and the MIC80 of norfloxacin (NFLX), ofloxacin (0FLX), enoxacin (ENX) and ciprofloxacin (CPFX) were 6.25, 1.56, 6.25 and 0.78 μg/ml, respectively, in 97 strains. Adverse drug reactions were observed in 26 (5.0%, 38 cases) of 519 patients, including mostly gastrointestinal symptoms, CNS symptoms and hypersensitive symptoms. Abnormal clinical laboratory test values were observed in 49 (10.0%) of 490 patients. Major changes included increased eosinophil and transaminase. None of the reported symptoms or abnormal changes were serious. Based on clinical efficacy, adverse drug reactions and abnormal clinical laboratory test values, GPFX was judged to be useful in 432 (84.7%) of a total of 510 patients, 422 (84.9%) of 497 with RTI and 10 (76.9%) of 13 with UTI. From these results, GPFX was considered to be useful in the treatment of various infectious diseases, particularly RTI, in the field of internal medicine.
|Number of pages||19|
|Journal||Japanese Journal of Chemotherapy|
|Publication status||Published - Jan 1 1995|
ASJC Scopus subject areas
- Pharmacology (medical)