Clinical studies of gatifloxacin for infections in the surgical field

Abstract

We conducted clinical studies of gatifloxacin (GFLX) from November 1993 to February 1997 for treating infections in the surgical field (surgery, dermatology, otorhinolaryngology, gynecology, ophthalmology, and oral surgery), and published the results of individual studies in earlier issues of this journal. Subsequent recollation of case reports with source data has shown the necessity of some corrections in published papers.We therefore collectively report results based on our reanalysis of all data.
1. Clinical pharmacokinetics and tissue penetration
GFLX penetration into tissue (gallbladder wall, skin, mucosa of middle ear and paranasal sinus, tonsil, parotid gland, pelvic genital organ, conjunctiva, tarsal gland, gingiva, and palatine mucosa) ranged from 1.24 to 4.64 and into bile, skin exudates, and exudate in oral surgery ranged from 1.24 to 9.47 versus concentration in serum.Data in all related areas of surgery reconfirmed that GFLX tissue penetration is as good as that of existing fluoroquinolones.
2. Clinical efficacy
Clinical efficacy by field was 88.3%(113/128) in surgery, 86.9%(139/160) in dermatology, 83.5%(162/194) in otorhinolaryngology, 93.8%(137/146) in gynecology, 94.2%(114/121) in ophthalmology, and 90.5%(153/169) in oral surgery.
3. Bacteriological response
Bacteriological efficacy by patient in each field was 88.9%(96/108) in surgery, 88.5%(85/96) in dermatology, 87.1%(142/163) in otorhinolaryngology, 87.0%(60/69) in gynecology, 96.0%(72/75) in ophthalmology, and 99.1%(109/110) in oral surgery. Bacteriological elimination by causative isolate in the surgical field was 93.0%(572/615) for gram-positive aerobes, 94.2%(195/207) for gram-negative aerobes, 96.5%(223/231) for gram-positive anaerobes, and 99.5%(198/199) for gram-negative anaerobes.
4. Safety
The incidence of adverse drug reactions and abnormal laboratory findings noted with GFLX in all studies is similar to that of existing fluoroquinolones. No event was serious or clinically significant.
In conclusion, results after reanalysis are consistent with those published, and indicate that GFLX is a highly effective drug for treating infections in all surgical fields indicated.