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KMID : 0378019930360060070
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New Medical Journal
1993 Volume.36 No. 6 p.70 ~ p.78
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The Efficacy and Safety of Ofloxacin Otic Solution on the Otitis Media Clinical and Experimental Studies
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Abstract
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For the investigation of the efficacy and safety of a new quinolone derivative,Ofloxacin otic solution, the clinical study was carried out in 46 cases suffering from acute (8 patients) or chronic (38 patients) otitis media, using following inclusion criteria: 1) patients with otorrhea from the middle ear due to either acute or chronic otitis media, 2) patients with no history of the allergic reaction to antibiotics, 3) patients with no previous antibiotics treatment during one week prior to start this study.
In order to observe the influence of Ofloxacin otic solution upon the organ of Corti, experimental study was also performed in 15 albino guinea pigs showing positive preyer reflex . For the clinical study, 0.3% Ofloxacin otic solution was administrated to the middle ear of each patient (5 drops, twice a day, for 7 to 14 days). The clinical efficacy was evaluated using following criteria: 1) Cured-complete resolution of symptoms and signs, 2) Improvedpartial resolution of symptoms and signs, 3) Poor-no change of symptoms and signs. Before the drug administration, bacteriological studies (identification of causative bacteria, sensitivity to Ofloxacin, antimicrobial activity of Ofloxacin) were conducted and bone- conduction thresholds were measured before and after the drug administration.
For the experimental study, 1 ml of 0.3% Ofloxacin solution was administrated into the left bulla of each animal (twice a day, for 7 days) and the right side was used as a control ear. Auditory brainstem response (ABR) were measured at the vertex of each animal 7 days
after the drug administration and histologic examination (LM for middle ear mucosa & SEM for cochlea) was also conducted. The results were as follows
1. The efficacy rate of Ofloxacin otic solution was 93.4%(43 out of 46 cases), cured in 6 cases and improved in 37 cases.
2. In bacteriological studies, Staphylococcus aureus was the most common causative microorganism (43%) and others were G.negative bacilli (13%),, P.aeruginosa (11%), S.coagulase negative (9%), miscellaneous (9%). In 7 cases (15%) no causative bacteria were identified.
3. All but one bacteria showed a favorable sensitivity to Ofloxacin otic solution. In addition, P.aeruginosa and S.marcescens had a high activity against Ofloxacin (P.aeruginosa : 128,?g/ml of MIC, S.marcescens : 32?g/mi of MIC) and others showed a minimal activity against Ofloxacin (0.5-8,? g/ml of MIC).
4. In clinical study all subjects showed no significant changes of bone conduction thresholds. However, in experimental study a significant ABR difference between control and experimental ears were noticed in 4 animals.
5. Histologic examination revealed a negligible swelling of the middle ear mucosa and no significant -hair cell damage of the cochlea was observed.
Present results suggest that 0.3% Ofloxacin otic solution is highly useful and very safe in cases of both acute and chronic otitis media.
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