Local treatment of purulent chronic otitis media with ciprofloxacin

We evaluated the efficacy of ciprofloxacin eardrops compared to tobramycin and to a placebo in the treatment of chronic suppurative otitis media. 60 ears were randomly assigned to treatment for 3 weeks with ciprofloxacin, tobramycin or placebo eardrops. The organism most commonly isolated from the ear discharge was Pseudomonas aeruginosa. The clinical responses were 78.9% and 72.2%, respectively, in the ciprofloxacin and tobramycin groups, while it was only 41.2% in the placebo group. Treatment with ciprofloxacin eardrops seemed to be at least as efficient as treatment with tobramycin. Considering the lack of ototoxicity of ciprofloxacin, this treatment may be best for chronic otitis media.     

Chronic otitis media treated topically with ciprofloxacin or tobramycin

OBJECTIVE: To evaluate the efficacy of ciprofloxacin compared with tobramycin and placebo ear drops in the treatment of chronic suppurative otitis media without cholesteatoma. DESIGN: Sixty ears (in 51 patients) were randomly divided into 3 treatment groups: ciprofloxacin hydrochloride, tobramycin, and placebo interventions. SETTING: The otolaryngology department of a university teaching hospital. INTERVENTION: All ears were treated topically for 3 weeks. MAIN OUTCOME MEASURES: Each patient received a small, numbered bottle and was instructed to instill 5 drops 3 times daily for 3 weeks. The final clinical and bacteriologic assessment was made after 3 weeks. RESULTS: The organism most commonly isolated from the ear discharge was Pseudomonas aeruginosa. Its sensitivity to ciprofloxacin and tobramycin was 94.2% and 70.6%, respectively. The clinical response was 78.9%, 72.2%, and 41.2% in the ciprofloxacin, tobramycin, and placebo groups, respectively. The bacteriologic response rate was 66.7% for the ciprofloxacin and tobramycin groups and 20% for the placebo group. Treatment with ciprofloxacin ear drops seemed to be as effective as treatment with tobramycin. CONCLUSION: While the lack of ototoxicity of ciprofloxacin was not tested in our study, this treatment may be considered as a potential topical therapy for cases of chronic suppurative otitis media.     

Methodical aspects of pneumatic segment plethysmography. III. Measuring tourniquet problems

A retrospective study was made of 200 chronic otitis media patients. Simple chronic otitis media was observed in 76 per cent of cases; the rest were associated with cholesteatoma. In about one third of the patients, the contralateral ear showed some inflammatory middle ear disease as well. The average time lapse between initial symptoms and hospitalization was about 10 years. The events leading to the tympanic perforation were difficult to ascertain, but included probably acute otitis media, possibly external otitis, trauma, and a rather large group (35-40 per cent) of insidious 'essential perforations'. The aetiology of the 'essential perforations' is so far not known, but might be non-inflammatory in nature but related to insufficient middle ear aeration and hypo-pneumatization as well as to what is termed atelectatic ears. The bacteria isolated from chronic otitis media ears (usually gram negative bacteria and staphylococcus aureus) are usually not the types of micro-organisms found in association with any primary or acute otitis media. It is proposed that the bacterial infection encountered in what is termed 'chronic otitis media' is often a secondary infection of a primary perforated tympanic membrane, the perforation originating or persisting in underventilated ears, and having arisen from various causes--some of them as yet unknown.     

Why use clinical pathways rather than practice guidelines?

Chronic suppurative otitis media (CSOM) without cholesteatoma, the surgical treatment of which is still controversial, is a common diagnosis in otologic practice. A retrospective analysis of 323 patients who underwent surgery for noncholesteatomatous chronic otitis media in the Gruppo Otologica, Piacenza, Italy, between April 1983 and December 1993 is presented. Cases were separated into three groups according to different surgical treatment modalities and conditions of the ears at the time of operation. Group I (n = 53) consisted of cases of CSOM treated by tympanoplasty without mastoidectomy (TLWOM). Group II (n = 28) included cases of CSOM treated by tympanoplasty with mastoidectomy (TLWM). Intact canal wall technique was used in these cases. The ears in both these groups were discharging severely at the time of surgery. Group III (n = 242) included patients whose ears were dry at the time of surgery but who had had previous recurrent episodes of suppuration and who were treated by TLWOM. At the last follow-up, graft success rates for groups I, II, and III were 90.5%, 85.7%, and 89.2%, respectively, and mean residual gaps were 17.2 dB, 20.1 dB, and 19.4 dB, respectively. There was no statistically significant difference between the three groups either on graft success rates (p > 0.05) or on final functional hearing outcome (p > 0.05). TLWM is the preferable treatment modality for most surgeons in noncholesteatomatous CSOM. Nevertheless, in our experience TLWOM yields comparable results for this group of patients. In addition, we could not find any significant difference in results of graft success and final functional hearing rates between dry and discharging ears (p > 0.05).     

A new dosage regimen for topical application of ciprofloxacin in the management of chronic suppurative otitis media

The clinical and bacteriologic efficacy of topically applied ciprofloxacin was studied in 60 patients with chronic suppurative otitis media. Two hundred fifty and 125 microg/ml concentrations of ciprofloxacin solutions were given to two groups of patients. The duration of therapy was determined according to the clinical cure at follow-up. More than 21 days of therapy was not needed in any patient. The clinical cure rate with 250 microg/ml ciprofloxacin was 78.1% at 14 days and with 125 microg/ml it was 83.3%. However, a 100% clinical cure rate and complete bacteriologic eradication was obtained in 21 days in both groups. In each group only one patient had otomycosis by the fourteenth day of therapy, although ear discharge had ceased. It was concluded that 125 microg/ml ciprofloxacin could be applied as successfully as 250 microg/ml, and the duration of therapy had to be at least 14 days. This new dosage regimen can be adopted as an optimal dosage for ototopical application of ciprofloxacin in chronic suppurative otitis media. It will also obviously decrease the expense of therapy.     

Brainstem auditory evoked potentials in young children before and after tympanostomy tube placement

To evaluate the effect of tympanostomy tube placement upon the hearing function of infants and young children, brainstem auditory evoked potentials (BAEP) were recorded in a group of young children (mean age 22 mos) receiving this treatment for otitis media with effusion (OME). For comparison, a group of healthy infants with normal behavioral audiometry were also tested with BAEP. Hearing loss was estimated for each ear using peak V latency-intensity curves. To evaluate the immediate effect of tube placement, 98 ears in 52 children were tested immediately before and after tube insertion. The 63 ears with effusion had prolonged peak latencies that decreased significantly (P < 0.001) immediately after tube placement and a mean hearing loss estimate of 22 dB that improved significantly (P < 0.0001) to 11 dB immediately after tube insertion. The 35 ears without effusion at myringotomy had a mean hearing loss estimate of 8 dB that did not change significantly after tube insertion. To evaluate the short-term effect of tube presence, 39 ears in 25 children were tested 3 weeks to 18 months after tube insertion. The 28 ears with dry tubes had a mean hearing loss estimate of 3 dB, and the 11 ears with otorrhea had a mean hearing loss estimate of 31 dB. The magnitude of mean hearing loss estimates in these young children with OME and the improvement in hearing function with tube placement is similar to that reported in older children studied with BAEP and audiometry. The study groups with a history of otitis media that had resolved by the time of testing had isolated prolongation of mean III-V interpeak latencies compared to normals (P < 0.01). These studies show that BAEP techniques are useful in estimating hearing loss in children with OME who are difficult to test by behavioral audiometry and show changes in rostral brainstem transmission in very young children with a history of OME.     

Oropharyngeal tumors of dogs--a clinical study of 79 cases

Secretory otitis media is defined as a fluid in the middle ear without signs or symptoms of infection. As the aetiology and pathogenesis of the disease are unknown, and as it affects children aged from 3 to 12 years, treatment procedures proposed for management of secretory otitis media, are not uniform. Some authors [1, 4, 6] consider that functional or mechanical obstructions of the Eustachian tube could provoke secretory otitis. The purpose of the treatment is to remove exudate from the middle ear and appropriately ventilate it for a longer period. That could instantly normalize the hearing and exclude the appearance of late complications of secretory otitis. Although the disease could heal spontaneously, the treatment should be performed immediately for preventing sequelae of secretory otitis. The aim of the study was to evaluate possible aetiologic factors of secretory otitis in our population, and to evaluate results of lympanometry in children with exudate in the middle ear. There were 65 children, aged from 3 to 12 years (Table 1), who complained of deafness and were examined at the ORL Department in Banja Luka. The clinical examination revealed the integrity and color of tympanic membrane, scars, adhesions and atrophic areas. Audiometry and tympanometry had been performed in addition. Patients who proved to have exudate in the middle ear received nasal decongestants and mucolitics during three months, and were evaluated every three weeks by audiometry and tympanometry. Pathologic findings in the nose and epipharynx were the most common findings: enlarged adenoids in 38 (58%) patients, hypetrophic rhinitis in 15 (23%) and allergic rhinitis in 5 (8%) patients. Frequent relapses of middle ear infection in the first three years of life were found in 26 (40%) patients and early first attacks in the first year of life in 15 (23%) patients (Table 2). Premature onset (15%) and allergy (21%) had also been frequently found. Results of tympanometry and audiometry are shown in Table 3. Exudate in the middle ear and type B tympanogram were found in 86 ears, while in other patients dysfunction of the Eustachian tube and type C1 and C2 tympanograms were found. After 6 weeks the exudate disappeared in 16 ears and tympanogram converted in type A and type C2, while the initially found C1 tympanogram was transformed in type A in 5 of 13 ears. After 12 weeks the tympanogram type B was found in 46 ears, while in 40 ears (47%) the tympanogram was changed in type A and type C2. After 6 and 12 weeks of therapy tympanometric types were statistically examined by chi 2 test. We have found a significant difference in tympanometric types and prevalence of type A and C1 tympanograms. Paracentesis and insertion of ventilating tubes were done in 46 ears with the remaining exudate. We have found mucous exudate in 35 (76%) ears associated with retraction and scars of tympanic membrane (Table 4), what indicated that the longer duration of mucous exudate caused degenerative changes in the middle ear. Serous exudate, found in 9 ears (24%), did not affect the color and integrity of the tympanic membrane. Sensitivity of tympanometry in detection of exudate in the middle ear was 96%. Secretory otitis media is a frequent disease in childhood, that could cause functional and morphological sequelae in the middle ear. As for now, there is no unique concept of diagnosis and treatment of the disease, and it is still a current problem. We suggest a three-month evaluation of tympanometric and audiometric patterns, repeated every three weeks, in children suspected of having exudate in the middle ear. There is a large trend of spontaneous disappearance of exudate in the middle ear and changing of tympanogram type. Such children should be evaluated over the period of one year, and if there is no relapse additional treatment should not be carried out. If exudate in the middle ear persists for three months and type of the tympanogram is unchanged, myringotomy and insert     

Pathogens isolated during treatment failures in otitis

OBJECTIVES: A prospective study in the Paris region to evaluate the clinical and bacteriologic epidemiology of acute otitis media in infants in whom oral antibiotic therapy resulted in clinical failure. METHODS: The study included 186 children with a mean age of 17.5 +/- 13.1 months. Two-thirds of them attended a day-care center and 40.8% had a history of recurrent otitis media. The most frequently prescribed prior antibiotics were amoxicillin-clavulanic acid (43% of cases), an oral third generation cephalosporin (22.6%), erythromycin-sulfisoxazole (11.8%) and a first generation cephalosporin (10.2%). The average duration of antibiotic therapy was 6.9 +/- 2.65 days. Specimens for bacterial cultures included 188 samples of middle ear fluid obtained by tympanocentesis and 37 collected from otorrhea fluid. RESULTS: One hundred forty-one samples (62.7%) from 126 children yielded 170 bacterial isolates. In 60 children (32.3%) the culture of the ear pus was sterile. Among the 170 bacterial isolates: 67 (39.4%) were Streptococcus pneumoniae (59 patients), of which 77.6% had reduced susceptibility to penicillin (PRSP with penicillin MIC > or = 0.125 mg/l); 61 (35.9%) were Haemophilus influenzae (56 patients) of which 49.2% were beta-lactamase producers; and 8 were Moraxella catarrhalis (8 patients), of which 87.5% were beta-lactamase producers. Thirty-six patients were infected by S. pneumoniae with penicillin MIC > or =1 mg/l. In our study attending day-care center (P = 0.04), temperature >38 degrees C with signs of otalgia (P = 0.02), age <2 years (P = 0.048) and prior antibiotic treatment with erythromycin-sulfisoxazole (P = 0.006) were independently predictive risk factors for patients infected with penicillin-resistant S. pneumoniae. Pneumococcal serogroups 23, 14 and 19 were predominant (25.4, 25.4 and 23.8%, respectively). Penicillin resistance was mainly associated with serogroups 23 and 14. CONCLUSIONS: Penicillin-resistant S. pneumoniae isolates are frequently responsible for therapeutic failure in cases of acute otitis media in the Paris region.     

Epidemiology of otitis media with effusion in children

The recently accepted international classification for otitis media was applied to a study population of 898 children less than 12 years of age having otitis media with effusion persisting at least three months. Mucoid effusion was aspirated from 48% of ears, was found more often in younger than older patients, was more often bilateral, and was a more stable state during longitudinal observation than was serous otitis media or purulent otitis media (POM). Serous otitis media occurred in only 10% of ears, but was found more often than in younger patients; POM was found in only 7% of ears. Otoscopy did not distinguish among the three effusion types. Known middle-ear pathogens were cultured more often behind red and bulging tympanic membranes from these cases of chronic effusion than behind membranes lacking these characteristics. These observations provide an epidemiologic and clinical base for further investigations of these otitis media types.     

Complicated urinary infection in spinal injury patients: fleroxacin compared with ciprofloxacin

The efficacy and safety of fleroxacin and ciprofloxacin were evaluated in a single-centre, prospective, randomised, blinded study of patients with complicated urinary infection in a spinal injury unit. Patients were randomised to receive oral fleroxacin 400 mg once daily (n = 68) or oral ciprofloxacin 500 mg twice daily (n = 65) for 10 days. Clinical cure assessed 5-9 days after therapy was obtained in 41 of 42 (98%) assessable patients in the fleroxacin group, and in 41 of 43 (95%) of the ciprofloxacin group, and was maintained at the 6-week follow-up visit in all but 1 patient in each group. Bacteriological eradication rates 5-9 days after therapy exceeded 88% in the fleroxacin group and 86% in the ciprofloxacin group, and 69 and 65%, respectively, 6 weeks after completion of therapy. Adverse events occurred in a similarly low percentage of patients (19 and 20%) in both treatment groups, and consisted primarily of nausea. Once daily fleroxacin appears to be as safe and effective as twice daily ciprofloxacin and both represent efficacious treatment in complicated urinary infection in spinal injury patients.     

Intratemporal complications of acute otitis media in infants and children

We reviewed our experience with 100 children admitted to Children's Hospital of Pittsburgh between 1980 and 1995 with an intratemporal complication of acute otitis media. Seventy-two patients were treated for acute mastoiditis. Of these 72 children, 54 (75.0%) were treated conservatively with broad-spectrum intravenous antibiotics and myringotomy. Eighteen (25.0%) required mastoidectomy for treatment of a subperiosteal or Bezold's abscess or cholesteatoma, or because of poor response to conservative therapy. Twenty-two children presented with facial paralysis, complete in 5 (22.7%) and incomplete in 17 (77.3%). Eighteen (81.8%) were treated conservatively, but four required mastoid surgery. Nineteen patients had adequate follow-up; of these, 15 recovered normal facial function but 4 were left with partial paralysis. Three patients presented with serous labyrinthitis and recovered completely with conservative therapy. Of the two patients who presented with suppurative labyrinthitis, one was treated conservatively, but the other required tympanomastoidectomy with cochleotomy; both patients had permanent, profound sensorineural hearing loss in the affected ear. Four patients presented with acute petrositis, and in all four it resolved with mastoidectomy. In the antibiotic era, intratemporal complications of acute otitis media still occur in otherwise healthy children, often after inadequate treatment of acute otitis media.     

Incidence of acute otitis media associated with group A and B respiratory syncytial virus infections

The comparative association of respiratory syncytial virus group A and B infections with acute otitis media was determined by analysing the hospital records of children with community-acquired respiratory syncytial virus infection during three successive outbreaks from 1987 to 1992. Of 326 episodes analysed, 192 (59%) were caused by group A and 134 (41%) by group B infections. Acute otitis media was diagnosed in 101 (75%) children with group B infection, compared with 119 (62%) with group A infection (p = 0.01). Group A infections were more often associated with wheezing (71% versus 59% in group B; p = 0.02) and oxygen therapy in inpatients (48% versus 31%, respectively; p = 0.008). The higher incidence of acute otitis media associated with group B infections was observed both after adjustment for potential confounding variables and during each outbreak.     

Long-term treatment of ulcerative colitis with ciprofloxacin: a prospective, double-blind, placebo-controlled study

BACKGROUND & AIMS: Although bacterial bowel flora may be one of the contributing factors in the pathogenesis of chronic mucosal inflammation, antibiotic treatment has no established role in ulcerative colitis. The aim of the study was to evaluate the role of ciprofloxacin in the induction and maintenance of remission in ulcerative colitis in patients responding poorly to conventional therapy with steroids and mesalamine. METHODS: Ciprofloxacin (n = 38; 500-750 mg twice a day) or placebo (n = 45) was administered for 6 months in a double-blind, randomized study with a high but decreasing dose of prednisone and maintenance treatment with mesalamine including follow-up for the next 6 months. Clinical assessment and colonoscopic evaluation were performed at 0, 3, 6, and 12 months. Treatment failure, the primary end point, was defined as both symptomatic and endoscopic failure to respond. RESULTS: During the first 6 months, the treatment-failure rate was 21% in the ciprofloxacin-treated group and 44% in the placebo group (P = 0.02). Endoscopic and histological findings were used as secondary end points and showed better results in the ciprofloxacin group at 3 months but not at 6 months. CONCLUSIONS: Addition of a 6-month ciprofloxacin treatment for ulcerative colitis improved the results of conventional therapy with mesalamine and prednisone.     

Multicentre comparative study of the efficacy and safety of azithromycin compared with amoxicillin/clavulanic acid in the treatment of paediatric patients with otitis media

An open multicentre study was conducted in 484 children between the ages of 6 months and 12 years with otitis media to compare the efficacy, the safety and the tolerance of once-daily azithromycin given for three days versus thrice-daily amoxicillin/clavulanic acid (CA) given for ten days. A satisfactory response (cure plus improvement) was noted 10 to 14 days after the start of treatment in 199 of 215 (92.6%) azithromycin-treated children and in 186 of 198 (93.9%) amoxicillin/CA-treated children. The relationship between treatment and clinical response was independent of chronicity of infection and the presence or absence of a perforated eardrum. Improvement in signs and symptoms of otitis media occurred significantly more rapidly in the children treated with azithromycin. Treatment-related or possibly treatment-related adverse events were recorded in 11 of 243 (4.5%) azithromycin-treated patients and in 20 of 240 (8.3%) treated with amoxicillin/CA. No patients in the azithromycin treatment group were withdrawn from treatment, but six amoxicillin/CA patients, including two < 2 years of age, discontinued treatment prematurely because of adverse events; the difference between treatment groups was statistically significant (p = 0.0146). It is concluded that azithromycin given as an oral suspension once daily for three days is as safe and effective as amoxicillin/CA given thrice daily for ten days in the treatment of children with otitis media.     

Changes in fluid filtration capacity and blood flow after tourniquet in knee operations with spinal anesthesia

In this randomized, multicenter, observer-blind study, the efficacy, safety and tolerability of amoxycillin/clavulanate and cefaclor were compared in children with a clinical diagnosis of acute otitis media. Patients aged between 1 and 12 years received either amoxycillin/clavulanate (250 mg/62 mg t.i.d., or 125 mg/31 mg t.i.d. if aged under 6 years) or cefaclor (250 mg t.i.d., or 125 mg t.i.d. if aged under 6 years) for 7 days. The amoxycillin/clavulanate regimen was based on a dose of 20/5 mg/kg/day (representing 20 mg amoxycillin plus 5 mg clavulanic acid) in three divided doses. Patients were followed-up at the end of therapy and on days 10-12 and 38-40. At the end of the study (days 38-40), clinical success rates were 91.4% for amoxycillin/clavulanate and 78.6% for cefaclor. The difference was statistically significant (p = 0.008). After the 7 days of treatment, 3 patients (2.9%) in the amoxycillin/clavulanate group had clinical failure, compared with 18 patients (16.1%) in the cefaclor group (p < 0.001). Both treatments were well tolerated and there were no statistically significant differences between the groups in adverse event profiles. The incidence of diarrhea was low (7.0% amoxycillin/clavulanate, 8.4% cefaclor) and was generally of mild or moderate intensity. The study demonstrated that amoxycillin/clavulanate was significantly more effective clinically than cefaclor in the treatment of acute otitis media in children.     

Validation of therapeutical policy choice in exudative otitis media

132 patients with diagnosis acute or subacute exudative otitis media were treated conservatively (n = 79) or surgically (n = 53). Conservative treatment was effective in 41% of the cases, surgical treatment produced positive results in 62.3%. The operative treatment combined elements of endoscopic nasal surgery and methods used in tympanoplasty, plastic treatment of the auditory tube, surgery of the internal ear.     

Gas exchange function of the middle ear in patients with otitis media with effusion

Gas exchange function through the middle ear mucosa was assessed using nitrous oxide (N2O) in patients with otitis media with effusion (OME), as well as in normal ears during elective surgery for unrelated disorders. In all normal ears except one (n = 43), an increase in pressure was observed after N2O inhalation. In 42 of 84 ears with OME, a pressure increase was observed, but not in the remaining 42 ears (50%), indicating that the gas exchange function in these latter ears was impaired. In 21 of the 42 ears showing no middle ear pressure increase following N2O inhalation, the middle ear pressure was again monitored after myringotomy and aspiration of the effusion A pressure increase was found in 16 ears, indicating that the impairment in gas exchange function in ears with OME may be reversible in most cases. Computed tomography of the mastoid was examined preoperatively in 66 ears, with the presence or absence of a middle ear pressure change well correlated in 57 ears with the presence or absence of mastoid aeration.     

Evaluation of cefaclor in acute otitis media caused by ampicillin-resistant H. influenzae

Cefaclor was used to treat 13 children with acute otitis media caused by ampicillin-resistant strains of Hemophilus influenzae. The children were re-examined on days 4, 10, and 28. Pharmacologic compliance was assessed by means of a bioinhibition assay on a urine specimen obtained on days 4, 7, and 10. Nine of the 13 children had evidence by tympanogram of residual otitis media with effusion (secretory otitis media). Of these, three were noted to have a bulging, yellow or grey eardrum, which suggested an ongoing acute process. A second middle ear culture was obtained from two of the 3 children, but no pathogens were recovered. Two others had recurrence of otitis shortly after cessation of therapy. Cefaclor is an acceptable antibiotic for the treatment of ampicillin-resistant acute otitis media; but, after cefaclor therapy, some children continued to have a bulging eardrum and sterile pus in the middle ear or had recurrences of otitis soon after cessation of therapy.     

Influence of the gas exchange function through the middle ear mucosa on the development of sniff-induced middle ear diseases

To investigate the influence of gas exchange function through the middle ear mucosa on the development of sniff-induced middle ear diseases, the authors examined the mastoid pneumatization among patients with sniffing habit using computed tomography, and also examined the change of negative middle ear pressure induced by sniffing using tympanogram. In 20 ears with cholesteatoma or adhesive otitis media, the areas of mastoid cavity measured at the level of the lateral semicircular canal were significantly smaller than those in 26 ears with otitis media with effusion (OME) or attic retraction and in eight normal ears with sniffing habit (P < .01 and P < .0001, respectively). In 26 ears with OME or attic retraction, the areas of mastoid cavity were significantly smaller than those in eight normal ears with sniffing habit (P < .0001). By contrast, in the four ears with sniff-induced middle ear disease, the recovery of negative middle ear pressure in 5 minutes without swallowing was less than 10 mm H2O, whereas in all seven ears with normal eardrum, negative middle ear pressure recovered by more than 20 mm H2O in 5 minutes. These findings suggested that impairment of gas exchange function through the middle ear mucosa, as well as eustachian tube dysfunction, might be closely related to the development of sniff-induced middle ear diseases.