Khaled A.Mustafa, MD
otolaryngeologist ,Directorate Of Royal Medical Surfaces (DRMS)

Correspondance
Dr.Khaled Mustafa, MD,
P.O.Box 150029,
Postcode: 13115, Zarqa, JORDAN
Email: khaledh12345@yahoo.com

Otitis media is a common problem in children. It may be associated with effusion for which tympanostomy tube insertion may be required⁽¹⁾, however this procedure may be complicated by otorrhea in about 50% of cases⁽²⁾. Topical CP has been considered the treatment of choice for patients with otitis media and tympanostomy. It belongs to the Fluoroquinolone group of antibiotics and is a broad spectrum antibiotic that covers most of the pathogens involved in otitis media with tympanostomy tubes^(3,4). Although the use of topical steroids has a tendency to delay wound healing in cutaneous wounds^(5,6) its effect on specialized tissues healing, including the tympanic membrane has not been studied in Jordan but some studies done around the world revealed that when topical steroids are combined with topical antibiotics it provides rapid resolution of otorrhea^(7,8).

The object of this study was to examine the effect of combined topical antibiotic and steroid on children with acute otitis media and effusion who underwent myringotomy.

This study was done in King Hussein Medical Center between July 2007 and July 2008. 139 children aged between 2 and 14 years were diagnosed to have acute otitis media with effusion and underwent myringotomy; 19 children were excluded from the study because they had suppurative ear infections, chronic nasal obstruction or persistent rhinorrhea, a past or current history of immunosuppressive disorders or immunosuppressive therapy, diabetes and poor compliance patients. After taking baseline ear culture, the remaining 120 patients were divided into two grou,ps the first one those who received topical combination of CDX and the second group those who received topical CP alone. In both groups the medications were given in a dose of 3 drops twice daily for 7 days.

All patients were evaluated in the 1st, 3rd, 7th and 14th day post drug administration regarding their clinical response including the reduction in granulation tissue. The response was graded as follows:

Grade 0 if complete resolution occurred. -
-Grade I if partial resolution occurred.
-Grade II if no change occurred in the patient condition.
-Grade III if the patient condition worsens.

Another ear culture was taken in the 7th and 14th day from patients with grade II and III.

19 patients out of the 120 had negative baseline ear culture. From those, 10 of them received topical combination of CDX and had complete resolution (grade 0) by the 3rd day and the rest of them received topical CP alone , but they had complete resolution (grade 0) by the 7th day. The causative micro organisms in the remaining 101 patients are summarized in Table (1).

There was no statistically significant difference in the results of the microbiological cultures regarding age and sex.

In the patients with positive culture results (101 patients), 51 of them received topical CP alone, while topical combination of CDX was administered for the remaining 50 patients. The results of their assessment on the 1st, 3rd, 7th and 14th day post drug administration are summarized in Table (2).

This was the first prospective study done in Jordan to compare the effect of combined topical administration of steroids and antibiotics on child patients who underwent myringotomy for acute otitis media with effusion.

Patients with negative baseline ear culture formed 15.8% of all cases, those who received topical CDX had more rapid resolution of otorrhea compared to those who received topical CP alone. This suggests the important role of steroids in reducing the inflammation of specialized tissues regarding the causative micro organisms. The most common causative agent was streptococci pneumonia, which is similar to the results found world wide⁽⁹⁾. There was no statistical significance of the type of micro organisms regarding the response to medication. This emphasizes that CP is an excellent medication in covering a wide variety of micro organisms causing otitis media.

If we have quick look at Table (2) which summarizes the results of drug administration to patients with positive cultures, we will notice easily that the use of topical combined CDX produced a dramatic response of complete or partial resolution in 54% of cases compared with 27.5% in patients who used CP alone, in addition to that, the percentage of patients who did not improve (26.0%) or whose condition worsened (20.0%) was less in patients exposed to the combined CDX. This describes the powerful effect of CDX on controlling otorrhea in myringotomy patients and in turn avoiding undesirable discomfort of ear symptoms. This excellent response to CDX continued on the 3rd day where we have 70.0% of cases in grade 0 and I, compared to only 35.2% of patients with topical CP alone. However the difference in response between the two groups started to decline by the 7th day; in those patients who used combined CDX 80% of them showed complete or partial resolution of otorrhea compared with only 54.9% in those with CP alone. By the 14th day there was little difference in the response of the two groups to medication, in patients with CDX 84.0% showed complete resolution of otorrhea (grade 0), and 8.0% showed partial resolution (grade I), 6.0% had no change in their clinical condition (grade II) and only 2.0% had worse symptoms. While in patients with CP alone, 78.4% which is close to the percentage found in the other group, 9.8% also had partial resolution, 3.9% had no change in their clinical situation and 3.9% had a worse clinical condition.

It was obvious that the use of topical steroid when added to antibiotics provides dramatic relief of otorrhea in patients with myringotomy. This suggests that steroids play a major role in decreasing the inflammatory process in specialized tissues even in the presence of infective agents. This role of steroids was suggested in many studies, one of them done at Pittsburgh in 2006 by Hebda, Patrical A,. et al in which they assessed the histological response of tympanic membranes for CDX after myringotomy. This study revealed that Myringotomy healing was modulated by treatment with CDX, as evidenced by decreased granulation tissue formation and perforation healing rates, and proceeded normally after the treatment was discontinued⁽¹⁰⁾. It was also evaluated in a study of 300 children undergoing tympanostomy tube placement, prophylactic administration of neomycin/polymyxin B/hydrocortisone drops, administered either as a single intraoperative dose or as an intraoperative dose followed by a 5-day course, significantly decreased the incidence of post-tympanostomy otorrhea in comparison with no treatment. In another study⁽¹¹⁾, treatment with either neomycin/colistin/hydrocortisone drops or gentamicin 0.3% drops for 14 days was compared in 55 patients with otorrhea complicating recurrent otitis media with tympanic membrane perforation, otitis externa, or infected mastoid cavities and postoperative tympanoplasties. Both treatments proved equally safe; whereas the antibiotic-corticosteroid combination appeared to relieve inflammation more effectively. The antibiotic alone was more effective in eradicating the infecting organism⁽¹²⁾. An antibiotic-corticosteroid preparation (gentamicin/hydrocortisone) has also been found to be more effective than a corticosteroid alone (betamethasone) in producing disease inactivity in patients with non-cholesteatomatous chronic otitis media⁽¹³⁾.

CP is an excellent medication in covering a wide variety of micro organisms causing otitis media. Streptococcus pneumonia is the most common infective agent involved in otitis media with effusion, in Jordan. CDX treatment is helpful in enhancing middle ear drainage and increasing middle ear concentrations of CDX when tympanostomy tube surgery is performed in patients with active otitis media and effusion. The finding of perforation healing with early CDX therapy suggests that a short course of this antibiotic/anti-inflammatory preparation after tympanostomy tube placement may be used safely to reduce otorrhea and prevent or treat infection without increasing the risk of premature tube extrusion or adversely affecting normal healing of the tympanic membrane. Although the combined CDX does not improve the final outcome of otorrhea in patients with myringotomy for otitis media with effusion, it has an important role in early and rapid relief of undesirable ear symptoms.

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