| Popis: |
Chronic mucosal otitis media (COM) is one of the most common infectious diseases in children worldwide. As it causes considerable morbidity and is a major global cause of hearing impairment, establishing its most effective treatment is important. It is generally accepted that antibiotic eardrops should be the first step in treating COM, and surgery the last when optimal medical treatment has failed. What optimal medical treatment beyond eardrops entails, however, has not been established. We therefore initiated a randomized placebo controlled trial of a 6- to 12-week course of orally administered trimethoprim/sulfamethoxazole (TMP-SMX) in children with chronic active mucosal otitis media. 101 children aged 1 to 12 years with a documented history of continuous otorrhea for at least 12 weeks were randomized to receive 6 to 12 weeks of orally administered TMP-SMX (18 mg/kg, 2 times per day) or placebo and were monitored for 1 year. At 6 and 12 weeks follow-up, cure rates were 72% and 68% in children treated with TMP-SMX and 47% and 53% in those treated with placebo. At 1 year, the cure rate was similar in both groups; 25% and 20%, respectively. A cost-effectiveness analysis of this treatment regimen showed that the average extra costs to cure 1 child from otorrhea were 400 and 1,113 Euros after 6 and 12 weeks follow-up, respectively. Alongside this trial we studied risk factors for COM in children. Using a case control design, we found that factors independently associated with COM in children were previous tympanostomy tube insertion, more than 3 upper respiratory tract infections in the past 6 months, low parental education level, and having older siblings. Factors independently associated with COM after tympanostomy tube insertion were more than 3 episodes of acute otitis media in the past year, attending day care, and having older siblings. The innate and adaptive immune function of children with COM was found not to differ from that of healthy controls. Finally, we studied the effects of prolonged treatment with TMP-SMX on carriage and antibiotic susceptibility of the microbial flora in children with COM. Antibiotic resistance of the nasopharyngeal and intestinal flora increased during treatment with TMP-SMX, but returned to baseline values after discontinuation of TMP-SMX. We concluded that a 6 to 12 week course of TMP-SMX (18mg/kg twice daily) is beneficial in children suffering from active chronic otitis media. This treatment effect is most pronounced with the shorter course, and disappears if the medication is discontinued. In light of its clinical benefit and tolerability, limited costs and reversibility of antibiotic resistance, we advice to treat children with persistent symptoms of otorrhea despite conventional management with eardrops and short-term antibiotics with a prolonged course of TMP-SMX. Ideally, interventions for COM should be aimed at prevention. At present, these are not available. It is therefore crucial that creative options based on modern insights into the pathofysiology of COM are developed. |
