Highlights of Pediatric Academic Societies' 2006 Annual Meeting

2006年4月29日－5月2日

美国加利福尼亚州旧金山

April 29, 2006 - May 2, 2006, San Francisco, California

Revisiting the 2004 AOM Management Guidelines
William T. Basco, Jr., MD
Overview
As part of their annual meeting, the Pediatric Academic Societies (PAS) and the Pediatric Infectious Diseases Society cosponsored a Hot Topic session where a number of speakers reviewed diagnosis and treatment of acute otitis media (AOM). The session began with a review of management guidelines and included descriptions of the most recent data related to current treatment approaches.

Review of the AOM Guidelines
Guidelines published in 2004 by the Subcommittee on Management of Acute Otitis Media of the American Academy of Pediatrics (AAP)[1] were reviewed by Dr. Jerome O. Kline,[2] Boston University School of Medicine, Boston, Massachusetts. He primarily focused on 4 areas: (1) the definition of AOM; (2) the recommendation to consider watchful waiting with certain patients; (3) recommendations for initial therapy and second-line treatment; and (4) possible prevention of AOM.

According to the AAP guidelines, the following criteria are essential for the diagnosis of AOM:

Recent onset of signs and symptoms of middle ear inflammation

Presence of middle ear effusion, with either bulging of the tympanic membrane, decreased mobility, or an air-fluid level

Signs and symptoms of middle ear inflammation such as erythema or otalgia (ear pain)
Dr. Kline stressed that determination of some of the criteria may necessitate use of pneumatic otoscopy (ie, to demonstrate decrease in tympanic membrane mobility).

To successfully implement these guidelines, a clinician must be able to determine whether a patient has severe AOM or nonsevere AOM. The challenges of determining severe or nonsevere AOM were also reviewed in more detail later in the session. A general definition of severe AOM includes a temperature greater than 39º C in association with severe otalgia.

Perhaps the most controversial aspect of the 2004 guidelines is the suggestion that selected patients may be managed with watchful waiting instead of being treated with antibiotics at the time of diagnosis. For the purposes of the recommendations, the guidelines divided patients with AOM into 2 categories, based on the clarity of the history and the physical examination findings -- a certain and an uncertain group. The guidelines suggest children younger than 6 months of age should be treated with antibiotics regardless of the clarity of AOM diagnosis, so that even uncertain cases should be treated with antibiotics. Children aged 6 to 24 months with certain AOM should also receive antibiotics. However, if the diagnosis is uncertain and the symptoms are not severe, the practitioner could consider watchful waiting, with reassessment within 72 hours.[1]

For children older than 24 months, those with certain AOM can be observed if the symptoms are not severe, and all with uncertain diagnoses should be observed. Dr. Kline maintained that it is too early to know whether these suggestions for watchful waiting have met with widespread acceptance by clinicians. Additional data are needed before this can be determined.

The importance of the recommended first- and second-line therapies put forth in the guidelines was reiterated. A first-line drug would be prescribed if treatment was initiated at diagnosis or after symptoms continue or worsen during a period of observation. It is Dr. Kline's opinion that the recommended drug therapy components of the guidelines have not been adequately followed by many clinicians.

For nonsevere episodes of AOM, amoxicillin remains the first-line drug of choice, whether prescribed at time of diagnosis or after failed observation. For severe episodes, the guidelines recommend the use of amoxicillin/clavulanic acid, again, whether prescribed at time of diagnosis or after failed observation.[1]

Dr. Kline stressed that cephalosporins should only be considered as acceptable first-line treatment for patients with penicillin allergy. The drug with the most universal acceptance as a second-line drug in a penicillin-allergic patient is ceftriaxone, given intramuscularly for 1 to 3 days; ceftriaxone intramuscularly was the consensus recommendation for treating severe AOM, regardless of whether treatment is initial, after observation, or after failed treatment with another antibiotic.

Dr. Kline concluded with a review of statistics about diagnosis of and prescribing for AOM. In 2003, Finklestein and colleagues[3] demonstrated a general decline in antibiotic prescribing from 1996-2000. In particular, the investigators demonstrated that the decrease in prescribing for AOM accounted for 59% of the decrease in overall antibiotic prescribing rates, and this drop was attributed to fewer diagnoses of AOM over the time period.

Implementing Watchful Waiting
Dr. David P. McCormick,[4] University of Texas Medical Branch, Galveston, Texas, discussed whether the concept of watchful waiting can work for children diagnosed with AOM. He reviewed the spectrum of AOM presentations and described a tool used to identify candidates for watchful waiting.

In an investigation by Siegel and colleagues,[5] almost 200 children with AOM were managed by providing a safety net prescription and treating pain. The parents were told to fill the safety net prescription if symptoms were not improved within 72 hours. This approach resulted in a 69% decrease in antibiotic prescribing -- only 31% of parents filled the prescription.[5] However, this investigation was not a randomized study.

McCormick and colleagues[6] designed and completed a randomized study, published in 2005. This investigation evaluated the safety, efficacy, and acceptability of a watchful waiting approach in children with nonsevere AOM. The 266 subjects had clinical symptoms and evidence of AOM seen on otoscopic examination. Nasopharyngeal cultures from each participant were obtained at enrollment and at Day 10.

The severity of participants' AOM symptoms were evaluated at enrollment and at Days 12 and 30. The classification of nonsevere involved symptom scores and physical finding scores previously developed by the authors.[7] Patients' AOM was considered nonsevere if they were in the lower 50% of the symptom/discomfort reporting scale.

Children in the treatment arm received amoxicillin at 90 mg/kg/day (divided twice daily) for 10 days. If a treatment-group subject experienced treatment failure, he or she was treated with amoxicillin/clavulanate (same dose as amoxicillin). Watchful waiting subjects initiated the amoxicillin-only treatment in the case of treatment failure of watchful waiting. No routine pain control regimen was prescribed. Parental satisfaction was measured by survey at Days 12 and 30. A participant was considered a treatment failure if he or she returned during Days 1-12 with a symptom severity index higher than their severity index at enrollment, or if they returned with physical findings worse than at the initial visit

This study demonstrated that a watchful waiting approach could reduce overall antibiotic use by 66%: two thirds of the parents of children assigned to the watchful waiting arm did not fill the prescription for antibiotics during the 12-day observation period. However, the outcomes were slightly different for patients older or younger than 2 years of age. In children older than age 2, 77% were better within the 12-day observation period if they were treated with antibiotic compared with 76% of the patients<