title: The effect of the leukotriene antagonist pranlukast on pediatric acute otitis media.
abstract: OBJECTIVE
  Conventional treatment for acute otitis media mainly targets bacteria with antibiotics, neglecting to control for mediators of inflammation. Mediators of inflammation, such as leukotrienes, have been identified in patients with acute otitis media (AOM) or subsequent secretory otitis media (SOM). They can cause functional eustachian tube dysfunction or increase mucous in the middle ear, causing persistent SOM following AOM. The objective of the present study was to evaluate whether or not administration of pranlukast, a widely used leukotriene C4, D4, and E4 antagonist, together with antibiotics could inhibit the progression to SOM.
  
  
  METHODS
  Children with AOM, who were from two to 12 years old, were randomly divided into two groups as follows: a control group in which 50 patients received antibiotic-based conventional treatment according to guidelines for treating AOM proposed by the Japan Otological Society (version 2006); and a pranlukast group, in which 52 patients were administered pranlukast for up to 28 days as well as given conventional treatment. Cases were regarded as persistent SOM when a tympanogram was type B or C2 four weeks after treatment was initiated.
  
  
  RESULTS
  Two patients in the pranlukast group and 3 patients in the control group were excluded because they relapsed AOM within 28 days after initial treatment. Therefore, the analysis included 50 and 47 subjects in the pranlukast and control groups, respectively. The percentage of patients diagnosed with persistent SOM (22.0%) was significantly smaller in the pranlukast group compared with the control group (44.7%) (p = 0.018, chi-squared test).
  
  
  CONCLUSIONS
  The results indicate that combined treatment of AOM with antibiotics and a leukotriene antagonist to control inflammation is useful for preventing progression to persistent SOM.
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan. Electronic address: y-naka@med.nagoya-cu.ac.jp.
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Nakamura
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Hamajima
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Motohiko
authors.initials: M
authors.lastname: Suzuki
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Esaki
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Yokota
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Oshika
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Ippei
authors.initials: I
authors.lastname: Takagi
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Keiko
authors.initials: K
authors.lastname: Yasui
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Naoya
authors.initials: N
authors.lastname: Miyamoto
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Kazuko
authors.initials: K
authors.lastname: Sugiyama
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Meiho
authors.initials: M
authors.lastname: Nakayama
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Murakami
mesh_terms: D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002867:Chromones / Q000627:therapeutic use*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D010034:Otitis Media with Effusion / Q000175:diagnosis / Q000517:prevention & control
chemical_list: D000900:Anti-Bacterial Agents; D002867:Chromones; D020024:Leukotriene Antagonists; C047681:pranlukast
keywords: Acute otitis media; Leukotriene antagonist; Pranlukast; Secretory otitis media