title: Longitudinal results of intratympanic injection of budesonide for otitis media with effusion in children over 12 years and adults.
abstract: OBJECTIVE
  To assess the longitudinal curative effect and improvement of subjective symptoms by using intratympanic injection of Budesonide(BUD) for otitis media with effusion (OME) patients older than 12 years and adults.
  
  
  METHODS
  A single-blind, randomized, parallel-controlled prospective study.
  
  
  METHODS
  Hospital, outpatient.
  
  
  METHODS
  Ninety patients (112 ears) who were diagnosed as having OME were recruited and then randomized to BUD, dexamethasone (DEX), and sodium chloride (NS) groups, the latter two served as controls.
  
  
  METHODS
  The randomly allocated patients received intratympanic injection of BUD (0.5 mg/1 ml), DEX (2 mg/1 ml), or 0.9% NS solution (1 ml) once a week.
  
  
  METHODS
  Survival analysis was applied to compare the longitudinal curative effects among the 3 groups. Meanwhile, the 6 main subjective symptoms were scored by 10-point visual scale, and physician's evaluations were preformed during treatment and follow-up.
  
  
  RESULTS
  After adjustment for course of disease, volume, and characters of effusion, the relative risk (RR) of BUD is 0.139 (95% CI, 0.054-0.358) when compared with NS. Survival curve demonstrated that the rank of longitudinal therapeutic efficacy was BUD, DEX, and NS (p < 0.05). Both BUD and DEX showed improvements in subjective symptoms and quality of life compared with NS (p < 0.05). In the aspect of improving the symptom of stuffy ear, BUD showed advantage over both DEX and NS. During and after treatment, no serious complications or sequelae were observed.
  
  
  CONCLUSIONS
  Intratympanic injection with BUD for OME patients showed advantages in improving long-term therapeutic efficacy, it was a safe and effective intervention for adolescents and adults with OME.
authors.affiliation: Department of Otorhinolaryngology Head and Neck Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, Republic of China.
authors.forename: Fengling
authors.initials: F
authors.lastname: Yang
authors.forename: Yu
authors.initials: Y
authors.lastname: Zhao
authors.forename: Ping
authors.initials: P
authors.lastname: An
authors.forename: Yongbo
authors.initials: Y
authors.lastname: Zheng
authors.forename: Rong
authors.initials: R
authors.lastname: Yu
authors.forename: Deying
authors.initials: D
authors.lastname: Gu
authors.forename: Hong
authors.initials: H
authors.lastname: Zheng
mesh_terms: D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use*; D002648:Child; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use; D004432:Ear, Middle; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000473:pathology; D016037:Single-Blind Method; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide; D003907:Dexamethasone