(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Otitis-Media

The objective of the present work was to analyse the available pharmaceutical products used for treatment of otitis media. The rational application of these medications makes it possible to eliminate rapidly a variety of etiological factors, reduce the severity of inflammation, and improve the quality of life of the patients. One of the approaches to the achievement of these goals for the patients with otitis externa and otitis media consists of the use of combined preparations containing antibacterial, antimycotic, anti-inflammatory and analgetic components. Candibiotic is a four-components drug composed of chloramphenicol, clotrimazol, beclomethasone and lidocaine. The advantages of Candibiotic include high therapeutic efficacy due to its ethiotropic and pathogenetic activity and safety as its components do not have ototoxicity in the case of local application).

Topics: Administration, Topical; Anesthetics, Local; Anti-Bacterial Agents; Anti-Inflammatory Agents; Antifungal Agents; Beclomethasone; Chloramphenicol; Clotrimazole; Drug Combinations; Humans; Lidocaine; Otitis Externa; Otitis Media

Following otitis media, 10% to 50% of children develop residual middle ear effusion with concurrent hearing loss and potential cognitive, behavioral, and language impairment. Prophylactic antibiotics and tympanostomy tubes are currently recommended treatments for chronic middle ear effusion.. In a double-blind, placebo-controlled, randomized study of chronic middle ear effusion, we assessed the effectiveness of topical intranasal beclomethasone as an adjunct to prophylactic antibiotic therapy.. Sixty-one children, aged 3 to 11 years with persistent middle ear effusion greater than 3 months, were randomized into three treatment groups: (1) prophylactic antibiotics; (2) prophylactic antibiotics plus intranasal beclomethasone (336 micrograms/day); and (3) prophylactic antibiotics plus intranasal placebo. Patients were evaluated with aeroallergen skin tests at entry; and tympanogram, otoscopic examination, and symptom questionnaire at 0, 4, 8, and 12 weeks.. While middle ear pressures, otoscopic examinations, and symptom scores were improved for each treatment group over 12 weeks of therapy, the beclomethasone plus antibiotics group improved all three measures more rapidly than the antibiotics-alone and placebo nasal spray plus antibiotics groups over the first 8 weeks. Only the beclomethasone group significantly improved left (P = .004) and right (P = .01) middle ear pressures over 12 weeks. Resolution of chronic middle ear effusions was more frequent in the beclomethasone group (P < or = .05 at 4 and 8 weeks). No difference in response to nasal steroids was observed between atopic and nonatopic subjects.. We conclude that intranasal beclomethasone may be a useful adjunct to prophylactic antibiotic treatment of chronic middle ear effusion.

Topics: Acoustic Impedance Tests; Acute Disease; Administration, Intranasal; Anti-Bacterial Agents; Anti-Inflammatory Agents; Beclomethasone; Child; Child, Preschool; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Otitis Media with Effusion; Otoscopes; Patient Compliance; Severity of Illness Index; Sinusitis; Treatment Outcome

The effect of a beclomethasone dipropionate nasal spray on middle ear effusion was tested in a double-blind study of drug vs placebo (vehicle). Seventy children, aged 4-14 years, sprayed each nostril twice daily for one month. Among them 35 received a daily dose of 400 micrograms of the beclomethasone. The results of tympanometry, audiometry and otomicroscopy were compared in the two groups, and the statistical analysis revealed P-values around 0.5. The conclusion is that the active drug had no effect on middle ear effusion in the population investigated.

Topics: Acoustic Impedance Tests; Administration, Intranasal; Adolescent; Audiometry, Pure-Tone; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Otitis Media

Topics: Administration, Intranasal; Beclomethasone; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Hypersensitivity; Infant; Male; Otitis Media; Sulfisoxazole; Time Factors