[Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children].
A 6-month double-blind, prospective, randomized, placebo-controlled trial was conducted to establish the safety and efficacy of OM-85-BV in the treatment of subacute sinusitis and in the following prevention of the respiratory tract infections in 56 children from 18 months to 9 years of age. In the subacute phase of the sinusitis the patients were given one OM-85-BV capsule (3.5 mg of bacterial extracts) (n = 26) or placebo (n = 30), daily for ten days; additionally both groups took amoxicillin/clavulanate 40/10 mg/kg daily in three divided doses for 21 days. For the following two months the patients took one OM-85-BV capsule or placebo, ten days a month. In the subacute phase the OM-85-BV group of patients improved sooner (5.56 +/- 4.98 vs 10 +/- 8.49 days) and had a shorter convalescence (15.38 +/- 8.91 vs 20.28 +/- 7.17 days). During the six month follow-up the patients in the OM-85-BV group had a lower number of infections (1.56 +/- 0.3 vs 2.22 +/- 0.43) and required a lower number of drug treatments (1.47 +/- 0.32 vs 1.94 +/- 0.42). One patient treated with OM-85-BV presented a mild rash which disappeared three days after the drug discontinuation. We conclude that OM-85-BV is safe at pediatric ages, as well as accelerates the cure and improvement of subacute sinusitis while it lowers the incidence of respiratory infections.
Gómez Barreto
D
D
Servicio de Urgencias y Terapia Ambulatoria, Arzneimittelforshung BASF Pharma, México, Distrito Federal, México.
De la Torre
C
C
Alvarez
A
A
Faure
A
A
Berber
A
A
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria; D002457:Cell Extracts; D002648:Child; D002675:Child, Preschool; D019818:Clavulanic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D016527:Drug Costs; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D004363:Drug Utilization; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D012008:Recurrence; D012852:Sinusitis / Q000188:drug therapy* / Q000191:economics / Q000517:prevention & control; D016896:Treatment Outcome; D000095983:Bacterial Lysates
D000276:Adjuvants, Immunologic; D000658:Amoxicillin; D002457:Cell Extracts; D019818:Clavulanic Acid; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates
Seguridad y eficacia de OM-85-BV más amoxicilina/clavulanato en el tratamiento de la sinusitis subaguda y prevención de infecciones recurrentes en niños.