Prevention of recurrent respiratory tract infections in children using a ribosomal immunotherapeutic agent: a clinical review.Paediatr Drugs. 2006; 8(4):235-43.PD
Recurrent respiratory tract infections (RRTIs) in children constitute a serious problem worldwide. Some children experience considerable morbidity as a result of RRTIs and receive repeated courses of antibacterials that are not effective against viral infectious agents and can increase bacterial resistance. Furthermore, the direct and indirect costs of RRTIs to the community are substantial. In this article, we review the available clinical evidence relating to use of the bacterial immunostimulant Ribomunyl for the prevention of RRTIs in children. The product is composed of ribosomal fractions from four bacteria involved in RRTIs as well as a membrane fraction from one of these bacteria (Klebsiella pneumoniae). Ribomunyl stimulates production of specific humoral and secretory antibodies against the four bacterial strains included in the compound. The product also stimulates non-specific immunity. Thus, Ribomunyl stimulates both the innate and acquired immune systems and offers preventive efficacy against both bacterial and viral infections. To perform this review, we searched the MEDLINE database for articles on Ribomunyl and then included only those publications that described placebo-controlled studies, complied with Good Clinical Practice standards, used the product in official registered indications, and administered it at the recommended dosages. In this way, we were able to generate a comprehensive profile of use of the product and draw valid conclusions about its clinical role. In clinical trials of children, Ribomunyl reduced the number of upper or lower RRTIs, the primary outcome measures. Other favorable results relating to efficacy parameters that served as secondary outcome measures in these studies included a reduction in antibacterial treatments, shorter duration of recurrent episodes, reduced need for other medications such as expectorants, smaller number of lost school days or parent absenteeism from work, less fever, and reduced hearing loss. Studies focusing on particular conditions, such as otitis media, or those that included specific patient groups, such as very young children, reported similar findings. Adverse events occurred very rarely and were mild. Their frequency was similar to that reported in placebo groups, and consisted mostly of fever, otorhinolaryngologic symptoms, and cutaneous events. In conclusion, this review clearly demonstrated that Ribomunyl is effective in preventing upper and lower RRTIs in children. Ribomunyl provided a reduction in the number, duration, and severity of infectious episodes and, thereby, reduced antibacterial use and the likelihood of consequent development of bacterial resistance. Ribomunyl also decreased absence from work or school, which has important economic consequences.