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Safety and tolerability of ribosome-component immune modulator in adults and children

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Ribosomal preparations (ribosome-component immune modulators [RCIMs]) do not contain attenuated bacteria and, in contrast to live bacterial extracts, which may induce severe side effects, retain immune stimulating activity without infectious capability. This study was designed to profile the tolerability of RCIM by reviewing narratively all randomized, double-blind, placebo-controlled clinical trials and open-label studies as well as data from postmarketing surveillance studies representing >30 million prescriptions. In the various clinical trials, RCIM tolerability in terms of clinical and laboratory parameters was good. There were no significant differences between patients receiving active treatment or placebo in a survey of tolerability results from randomized, double-blind, placebo-controlled studies. Pharmacovigilance analysis does not show a change in the risk profile of RCIM. The only contraindication was correlated with known hypersensitivity to any of the product components. RCIM should not be used in case of acute streptococcal glomerulonephritis, acquired immune deficiency syndrome, severe viral disease, or severe autoimmune disease. Risk associated with the use of RCIM is negligible in recurrent upper and lower airway infections in selected populations, such as children and elderly people.
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Keywords: Adverse reactions; bacterial extracts; contraindications; drug interactions; pharmacovigilance; postmarketing; ribosomal-component immune modulator (RCIM); safety; side effects; tolerability profile

Document Type: Research Article

Affiliations: Cardiopulmonary Department, Section of Respiratory Disease, Rasori Hospital–University of Parma, Parma, Italy

Publication date: 2009-07-01

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  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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