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Aiutarli a difendersi. Cosa funziona e cosa no

Aiutarli a difendersi. Cosa funziona e cosa no . Dal mito alla realtà . Alessandro Fiocchi – Sergio Arrigoni Melloni Pediatria, Milano. Care for a clean environment. Consider minor immunomodulators The evidences for immunostimulation . Health impact of exposure

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Aiutarli a difendersi. Cosa funziona e cosa no

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  1. Aiutarli a difendersi. Cosa funziona e cosa no Dal mito alla realtà Alessandro Fiocchi – Sergio Arrigoni Melloni Pediatria, Milano

  2. Care for a clean environment. • Consider minor immunomodulators • The evidences for immunostimulation

  3. Health impact of exposure to environmental tobacco smoke in Italy Forastiere F. Epidemiol Prev. 2002; 26:18-29

  4. “Io fumo solo in balcone dottore!” • Numerosi studi dimostrano che anche quando i genitori dicono di fumare all’aperto l’esposizione del bambino al fumo passivo non viene ridotta. • Perché? Johansson A et al. Indoor and outdoor smoking: impact on children's health. Eur J Public Health. 2003; 13:61-6 Nelson R. Smoking outside still causes second-hand smoke exposure to children.Lancet 2002;359:1675 Bahcecilier N. Parental smoking behaviour and the urinary cotinine level of asthmatic children. J Asthma 1999;36:171-5

  5. Air pollution and mortality Lacasana M. Exposure to ambient air pollution and prenatal and early childhood health effects. Eur J Epidemiol. 2005;20:183-99. Erbas B. Air pollution and childhood asthma emergency hospital admissions:estimating intra-city regional variations. Int J Environ Health Res. 2005;15:11-20

  6. Air pollution and morbidity Lin M. Coarse particulate matter and hospitalization for respiratory infections in children younger than 15 years in Toronto: a case-crossover analysis. Pediatrics. 2005;116:e235-40 Erbas B. Air pollution and childhood asthma emergency hospital admissions:estimating intra-city regional variations. Int J Environ Health Res. 2005;15:11-20

  7. PM10 ed accessi in PS per sintomi respiratoriR2 = 0.28; P < 0.02 PM10 mcg/m3 Numero accessi respiratori Caddeo A. Impatto dell’esposizione al PM10 sulla frequenza di visite per patologie respiratorie in un pronto soccorso pediatrico. Dal Mito alla Realtà, 31 gennaio – 1 febbraio 2008

  8. Air pollution and morbidity Is there association between short-term exposure to ultrafine particles and morbidity in Copenhagen, Denmark? NCtot (6-700 nm in diameter) in 2001 – 2004 vs. hospital admissions due to asthma in children (5-18 years) PM10 vs. PM2.5 vs. ambient gasses NO2 and PM2.5 > PM10 for pediatric asthma Traffic sources are related with paediatric asthma attacks Andersen ZJ. Size distribution and total number concentration of ultrafine and accumulation mode particles and hospital admissions in children and the elderly in Copenhagen, Denmark. Occup Environ Med. 2007 Nov 7; [Epub ahead of print]

  9. Fungal levels in the home and lower respiratory tract illnesses in the first year of life Stark PC. Am J Respir Crit Care Med 2003; 168:232–7

  10. Regimen Sanitatis SalerniSecolo XI Che l’aria sia pura, tersa e luminosa, che non sia infetta o graveolente. • Caput XIV : De aere “ Aere fit purus,fit lucidus, et bene clarus, infectus neque sit, nec olens foetore cloacae.”

  11. Rinse-free hand sanitizers reduce school absenteism Meadows E, Le Saux N. A systematic review of the effectiveness of antimicrobial rinse-free hand sanitizers for prevention of illness-related absenteeism in elementary school children. BMC Public Health. 2004;4:50-7

  12. Pneumonia < 5 years Luby SP. Effect of handwashing on child health: a randomised controlled trial. Lancet 2005;366:225-33

  13. URTIs < 15 years Luby SP. Effect of handwashing on child health: a randomised controlled trial. Lancet 2005;366:225-33

  14. Cough & dyspnoea < 15 years Luby SP. Effect of handwashing on child health: a randomised controlled trial. Lancet 2005;366:225-33

  15. Regimen Sanitatis SalerniSecolo XI Se vuoi vivere sano a lungo lavati spesso le mani • Caput XXIII :De utilitate lotionis manuus “ Lotio post mensam tibi confert munera bina: mundificat palmas, et lumina redit acuta, si fore vis sanus,ablue saepe manus.”

  16. Care for a clean environment. • Appropriate treatment of minor immunodeficiencies • The evidences for immunostimulation

  17. The direct and indirect costs of respiratory infections to the community are substantial • A health diary from 600 families in Melbourne • 80% at least one respiratory episode/15 months • 2.2 respiratory episodes / person / year • mean episode duration: 6.3 days • children < 2 years: - most likely to have at least one respiratory episode - greater number of episodes per person - the longest episode duration (6.8 days) • 28.7% respiratory episodes  doctor's visit • 23%  time off school Leder K.A community-based study of respiratory episodes in Melbourne. Aust N Z J Public Health. 2003; 27:399-404

  18. Allergic children have more numerous and severe respiratory infections than non-allergic children Ciprandi G. Pediatr Allergy Immunol 2006: 17: 389–91

  19. Respiratory infections in schoolchildren:co-morbidity and risk factors. Karevold G. Arch Dis Child 2006; 91:391–5

  20. Certain children constitute a group with high morbidity Annual incidence of bacterial RTI:  Children with high morbidity are susceptible to RTIs and other illnesses over a long period of years Soderstrom M Respiratory tract infections in children with recurrent episodes as preschoolers. Acta Paediatr Scand. 1991;80:688-95

  21. Recurrent respiratory infections and phagocytosis AIM: do phagocytosis (FAG) and reactive oxygen intermediates (ROI) production deficiencies impact on pediatric RRI? STUDY POPULATION: 90 children with RRI vs, 19 healthy children. RESULTS: FAG and ROI significantly decreased compared to the control values CONCLUSIONS: a possible etiological role of FAG and ROI deficiencies of polymorphonuclear neutrophils in the genesis of pediatric RRI Don M. Recurrent respiratory infections and phagocytosis in childhood. Pediatr Int. 2007;49:40-7

  22. Mannose-binding lectin MBL insufficiency • bacterial infection • meningococcal sepsis • predispose to HIV infection • TB Eisen DP. Impact of mannose-binding lectin on susceptibility to infectious diseases. Clin Infect Dis. 2003; 37:1496-505

  23. Recurrent respiratory infections and immune defects IgG2 subclass deficiency  pneumonia, sinusitis, invasive pneumococcal disease IgA deficiency  pneumonia, otitis, diarrhoea G2m(n) allotype of IgG2  susceptibility to encapsulated bacteria Fc receptor IIa: H131 high affinity, FcRIIa-R131 low affinity for IgG2 Heterozygotic C2 deficiency in 1%–1.5% of the general population Homozygous deficiency of C4A or C4B in 3% of the population Mannose-binding lectin (MBL2) activates the complement system Bossuyt X. Coexistence of (partial) immune defects and risk of recurrent respiratory infections. Clin Chem. 2007;53:124-30

  24. Recurrent respiratory infections and immune defects Bossuyt X. Coexistence of (partial) immune defects and risk of recurrent respiratory infections. Clin Chem. 2007;53:124-30

  25. Specific antigens Natural Vector Adjuvant Immunostimulant Ribosomial Immunotherapy Specific Immune response Aspecific Immune Response

  26. Epitopes Ribosome Specific antigens Natural Vector Adjuvant Proteoglicans Immunostimulant Ribosomial Immunotherapy Specific Immune response Aspecific Immune Response

  27. Microbiology • Extraction • Purification • Conjugation • Sterile conditioning

  28. The ribosome 30 S 8 nm X 14 nm 50 S 16 nm

  29. Care for a clean environment. • Consider minimal immunodeficiences • The evidences for immunostimulation

  30. Levels of evidence Shekelle PG. Clinical guidelines: Developing guidelines. BMJ, 1999; 318: 593 -6

  31. Berber A.J A meta-analysis of randomized placebo-controlled clinical trials on the prevention of respiratory tract infections in children using immunostimulants. Investig Allergol Clin Immunol. 2001; 1: 235-46 Immunoistimulants and ARTIs: a meta-analysis  DATA SOURCES: Medline, EMBASE databases, and register of Cochrane Acute Respiratory Infection Group REVIEW METHODS: RCTs on the prevention of ARTIs in childrenJadad's instrument

  32. Mean percent reduction of ARTIs Berber A.J. Investig Allergol Clin Immunol. 2001; 1: 235-46

  33. RESULTS: Four of five RCTs with Jadad's score > 3 showed significant reduction of ARTIs in immunostimulant groups - 42.64%, (95% confidence - 45.19 / - 40.08%); - 60% mean number of ARTIs in treated vs. placebo group. CONCLUSIONS: immunostimulants are an effective treatment for the prevention of ARTI. Further high-quality RCTs are required Immunostimulants and ARTIs: a meta-analysis  Berber A.J A meta-analysis of randomized placebo-controlled clinical trials on the prevention of respiratory tract infections in children using immunostimulants. Investig Allergol Clin Immunol. 2001; 1: 235-46

  34. Immunostimulants for preventing respiratory tract infection in children. • ISs reduce the incidence of ARTIs in children by 40% on average • Heterogeneity and poor quality of the trials • Safety profile is good • Further high-quality trials are needed Del Rio-Navarro BE. Cochrane Database Syst Rev. 2006;(4):CD004974.

  35. Levels of evidence Shekelle PG. Clinical guidelines: Developing guidelines. BMJ, 1999; 318: 593 -6

  36. Placebo-controlled RCT randomization active treatment run-in placebo

  37. Immucytal in children with otitis media + URTIs • - Trial: Double-blind placebo study over 6 months • 84 children aged 4-14 years with otitis media with at least 2 years of recurrent or chronic respiratory tract infections,and/or at least 3 episodes requiring doctor visit and treatment during previous winter • Assessment criteria: • Frequency, duration, severity of otitis • Hearing test Mora R.Int J Pediatr Otorhinolaryngol. 2002;63:1-8 Pr Fiocchi - RRTIs in Children: Definition and interest of Ribomunyl

  38. Immucytal in children with otitis media + URTIs Results • Reduction infectious episodes by 50% • Reduction by 50% episode duration • 62 % vs. 21% patients ameliorated at hearing tests (p > 0.001) Mora R.Int J Pediatr Otorhinolaryngol. 2002;63:1-8

  39. Levels of evidence Shekelle PG. Clinical guidelines: Developing guidelines. BMJ, 1999; 318: 593 -6

  40. Levels of evidence Shekelle PG. Clinical guidelines: Developing guidelines. BMJ, 1999; 318: 593 -6

  41. Efficacy of Ribomunyl® in children with RRTIs & bronchospasm • Patients: 338 children (range:4-17y) with recurrent respiratory tract infections and bronchospasm • Treatment: Ribomunyl® for 7 months • Assessment criteria: • Change in clinical score • Immunological parameters (D0, M4, M7) • Plasma IgG, IgA & IgM levels; plasma bacterial strain-specific IgE • T-lymphocyte counts Hofman JA. Efficacy in RRTIs and bronchospastic symptoms. Abstract 616, XXI Congress of EAACI, 2002 Pr Fiocchi - RRTIs in Children: Definition and interest of Ribomunyl

  42. Efficacy of Ribomunyl® in children with RRTIs & bronchospasm • - Clinical results: • 62%  in severity score • 71%  in antibiotic use • 76%  in RRTI • - Immunological parameters: in line with clinical improvement • Signif.  sp IgE against bacterial antigen from M4 till M7 P<0.001) • Signif.  IgA from M4 till M7 (P<0.05) • Signif.  IgG and IgM at M7 (P<0.05) • Signif.  total T lymphocytes at M7 (P<0.05) • Conclusions: Ribomunyl reduces RRTIs in children with • bronchospastic symptoms. Ribomunyl reduces sIgE Hofman JA. Efficacy in RRTIs and bronchospastic symptoms. Abstract 616, XXI Congress of EAACI, 2002 Pr Fiocchi - RRTIs in Children: Definition and interest of Ribomunyl

  43. Levels of evidence Shekelle PG. Clinical guidelines: Developing guidelines. BMJ, 1999; 318: 593 -6

  44. DATA SOURCES: review of studies [1983 – 2003] of 3 and 6 months' duration comprising part of the international registration fileCASELOAD: Nineteen RCTs 2117 patients (1215 children and 902 adults) Ribosomal immunostimulant n = 1062 Placebo n = 1055  Ribosomal immunostimulation Bellanti J. Ribosomal immunostimulation: assessment of studies evaluating its clinical relevance in the prevention of upper and lower respiratory tract infections in children and adults. BioDrugs. 2003; 17: 355-67.

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