Imunoglukan P4H^® in the Prevention of Recurrent Respiratory Infections in Childhood

Czech version

Authors: M. Jeseňák ¹; L. Sanislo ²; R. Kuniaková ³; Z. Rennerová ⁴; J. Buchanec ¹; Peter Bánovčin ¹
Authors‘ workplace: Klinika detí a dorastu, Centrum experimentálnej a klinickej respirológie, Univerzita Komenského ; Jesseniova lekárska fakulta v Martine, Univerzitná nemocnica Martin prednosta prof. MUDr. P. Bánovčin, CSc. ¹; Onkologický ústav sv. Alžbety, s. r. o., Bratislava prednosta doc. MUDr. J. Kaušitz, CSc. ²; Pleuran, s. r. o., Bratislava riaditeľ JUDr. J. Gabriž ³; Pneumo-Alergo Centrum, n. z. z., Bratislava prednosta doc. MUDr. M. Brezina, CSc. ⁴
Published in: Čes-slov Pediat 2010; 65 (11): 639-647.
Category: Original Papers

Overview

Background:
Respiratory diseases are among the most common ailments in paediatric clinical practice. Children often present with recurrent upper or lower respiratory tract infections. Beta-glucans are potent natural immunomodulators that have been proven effective in multiple studies for the treatment and prevention of various conditions caused by disturbances in the immune system.

Aim:
The aim of our open clinical trial was the evaluation of the effect of Imunoglukan P4H^® syrup on the frequency and some selected characteristics of recurrent respiratory infections in childhood.

Patients and methods:
Our study group consisted of 215 children (mean age 4.7±1.9 years) selected by 28 paediatricians from the Slovak and Czech Republics. The enrolment criterion was at least 5 infections of the upper airways in the last year. The paediatricians filled out the case report form for each study subject, providing baseline and end-of-study data. Patients took Imunoglukan P4H^® syrup at the standard once-daily dose of 1 mL/5 kg body weight for at least 3 months.

Results:
A positive response to the Imunoglukan P4H^® syrup, i.e. a ≥50% reduction of the frequency of recurrent respiratory infections, was observed in 153 children (71.2%). The average annual incidence of respiratory infections in children with a positive response to Imunoglukan P4H^® therapy was 3.6 and was significantly lower compared to that in unresponsive patients (3.6 vs. 8.9, p<0.001). The therapy did not show statistically significant effect on the frequency of febrile episodes, need for antibiotics or duration of infection. No adverse effects of Imunoglukan P4H^® syrup were reported, with the therapy being very well tolerated.

Conclusions:
The results of our open clinical trial proved the therapeutic and preventive effects of Imunoglukan P4H^® syrup on the frequency of recurrent respiratory infections in childhood. Its potent, targeted and broad immunomodulatory effect involving various immune pathways and its safety make Imunoglukan P4H^® syrup suitable for use in many indications in childhood.

Key words:
children, Imunoglukan P4H^®, immunomodulation, prevention, recurrent respiratory infections

Sources

1. Woroniecka M, Ballow M. Office evaluation of children with recurrent infection. Pediatr. Clin. North Am. 2000; 47: 1211–1224.

2. De Martino M, Ballotti S. The child with recurrent respiratory infections: normal or not? Pediatr. Allergy Immunol. 2007; 18(Suppl. 18): 13–18.

3. Galli L, De martino M, Muccioli AT. Biological response modifiers in children with recurrent respiratory infections. J. Chemother. 1991; 3: 196–202.

4. Couriel J. Assessment of the child with recurrent chest infections. Br. Med. Bul. 2002; 61: 115–132.

5. De Vries E. Immunological investigations in children with recurrent respiratory infections. Pediatr. Res. Rev. 2001; 2: 32–36.

6. Jeseňák M, Rennerová Z, Pohanka V, Bánovčin P. Prevencia recidivujúcich infekcií respiračného traktu u detí. 1. časť – Baktériové imunomodulátory. Pediatria (Bratisl.) 2009; 4: 67–72.

7. Bystroň J. Imunomodulace u recidivujících infekcí dýchacích cest. Klin. Farmakol. Farm. 2005; 19: 235–238.

8. Bousquet J, Olivieri D. Role of Ribomunyl® in the prevention of recurrent respiratory tract infections in adults: overview of clinical results. Treat. Respir. Med. 2006; 5: 317–324.

9. Bystroň J. Perorální bakteriální imunomodulátory a medicína založená na důkazech. Alergie 2003; 5: 284–290.

10. Hrubiško M. Imunomodulátory z baktérií – prirodzená podpora telu vlastných obranných mechanizmov. Ambulantná Terapia 2008; 2: 3–6.

11. Steurer-Stey C, Lagler L, Straub DA, et al. Oral purified bacterial extracts in acute respiratory tract infections in childhood: a systematic quantitative review. Eur. J. Pediatr. 2007; 166: 365–376.

12. Bartůňková J, Vernerová E. Postavení imunomodulátorů v léčbě respiračních a alergických onemocnění. Medicina po Promoci 2007; 8(Suppl. 1): 73–79.

13. Čáp P. Imunológia pre prax – význam imunomodulačnej terapie. Medinews 2008; 4: 165–166.

14. Jeseňák M, Rennerová Z, Havlíčeková Z, et al. Prevencia recidivujúcich infekcií respiračného traktu u detí. 2. časť – Ostatné doplnkové farmakologické i nefarmakologické možnosti. Pediatria (Bratisl.) 2009; 4: 167–173.

15. Honzíková M, et al. Systémová enzymoterapie v komplexní léčbě recidivujících zánětů dýchacích cest u dětí – postregistrační retrospektivní multicentrické hodnocení. Čes.-slov. Pediat. 2004; 54: 513–521.

16. Slatter MA, Gennery AR. Clinical immunology review series: An approach to the patient with recurrent infections in childhood. Clin. Exp. Immunol. 2008; 152: 389–396.

17. Wood P, Peckham D. Investigating recurrent respiratory infections in primary care. Br. Med. J. 2009; 339: 1141–1143..

18. Bergendiová-Sedláčková K, Ferenčík M, Tibenská E, et al. Vplyv športovej záťaže na imunitný systém. Čes.-slov. Pediat. 2000; 7: 442–447.

19. Jeseňák M, Rennerová Z, Bánovčin P. Možnosti použitia Imunoglukánu® v pediatrii. Pediatria (Bratisl.) 2009; 4: 237–243.

20. Novak M, Vetvicka V. Beta-glucans, history, and the prezent: immunomodulatory aspects and mechanisms of action. J. Immunotoxicol. 2008; 5: 47–57.

21. Sanisló Ľ. Imunoglukán. Revue Medicíny v Praxi 2009; 7: 5–7.

22. Li C, Ha T, Kelley J, et al. Modulating Toll-like receptors mediated signalling by (1→3)-beta-D-glucan rapidly induces cardioprotection. Cardiovasc. Res. 2004; 61: 538–547.

23. Dalmo RA, Bogwald J. β-glucans as conductor of immune symphonies. Fish Shellfish Immunol. 2008; 25: 384–396.

24. Chen J, Seviour R. Medicinal importance of fungal β-(1→3), (1→6)-glucans. Myc. Res. 2007; 111: 635–652.

25. Procházka Z, Végh V, Kuniaková R. Beta-glukán alebo hliva ustricovitá? Lekárnik 2008; 13: 32.

26. Brown GD. Dectin-1: a signalling non-TLR pattern-recognition receptor. Nat. Rev. Immunol. 2006; 6: 33–43.

27. Brown GD, Gordon S. Immune recognition of fungal β-glucans. Cell. Microbiol. 2005; 7: 471–479.

28. Bobek P, Nosalova V, Cerna S. Effect of pleuran (beta-glucan from Pleuritis ostreatus) in diet or dribling fluid in colitis in rats. Nahrung 2001; 45: 360–363.

29. Lull C, Wichers J, Savelkoul HF. Anti-inflammatory and immunomodulating properties of fungal metabolites. Mediators Inflam. 2005; 2: 63–80.

30. Hong F, Yan J, Baran JT, et al. Mechanism by which orally administered beta-1,3-glucans enhance the tumoricidal activity of antitumor monoclonal antibodies in murine tumor models. J. Immunol. 2004; 173: 797–806.

31. Jin M, Jung HJ, Choi JJ, et al. Activation of selective transcription factors and cytokines by water-soluble extract from Lentinus lepideus. Exp. Biol. Med. (Maywood) 2003; 228: 749–758.

32. Kodama N, Komuta K, Sakai N, et al. Enhancement of cytotoxicity of NK cells by D-fraction, a polysaccharide from Grifola frondosa. Oncol. Rep. 2005; 13: 497–502.

33. Lehne G, Haneberg B, Gaustad P, et al. Oral administration of a new soluble branched beta-1,3-D-glucan is well tolerated and can lead to increased salivary concentrations of immunoglobulin A in healthy volunteers. Clin. Exp. Immunol. 2006; 143: 65–69.

34. Majtan J, Kumar P, Koller J, et al. Induction of metalloproteinase 9 secretion from human keratinocytes by pleuran (β-glucan from Peurotus ostreatus). Z. Naturforsch. C. 2009; 64: 597–600.

35. Mantovani MS, Bellini MF, Angeli JPF, et al. β-glucans in promoting health: Prevention against mutation and cancer. Mut. Res. 2008; 658: 154–161.

36. Mizuno M, Shiomi Y, Minato K, et al. Fucogalactan isolated from Sarcodon aspratus elicits release of tumor necrosis factor-α and nitric oxide from murine macrophages. Immunopharmacology 2000; 46: 113–121.

37. Murata Y, Shimamura T, Tagami T, et al. The skewing to Th1 induced by lentinan is directed through the distinctive cytokine production by macrophages with elevated intracellular glutathione content. Int. Immunopharmacol. 2002; 2: 673–689.

38. Rossi GD, Vetvicka V, Yan J, et al. Therapeutic intervention with complement and beta-glucan in cancer. Immunopharmacology 1999; 42: 61–74.

39. Šemberová J, Paulovičová E, Jelemenská A, et al. Indukcia TNF-α imunomodulačnou liečbou s obsahom β-glukánu u detských pacientov so zväčšenou nosohltanovou mandľou. Klin. Imunol. Alergol. 2009; 19: 15–17.

40. Shimizu S, Kitada H, Yokota H, et al. Activation of the alternative complement pathway by Agaricus blazei Murill. Phytomedicine 2002; 9: 536–545.

41. Volman JJ, Ramakers JD, Plat J. Dietary modulation of immune system by β-glucans. Physiol. & Behaviour. 2008; 94: 276–284.

42. Haladová E, Mojžišová J, Smrčo P, et al. The effect of β (1,3/1,6)D-glucan on sellected non-specific and specific immunological parameters in dogs after vaccination. Folia Veterinaria 2009; 63: 43–46.

43. Smith MJ, Andreson R. Inhibition of mitogen-activated proliferation of human lymphocytes by hypochlorous acid in vitro: protection and reversal by ascorbate and cysteine. Agents Actions 1990; 30: 338–343.

44. Siegler BV. Enhancement of interferon procution by poly(rl)-poly(rC) in mousecell culture by ascorbic acid. Nature 1975; 254: 531–532.

45. Cohen HA, Varsano I, Kahan E, et al. Effectiveness of an herbal preparation containing echinacea, propolis, and vitamin C in preventing respiratory tract infections in children: a randomized, double-blind, placebo-controlled multicenter study. Arch. Pediatr. Adolesc. Med. 2004; 157: 217–221.