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2021, Number 6

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Revista Habanera de Ciencias Médicas 2021; 20 (6)

Biomodulina T® as an alternative to the treatment of septic shock in pediatrics

Reyes ZMC, Acevedo RY, Rodríguez CS

Language: Spanish
References: 47
Page: 1-8
PDF size: 650.10 Kb.


ABSTRACT

Introduction: Sepsis and septic shock are among the main causes of morbidity and mortality in the pediatric population worldwide. Finding alternative solutions to combat them through the development of immunomodulatory agents has attracted the interest of researchers in the last 20 years; Cuba has Biomodulina T®, a powerful immunomodulator.
Objective: To demonstrate that there is scientific evidence that supports the conduction of controlled clinical trials for the incorporation of Biomodulina T® into the treatment guidelines for sepsis in pediatric intensive care therapies.
Material and Methods: A search was carried out in the Medline, PubMed, SciELO, Lilacs, the Cochrane Library and the Web of Science databases between March 2019 and March 2020; the 47 most relevant articles for this research were selected.
Development: The immunopathogenesis of shock focuses on a complex phenotype and functional alterations of both the innate and adaptive immune systems with a decrease in the number of effector cells, an increase in subpopulations of immunosuppressive lymphocytes, and depletion of T cells. Biomodulina T® stimulates the production of T lymphocytes and strengthens the differentiation of lymphoblastoid cells of the thymus; medical practice suggests that its administration could be a promising strategy for immune restoration in pediatric patients with septic shock.
Conclusions: There is scientific evidence that supports the use of Biomodulina T® in patients with septic shock, which supports the reliability of conducting controlled clinical trials in the pediatric population for its subsequent incorporation into treatment guidelines in intensive care therapies.


REFERENCES

  1. Davis AL, Carcillo JA, Aneja RK, Deymann AJ, Lin JC, Nguyen TC, et al. American College of Critical Care Medicine ClinicalPractice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock. Crit Care Med [Internet].2017[Citado 16/03/2019];45(6):1061-93. Disponible en: https://www.nejm.org/doi/10.1056/NEJM198510173131618?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed

  2. Erratum: Global Epidemiology of Pediatric Severe Sepsis: The Sepsis Prevalence, Outcomes, and Therapies Study.Am J Respir Crit Care Med [Internet]. 2016 [Citado 16/03/2019];193(2):223-4. Disponible en:https://pubmed.ncbi.nlm.nih.gov/26771421/

  3. 3.Word Health Organization. Improving the prevention, diagnosis and clinical management of sepsis [Internet]. Geneva:WHO; 2018 [Citado 16/03/2020]. Disponible en: https://www.who.int/servicedeliverysafety/areas/sepsis/en/

  4. Hartman ME, Saeed MJ, Powell KN, Olsen MA. The Comparative Epidemiology of Pediatric Severe Sepsis. JIntensive Care Med [Internet].2019 [Citado 16/03/2020];34(6):472-9. Disponible en: https://pubmed.ncbi.nlm.nih.gov/29034782/

  5. Watson RS, Crow SS, Hartman ME, Lacroix J, Odetola FO. Epidemiology and Outcomes of Pediatric Multiple OrganDysfunction Syndrome. Pediatr Crit Care Med [Internet].2017 [Citado 16/03/2020];18(3 Suppl 1):S4-S16. Disponibleen: https://pubmed.ncbi.nlm.nih.gov/28248829/

  6. Hsu HE, Abanyie F, Agus MSD, Balamuth F, Brady PW, Brilli RJ, et al. A National Approach to Pediatric SepsisSurveillance. Pediatrics [Internet].2019 [Citado 16/03/2019];144(6):e20191790. Disponible en: https://pubmed.ncbi.nlm.nih.gov/31776196/

  7. MINSAP. Dirección Nacional de Registros Médicos y Estadísticas de Salud. Anuario Estadístico de Salud 2019[Internet]. La Habana: MINSAP; 2019 [Citado 16/03/2020]. Disponible en: http://www.sld.cu/anuncio/2020/05/09/publicado-el-anuario-estadistico-de-salud-2019

  8. MINSAP. Dirección Nacional de Registros Médicos y Estadísticas de Salud. Anuario Estadístico de Salud 2018[Internet]. La Habana: MINSAP; 2018 [Citado 16/03/2020]. Disponible en: http://www.sld.cu/anuncio/2019/04/26/publicado-el-anuario-estadistico-de-salud-2018

  9. MINSAP. Dirección Nacional de Registros Médicos y Estadísticas de Salud. Anuario Estadístico de Salud 2017[Internet].La Habana: MINSAP; 2017 [Citado 16/03/2020]. Disponible en: http://www.sld.cu/anuncio/2018/04/06/publicado-el-anuario-estadistico-de-salud-2017

  10. Bordogna A, Bergna D. Guías de procedimientos institucionales. Sepsis, sepsis severa y shock séptico. LudovicaPediátrica [Internet].2018 [Citado 16/03/2020];21(1):21-32. Disponible en: https://pesquisa.bvsalud.org/portal/resource/es/biblio-908696

  11. Torrealba G, Carnevale M. Factores de riesgo de pacientes con sepsis ingresados en la Unidad de CuidadosIntensivos Pediátricos. Servicio Desconcentrado Hospital Pediátrico Dr. Agustín Zubillaga. Boletín Médico DePostgrado [Internet].2018 [Citado 20/03/2019];34(1):44-8. Disponible en: https://revistas.uclave.org/index.php/bmp/article/view/2517

  12. Cartaya JM, Rovira LE, Segredo Y, Álvarez I, Acevedo Y, Moya A. Implementing ACCM critical care guidelines for septicshock management in a Cuban pediatric intensive care unit. MEDICC Review [Internet].2014 [Citado 17/04/2019];16(3-4):47-54. Disponible en: https://pubmed.ncbi.nlm.nih.gov/25208120/

  13. CECMED. Resumen de las características del producto. Biomodulina T [Internet]. La Habana: CECMED; 2020 [Citado20/02/2020]. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/rcp/biologicos/rcp_biomodulina.pdf

  14. Ferrer Vázquez M. Las patologías infantiles en la medicina greco helenística. Estudio y análisis historiográfico desdela práctica de la pediatría moderna [Tesis Doctoral]. España: Universitat Jaume I; 2017 [Citado 13/04/2020]. Disponibleen: https://www.tdx.cat/bitstream/handle/10803/420881/2017_Tesis_Ferrer%20Vazquez_Mario.pdf?sequence=1

  15. McSherry J. Thucydides’ syndrome. CMAJ [Internet].1998 [Citado 19/04/2019];159(1):21-2. Disponible en: https://pubmed.ncbi.nlm.nih.gov/9679482/

  16. Nishida O, Ogura H, Egi M, Fujishima S, Hayashi Y, Iba T, et al. The Japanese Clinical Practice Guidelines forManagement of Sepsis and Septic Shock 2016 (J-SSCG 2016). J Intensive Care [Internet].2018 [Citado 26/04/2019];6:7.Disponible en: https://pubmed.ncbi.nlm.nih.gov/29435330/

  17. Weiss SL, Peters MJ, Alhazzani W, Agus MS, Flori HR, Inwald DP, et al. Surviving sepsis campaign internationalguidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Intensive Care Med[Internet].2020 [Citado 28/04/2020];46(Suppl 1):10-67. Disponible en: https://pubmed.ncbi.nlm.nih.gov/32030529/

  18. Esteban E. Revisión de las nuevas definiciones sobre la sepsis y su aplicación en Pediatría. Rev EspPediatr [Internet].2017 [Citado 16/03/2020];73 (Supl 1):21-2. Disponible en: https://secip.com/wp-content/uploads/2018/04/3-que-hay-de-nuevo-en-la-sepsis.pdf

  19. Obonyo NG, Schlapbach LJ, Fraser JF. Corrigendum: Sepsis: Changing Definitions, Unchanging Treatment. FrontPediatr. 2020;7:538.

  20. De Souza DC, Barciela Brandão M, Piva JP. From the International Pediatric Sepsis Conference 2005 to the Sepsis-3Consensus. Rev Bras Ter Intensiva [Internet].2018 [Citado 13/01/2020];30(1):1-5. Disponible en: https://pubmed.ncbi.nlm.nih.gov/29742230/

  21. Singer M, Deutschman CS, Seymour CW, Shankar Hari M, Annane D, Bauer M, et al. The Third InternationalConsensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA [Internet].2016 [Citado 22/06/2019];315(8):801-10. Disponible en: https://pubmed.ncbi.nlm.nih.gov/4968574/

  22. Giamarellos Bourboulis EJ, Tsaganos T, Tsangaris I, Lada M, Routsi C, Sinapidis D, et al. Validation of the new Sepsis-3definitions: proposal for improvement in early risk identification. Clinical Microbiology Infection [Internet].2017[Citado 14/07/2019];23(2):104-9. Disponible en: https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(16)30558-4/fulltext

  23. Weiss S, Peters M, Alhazzani W, Agus M, Flori H, Inwald D, et al. Guías Internacionales de la Campaña paraSobrevivir a la Sepsis para el tratamiento en niños del shock/choqueséptico y la disfunción orgánica asociada a la sepsis.Intensive Care Medicine [Internet].2020 [Citado 16/04/2020];46(Supl 1):23-7. Disponible en: https://www.sccm.org/getattachment/SurvivingSepsisCampaign/Guidelines/Pediatric-Patients/Surviving-Sepsis-Guideline-Infographic-Spanish-Translations.pdf?lang=en-US

  24. Davis AL, Carcillo JA, Aneja RK, Deymann AJ, Lin JC, Nguyen TC, et al. American College of Critical Care MedicineClinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock: Erratum. Crit Care Med[Internet].2017 [Citado 17/11/2019];45(6):1061-93. Disponible en: https://pubmed.ncbi.nlm.nih.gov/28509730/

  25. Matics TJ, Sánchez Pinto LN. Adaptation and Validation of a Pediatric Sequential Organ Failure AssessmentScore and Evaluation of the Sepsis-3 Definitions in Critically Ill Children. JAMA Pediatr [Internet].2017 [Citado03/12/2019];171(10):e172352. Disponible en: https://pubmed.ncbi.nlm.nih.gov/28783810/

  26. Hotchkiss RS, Coopersmith CM, McDunn JE, Ferguson TA. The sepsis seesaw: tilting toward immunosuppression. NatMed [Internet].2009 [Citado 10/02/2020];15(5):496-7. Disponible en: https://pubmed.ncbi.nlm.nih.gov/19424209/

  27. Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, et al. Surviving sepsis campaign internationalguidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Intensive Care Med[Internet].2020 [Citado 29/04/2020];46(Supl 1):10-67. Disponible en: https://pubmed.ncbi.nlm.nih.gov/32030529/

  28. Arens C, Bajwa SA, Koch C, Siegler BH, Schneck E, Hecker A, et al. Sepsis-induced long-term immune paralysis--results of a descriptive, explorative study. Crit Care [Internet].2016 [Citado 17/11/2019];20:93. Disponible en: https://pubmed.ncbi.nlm.nih.gov/27056672/

  29. Davies R, O’Dea K, Gordon A. Immune therapy in sepsis: Are we ready to try again? J Intensive Care Soc[Internet].2018 [Citado 29/05/2019];19(4):326-44. Disponible en: https://pubmed.ncbi.nlm.nih.gov/30515242/

  30. Ding R, Meng Y, Ma X. The Central Role of the Inflammatory Response in Understanding the Heterogeneity ofSepsis-3. Biomed Res Int [Internet].2018 [Citado 16/02/2020];2018:5086516. Disponible en: https://pubmed.ncbi.nlm.nih.gov/29977913/

  31. Liu Q, Li CS. Programmed Cell Death-1/Programmed Death-ligand 1 Pathway: A New Target for Sepsis. ChinMed J (Engl) [Internet].2017 [Citado 26/11/2019];130(8):986-92. Disponible en: https://pubmed.ncbi.nlm.nih.gov/28397730/

  32. Watson RS, Crow SS, Hartman ME, Lacroix J, Odetola FO. Epidemiology and Outcomes of Pediatric Multiple OrganDysfunction Syndrome. Pediatr Crit Care Med [Internet].2017 [Citado 15/09/2019];18(3 Supl 1):S4-S16. Disponible en:https://pubmed.ncbi.nlm.nih.gov/28248829/

  33. Manzanares Arévalo MM. Comportamiento clínico de la sepsis grave / shock séptico en pacientes ingresados a laUnidad de Cuidados Intensivos Pediátrica, del Hospital Alemán Nicaragüense, del 1 de enero al 31 de diciembre de 2016[Tesis Especialidad Pediatría]. Managua: Universidad Nacional Autónoma de Nicaragua; 2017 [Citado 16/04/2019].Disponible en: https://repositorio.unan.edu.ni/4453/1/96912.pdf

  34. Peters van Ton AM, Kox M, Abdo WF, Pickkers P. Precision Immunotherapy for Sepsis. Front Immunol. 2018; 9:1926.

  35. Sims CR, Nguyen TC, Mayeux PR. Could Biomarkers Direct Therapy for the Septic Patient?. J Pharmacol Exp Ther[Internet].2016 [Citado 14/03/2020];357(2):228-39. Disponible en: https://pubmed.ncbi.nlm.nih.gov/26857961/

  36. Winkler MS, Rissiek A, Priefler M, Schwedhelm E, Robbe L, Bauer A, et al. Human leucocyte antigen (HLA-DR) geneexpression is reduced in sepsis and correlates with impaired TNFα response: A diagnostic tool for immunosuppression?.PLoS One [Internet].2017 [Citado 30/11/2019];12(8):e0182427. Disponible en: https://pubmed.ncbi.nlm.nih.gov/28771573/

  37. Dueñas Castell C, Ortiz Ruiz G, Borré Naranjo D. Sepsis: A Definition Under Construction. En: Ortiz Ruiz G,Dueñas Castell C.eds. Sepsis [Internet]. New York: Springer; 2018 [Citado 24/11/2019]. Disponible en: https://doi.org/10.1007/978-1-4939-7334-7_1

  38. Liu F, Wang HM, Wang T, Zhang YM, Zhu X. The efficacy of thymosin α1 as immunomodulatory treatment forsepsis: a systematic review of randomized controlled trials. BMC Infectious Diseases [Internet].2016 [Citado03/11/2019];16:488. Disponible en: https://europepmc.org/article/pmc/pmc4906180

  39. Dominari A, Hathaway Iii D, Pandav K, Matos W, Biswas S, Reddy G, et al. Thymosin alpha 1: A comprehensivereview of the literature. World J Virol [Internet].2020 [Citado 17/03/2020];9(5):67-78. Disponible en: https://pubmed.ncbi.nlm.nih.gov/33362999/

  40. Rodríguez Martín R, Vega Sánchez H, Peláez Borges A. Biomoduladores tímicos. Revista Cub Farm [Internet].1988[Citado 17/01/2020];22(2):72-83. Disponible en: https://pesquisa.bvsalud.org/portal/resource/pt/lil-74709

  41. MINSAP. Formulario Nacional de Medicamentos. [Internet]. La Habana: MINSAP; 2019 [Citado 06/03/2019].Disponible en: http://www.cdf.sld.cu/formulario/formulario.htm

  42. Suárez Formigo GM, Saavedra Hernández D. Biomodulina T May Restore Immunity in Older Adults. MEDICC Rev[Internet].2020 [Citado 01/08/2020];22(3):54-6. Disponible en: https://mediccreview.org/biomodulina-t-may-restoreimmunity-in-older-adults/

  43. Saavedra D, Fuertes SA, Suárez GM, González A, Lorenzo Luaces P, García B, et al. Biomodulina T partiallyrestores immunosenescent CD4 and CD8 T cell compartments in the elderly. Exp Gerontol [Internet]. 2019 [Citado16/01/2020];124:110633. Disponible en: https://pubmed.ncbi.nlm.nih.gov/31207285/

  44. Mollineda Tocoronte O, Martínez González A, Rabaza Perez J, Hernández Fernández C, Romero del So J. Respuestaal tratamiento en niños desnutridos menores de 1 año de edad. Rev Cubana Pediatr [Internet].1999 [Citado18/02/2020];71(4):191-6. Disponible en: http://scielo.sld.cu/pdf/ped/v71n4/ped01499.pdf

  45. Christian L, Rodríguez R, Rabassa J, Santamaría M, Romero JM. Hormonas Tímicas solas o combinadas. Suefecto sobre el Timo en niños con infecciones recurrentes. En: IV Congreso Nacional y VI Jornada Latinoamericanade Hematología, Inmunología y Medicina Transfusional; 2001 may 14-18; La Habana [Internet]. La Habana SociedadCubana De Hematología; 2001 [Citado 16/01/2020]. Disponible en: http://www.sld.cu/eventos/hematologia/hematologia

  46. Christian LR. Biomodulina T: Cruzada por la vida. Revista Ciencia para la Vida. 2003;8:30-1.

  47. Hernández A, Marín X, Martínez J. Efecto de la Biomodulina T en el tratamiento de la Uveítis Anterior. La Habana:Hospital Calixto García;1997




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