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SYSTEMATIC REVIEW OF PENTAGLOBIN EFFICACY IN PREVENTING MORTALITY IN NEWBORNS AND OLDER CHILDREN WITH BACTERIAL INFECTIONS AND SEPSIS

https://doi.org/10.17749/2070-4909.2016.9.1.050-057

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Abstract

Objectives. There is no consistent evidence of clinical efficacy of Pentaglobin for reducing mortality in newborns and older children with bacterial infections and sepsis. The aim of the study was to update evidence by considering recent clinical trials and analyzing age populations and comparators separately.

Methods. We searched publications in PubMed and the Cochrane Library in December 2014 and in October 2015. All-cause mortality was analyzed, and systematic review using meta-analysis and indirect comparison was carried out.

Results. Three meta-analyses and 7RCTs were considered, including 6 trials studied the effect of Pentaglobin in newborns, and one in children 1-24 months old. All interventions were applied with basic therapy (BT). In newborns mortality is lower in Pentaglobin than in all comparators groups, RR 0.51 [0.32; 0.82], and in BT with or without placebo, RR 0.56 [0.34; 0.91]. Children under 24 months receiving Pentaglobin also had lower mortality than in all comparators group, RR 0.51 [0.36; 0.72]. Indirect comparison of IgM and IgG in adults showed no differences, in newborns the difference is in favor of IgM, RR 0.51 [0.32; 0.82].

Conclusion. Pentaglobin is effective in reducing all-cause mortality in newborns with bacterial infection or sepsis in comparison with any comparators (BT with or without placebo, albumin, IgG), in children under 24 months in comparison to BT with or without albumin. Further head-to-head clinical trials are needed to enhance evidence.

About the Authors

V. K. Fedyaeva
The Russian Presidential Academy of National Economy and Public Administration
Russian Federation

Researcher at the Center for Health Technology Assessment;

junior researcher at the Health Care Finance Center of the Research Financial Institute of the Ministry of Finance of the Russian Federation, 

117335, Moscow, POB 90



O. Yu. Rebrova
The Russian Presidential Academy of National Economy and Public Administration; The Russian National Research Medical University named after N.I. Pirogov
Russian Federation

Leading Researcher at the Center for Health Technology Assessment of the Institute for Applied Economic Research;

Professor at the Department of Medical Cybernetics and Informatics;

PhD, DHab (Doctor of Medical Sciences),

ul. Ostrovityanova, 1, Moscow, 117997.



References

1. Pentaglobin. Instructions for use [Pentaglobin. Instruktsiyapoprimeneniyu (in Russian)]. URL: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?idReg=20718&t= (accessed: 05.10.2015)

2. Order of the Health Ministry of the Russian Federation of 13.03.2006 №148 «On approval of the standard of care to patients with bacterial sepsis of newborn" [PrikazMinzdravsotsrazvitiya RF ot 13.03.2006 №148 «Ob utverzhdenii standarta meditsinskoi pomoshchi bol'nym pri bakterial'nom sepsise novorozhdennogo» (in Russian)].

3. Akdag A., Dilmen U., Haque K. et al. Role of Pentoxifylline and/or IgM-Enriched Intravenous Immunoglobulin in the Management of Neonatal Sepsis. American Journal of Perinatology. 2014; 31 (10): 905-912.

4. Alejandria M.M., Lansang M.A.D., Dans L.F., Mantaring III J.B. Intravenous immunoglobulin for treating sepsis, severe sepsis and septic shock. Cochrane Database of Systematic Reviews. 2013; 9. Art. No.: CD001090.

5. Bucher H.C., Guyatt G.H., Griffith L.E. et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol. 1997; 50 (6): 683-691.

6. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. Editors: J.P.T. Higgins, S. Green. Chapter 8: Assessing risk of bias in included studies. URL: http://www.cochrane-handbook.org (accessed: 05.10.2015).

7. Dellinger R.P., Levy M.M., Rhodes A. et al. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013; 39: 2: 165-228.

8. El-Nawawy A., El-Kinany H., El-Sayed M.H., Boshra N. Intravenous polyclonal immunoglobulin administration to sepsis syndrome patients: A prospective study in a pediatric intensive care unit. Journal of Tropical Pediatrics. 2005; 51 (5): 271-278.

9. Erdem G. Yurdakök M., Tekinalp G., Ersoy F. The use of IgMenriched intravenous immunoglobulin for the treatment of neonatal sepsis in preterm infants. The Turkish Journal of Pediatrics. 1992; 35 (4): 277-281.

10. Haque K.N., Remo C., Bahakim H. Comparison of two types of intravenous immunoglobulins in the treatment of neonatal sepsis. Clinical and Experimental Immunology. 1995; 101 (2): 328-333.

11. Haque K.N., Zaidi M.H., Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. American Journal of Diseases of Children. 1988; 142 (12): 1293-1296.

12. Kreymann K.G. de Heer G., Nierhaus A., Kluge S. Use of polyclonal immunoglobulins as adjunctive therapy for sepsis or septic shock. Critical Care Medicine. 2007; 35 (12): 2677-2685.

13. Ohlsson A.,Lacy J.B. Intravenous immunoglobulin for suspected or proven infection in neonates. Cochrane Database of Systematic Reviews. 2013; 7. Art. No.: CD001239.

14. Reinhat K.,Brunkhorst F.M., Bone H.G. et al. Prevention, diagnosis, therapy and follow-up care of sepsis: 1st revision of S-2k guidelines of the German Sepsis Society (Deutsche Sepsis-Gesellschafte.V. (DSG)) and the German Interdisciplinary Association of Intensive Care and Emergency Medicine (Deutsche InterdisziplinäreVereinigungfürIntensiv – und Notfallmedizin (DIVI)). German Medical Science. 2010; 8. Doc14. ISSN 1612-3174.

15. Samatha S. et al. Role of IgM enriched intravenous immunoglobulin as an adjuvant to antibiotics in neonatal sepsis. Karnataka Pediatr J. 1997; 11: 1-6.

16. Seitz R.C., Turreson M., Grosse R. et al. Infusion of immunoglobulins for therapy of neonatal sepsis. Z Geburtshilfe Perinatol. 1995; 199: 288.


For citation:


Fedyaeva V.K., Rebrova O.Y. SYSTEMATIC REVIEW OF PENTAGLOBIN EFFICACY IN PREVENTING MORTALITY IN NEWBORNS AND OLDER CHILDREN WITH BACTERIAL INFECTIONS AND SEPSIS. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2016;9(1):50-57. (In Russ.) https://doi.org/10.17749/2070-4909.2016.9.1.050-057

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