Clinical-demographic and adverse-event characterization during treatment with Heberprot-P
Keywords:
Heberprot-P, diabetic foot, adverse reactionsAbstract
Introduction: Heberprot-P is a novel drug that has come for the reduction of amputation risks; like any drug it is not devoid of adverse events.Objectives: to characterize patients during Heberprot-P treatment according to demographic and clinical variables, as well as to describe adverse events reported during therapy.
Methods: a longitudinal study was conducted at the Comprehensive Care Clinic for patients with diabetic foot ulcers at "Policlínico Manuel Piti Fajardo" in Santo Domingo, Villa Clara, between January 2017 and September 2019. The sample was 104 patients who were applied the Heberprot-P. Variables used were: age, sex, Wagner's classification, etiopathogenic classification of the diabetic foot, treatment effectiveness and reported adverse events (frequency, intensity, severity and causality relationship were addressed).
Results: females and patients over 60 years old predominated (67.31%). According to Wagner's classification for diabetic foot ulcer, grade 1 prevailed (73.08%), and according to etiopathogenesis, patients with neuroinfective foot prevailed (58.65%). Total effectiveness of treatment was 90.38%. The most frequent adverse events were burning, pain and headache. Adverse events dependent on the mode of administration and the product itself (burning and pain) predominated, mostly of mild intensity and defined causality.
Conclusions: the beneficial effect of Heberprot-P in diabetic foot ulcers to achieve granulation was confirmed. Adverse events associated with treatment present similar characteristics to those reported at national and international level.
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References
1.Biblioteca Médica Nacional. Diabetes. Estadísticas Mundiales. Factográfico salud [Internet]. 2019 Jun [citado 05/02/2020];5(6):[aprox. 14 p.]. Disponible en: http://files.sld.cu/bmn/files/2019/06/factografico-de-salud-junio-2019.pdf
2.International Diabetes Federation. IDF Diabetes Atlas. 8th Edition. Brussels, Belgium: International Diabetes Federation; 2017 [citado 05/02/2020]. Disponible en: https://www.idf.org/e-library/epidemiology-research/diabetes-atlas/134-idf-diabetes-atlas-8th-edition.html
3.Cuba. Ministerio de Salud Pública. Dirección de Registros Médicos y Estadísticas de Salud. Anuario Estadístico de Salud 2018. La Habana: MINSAP; 2019 [citado 05/02/2020]. Disponible en: https://files.sld.cu/bvscuba/files/2019/04/Anuario-Electr%c3%b3nico-Espa%c3%b1ol-2018-ed-2019-compressed.pdf
4.Son JW, Lee SS, Kim SR, Yoo SJ, Cha BY, Son HY, et al. Low muscle mass and risk of type 2 diabetes in middle-aged and older adults: findings from the KoGES. Diabetologia [Internet]. 2017 May [citado 05/02/2020];60(5):865-872. Disponible en: https://link.springer.com/article/10.1007%2Fs00125-016-4196-9. https://doi.org/10.1007/s00125-016-4196-9
5.Domínguez Torres R, Hechavarría Espinosa A, Ortiz González LM, Suarez Rodríguez MJ. Polifarmacia en la tercera edad. Algunas consideraciones. Rev Electrón [Internet]. 2015 [citado 05/02/2020];38(5):[aprox. 9 p.]. Disponible en: http://revzoilomarinello.sld.cu/index.php/zmv/article/view/607/pdf_228
6.Díaz Díaz O, Orlandi González N. Manual para el diagnóstico y tratamiento del paciente diabético en el nivel primario de salud. La Habana: Editorial Ciencias Médicas; 2016. p. 78-114.
7.Trujillo Pedrosa PM, George Arse M, Ortega Sánchez JR. Complicación que se presenta en los pacientes al tratamiento con Heberprot-p en un área de salud. Acta Méd Centro [Internet]. 2017 [citado 05/02/2020];11(2):[aprox. 8 p.]. Disponible en: http://www.revactamedicacentro.sld.cu/index.php/amc/article/view/827/1069
8.Colectivo de autores. Infiltración del Heberprot-p. Un tratamiento eficaz para la úlcera de pie diabético; 2da ed. La Habana: Editorial Elfos Scientiae; 2009. p. 22-34.
9.Fernández-Montequín JI, Betancourt BY, Leyva-Gonzalez G, Mola EL, Galán-Naranjo K, Ramírez-Navas M, et al. Intralesional administration of epidermal growth factor-based formulation (Heberprot-P) in chronic diabetic foot ulcer: treatment up to complete wound closure. Int Wound J [Internet]. 2009 [citado 06/02/2020];6(1):67-72. Disponible en: https://www.ncbi.nlm.nih.gov/pubmed/19291119. https://doi.org/10.1111/j.1742-481X.2008.00561.x
10.Yera IB, Alonso L, Álvarez A, Debesa F. Postmarketing effectiveness and safety of Heberprot-P for diabetic foot ulcer treatment in Cuba. Biotecnol Apl [Internet]. 2010 Abr-Jun [citado 06/02/2020];27(2):127-128. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1027-28522010000200007&lng=es&nrm=iso&tlng=en
11.Brunton LL, Lazo JS, Parker KL. Goodman-Gilman. Las bases farmacológicas de la terapéutica. 12th ed. Ciudad México, DF: McGraw-Hill Interamericana; 2012.
12.Flórez J. Farmacología Humana. 6ta ed. Barcelona: Masson; 2014.
13.G Jiménez, I Alfonso, DM Calvo, M López, L Broche, C Lara. Normas y procedimientos de trabajo del Sistema Cubano de Farmacovigilancia. La Habana: Unidad Coordinadora Nacional; 2011.
14.Inglés Maury D, Pérez Inglés L, Serrano Frómeta L, Tudela Turcáz L, Fernández Arnejo L. Terapéutica ambulatoria con Heberprot-P en pacientes con úlceras de pie diabético. Rev Inf Cient [Internet]. 2014 [citado 05/02/2020];87(5):914-922. Disponible en: http://www.revinfcientifica.sld.cu/index.php/ric/article/view/1076
15.González Benavides C, Pérez Mederos LM, Peraltas Pérez G. Resultados de la utilización del heberprot-P®. Acta Méd Centro [Internet]. 2014 [citado 05/02/2020];8(4):[aprox. 7 p.]. Disponible en: http://www.revactamedicacentro.sld.cu/index.php/amc/article/view/192
16.Verdaguer Pérez L, Muguercia Silva JL, Ayala Lafargue D, Bertrán Bahades J, Estrada Ladoy L. Experiencias en el tratamiento con Heberprot-P® en pacientes con pie diabético. MEDISAN [Internet]. 2017 Ago [citado 05/02/2020];21(8):993-999. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1029-30192017000800005&lng=es
17.Turns M. Prevention and management of diabetic foot ulcers. Br J Community Nurs [Internet]. 2015 Mar [citado 05/02/2020]; Suppl Wound Care: S30, S32, S34-7. Disponible en: https://www.ncbi.nlm.nih.gov/pubmed/25757381
18.Garelli Guillermo, Calvagno M, Tolstano A, Carrio M, Bullo F, Gómez R. Tratamientos de úlceras severas de pie diabético con factor de crecimiento epidérmico recombinante (Heberprot-p®).Rev Argent Cir Cardiovasc [Internet]. 2012 Nov-Dic [citado 05/02/2020];10(3):153-162. Disponible en: http://www.caccv.org.ar/raccv-es-2012/RACCV_X_nro3_2012_Art_pag153_ESP.pdf
19.Montequin J, Valenzuela C, Savigne W, Gonzalez O, Sancho N, Rivero F, et al. Intra-lesional injections of recombinent human epidermal grounth factor promote granulation and healing in advanced diabetic foot ulcer: Multicenter, randomised, placebo-controllet-double-blind study. Int Wound J [Internet]. 2009 Dec [citado 05/02/2020];6(6):432-43. Disponible en: https://pubmed.ncbi.nlm.nih.gov/20051095/
20.Silva Pupo M, González Moya IA, Valenciano García Y, González Cedeño M. Evolución de lesiones complejas en el pie diabético con uso de Heberprot-P®. AMC [Internet]. 2015 Jul-Ago [citado 05/02/2020];19(4):357-365. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1025-02552015000400007
21.Trujillo Pedroza PM, George Arce M, Valdés Morales Y, Ortega Sánchez JR, Mendoza Molina A. Resultados del Programa de atención integral al paciente con pie diabético. Acta Méd Centro [Internet]. 2018 [citado 05/02/2020];13(1):[aprox. 8 p.]. Disponible en: http://revactamedicacentro.sld.cu/index.php/amc/article/view/982/1261
22.Álvarez CrespoI AR, Alonso Carbonell L, Yera Alós I, García Milián AJ, Marrero Miragaya MA. Caracterización de los eventos adversos reportados durante el tratamiento con Heberprot-P® en cuatro provincias de Cuba. Rev Horizonte Sanitario [Internet]. 2015 [citado 05/02/2020];14(2):42-46.Disponible en: http://revistas.ujat.mx/index.php/horizonte/article/view/950/889
23.Navarro Despaigne DA. Diabetes mellitus in the elderly from the foot to the head. V Congreso Internacional: Combatiendo la diabetes y sus complicaciones más severas. Matanzas; 2018.
24.Díaz Díaz O. La importancia de desarrollar estructuras eficientes de educación terapéutica en pacientes con diabetes. Rev Cubana Endocrinol [Internet]. 2016 May-Ago [citado 05/02/2020];27(2):120-122. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S156129532016000200001&lng=es
25.Bakker K, Apelqvist J, Lipsky BA, Van Netten JJ, International Working Group on the Diabetic Foot. The IWGDF guidance on the management and prevention of foot problems in diabetes: development of an evidence-based global consensus. Diabetes Metab Res Rev [Internet]. 2016 Jan [citado 05/02/2020];32(supl 1):2-6. Disponible en: https://www.ncbi.nlm.nih.gov/pubmed/26409930
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