Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcer
<p><strong>Foundation</strong>: Intensive pharmacovigilance is an effective tool to detect adverse reactions in relatively new drugs that have sanitary registration by a regulatory agency.<br /><strong>Objective</strong>: to describe the adverse reactions of Heber...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | Spanish |
| Published: |
Centro Provincial de Información de Ciencias Médicas. Cienfuegos
2024-09-01
|
| Series: | Medisur |
| Subjects: | |
| Online Access: | http://medisur.sld.cu/index.php/medisur/article/view/45250 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832576833389854720 |
|---|---|
| author | Annavely González Ocaña Ana María Ramos Cedeño Yeny Dueñas Pérez Francisco Carlos Valladares Más Yahima Arrechea Betancourt |
| author_facet | Annavely González Ocaña Ana María Ramos Cedeño Yeny Dueñas Pérez Francisco Carlos Valladares Más Yahima Arrechea Betancourt |
| author_sort | Annavely González Ocaña |
| collection | DOAJ |
| description | <p><strong>Foundation</strong>: Intensive pharmacovigilance is an effective tool to detect adverse reactions in relatively new drugs that have sanitary registration by a regulatory agency.<br /><strong>Objective</strong>: to describe the adverse reactions of Heberprot-P® in patients with diabetic foot ulcer.<br /><strong>Methods</strong>: descriptive, prospective, intensive pharmacovigilance study, carried out in the Dr. Gustavo Aldereguía Lima Hospital’s Angiology service, Cienfuegos, in 2022. This included 170 patients with diagnostic criteria for diabetic foot ulcer, treated with at least one dose of Heberprot-P®. In addition to sociodemographic variables, the type of adverse event, intensity, severity and causality were analyzed.<br /><strong>Results</strong>: Patients with white skin color and over 60 years of age predominated. There were 210 adverse events, which were most frequently manifested by burning and pain at the injection site, tremor and chills, especially of mild intensity (61.4%) and with a probable causal relationship (76.6%).<strong><br />Conclusions</strong>: Despite being a safe drug, more pharmacovigilance studies related to Heberprot-P® should be carried out, since all marketed drugs require continuous monitoring.</p> |
| format | Article |
| id | doaj-art-70821d98c06643c3acbf48ec123c292b |
| institution | Kabale University |
| issn | 1727-897X |
| language | Spanish |
| publishDate | 2024-09-01 |
| publisher | Centro Provincial de Información de Ciencias Médicas. Cienfuegos |
| record_format | Article |
| series | Medisur |
| spelling | doaj-art-70821d98c06643c3acbf48ec123c292b2025-01-30T21:29:03ZspaCentro Provincial de Información de Ciencias Médicas. CienfuegosMedisur1727-897X2024-09-012259049102552Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcerAnnavely González Ocaña0Ana María Ramos Cedeño1Yeny Dueñas Pérez2Francisco Carlos Valladares Más3Yahima Arrechea Betancourt4Universidad de Ciencias Médicas de Cienfuegos. CienfuegosUniversidad de Ciencias Médicas de Cienfuegos. CienfuegosUniversidad de Ciencias Médicas de Cienfuegos. CienfuegosUniversidad de Ciencias Médicas de Cienfuegos. CienfuegosUniversidad de Ciencias Médicas de Cienfuegos. Cienfuegos<p><strong>Foundation</strong>: Intensive pharmacovigilance is an effective tool to detect adverse reactions in relatively new drugs that have sanitary registration by a regulatory agency.<br /><strong>Objective</strong>: to describe the adverse reactions of Heberprot-P® in patients with diabetic foot ulcer.<br /><strong>Methods</strong>: descriptive, prospective, intensive pharmacovigilance study, carried out in the Dr. Gustavo Aldereguía Lima Hospital’s Angiology service, Cienfuegos, in 2022. This included 170 patients with diagnostic criteria for diabetic foot ulcer, treated with at least one dose of Heberprot-P®. In addition to sociodemographic variables, the type of adverse event, intensity, severity and causality were analyzed.<br /><strong>Results</strong>: Patients with white skin color and over 60 years of age predominated. There were 210 adverse events, which were most frequently manifested by burning and pain at the injection site, tremor and chills, especially of mild intensity (61.4%) and with a probable causal relationship (76.6%).<strong><br />Conclusions</strong>: Despite being a safe drug, more pharmacovigilance studies related to Heberprot-P® should be carried out, since all marketed drugs require continuous monitoring.</p>http://medisur.sld.cu/index.php/medisur/article/view/45250farmacovigilanciafactor de crecimiento epidérmicoefectos colaterales y reacciones adversas relacionados con medicamentosfarmacologíapie diabético |
| spellingShingle | Annavely González Ocaña Ana María Ramos Cedeño Yeny Dueñas Pérez Francisco Carlos Valladares Más Yahima Arrechea Betancourt Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcer Medisur farmacovigilancia factor de crecimiento epidérmico efectos colaterales y reacciones adversas relacionados con medicamentos farmacología pie diabético |
| title | Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcer |
| title_full | Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcer |
| title_fullStr | Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcer |
| title_full_unstemmed | Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcer |
| title_short | Intensive pharmacovigilance of Heberprot-P® in patients with diabetic foot ulcer |
| title_sort | intensive pharmacovigilance of heberprot p r in patients with diabetic foot ulcer |
| topic | farmacovigilancia factor de crecimiento epidérmico efectos colaterales y reacciones adversas relacionados con medicamentos farmacología pie diabético |
| url | http://medisur.sld.cu/index.php/medisur/article/view/45250 |
| work_keys_str_mv | AT annavelygonzalezocana intensivepharmacovigilanceofheberprotpinpatientswithdiabeticfootulcer AT anamariaramoscedeno intensivepharmacovigilanceofheberprotpinpatientswithdiabeticfootulcer AT yenyduenasperez intensivepharmacovigilanceofheberprotpinpatientswithdiabeticfootulcer AT franciscocarlosvalladaresmas intensivepharmacovigilanceofheberprotpinpatientswithdiabeticfootulcer AT yahimaarrecheabetancourt intensivepharmacovigilanceofheberprotpinpatientswithdiabeticfootulcer |