becaplermin
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Como complemento del cuidado adecuado, úlceras neuropáticas diabéticas de miembros inferiores que alcanzan tejido subcutáneo o más profundo y tienen irrigación suficiente.
Contraindicaciones
Absolutas
- Neoplasia conocida en el lugar de aplicación.
Advertencias clínicas
- Advertencia mayor · Se han notificado neoplasias alejadas del lugar de aplicación; valorar cuidadosamente beneficios y riesgos en pacientes con cáncer conocido. Considerar sensibilización o irritación si aparece reacción local. — openFDA REGRANEX gel 0.01% set ID 377b3021-13d7-96d5-e063-6394a90a8ca3
- No sustituye al desbridamiento, alivio de presión ni control de infección. No está establecida su eficacia en úlceras por presión o estasis venosa, úlceras isquémicas ni heridas que cierran por primera intención. — openFDA REGRANEX gel 0.01% set ID 377b3021-13d7-96d5-e063-6394a90a8ca3
- Solo para uso tópico; no administrar por vía oral, oftálmica ni intravaginal. No se ha establecido su efecto sobre articulaciones, tendones, ligamentos o hueso expuestos, ni se ha estudiado con otros medicamentos tópicos en la misma úlcera. — openFDA REGRANEX gel 0.01% set ID 377b3021-13d7-96d5-e063-6394a90a8ca3
Eventos adversos
Comunes (≥1%)
Erupción eritematosa
Raros pero graves
Neoplasias alejadas del lugar de aplicación
Embarazo y lactancia
No hay datos suficientes en embarazo. En lactancia, ponderar los beneficios de amamantar, la necesidad materna y posibles efectos en el lactante.
Bibliografía reciente (PubMed)
Diabetic foot ulcers (DFUs) are a complication of diabetes that have long been neglected. To date, a single drug (becaplermin containing platelet-derived growth factor, PDGF) has been approved by the FDA 27 years ago; however, it is seldom used because of its modest efficacy. The standard-of-care for DFUs is debridement, off-loading, and infection control with antibiotics, with hyperbaric oxygen (HBO) therapy being the treatment of last recourse. The paucity of understanding what accelerates diabetic wound healing results in more than 150,000 lower-limb amputations in the United States every year. A new paradigm for treatment of DFUs is proposed based on the higher levels of active matrix metalloproteinase (MMP)-9 with the more severe and infected human DFUs, and the demonstrated detrimental role of MMP-9 and the beneficial repair role of MMP-8 in diabetic mice. Selective inhibition of MMP-9 with the small molecule (R)-ND-336 lowered inflammation, reduced reactive oxygen species (ROS), and increased angiogenesis, without affecting MMP-8 to allow the natural repair mechanisms to take place. (R)-ND-336 showed better efficacy than becaplermin in diabetic mice. Becaplermin (PDGF) and HBO therapy work by decreasing MMP-9, but they do not completely suppress MMP-9 activity.
Cutaneous wound healing consists of four stages: hemostasis, inflammation, proliferation/repair, and remodeling. While healthy wounds normally heal in four to six weeks, a variety of underlying medical conditions can impair the progression through the stages of wound healing, resulting in the development of chronic, non-healing wounds. Great progress has been made in developing wound dressings and improving surgical techniques, yet challenges remain in finding effective therapeutics that directly promote healing. This review examines the current understanding of the pro-healing effects of targeted pharmaceuticals, re-purposed drugs, natural products, and cell-based therapies on the various cell types present in normal and chronic wounds. Overall, despite several promising studies, there remains only one therapeutic approved by the United States Food and Drug Administration (FDA), Becaplermin, shown to significantly improve wound closure in the clinic. This highlights the need for new approaches aimed at understanding and targeting the underlying mechanisms impeding wound closure and moving the field from the management of chronic wounds towards resolving wounds.
Since the only and the milestone FDA approval of becaplermin gel (RegranexTM, 0.01% human recombinant PDGF-BB) as a (diabetic) wound healing therapeutic more than 25 years ago, no new therapeutic (excluding physical therapies, devices, dressings, anti-microbial agents, or other preventive treatments) for any type of wound healing has advanced to clinical applications. During the same period of time, the FDA has approved additional 250 new drugs for various human tumors, which were famously described as "wounds that do not heal". Two similar pathological conditions have experienced such a dramatic difference in therapeutics. More surprisingly, few in the wound healing community seem to be alarmed by this mysterious deficit. As it is often said, "damaging is far easier than re-building". In contrast to the primary duty of a cancer drug to damage a single molecule of the signaling network, a wound healing drug must be able to re-build the multi-level damages in the wound. No known single molecule alone is capable of repairing multi-cell-type and multi-pathway damages all at once. We argue that the previous single molecule-based strategy for developing wound healing therapeutics is profoundly flawed in theory. The future success of effective wound healing therapeutics requires a fundamental change in the paradigm.
To qualitatively review reports on lateral line depigmentation (LLD) in marine and freshwater fish. English-language publications concerning LLD published before March 1, 2020. Electronic searches of CAB abstracts, PubMed, and Web of Science databases and the proceedings of the International Association of Aquatic Animal Medicine were performed. Records were systematically screened and selected for inclusion in an integrative review. Bibliographies of records included in the review were examined to identify other records to be screened. Included records were qualitatively reviewed. Evidence level and quality were graded according to previously described criteria. Information pertinent to epidemiological factors, etiopathogenesis, clinical and histopathologic findings, treatment, and prevention of LLD was collected. 401 records were screened, and 24 unique publications (16 peer-reviewed articles, 1 textbook, and 7 abstracts) were included in the study; 12 (50%), 1 (4%), 6 (25%), and 5 (21%) were classified as evidence level I (experimental), II (quasi-experimental), III (nonexperimental), and V (clinical reports or clinician experience), respectively. Seventeen (71%) and 7 (29%) reports were classified as high quality and good quality, respectively. LLD should be considered a clinical observation indicative of a dermatologic response of fish to suboptimal conditions; LLD should continue to be adopted as the preferred term to describe the classic signs. Whereas gross findings are similar among species, histologic findings can vary. Evidence-based treatment of LLD for individual fish consists of source control (changing tanks or systems), topical treatment with 0.01% becaplermin gel, supportive care, and antimicrobial treatment when warranted. For schools of fish, treatment and prevention of LLD should be focused on improving suboptimal environmental and physiologic conditions.
Diabetes foot ulcers are a leading cause of death in diabetic individuals. There are very few medicines and treatments that have received regulatory clearance for this indication, and numerous compounds from various pharmacological classes are now in various stages of clinical studies for diabetic foot ulcers treatment. Multiple risk factors contribute to diabetic foot ulcers, including neuropathy, peripheral artery disease, infection, gender, cigarette smoking, and age. The present difficulties in diabetic foot ulcers treatment are related to bacterial resistance to currently utilized antibiotics. Inhibition of the quorum sensing (QS) system and targeting matrix metallopeptidase-9 (MMP-9) are promising. This study focuses on the difficulties of existing treatment, current treatment technique, and novel pharmacological targets for diabetic foot ulcer. The electronic data base search diabetic for literature on foot ulcers treatment was carried out using Science Direct, PubMed, Google-Scholar, Springer Link, Scopus, and Wiley up to 2021. Becaplermin, a medication that targets MMP-9, glyceryl trinitrate, which inhibits the bacterial quorum sensing system, probiotic therapy, and nano technological solutions are just a few of the novel pharmaceuticals being developed for diabetic foot ulcers treatment. A combination of therapies, rather than one particular agent, will be the best option for treatment of Diabetes foot ulcer since it is multifactorial factors that render occurs of diabetic foot ulcer.