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1.
Disaster Med Public Health Prep ; : 1-11, 2019 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-31581970

RESUMO

INTRODUCTION: Burn disasters represent a real challenge to burn centers worldwide. Several burn disasters with a considerable number of casualties happened in Belgium in the past. The positioning of burn centers is a significant issue to account for in a burn disaster preparedness and response. The objectives of this study are to identify the geographic coverage and accessibility of the burn centers in Belgium in the realm of a burn disaster scenario. METHOD: Cross-sectional secondary analysis was performed using data from the Belgian Burn Association and Belgian Department of the Statistic. Data were analyzed using ArcGIS, a geographic information system tool to identify the coverage of burn centers within half an hour driving time, and access time of both populations in the districts and the disaster-prone areas to the individual burn centers. RESULTS: Around 7.3 million (65%) people are covered by a half an hour driving time window from the burn centers. However, the accessibility to the individual burn centers is varied across different regions and provinces. CONCLUSION: There is a slightly over-supply of burn centers in the mid part of the country, contrasted by an under-supply and poor accessibility for the population living near the borders, particularly in the south part of the country. This study would provide a benchmark for stakeholders in Belgium and other industrial countries to consider the coverage and accessibility of the burn centers as part of preparation and planning for burn disasters in the future.

2.
J Burn Care Res ; 40(6): 869-877, 2019 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-31211825

RESUMO

Burn disaster is defined as a massive influx of patients that exceeds a burn center's capacity and capability. This study investigates the capacity and capability of burn centers to respond to burn disasters in the Belgian ground. Quantitative survey and qualitative semistructured interview questionnaires were administered directly to key informants of burn centers. The data collected from both methods were compared to get a more in-depth overview of the issue. Quantitative data were converted into a narrative to enrich the qualitative data and included in the thematic analysis. Finally, data from both methods were analyzed and organized into five themes. The Belgian Association of Burn Injury (BABI) has a specific prehospital plan for burn disaster management. Once the BABI Plan is activated, all burn centers respond as one entity. Burn Team (B-Team) is a professional team that is formed in case of urgent need and it is deployed to a scene or to nonburn specialized hospitals to help in disaster relief. The challenges for burn disasters response occur particularly in the area of triage, transfer, communication, funding, and training. We conclude that there is a variation in the capacity and capability of burn centers. Overall, the system of burn disaster management is advanced and it is comparable to other high-income countries. Nevertheless, further improvement in the areas of preparation, triage, communication, and finally training would make disaster response more resilient in the future. Therefore, there is still space for further improvement of the management of burn disasters in Belgium.

3.
Lancet Infect Dis ; 19(1): 35-45, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30292481

RESUMO

BACKGROUND: Wound infections are the main cause of sepsis in patients with burns and increase burn-related morbidity and mortality. Bacteriophages, natural bacterial viruses, are being considered as an alternative therapy to treat infections caused by multidrug-resistant bacteria. We aimed to compare the efficacy and tolerability of a cocktail of lytic anti-Pseudomonas aeruginosa bacteriophages with standard of care for patients with burns. METHODS: In this randomised phase 1/2 trial, patients with a confirmed burn wound infection were recruited from nine burn centres in hospitals in France and Belgium. Patients were eligible if they were aged 18 years or older and had a burn wound clinically infected with P aeruginosa. Eligible participants were randomly assigned (1:1) by use of an interactive web response system to a cocktail of 12 natural lytic anti-P aeruginosa bacteriophages (PP1131; 1 × 106 plaque-forming units [PFU] per mL) or standard of care (1% sulfadiazine silver emulsion cream), both given as a daily topical treatment for 7 days, with 14 days of follow-up. Masking of treatment from clinicians was not possible because of the appearance of the two treatments (standard of care a thick cream, PP1131 a clear liquid applied via a dressing), but assignments were masked from microbiologists who analysed the samples and patients (treatment applied while patients were under general anaesthetic). The primary endpoint was median time to sustained reduction in bacterial burden by at least two quadrants via a four-quadrant method, assessed by use of daily swabs in all participants with a microbiologically documented infection at day 0 who were given at least one sulfadiazine silver or phage dressing (modified intention-to-treat population). Safety was assessed in all participants who received at least one dressing according to protocol. Ancillary studies were done in the per-protocol population (all PP1131 participants who completed 7 days of treatment) to assess the reasons for success or failure of phage therapy. This trial is registered with the European Clinical Trials database, number 2014-000714-65, and ClinicalTrials.gov, number NCT02116010, and is now closed. FINDINGS: Between July 22, 2015, and Jan 2, 2017, across two recruitment periods spanning 13 months, 27 patients were recruited and randomly assigned to receive phage therapy (n=13) or standard of care (n=14). One patient in the standard of care group was not exposed to treatment, giving a safety population of 26 patients (PP1131 n=13, standard of care n=13), and one patient in the PP1131 group did not have an infection at day 0, giving an efficacy population of 25 patients (PP1131 n=12, standard of care n=13). The trial was stopped on Jan 2, 2017, because of the insufficient efficacy of PP1131. The primary endpoint was reached in a median of 144 h (95% CI 48-not reached) in the PP1131 group versus a median of 47 h (23-122) in the standard of care group (hazard ratio 0·29, 95% CI 0·10-0·79; p=0·018). In the PP1131 group, six (50%) of 12 analysable participants had a maximal bacterial burden versus two (15%) of 13 in the standard of care group. PP1131 titre decreased after manufacturing and participants were given a lower concentration of phages than expected (1 × 102 PFU/mL per daily dose). In the PP1131 group, three (23%) of 13 analysable participants had adverse events versus seven (54%) of 13 in the standard of care group. One participant in each group died after follow-up and the deaths were determined to not be related to treatment. The ancillary study showed that the bacteria isolated from patients with failed PP1131 treatment were resistant to low phage doses. INTERPRETATION: At very low concentrations, PP1131 decreased bacterial burden in burn wounds at a slower pace than standard of care. Further studies using increased phage concentrations and phagograms in a larger sample of participants are warranted. FUNDING: European Commission: Framework Programme 7.


Assuntos
Queimaduras/microbiologia , Queimaduras/terapia , Tolerância a Medicamentos , Terapia por Fagos/métodos , Infecções por Pseudomonas/terapia , Fagos de Pseudomonas , Adulto , Idoso , Antibacterianos/uso terapêutico , Bélgica , Método Duplo-Cego , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Infecções por Pseudomonas/microbiologia , Pseudomonas aeruginosa/virologia , Resultado do Tratamento
5.
PLoS One ; 12(7): e0182121, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28750102

RESUMO

Bacteriophages could be used along with burn wound care products to enhance antimicrobial pressure during treatment. However, some of the components of the topical antimicrobials that are traditionally used for the prevention and treatment of burn wound infection might affect the activity of phages. Therefore, it is imperative to determine the counteraction of therapeutic phage preparations by burn wound care products before application in patients. Five phages, representatives of two morphological families (Myoviridae and Podoviridae) and active against 3 common bacterial burn wound pathogens (Acinetobacter baumannii, Pseudomonas aeruginosa and Staphylococcus aureus) were tested against 13 different products commonly used in the treatment of burn wounds. The inactivation of the phages was quite variable for different phages and different products. Majority of the anti-infective products affected phage activity negatively either immediately or in the course of time, although impact was not always significant. Products with high acidity had the most adverse effect on phages. Our findings demonstrate that during combined treatment the choice of phages and wound care products must be carefully defined in advance.


Assuntos
Bacteriófagos/fisiologia , Queimaduras/virologia , Infecção dos Ferimentos/virologia , Anti-Infecciosos/química , Concentração de Íons de Hidrogênio
7.
Crit Care Med ; 44(12): e1246-e1250, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27414478

RESUMO

OBJECTIVE: To describe a case of partial nephrogenic diabetes insipidus in a burned patient after prolonged delivery of low inspired concentrations of sevoflurane via an Anesthetic Conserving Device. DATA SOURCES: Clinical observation. STUDY SELECTION: Case report. DATA EXTRACTION: Relevant clinical information. DATA SYNTHESIS: A 34-year-old man was admitted with burns covering 52% of his total body surface area. Mechanical ventilation was provided during sedation with continuous infusions of sufentanil and midazolam. Sedation became increasingly difficult, and in order to limit administration of IV agents, sevoflurane was added to the inspiratory gas flow. This was provided using an Anesthetic Conserving Device and continued for 8 days. The patient rapidly developed polyuria and hypernatremia with an inappropriate decrease in urinary osmolality. Administration of desmopressin resulted in only a modest effect on renal concentrating ability. After cessation of sevoflurane, all variables returned to normal within 5 days. The results of further investigations (cerebral computed tomographic scan, cerebral magnetic resonance imaging, and serum arginine vasopressin concentration) were compatible with a diagnosis of partial nephrogenic diabetes insipidus. The temporal sequence of clinical findings in relation to sevoflurane administration suggests that the sevoflurane was the probable underlying cause. CONCLUSIONS: Clinicians should be aware of the possibility of sevoflurane-induced diabetes insipidus not only during general anesthesia but also in the intensive care setting of sedation in critically ill patients. This is especially important in patients, such as those with severe burns, in whom preserved renal concentrating ability is important to ensure compensation for extrarenal fluid losses.


Assuntos
Anestésicos Inalatórios/efeitos adversos , Queimaduras/terapia , Sedação Consciente/efeitos adversos , Nefropatias Diabéticas/induzido quimicamente , Éteres Metílicos/efeitos adversos , Adulto , Anestésicos Inalatórios/administração & dosagem , Anestésicos Inalatórios/uso terapêutico , Sedação Consciente/instrumentação , Sedação Consciente/métodos , Humanos , Masculino , Éteres Metílicos/administração & dosagem , Éteres Metílicos/uso terapêutico , Respiração Artificial/métodos , Sevoflurano
8.
PLoS One ; 11(5): e0156237, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27223476

RESUMO

Multidrug resistant Acinetobacter baumannii and its closely related species A. pittii and A. nosocomialis, all members of the Acinetobacter calcoaceticus-baumannii (Acb) complex, are a major cause of hospital acquired infection. In the burn wound center of the Queen Astrid military hospital in Brussels, 48 patients were colonized or infected with Acb complex over a 52-month period. We report the molecular epidemiology of these organisms, their clinical impact and infection control measures taken. A representative set of 157 Acb complex isolates was analyzed using repetitive sequence-based PCR (rep-PCR) (DiversiLab) and a multiplex PCR targeting OXA-51-like and OXA-23-like genes. We identified 31 rep-PCR genotypes (strains). Representatives of each rep-type were identified to species by rpoB sequence analysis: 13 types to A. baumannii, 10 to A. pittii, and 3 to A. nosocomialis. It was assumed that isolates that belonged to the same rep-type also belonged to the same species. Thus, 83.4% of all isolates were identified to A. baumannii, 9.6% to A. pittii and 4.5% to A. nosocomialis. We observed 12 extensively drug resistant Acb strains (10 A. baumannii and 2 A. nosocomialis), all carbapenem-non-susceptible/colistin-susceptible and imported into the burn wound center through patients injured in North Africa. The two most prevalent rep-types 12 and 13 harbored an OXA-23-like gene. Multilocus sequence typing allocated them to clonal complex 1 corresponding to EU (international) clone I. Both strains caused consecutive outbreaks, interspersed with periods of apparent eradication. Patients infected with carbapenem resistant A. baumannii were successfully treated with colistin/rifampicin. Extensive infection control measures were required to eradicate the organisms. Acinetobacter infection and colonization was not associated with increased attributable mortality.


Assuntos
Infecções por Acinetobacter/tratamento farmacológico , Infecções por Acinetobacter/epidemiologia , Acinetobacter baumannii/isolamento & purificação , Acinetobacter calcoaceticus/isolamento & purificação , Queimaduras/microbiologia , Colistina/uso terapêutico , Infecções por Acinetobacter/microbiologia , Acinetobacter baumannii/genética , Acinetobacter calcoaceticus/genética , Adolescente , Adulto , África do Norte/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Técnicas de Tipagem Bacteriana , Bélgica/epidemiologia , Criança , Pré-Escolar , Farmacorresistência Bacteriana , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Tipagem de Sequências Multilocus , Reação em Cadeia da Polimerase Multiplex , RNA Bacteriano/análise , RNA Ribossômico 16S/análise , Resultado do Tratamento , Adulto Jovem
9.
Skin Pharmacol Physiol ; 28(5): 250-4, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25998853

RESUMO

Wound healing following partial thickness thermal burns is commonly hampered by the risk of hypertrophic scarring. Skin myofibroblast (MF) density is commonly increased in postburn healing. The transition between fibroblast-like cells and α-smooth muscle actin (SMA)+ MF possibly begins with CD14+ monocytes, evolving to CD14+ CD34+ fibrocytes, followed by ß-SMA+ protomyofibroblast (PMF) maturation. Skin biopsies from 25 burn patients were collected about 1 and 4 weeks after injury. Immunohistochemistry was performed using monoclonal antibodies to α-SMA, ß-SMA, factor XIIIa, lysozyme, Mac 387, CD14, CD117 and Ulex europaeus agglutinin-1 (UEA-1). The set of Mac 387+ and CD14+ monocytes was accompanied by both CD34+ fibrocytes and factor XIIIa+ dendrocytes. By contrast, ß-SMA+ PMF were rare. Of note, α-SMA+ MF were more abundant at week 4 than at week 1 (p < 0.01). The UEA-1+ endothelial cells showed marked variations in their dermal distribution, irrespective of the densities in the other scrutinized cells. In conclusion, healing of partial thickness thermal burns involves a diversity of cell types including PMF. In the present samples, the PMF density remained low. © 2015 S. Karger AG, Basel.


Assuntos
Queimaduras/metabolismo , Miofibroblastos/metabolismo , Pele/metabolismo , Cicatrização/fisiologia , Actinas/metabolismo , Adulto , Biópsia , Queimaduras/patologia , Feminino , Fibroblastos/metabolismo , Humanos , Imuno-Histoquímica , Receptores de Lipopolissacarídeos/metabolismo , Masculino , Pessoa de Meia-Idade , Pele/patologia , Fatores de Tempo , Adulto Jovem
11.
Exp Dermatol ; 24(5): 349-54, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25704791

RESUMO

High-definition optical coherence tomography (HD-OCT) permits real-time 3D imaging of the impact of selected agents on human skin allografts. The real-time 3D HD-OCT assessment of (i) the impact on morphological and cellular characteristics of the processing of human acellular dermal matrices (HADMs) and (ii) repopulation of HADMs in vitro by human fibroblasts and remodelling of the extracellular matrix by these cells. Four different skin decellularization methods, Dispase II/Triton X-100, Dispase II/SDS (sodium dodecyl sulphate), NaCl/Triton X-100 and NaCl/SDS, were analysed by HD-OCT. HD-OCT features of epidermal removal, dermo-epidermal junction (DEJ) integrity, cellularity and dermal architecture were correlated with reflectance confocal microscopy (RCM), histopathology and immunohistochemistry. Human adult dermal fibroblasts were in vitro seeded on the NaCl/Triton X-100 processed HADMs, cultured up to 19 days and evaluated by HD-OCT in comparison with MTT proliferation test and histology. Epidermis was effectively removed by all treatments. DEJ was best preserved after NaCl/Triton X-100 treatment. Dispase II/SDS treatment seemed to remove all cellular debris in comparison with NaCl/Triton X-100 but disturbed the DEJ severely. The dermal micro-architectural structure and vascular spaces of (sub)papillary dermis were best preserved with the NaCl/Triton X-100. The impact on the 3D structure and vascular holes was detrimental with Dispase II/SDS. Elastic fibre fragmentation was only observed after Dispase II incubation. HD-OCT showed that NaCl/Triton X-100 processed matrices permitted in vitro repopulation by human dermal fibroblasts (confirmed by MTT test and histology) and underwent remodelling upon increasing incubation time. Care must be taken in choosing the appropriate processing steps to maintain selected properties of the extracellular matrix in HADMs. Processing HADMs with NaCl/Triton X-100 permits in vitro the proliferation and remodelling activity of human dermal fibroblasts. HD-OCT provides unique real-time and non-invasive 3D imaging of tissue-engineered skin constructs and complementary morphological and cytological information.


Assuntos
Derme Acelular , Transplante de Pele , Tomografia de Coerência Óptica/métodos , Adulto , Proliferação de Células , Células Cultivadas , Sistemas Computacionais , Derme/citologia , Fibroblastos/citologia , Humanos , Imageamento Tridimensional , Octoxinol , Cloreto de Sódio , Engenharia Tecidual , Tecidos Suporte , Transplante Homólogo
12.
Int J Burns Trauma ; 4(2): 66-73, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25356373

RESUMO

Antibiotic resistance has become a major public health problem and the antibiotics pipeline is running dry. Bacteriophages (phages) may offer an 'innovative' means of infection treatment, which can be combined or alternated with antibiotic therapy and may enhance our abilities to treat bacterial infections successfully. Today, in the Queen Astrid Military Hospital, phage therapy is increasingly considered as part of a salvage therapy for patients in therapeutic dead end, particularly those with multidrug resistant infections. We describe the application of a well-defined and quality controlled phage cocktail, active against Pseudomonas aeruginosa and Staphylococcus aureus, on colonized burn wounds within a modest clinical trial (nine patients, 10 applications), which was approved by a leading Belgian Medical Ethical Committee. No adverse events, clinical abnormalities or changes in laboratory test results that could be related to the application of phages were observed. Unfortunately, this very prudent 'clinical trial' did not allow for an adequate evaluation of the efficacy of the phage cocktail. Nevertheless, this first 'baby step' revealed several pitfalls and lessons for future experimental phage therapy and helped overcome the psychological hurdles that existed to the use of viruses in the treatment of patients in our burn unit.

13.
Exp Dermatol ; 23(10): 725-30, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25047067

RESUMO

While real-time 3-D evaluation of human skin constructs is needed, only 2-D non-invasive imaging techniques are available. The aim of this paper is to evaluate the potential of high-definition optical coherence tomography (HD-OCT) for real-time 3-D assessment of the epidermal splitting and decellularization. Human skin samples were incubated with four different agents: Dispase II, NaCl 1 M, sodium dodecyl sulphate (SDS) and Triton X-100. Epidermal splitting, dermo-epidermal junction, acellularity and 3-D architecture of dermal matrices were evaluated by High-definition optical coherence tomography before and after incubation. Real-time 3-D HD-OCT assessment was compared with 2-D en face assessment by reflectance confocal microscopy (RCM). (Immuno) histopathology was used as control. HD-OCT imaging allowed real-time 3-D visualization of the impact of selected agents on epidermal splitting, dermo-epidermal junction, dermal architecture, vascular spaces and cellularity. RCM has a better resolution (1 µm) than HD-OCT (3 µm), permitting differentiation of different collagen fibres, but HD-OCT imaging has deeper penetration (570 µm) than RCM imaging (200 µm). Dispase II and NaCl treatments were found to be equally efficient in the removal of the epidermis from human split-thickness skin allografts. However, a different epidermal splitting level at the dermo-epidermal junction could be observed and confirmed by immunolabelling of collagen type IV and type VII. Epidermal splitting occurred at the level of the lamina densa with dispase II and above the lamina densa (in the lamina lucida) with NaCl. The 3-D architecture of dermal papillae and dermis was more affected by Dispase II on HD-OCT which corresponded with histopathologic (orcein staining) fragmentation of elastic fibres. With SDS treatment, the epidermal removal was incomplete as remnants of the epidermal basal cell layer remained attached to the basement membrane on the dermis. With Triton X-100 treatment, the epidermis was not removed. In conclusion, HD-OCT imaging permits real-time 3-D visualization of the impact of selected agents on human skin allografts.


Assuntos
Epiderme/anatomia & histologia , Tomografia de Coerência Óptica/métodos , Colágeno/metabolismo , Sistemas Computacionais , Derme/anatomia & histologia , Derme/metabolismo , Endopeptidases , Epiderme/metabolismo , Humanos , Imageamento Tridimensional , Microscopia Confocal , Octoxinol , Cloreto de Sódio , Dodecilsulfato de Sódio , Engenharia Tecidual , Adulto Jovem
14.
Biomed Res Int ; 2014: 621316, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24868534

RESUMO

The excessive and improper use of antibiotics has led to an increasing incidence of bacterial resistance. In Europe the yearly number of infections caused by multidrug resistant bacteria is more than 400.000, each year resulting in 25.000 attributable deaths. Few new antibiotics are in the pipeline of the pharmaceutical industry. Early in the 20th century, bacteriophages were described as entities that can control bacterial populations. Although bacteriophage therapy was developed and practiced in Europe and the former Soviet republics, the use of bacteriophages in clinical setting was neglected in Western Europe since the introduction of traditional antibiotics. Given the worldwide antibiotic crisis there is now a growing interest in making bacteriophage therapy available for use in modern western medicine. Despite the growing interest, access to bacteriophage therapy remains highly problematic. In this paper, we argue that the current state of affairs is morally unacceptable and that all stakeholders (pharmaceutical industry, competent authorities, lawmakers, regulators, and politicians) have the moral duty and the shared responsibility towards making bacteriophage therapy urgently available for all patients in need.


Assuntos
Infecções Bacterianas/terapia , Bacteriófagos/química , Farmacorresistência Bacteriana , Antibacterianos/uso terapêutico , Bactérias , Infecções Bacterianas/tratamento farmacológico , Terapia Biológica/tendências , Indústria Farmacêutica/tendências , Ética Médica , Europa (Continente) , Humanos , Princípios Morais
15.
Burns ; 40(8): 1707-12, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24726294

RESUMO

INTRODUCTION: The pathophysiology of toxic epidermal necrolysis (TEN) is thought to be related to a drug-induced oxidative stress combined with TNFα overexpression by keratinocytes. None of the current treatments for TEN including systemic corticosteroids, cyclosporine and intravenous administration of immunoglobulins has proven superior over supportive care only. METHODS: A total of 10 TEN patients were enrolled to be treated at admission in burn units with the antioxidant N-acetylcysteine [NAC, 150mg/kg in a 20-h intravenous (IV) administration], or the combination of the same IV NAC perfusion with the anti-TNFα antibody infliximab (Remicade(®)), administered at a 5mg/kg dosage as a single 2-h IV administration. TEN was confirmed by a skin biopsy taken from a bullous lesion. At entry in the trial and 48h later, the illness auxiliary score (IAS) of clinical severity was determined and the extent in altered skin area (erythema and blisters) was assessed as a relative body area. Skin biopsies of both clinically uninvolved and erythematous areas were collected and immunohistochemistry was performed for assessing the density of inflammatory cells (CD8+ T cells, CD68+ macrophages) and keratinocytes enriched in intracellular calcium (Ca(++)) identified by the Mac387 anti-calprotectin antibody. RESULTS: No unexpected drug-induced adverse event was noticed. After 48h of both treatment modalities, improvements were not observed in the extent of skin involvement and in IAS. Immunohistopathology showed the absence of reduction in the amount of intraepidermal inflammatory cells. An increased intracellular Ca(++) load in clinically uninvolved keratinocytes and in erythematous epidermis was noticed. This latter finding suggested the progression in the way of the apoptotic process. On burn unit discharge, the survival in each modality of treatment was not improved compared to the expected outcomes determined from the IAS at admission. CONCLUSIONS: In this proof-to-concept attempt, NAC treatment or its combination with infliximab did not appear to reverse the evolving TEN process.


Assuntos
Acetilcisteína/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Queimaduras/complicações , Fármacos Dermatológicos/uso terapêutico , Depuradores de Radicais Livres/uso terapêutico , Síndrome de Stevens-Johnson/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antígenos CD/análise , Feminino , Humanos , Imuno-Histoquímica , Infliximab , Macrófagos/imunologia , Masculino , Pessoa de Meia-Idade , Síndrome de Stevens-Johnson/imunologia , Síndrome de Stevens-Johnson/patologia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto Jovem
16.
Arch Immunol Ther Exp (Warsz) ; 62(2): 117-29, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24500660

RESUMO

The worldwide emergence of antibiotic resistances and the drying up of the antibiotic pipeline have spurred a search for alternative or complementary antibacterial therapies. Bacteriophages are bacterial viruses that have been used for almost a century to combat bacterial infections, particularly in Poland and the former Soviet Union. The antibiotic crisis has triggered a renewed clinical and agricultural interest in bacteriophages. This, combined with new scientific insights, has pushed bacteriophages to the forefront of the search for new approaches to fighting bacterial infections. But before bacteriophage therapy can be introduced into clinical practice in the European Union, several challenges must be overcome. One of these is the conceptualization and classification of bacteriophage therapy itself and the extent to which it constitutes a human medicinal product regulated under the European Human Code for Medicines (Directive 2001/83/EC). Can therapeutic products containing natural bacteriophages be categorized under the current European regulatory framework, or should this framework be adapted? Various actors in the field have discussed the need for an adapted (or entirely new) regulatory framework for the reintroduction of bacteriophage therapy in Europe. This led to the identification of several characteristics specific to natural bacteriophages that should be taken into consideration by regulators when evaluating bacteriophage therapy. One important consideration is whether bacteriophage therapy development occurs on an industrial scale or a hospital-based, patient-specific scale. More suitable regulatory standards may create opportunities to improve insights into this promising therapeutic approach. In light of this, we argue for the creation of a new, dedicated European regulatory framework for bacteriophage therapy.


Assuntos
Antibacterianos/uso terapêutico , Infecções Bacterianas/terapia , Bacteriófagos/fisiologia , Terapia Biológica , Infecções Bacterianas/virologia , Terapia Biológica/tendências , Biotecnologia , Códigos de Ética/legislação & jurisprudência , Resistência a Medicamentos , União Europeia , Humanos
18.
Cell Tissue Bank ; 14(4): 525-60, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24052113

RESUMO

The transplantation of conventional human cell and tissue grafts, such as heart valve replacements and skin for severely burnt patients, has saved many lives over the last decades. The late eighties saw the emergence of tissue engineering with the focus on the development of biological substitutes that restore or improve tissue function. In the nineties, at the height of the tissue engineering hype, industry incited policymakers to create a European regulatory environment, which would facilitate the emergence of a strong single market for tissue engineered products and their starting materials (human cells and tissues). In this paper we analyze the elaboration process of this new European Union (EU) human cell and tissue product regulatory regime-i.e. the EU Cell and Tissue Directives (EUCTDs) and the Advanced Therapy Medicinal Product (ATMP) Regulation and evaluate its impact on Member States' health care systems. We demonstrate that the successful lobbying on key areas of regulatory and policy processes by industry, in congruence with Europe's risk aversion and urge to promote growth and jobs, led to excessively business oriented legislation. Expensive industry oriented requirements were introduced and contentious social and ethical issues were excluded. We found indications that this new EU safety and health legislation will adversely impact Member States' health care systems; since 30 December 2012 (the end of the ATMP transitional period) there is a clear threat to the sustainability of some lifesaving and established ATMPs that were provided by public health institutions and small and medium-sized enterprises under the frame of the EUCTDs. In the light of the current economic crisis it is not clear how social security systems will cope with the inflation of costs associated with this new regulatory regime and how priorities will be set with regard to reimbursement decisions. We argue that the ATMP Regulation should urgently be revised to focus on delivering affordable therapies to all who are in need of them and this without necessarily going to the market. The most rapid and elegant way to achieve this would be for the European Commission to publish an interpretative document on "placing on the market of ATMPs," which keeps tailor-made and niche ATMPs outside of the scope of the medicinal product regulation.


Assuntos
Transplante de Células/economia , Transplante de Células/legislação & jurisprudência , Comércio , Assistência à Saúde/legislação & jurisprudência , União Europeia , Legislação como Assunto , Transplantes/economia , Transplante de Células/ética , Assistência à Saúde/economia , Assistência à Saúde/ética , Indústria Farmacêutica/legislação & jurisprudência , Humanos , Legislação como Assunto/ética , Políticas
19.
J Emerg Trauma Shock ; 5(2): 178-80, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22787349

RESUMO

Assault chemical burns are uncommon in northern Europe. Besides local toxicity, systemic manifestations are possible after strong acid exposure. A 40-year-old woman was admitted 1 h after a criminal assault with sulfuric acid. The total burned surface area was 35%, third degree. Injury was due to sulfuric acid (measured pH 0.9) obtained from a car battery. Immediate complications were obstructive dyspnea and metabolic acidosis. The admission arterial pH was 6.92, with total bicarbonate 8.6 mEq/l and base deficit 23.4 mEq/l. The correction of metabolic acidosis was achieved after several hours by the administration of bicarbonate and lactate buffers. The patient developed several burns-related complications (sepsis and acute renal failure). Cutaneous projections of strong acids may cause severe metabolic acidosis, particularly when copious irrigation and clothes removal cannot be immediately performed at the scene.

20.
Cell Tissue Bank ; 13(3): 487-98, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22718427

RESUMO

With this analysis we would like to raise some issues that emerge as a result of recent evolutions in the burgeoning field of human cells, tissues, and cellular and tissue-based product (HCT/P) transplantation, and this in the light of the current EU regulatory framework. This paper is intended as an open letter addressed to the EU policy makers, who will be charged with the review and revision of the current legislation. We propose some urgent corrections or additions to cope with the rapid advances in biomedical science, an extensive commercialization of HCT/Ps, and the growing expectation of the general public regarding the ethical use of altruistically donated cells and tissues. Without a sound wake-up call, the diverging interests of this newly established 'healthcare' industry and the wellbeing of humanity will likely lead to totally unacceptable situations, like some of which we are reporting here.


Assuntos
Preparações Farmacêuticas/economia , Bancos de Tecidos/economia , Transplante Homólogo/economia , União Europeia , Humanos , Internacionalidade , Transferência de Tecnologia
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