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1.
Intensive Care Med ; 50(4): 493-501, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38526578

RESUMO

An implantable left ventricular assist device (LVAD) is indicated as a bridge to transplantation or recovery in the United Kingdom (UK). The mechanism of action of the LVAD results in a unique state of haemodynamic stability with diminished arterial pulsatility. The clinical assessment of an LVAD recipient can be challenging because non-invasive blood pressure, pulse and oxygen saturation measurements may be hard to obtain. As a result of this unusual situation and complex interplay between the device and the native circulation, resuscitation of LVAD recipients requires bespoke guidelines. Through collaboration with key UK stakeholders, we assessed the current evidence base and developed guidelines for the recognition of clinical deterioration, inadequate circulation and time-critical interventions. Such guidelines, intended for use in transplant centres, are designed to be deployed by those providing immediate care of LVAD patients under conditions of precipitous clinical deterioration. In summary, the Joint British Societies and Transplant Centres LVAD Working Group present the UK guideline on management of emergencies in implantable LVAD recipients for use in advanced heart failure centres. These recommendations have been made with a UK resuscitation focus but are widely applicable to professionals regularly managing patients with implantable LVADs.


Assuntos
Deterioração Clínica , Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Humanos , Emergências , Insuficiência Cardíaca/terapia
2.
JID Innov ; 1(4): 100045, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34909742

RESUMO

Cutaneous squamous cell carcinoma is the second most common skin cancer in the United States. Currently, there is no standardized management approach for patients with cutaneous squamous cell carcinoma who develop metastatic or locally advanced disease and are not candidates for curative surgery or curative radiation. To address this issue, the Expert Cutaneous Squamous Cell Carcinoma Leadership program convened an expert steering committee to develop evidence-based consensus recommendations on the basis of a large, structured literature review. Consensus was achieved through modified Delphi methodology. The steering committee included five dermatologists, three medical oncologists, two head and neck surgeons, one radiation oncologist, and a patient advocacy group representative. The steering committee aligned on the following clinical topics: diagnosis and identification of patients considered not candidates for surgery; staging systems and risk stratification in cutaneous squamous cell carcinoma; the role of radiation therapy, surgery, and systemic therapy in the management of advanced disease, with a focus on immunotherapy; referral patterns; survivorship care; and inclusion of the patient's perspective. Consensus was achieved on 34 recommendations addressing 12 key clinical questions. The Expert Cutaneous Squamous Cell Carcinoma Leadership steering committee's evidence-based consensus recommendations may provide healthcare professionals with practically oriented guidance to help optimize outcomes for patients with advanced cutaneous squamous cell carcinoma.

3.
J Cardiovasc Pharmacol Ther ; 24(4): 359-364, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30614246

RESUMO

AIMS: There are limited data on aspirin (ASA) desensitization for patients with coronary disease. We present our experience with a rapid nurse-led oral desensitization regimen in patients with aspirin sensitivity undergoing coronary angiography. METHODS: This single-center retrospective observational study includes patients with a history of ASA sensitivity undergoing coronary angiography with intent to perform percutaneous coronary intervention (PCI). RESULTS: Between January 2012 and January 2017, 24 patients undergoing coronary angiography for stable coronary disease (7 cases) or acute coronary syndromes (non-ST-segment myocardial infarction [NSTEMI; 8 cases], STEMI [9 cases]) underwent aspirin desensitization having reported previous reactions to aspirin. At initial presentation, previous sensitivity reactions were reported as: mucocutaneous reactions in 17 patients (urticaria in 3 [13%], nonurticarial rash in 6 [25%], angio-oedema in 8 [33%]), respiratory sensitivity in 4 (17%), and systemic anaphylactoid reactions in 3 (13%). Seventeen (71%) patients underwent PCI. Desensitization was acutely successful in 22 (92%) patients and unsuccessful in 2 (8%) patients who both had a single short-lived episode of acute bronchospasm treated successfully with nebulized salbutamol. Fifteen successfully desensitized patients completed 12 months of aspirin; no patient had recurrent hypersensitivity reaction. Aspirin was stopped prior to 12 months in 7 patients (replaced by warfarin [1 case], no antiplatelet or single antiplatelet clinically indicated and clopidogrel chosen [4 cases], patient choice without evidence of recurrent hypersensitivity [1 case], and death due to cardiogenic shock following STEMI [1 case]). CONCLUSION: A rapid aspirin desensitization protocol is safe and effective across a broad spectrum of hypersensitivity reactions and clinical presentations.


Assuntos
Síndrome Coronariana Aguda/terapia , Aspirina/administração & dosagem , Dessensibilização Imunológica , Hipersensibilidade a Drogas/prevenção & controle , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Síndrome Coronariana Aguda/diagnóstico por imagem , Idoso , Idoso de 80 Anos ou mais , Aspirina/efeitos adversos , Aspirina/imunologia , Dessensibilização Imunológica/efeitos adversos , Dessensibilização Imunológica/enfermagem , Hipersensibilidade a Drogas/diagnóstico , Hipersensibilidade a Drogas/imunologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/imunologia , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Fatores de Tempo , Resultado do Tratamento
4.
J Clin Aesthet Dermatol ; 11(9): 28-31, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30319728

RESUMO

Background: Ad-hoc reports within clinical studies of imiquimod for the treatment of actinic keratosis (AK) have suggested the drug can improve both skin texture and overall signs of photodamage. Objective: We sought to assess the efficacy and tolerability of imiquimod 3.75% and 2.5% cream for the treatment of photodamage in patients with AK of the full face or balding scalp. Methods: A meta-analysis of four identical multicenter, randomized, double-blind, vehicle-controlled studies was conducted. The studies included a total of 969 adult subjects (aged 33-91 years) with 5 to 20 visible lesions or palpable AKs in an area exceeding 25cm2 on either the face or balding scalp. Patients were randomized to imiquimod 3.75%, imiquimod 2.5%, or vehicle cream (1:1:1). Up to two packets (250mg each) were applied per dose once daily for two two-week treatment cycles, separated by a two-week no-treatment interval. Photodamage improvement was assessed at study end based on subjects' baseline assessments using a seven-point scale. Local skin reactions were recorded throughout the study. Results: Combined Investigator's Global Integrated Photodamage (IGIP) score was "significantly" or "much" improved in 57.6 percent (n=175) of patients treated with imiquimod 2.5% cream and in 69.6 percent (n=208) of patients treated with imiquimod 3.75% cream versus in 25.7 percent (n=76) of patients treated with the vehicle. Mean IGIP scores at end of study were 1.67, 1.98, and 0.73, respectively (both actives P<0.0001 versus vehicle). Conclusion: Both imiquimod 2.5% and 3.75% creams showed a positive effect on photodamage when compared with the vehicle cream.

5.
Coron Artery Dis ; 29(7): 564-572, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29944476

RESUMO

BACKGROUND: The PRAMI and CvLPRIT trials support preventive percutaneous coronary intervention (PCI) for multivessel coronary disease found during ST-segment elevation myocardial infarction (STEMI). We assess our real-world experience of the management of multivessel disease identified during primary PCI (PPCI) in a large UK regional centre. PATIENTS AND METHODS: All STEMI patients who underwent culprit-only PPCI during the study period (August 2011 to August 2013) were retrospectively assessed for eligibility to each trial. The two resulting groups were designated as the 'observational' cohorts. Primary outcomes were then determined and compared with the culprit-only revascularisation cohorts from the respective published randomized controlled trials (RCTs). RESULTS: A total of 1143 consecutive cases were presented during the study period. Of these, 343 would have been suitable for inclusion to PRAMI and were included in the 'observational PRAMI' cohort; 196 patients were included in the 'observational CvLPRIT' cohort.The 'observational PRAMI' cohort experienced fewer primary outcome events (13.1 vs. 22.9%), cardiac deaths (0.6 vs. 4.3%) and nonfatal myocardial infarctions (3.5 vs. 8.7%) than the culprit-only PCI PRAMI cohort (n=231); there were significantly more diabetics (P=0.022) and anterior STEMI initial presentations in the culprit-only PCI PRAMI cohort. Primary outcomes were comparable to those of the preventive PCI PRAMI cohort.The 'observational CvLPRIT' cohort showed no significant difference in primary outcomes over 12 months (16.8 vs. 21.2%), but significantly lower all-cause mortality (2 vs. 6.9%) than the culprit-only PCI CvPLRIT cohort (n=146). The 30-day event rates were similar to the preventive PCI arm; the 12-month events were better than the nonpreventive, but not as good as the preventive RCT cohorts. CONCLUSION: Outcomes from culprit-only primary PCI for multivessel disease in patients selected by the RCT criteria from an all-comers population representing real-life experience are better than those published in the two main RCTs. The RCTs may have selected a high-risk population for study exaggerating the benefits of preventive PCI.


Assuntos
Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Fatores de Tempo , Resultado do Tratamento
6.
J Drugs Dermatol ; 16(5): 438-444, 2017 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-28628679

RESUMO

Background: Actinic keratosis (AK) can affect large skin areas. Ingenol mebutate (IngMeb) gel (0.015% and 0.05%) is approved for topical treatment of AK in a single contiguous area of ~25 cm2.

Objective: The study sought to determine the maximum tolerated dose (MTD), efficacy, and tolerability of IngMeb applied to AK on a contiguous area less than equal to 250 cm2.

Methods: Part 1 determined the MTD of IngMeb at 7 concentrations for 2 or 3 days. Part 2 assessed efficacy and tolerability at the MTD and one dose lower for 2 or 3 days vs vehicle.

Results: Four dosing regimens with an acceptable benefit-to-risk ratio were identified: 0.018% and 0.027% once daily for 2 or 3 days. Complete clearance at 8 weeks was achieved by 21.3% to 39.1% of IngMeb-treated patients vs 0% to 3.2% treated with vehicle. Composite local skin response scores peaked on the day after the last application, rapidly declined, and were near baseline at 2 weeks. Adverse events were predominantly mild or moderate.

Limitations: The study evaluated a limited number of doses in a population of only white patients.

Conclusion: IngMeb gel was effective and well tolerated as field treatment of AK on the full face, full scalp, and up to 250 cm2 on the chest.

J Drugs Dermatol. 2017;16(5):438-444.

.


Assuntos
Diterpenos/administração & dosagem , Diterpenos/efeitos adversos , Face , Ceratose Actínica/tratamento farmacológico , Couro Cabeludo/efeitos dos fármacos , Tórax/efeitos dos fármacos , Administração Tópica , Idoso , Relação Dose-Resposta a Droga , Face/patologia , Feminino , Humanos , Ceratose Actínica/diagnóstico , Masculino , Pessoa de Meia-Idade , Dor/induzido quimicamente , Prurido/induzido quimicamente , Couro Cabeludo/patologia , Tórax/patologia , Resultado do Tratamento
8.
Sci Total Environ ; 511: 489-500, 2015 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-25576792

RESUMO

We examined mercury (Hg) speciation in water and sediment of the Great Salt Lake and surrounding wetlands, a locale spanning fresh to hypersaline and oxic to anoxic conditions, in order to test the hypothesis that spatial and temporal variations in Hg concentration and methylation rates correspond to observed spatial and temporal trends in Hg burdens previously reported in biota. Water column, sediment, and pore water concentrations of methylmercury (MeHg) and total mercury (THg), as well as related aquatic chemical parameters were examined. Inorganic Hg(II)-methylation rates were determined in selected water column and sediment subsamples spiked with inorganic divalent mercury (204Hg(II)). Net production of Me204Hg was expressed as apparent first-order rate constants for methylation (kmeth), which were also expanded to MeHg production potential (MPP) rates via combination with tin reducible 'reactive' Hg(II) (Hg(II)R) as a proxy for bioavailable Hg(II). Notable findings include: 1) elevated Hg concentrations previously reported in birds and brine flies were spatially proximal to the measured highest MeHg concentrations, the latter occurring in the anoxic deep brine layer (DBL) of the Great Salt Lake; 2) timing of reduced Hg(II)-methylation rates in the DBL (according to both kmeth and MPP) coincides with reduced Hg burdens among aquatic invertebrates (brine shrimp and brine flies) that act as potential vectors of Hg propagation to the terrestrial ecosystem; 3) values of kmeth were found to fall within the range reported by other studies; and 4) MPP rates were on the lower end of the range reported in methodologically comparable studies, suggesting the possibility that elevated MeHg in the anoxic deep brine layer results from its accumulation and persistence in this quasi-isolated environment, due to the absence of light (restricting abiotic photo demethylation) and/or minimal microbiological demethylation.


Assuntos
Monitoramento Ambiental , Lagos/química , Compostos de Metilmercúrio/análise , Poluentes Químicos da Água/análise , Metilação , Salinidade , Utah
10.
J Drugs Dermatol ; 13(6): 741-7, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24918567

RESUMO

INTRODUCTION: Recurrence rates of actinic keratosis (AK) lesions after cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery. METHODS: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients ≥18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. RESULTS: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P =.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P =.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. CONCLUSIONS: Field treatment with ingenol mebutate 0.015% gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following cryosurgery reduced development of new lesions in the treated field.


Assuntos
Fármacos Dermatológicos/uso terapêutico , Diterpenos/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Criocirurgia/métodos , Fármacos Dermatológicos/efeitos adversos , Diterpenos/efeitos adversos , Método Duplo-Cego , Feminino , Seguimentos , Géis , Humanos , Ceratose Actínica/patologia , Ceratose Actínica/cirurgia , Masculino , Pessoa de Meia-Idade
11.
J Drugs Dermatol ; 13(2): 154-60, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24509965

RESUMO

INTRODUCTION: Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions. METHODS: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus cryosurgery followed by vehicle. RESULTS: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after cryosurgery. Treatment after cryosurgery was well tolerated. CONCLUSIONS: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone.


Assuntos
Fármacos Dermatológicos/uso terapêutico , Diterpenos/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Administração Cutânea , Idoso , Terapia Combinada , Criocirurgia/métodos , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Diterpenos/administração & dosagem , Diterpenos/efeitos adversos , Método Duplo-Cego , Face , Feminino , Seguimentos , Géis , Humanos , Ceratose Actínica/patologia , Ceratose Actínica/cirurgia , Masculino , Couro Cabeludo , Resultado do Tratamento
12.
J Drugs Dermatol ; 13(2): 166-9, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24509967

RESUMO

BACKGROUND: Imiquimod 3.75% and 2.5% creams were studied for the treatment of actinic keratosis (AK) of the full face or balding scalp, to determine comparable efficacy and tolerability to imiquimod 5% cream. METHODS: In two identical multicenter, randomized, double-blind, placebo controlled studies. Adult subjects with 5 to 20 visible lesions, or palpable AKs in an area that exceeded 25 cm² on either the face or balding scalp were randomized to imiquimod 3.75%, 2.5% or vehicle cream (1:1:1) applied once daily for two 2-week treatment cycles, with a 2-week, no-treatment interval between cycles. Efficacy was assessed 8 weeks posttreatment (End of Study Visit [EOS]). Primary efficacy was rate of complete clearance of AK lesions. Secondary efficacy endpoints were rate of partial clearance at EOS (≥ 75% reduction in number of AK lesions compared to baseline) and median percent decrease from baseline lesion count. Safety assessments included visual assessment of local skin reactions (LSRs), number and duration of study treatment rest periods required due to intolerant LSRs, adverse events (AEs) and clinical laboratory tests. RESULTS: Overall 479 patients were randomized to imiquimod 3.75%, 2.5%, or vehicle. Complete clearance rates were 35.6%, 30.6%, and 6.3% respectively (both P<.001 versus vehicle). The difference in complete clearance rates (imiquimod minus vehicle) was 29.3% and 24.3%, respectively. Partial clearance rates were 59.4%, 48.1%, and 22.6% respectively (both P<.001 versus vehicle). Median % reductions in AK lesions were 81.8%, 71.8%, and 25.0% respectively (P<.001 versus vehicle). All primary and secondary efficacy endpoints were greater in Study 1. Photodamage in the treatment area was 'much improved' with imiquimod 3.75%. Both active creams were well tolerated with few treatment-related discontinuations. CONCLUSIONS: In two well-controlled Phase 3 studies, both imiquimod 3.75% and 2.5% creams were more effective than vehicle and well tolerated when administered daily as a 2-week on/off/on regimen to treat AK. Reduction in AK lesions was comparable to that reported with imiquimod 5% with fewer local AEs.


Assuntos
Adjuvantes Imunológicos/uso terapêutico , Aminoquinolinas/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Adjuvantes Imunológicos/administração & dosagem , Adulto , Aminoquinolinas/administração & dosagem , Aminoquinolinas/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Face , Feminino , Humanos , Imiquimode , Ceratose Actínica/patologia , Masculino , Pessoa de Meia-Idade , Couro Cabeludo , Envelhecimento da Pele/efeitos dos fármacos , Resultado do Tratamento
13.
J Drugs Dermatol ; 12(11): 1278-82, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24196337

RESUMO

BACKGROUND: Imiquimod 3.75% and 2.5% creams were studied for the treatment of actinic keratosis (AK) of the full face or balding scalp, to determine comparable efficacy and tolerability to imiquimod 5% cream. METHODS: In two identical multicenter, randomized, double-blind, placebo controlled studies. Adult subjects with 5 to 20 visible lesions, or palpable AKs in an area that exceeded 25 cm² on either the face or balding scalp were randomized to imiquimod 3.75%, 2.5% or vehicle cream (1:1:1) applied once daily for two 2-week treatment cycles, with a 2-week, no-treatment interval between cycles. Efficacy was assessed 8 weeks posttreatment (End of Study Visit [EOS]). Primary efficacy was rate of complete clearance of AK lesions. Secondary efficacy endpoints were rate of partial clearance at EOS (≥ 75% reduction in number of AK lesions compared to baseline) and median percent decrease from baseline lesion count. Safety assessments included visual assessment of local skin reactions (LSRs), number and duration of study treatment rest periods required due to intolerant LSRs, adverse events (AEs) and clinical laboratory tests. RESULTS: Overall 479 patients were randomized to imiquimod 3.75%, 2.5%, or vehicle. Complete clearance rates were 35.6%, 30.6%, and 6.3% respectively (both P<.001 versus vehicle). The difference in complete clearance rates (imiquimod minus vehicle) was 29.3% and 24.3%, respectively. Partial clearance rates were 59.4%, 48.1%, and 22.6% respectively (both P<.001 versus vehicle). Median % reductions in AK lesions were 81.8%, 71.8%, and 25.0% respectively (-<.001 versus vehicle). All primary and secondary efficacy endpoints were greater in Study 1. Photodamage in the treatment area was 'much improved' with imiquimod 3.75%. Both active creams were well tolerated with few treatment-related discontinuations. CONCLUSIONS: In two well-controlled Phase 3 studies, both imiquimod 3.75% and 2.5% creams were more effective than vehicle and well tolerated when administered daily as a 2-week on/off/on regimen to treat AK. Reduction in AK lesions was comparable to that reported with imiquimod 5% with fewer local AEs.


Assuntos
Adjuvantes Imunológicos/uso terapêutico , Aminoquinolinas/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/efeitos adversos , Administração Cutânea , Idoso , Aminoquinolinas/administração & dosagem , Aminoquinolinas/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Face , Feminino , Humanos , Imiquimode , Ceratose Actínica/patologia , Masculino , Pessoa de Meia-Idade , Couro Cabeludo , Resultado do Tratamento
15.
J Am Acad Dermatol ; 68(1 Suppl 1): S39-48, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23228305

RESUMO

Actinic keratosis (AK) is a common ultraviolet light-induced skin lesion found on sun-exposed skin areas generally in older, fair-skinned people. It is part of a disease continuum observed in photodamaged skin that may lead to invasive squamous cell carcinoma. The presence of AK is associated with an increased risk of all skin cancers, as it is visible evidence of the carcinogenic effects of cumulative ultraviolet exposure. AKs are treated with lesion- and field-directed methods. Field-directed methods treat both the visible and subclinical lesions present in photodamaged skin, but treatment regimens are often lengthy and associated with poor tolerability because of vigorous local inflammatory reactions. Ingenol mebutate gel was recently approved by the Food and Drug Administration for topical treatment of AK. It induces cell death preferentially in transformed keratinocytes and promotes an inflammatory response that kills remaining tumor cells. In human studies, ingenol mebutate achieved high clearance rates of AK on the trunk or extremities and face or scalp after once-daily application for 2 or 3 consecutive daily treatments, when measured by complete or partial clearance of lesions. The localized inflammatory skin responses were generally mild to moderate and resolved in approximately 2 weeks on the face or scalp and 4 weeks on the trunk or extremities.


Assuntos
Diterpenos/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Idoso , Ensaios Clínicos como Assunto , Feminino , Humanos , Queratinócitos/patologia , Masculino , Pele/patologia , Neoplasias Cutâneas/patologia
16.
J Biomed Opt ; 17(6): 066018, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22734774

RESUMO

For rapid, intra-operative pathological margin assessment to guide staged cancer excisions, multimodal confocal mosaic scan image wide surgical margins (approximately 1 cm) with sub-cellular resolution and mimic the appearance of conventional hematoxylin and eosin histopathology (H&E). The goal of this work is to combine three confocal imaging modes: acridine orange fluorescence (AO) for labeling nuclei, eosin fluorescence (Eo) for labeling cytoplasm, and endogenous reflectance (R) for marking collagen and keratin. Absorption contrast is achieved by alternating the excitation wavelength: 488 nm (AO fluorescence) and 532 nm (Eo fluorescence). Superposition and false-coloring of these modes mimics H&E, enabling detection of cutaneous squamous cell carcinomas (SCC). The sum of mosaic Eo+R is false-colored pink to mimic the appearance of eosin, while the AO mosaic is false-colored purple to mimic the appearance of hematoxylin in H&E. In this study, mosaics of 10 Mohs surgical excisions containing invasive SCC, and five containing only normal tissue were subdivided for digital presentation equivalent to 4 × histology. Of the total 50 SCC and 25 normal sub-mosaics presented, two reviewers made two and three type-2 errors (false positives), respectively. Limitations to precisely mimic H&E included occasional elastin staining by AO. These results suggest that confocal mosaics may effectively guide staged SCC excisions in skin and other tissues.


Assuntos
Carcinoma de Células Escamosas/patologia , Microscopia Confocal/métodos , Cirurgia de Mohs/métodos , Neoplasias Cutâneas/patologia , Absorção , Laranja de Acridina/farmacologia , Artefatos , Carcinoma Basocelular/patologia , Colágeno/química , Citoplasma/metabolismo , Amarelo de Eosina-(YS)/química , Reações Falso-Positivas , Humanos , Queratinas/química , Invasividade Neoplásica , Reprodutibilidade dos Testes , Pele/patologia
18.
N Engl J Med ; 366(11): 1010-9, 2012 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-22417254

RESUMO

BACKGROUND: Actinic keratosis is a common precursor to sun-related squamous-cell carcinoma. Treating actinic keratoses and the surrounding skin area (i.e., field therapy) can eradicate clinical and subclinical actinic keratoses. Topical field therapy currently requires weeks or months of treatment. We investigated the efficacy and safety of a new topical field therapy for actinic keratosis, ingenol mebutate gel (0.015% for face and scalp and 0.05% for trunk and extremities). METHODS: In four multicenter, randomized, double-blind studies, we randomly assigned patients with actinic keratoses on the face or scalp or on the trunk or extremities to receive ingenol mebutate or placebo (vehicle), self-applied to a 25-cm(2) contiguous field once daily for 3 consecutive days for lesions on the face or scalp or for 2 consecutive days for the trunk or extremities. Complete clearance (primary outcome) was assessed at 57 days, and local reactions were quantitatively measured. RESULTS: In a pooled analysis of the two trials involving the face and scalp, the rate of complete clearance was higher with ingenol mebutate than with placebo (42.2% vs. 3.7%, P<0.001). Local reactions peaked at day 4, with a mean maximum composite score of 9.1 on the local-skin-response scale (which ranges from 0 to 4 for six types of reaction, yielding a composite score of 0 to 24, with higher numbers indicating more severe reactions), rapidly decreased by day 8, and continued to decrease, approaching baseline scores by day 29. In a pooled analysis of the two trials involving the trunk and extremities, the rate of complete clearance was also higher with ingenol mebutate than with placebo (34.1% vs. 4.7%, P<0.001). Local skin reactions peaked between days 3 and 8 and declined rapidly, approaching baseline by day 29, with a mean maximum score of 6.8. Adverse events were generally mild to moderate in intensity and resolved without sequelae. CONCLUSIONS: Ingenol mebutate gel applied topically for 2 to 3 days is effective for field treatment of actinic keratoses. (Funded by LEO Pharma; ClinicalTrials.gov numbers, NCT00742391, NCT00916006, NCT00915551, and NCT00942604.).


Assuntos
Fármacos Dermatológicos/uso terapêutico , Diterpenos/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Idoso , Fármacos Dermatológicos/efeitos adversos , Diterpenos/efeitos adversos , Extremidades/patologia , Dermatoses Faciais/tratamento farmacológico , Dermatoses Faciais/patologia , Feminino , Humanos , Ceratose Actínica/patologia , Masculino , Pessoa de Meia-Idade , Dermatoses do Couro Cabeludo/tratamento farmacológico , Dermatoses do Couro Cabeludo/patologia , Pele/patologia , Tórax/patologia , Resultado do Tratamento
19.
J Drugs Dermatol ; 10(2): 165-70, 2011 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21283921

RESUMO

OBJECTIVE: Assess long-term, sustained, complete clearance of actinic keratoses after treatment with imiquimod 3.75% or 2.5% cream using two two-week or three-week cycles of daily dosing. METHODS: Adults with five to 20 baseline actinic keratoses who achieved complete clearance at the eight-week post-treatment visit in four phase 3 placebo-controlled treatment studies were followed for an additional 12 months. RESULTS: For imiquimod 3.75% and 2.5% cream, respectively, complete clearance was sustained for 12 months in 17/42 (40.5%) and 13/39 (33.3%) subjects from the two-week cycle studies, and in 23/48 (47.9%) and 16/37 (43.2%) subjects from the three-week cycle studies. There were no safety concerns during the follow-up. CONCLUSION: In subjects with a median of eight to nine baseline actinic keratoses who achieved complete clearance after treatment of the full face or balding scalp with topical imiquimod 3.75% cream, complete clearance of all lesions (baseline, recurrent or new) was sustained in ≥ 40 percent of subjects for at least 14 months after the last dose. Clinicaltrials.gov identifier NCT00668733.


Assuntos
Aminoquinolinas/administração & dosagem , Ceratose Actínica/tratamento farmacológico , Adulto , Aminoquinolinas/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Face , Humanos , Imiquimode , Masculino , Couro Cabeludo , Fatores de Tempo , Resultado do Tratamento
20.
N Z Med J ; 123(1309): 18-25, 2010 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-20186239

RESUMO

AIMS: Primary angioplasty is superior to thrombolysis in ST elevation myocardial infarction (STEMI). This advantage is dependent on how quickly angioplasty can be performed. Several strategies have been suggested to cut door to balloon (D2B) times. We aimed to audit and reorganise the admission process to accelerate D2B times, in Waikato Hospital, New Zealand. METHODS: The admission process for STEMI was audited. Three changes were made. One step in the catheterisation lab activation system (referral to cardiology registrar on call) was removed. Single call pager activation of the catheterisation lab team was adopted. Feedback of timing performance data by email and printout was established. Timing data were collected for 6 months before and after these changes. RESULTS: After the admission process was changed 88.5% of patients had a D2B time <90 min vs 63.6% before. Median D2B times were reduced from 74.5 min to 59 min (p=0.09). Median time from admission to arrival at cath lab was reduced from 50 min to 35 min (p=0.019). CONCLUSIONS: Relatively minor changes in admission process, without new resources, can lead to reductions in door to balloon times. This was achieved in a hospital with a selective PPCI policy and modest annual volume of PPCI.


Assuntos
Angioplastia Coronária com Balão , Protocolos Clínicos , Infarto do Miocárdio/terapia , Admissão do Paciente , Retroalimentação , Feminino , Humanos , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Nova Zelândia , Fatores de Tempo
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