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2.
Radiography (Lond) ; 24(4): 298-303, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-30292497

RESUMEN

INTRODUCTION: A study was proposed to examine the impact to patients and the Oncology review team, of extending the role of the Therapeutic Radiographer to undertake follow up review of prostate cancer patients who have completed a radical course of external beam radiotherapy treatment. METHOD: A total of 30 patients attending for routine radiotherapy follow up were included in an observational study. Patients were assigned for review with a Doctor or a Therapeutic Radiographer using 1:1 randomisation and a number of time points were recorded and analysed. RESULTS: Of the 44 patients screened, 30 patients were recruited. Average time from scheduled appointment time to departure from clinic was 36 min for both the doctor and Therapeutic Radiographer. The average length of Consultation was 19 min for the Therapeutic Radiographer and 10 min for the Doctor. Average length of wait for patients from scheduled appointment time to being taken for review was 17 min for the Therapeutic Radiographer and 25 min for the Doctor. Of the patients who completed questionnaires, 23/28 had no preference of reviewer, 2/28 declared a preference to be seen by a doctor, whilst 3/28 stated a preference for review with a Therapeutic Radiographer. CONCLUSION: The results of the study are encouraging and should be further investigated in an attempt of developing what would be a very rewarding aspect of the Therapeutic Radiographers role.


Asunto(s)
Cuidados Posteriores/métodos , Técnicos Medios en Salud , Neoplasias de la Próstata/radioterapia , Radiografía/métodos , Adulto , Técnicos Medios en Salud/organización & administración , Humanos , Masculino , Satisfacción del Paciente , Rol Profesional , Estudios Prospectivos , Encuestas y Cuestionarios
3.
Lab Anim ; 45(4): 219-24, 2011 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-21558168

RESUMEN

The severity classification of procedures using animals is an important tool to help focus the implementation of refinement and to assist in reporting the application of the 3Rs (replacement, reduction and refinement). The recently revised Directive that regulates animal research and testing within the European Union requires Member States to ensure that all procedures are classified as 'non-recovery', 'mild', 'moderate' or 'severe', using assignment criteria set out by the European Commission (EC). However, these are focused upon terrestrial species, so are of limited relevance to fish users. A Working Group set up by the Norwegian Consensus-Platform for the 3Rs (Norecopa) has produced guidance on the classification of severity in scientific procedures involving fish, including examples of 'subthreshold', 'mild', 'moderate', 'severe' and 'upper threshold' procedures. The aims are to complement the EC guidelines and help to ensure that suffering in fish is effectively predicted and minimized. Norecopa has established a website (www.norecopa.no/categories) where more information on severity classification for procedures using fish, including field research, will be made available.


Asunto(s)
Experimentación Animal/normas , Bienestar del Animal , Peces , Investigación/clasificación , Animales , Guías como Asunto , Noruega
4.
Lett Appl Microbiol ; 52(3): 227-32, 2011 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21294758

RESUMEN

AIM: To assess the effect of several commercial essential oils samples Australian lemon myrtle (Backhousia citriodora), cinnamon bark (Cinnamomum zeylanicum), oregano (Origanum vulgare), thyme oil (Thymus vulgaris), clove bud (Eugenia caryophyllata), valerian (Valeriana officinalis) and Australian tea tree oil (Melaleuca alternifolia) on mycelium growth and spore germination of Monilinia fructicola. The effectiveness of lemon myrtle essential oil as a fumigant for the control of brown rot in nectarines was evaluated. METHODS AND RESULTS: Monilinia fructicola exhibited a different level of sensitivity to each tested essential oil with results suggesting that the essential oils provide excellent control of the pathogen with respect to mycelium growth and spore germination at very low concentrations, whereas for others higher concentrations are needed to reduce significant fungal growth. In vivo application of lemon myrtle essential oil effectively reduced the incidence of M. fructicola on noninoculated fruit. Fumigation of nectarines following inoculation did not reduce the incidence of brown rot in comparison with the inoculated control treatment. No evidence of phytotoxicity on the fruit was recorded. CONCLUSIONS: Lemon myrtle essential oil exhibited the strongest antifungal activity against M. fructicola, in vitro and to a lesser extent, under in vivo conditions. SIGNIFICANCE AND IMPACT OF THE STUDY: The results demonstrate that lemon myrtle essential oil, in particular, has potential as an antifungal agent to control M. fructicola.


Asunto(s)
Ascomicetos/efectos de los fármacos , Fungicidas Industriales/farmacología , Aceites Volátiles/farmacología , Aceites de Plantas/farmacología , Ascomicetos/crecimiento & desarrollo , Australia , Cinnamomum zeylanicum/química , Citrus/microbiología , Frutas/microbiología , Fumigación , Micelio/efectos de los fármacos , Micelio/crecimiento & desarrollo , Origanum/química , Esporas Fúngicas/efectos de los fármacos , Esporas Fúngicas/crecimiento & desarrollo , Syzygium/química , Thymus (Planta)/química
5.
Arch Gerontol Geriatr ; 52(2): 211-6, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-20416959

RESUMEN

We examined the long-term effects of a multi-component exercise program on balance, mobility and exercise behavior. The benefits of a community-based resistance and flexibility exercise intervention in a group of healthy older (60-75 years) individuals were recorded 12 months after completion of the randomized control intervention. Differences between those participants who continued to exercise and those who discontinued were investigated. Significant improvements from baseline in sit to stand (p<0.001), timed up and go (p=0.001), and sway (p<0.001) remained at follow up in the exercise intervention group, with a control group unchanged. Participants who continued exercising had significantly greater improvements in strength immediately after the intervention, compared to those who discontinued (p=0.004). Those who continued regular resistance training performed better in the step test at 12-month follow up (p=0.009) and believed that the program was of more benefit to their physical activity (p<0.001) than those who discontinued exercising. Benefits to balance and mobility persist 1 year after participation in a multi-component exercise program, due in part to some continuing participation in resistance training. Motivation to continue resistance training may be related real and perceived benefits attained from the intervention as well as the environmental context of the intervention.


Asunto(s)
Envejecimiento/fisiología , Terapia por Ejercicio , Ejercicio Físico/fisiología , Equilibrio Postural/fisiología , Entrenamiento de Fuerza , Anciano , Femenino , Humanos , Masculino , Motivación , Aptitud Física , Rango del Movimiento Articular , Caminata
6.
Heart ; 95(19): 1612-8, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19596690

RESUMEN

OBJECTIVE: To examine the safety and efficacy of emergency transradial primary percutaneous coronary intervention for ST-elevation myocardial infarction. DESIGN: Single-centre observational study with prospective data collection. SETTING: A regional cardiac centre, United Kingdom. PATIENTS: 1051 consecutive patients admitted with ST-elevation myocardial infarction, without cardiogenic shock, between November 2004 and October 2008. INTERVENTIONS: Percutaneous coronary interventions by radial and femoral access MAIN OUTCOME MEASURES: The primary outcome measures were procedural success, major vascular complication and failed initial access strategy. Secondary outcomes were in-hospital mortality and major adverse cardiac and cerebrovascular events, needle-to-balloon times, contrast volume used, radiation dose absorbed and time to discharge. Multiple regression analysis was used to adjust for potential differences between the groups. RESULTS: 571 patients underwent radial access and 480 femoral. A variable preference for radial access was observed among the lead operators (between 21% and 90%). Procedural success was similar between the radial and femoral groups, but major vascular complications were more frequent at the site of femoral access (0% radial versus 1.9% femoral, p = 0.001). Failure of the initial access strategy was more frequent in the radial group (7.7% versus 0.6%, p<0.001). Adjustment for other procedural and clinical predictors did not alter these findings. Needle-to-balloon time, as a measure of procedural efficiency, was equal for radial and femoral groups. CONCLUSIONS: In the setting of acute ST-elevation myocardial infarction without cardiogenic shock, transradial primary angioplasty is safe, with comparable outcomes to a femoral approach and a lower risk of vascular complications.


Asunto(s)
Angioplastia Coronaria con Balón/métodos , Infarto del Miocardio/terapia , Angioplastia Coronaria con Balón/efectos adversos , Angiografía Coronaria , Femenino , Arteria Femoral , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Arteria Radial , Resultado del Tratamiento
7.
Heart ; 95(5): 410-5, 2009 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-18977799

RESUMEN

BACKGROUND: The transradial approach for percutaneous coronary procedures has the advantage of reduced access site complications but is associated with specific technical challenges in comparison with the transfemoral approach. Transradial procedure failures can sometimes be due to variation in radial artery anatomy. However, data describing such variations are limited. OBJECTIVE: To evaluate the incidence and impact of radial artery anomalies in patients undergoing transradial coronary procedures. METHODS: Retrograde radial arteriography was performed in all patients presenting for a first-time radial procedure. Patient characteristics, radial artery anatomy and procedural outcome were assessed. RESULTS: 1540 consecutive patients were studied, 70.6% male, mean (SD) age 63.6 (11.1) years. The overall incidence of radial artery anomaly was 13.8% (n = 212). 108 (7.0%) patients had a high-bifurcating radial origin, 35 (2.3%) had a full radial loop, 30 (2.0%) had extreme radial artery tortuosity and 39 (2.5%) had miscellaneous anomalies such as radial atherosclerosis and accessory branches. Overall transradial procedural success was 96.8%. Procedural failure was more common in patients with anomalous anatomy than in patients with normal anatomy (14.2% vs 0.9%, p<0.001). Procedural failure in patients with high radial bifurcation, radial loop, severe radial tortuosity and other anomalies was 4.6%, 37.1%, 23.3% and 12.9%, respectively. 15 (1%) vascular complications occurred, all of which were treated conservatively without ischaemic sequelae. CONCLUSION: Anomalous radial artery anatomy is relatively common and is a significant cause of procedural failure. Within each specific anomalous pattern there is a differential procedural failure rate. This has implications for clinical practice and suggests a need for imaging of the radial artery after sheath insertion.


Asunto(s)
Angioplastia Coronaria con Balón/métodos , Arteria Radial/anomalías , Adulto , Anciano , Anciano de 80 o más Años , Angiografía/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Arteria Radial/diagnóstico por imagen , Resultado del Tratamiento , Adulto Joven
8.
Pharmacogenomics J ; 8(6): 365-74, 2008 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18332899

RESUMEN

The hypersensitivity (HSR) to abacavir (ABC) pharmacogenetics (PGx) program represents the progression from an exploratory discovery to a validated biomarker. Within the program, two retrospective PGx studies were conducted to identify HIV-1 patients at increased risk for ABC HSR, a treatment-limiting and potentially life-threatening adverse event. A strong statistical association between the major histocompatibility complex allele, HLA-B*5701, and clinically diagnosed ABC HSR was identified but varied between racial populations. Subsequently, ABC skin patch testing was introduced as a research tool to supplement clinical case ascertainment. In a randomized, prospective study evaluating the clinical utility of HLA-B*5701 screening, avoidance of ABC in HLA-B*5701-positive patients significantly reduced clinically diagnosed ABC HSR and eliminated patch test-positive ABC HSR. Finally, a retrospective PGx study supports the generalizability of the association across races. Prospective HLA-B*5701 screening should greatly reduce the incidence of ABC HSR by identifying patients at high risk for ABC HSR before they are treated.


Asunto(s)
Didesoxinucleósidos/efectos adversos , Hipersensibilidad a las Drogas/genética , Farmacogenética , Inhibidores de la Transcriptasa Inversa/efectos adversos , Antígenos HLA-B/genética , Humanos , Pruebas del Parche
9.
J Hum Nutr Diet ; 17(4): 337-49, 2004 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-15250843

RESUMEN

AIM: To update dietetic guidelines summarizing the systematic review evidence on dietary advice to prevent further events in people with existing cardiovascular disease (CVD) (secondary prevention). METHODS: The Cochrane Library, MEDLINE and EMBASE were comprehensively searched to November 2002 for systematic reviews on aspects of diet and heart health. Reviews were included if they searched systematically for randomised controlled trials relating to diet and secondary prevention of CVD. Two members of the UK Heart Health and Thoracic Dietitians Group critically appraised each review. The quality and results of each review were discussed and summarized in a meeting of the whole group. RESULTS: Providing evidence-based dietary information (including increasing omega-3 fat intake) to all people who have had a myocardial infarction will save more lives than concentrating dietary advice on just those in need of weight loss or lipid lowering. The practice of prioritizing dietetic time in secondary prevention to those with raised lipids is out of date since the advent of statin therapy. However, effective dietary advice for those with angina, stroke, peripheral vascular disease or heart failure is less clear. CONCLUSION: There is good systematic review evidence that dietary advice to those with coronary heart disease can reduce mortality and morbidity as well as modify some risk factors. Dietary advice that does this most effectively should be prioritized.


Asunto(s)
Enfermedades Cardiovasculares/dietoterapia , Enfermedades Cardiovasculares/prevención & control , Dietética , Medicina Basada en la Evidencia , Humanos , Guías de Práctica Clínica como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Reino Unido
10.
Clin Ther ; 23(10): 1603-14, 2001 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-11726000

RESUMEN

BACKGROUND: Hypersensitivity reactions consist of a variable group of clinical findings and have been described for a wide variety of chemical compounds. OBJECTIVE: This review characterizes the clinical profile of hypersensitivity to the nucleoside reverse transcriptase inhibitor abacavir sulfate. METHODS: We performed a retrospective medical review of pooled adverse events data from approximately 200,000 patients who received abacavir in clinical trials, through expanded-access programs, or by prescription from 1996 through 2000. Screened cases of hypersensitivity were classified as either definitive or probable. Definitive cases were identified when initial symptoms resolved on interruption of abacavir therapy and returned on reintroduction of abacavir therapy. RESULTS: A total of 1803 cases were identified, 1302 in the 30,595 patients participating in clinical trials or the expanded-access program and 501 in patients from the post-marketing experience. On review, 176 (9.8%) of these cases were considered definitive and the remainder probable. Based on the 1302 cases identified in clinical trials or the expanded-access program, the calculated incidence of hypersensitivity was 4.3%. Symptoms reported in > or = 20% of cases of this multiorgan reaction included fever, rash, malaise/fatigue, and gastrointestinal symptoms such as nausea, vomiting, and diarrhea, among others. Respiratory symptoms occurred in 30% of cases and included dyspnea (12%), cough (10%), and pharyngitis (6%). In 90% of cases, hypersensitivity reactions occurred within the first 6 weeks after initiation of abacavir (median time, 11 days); after an initial reaction, rechallenge with abacavir resulted in the reappearance of symptoms within hours of reexposure. Hypotension was present in 25% of these rechallenge reactions. Among patients who received abacavir in clinical trials, the mortality rate was 0.03% (3 per 10,000 patients). CONCLUSIONS: Hypersensitivity to abacavir is an idiosyncratic reaction and a distinct clinical syndrome characterized predominantly by systemic involvement. It can be expected to appear as a treatment-limiting event in approximately 5% of patients. The appearance of clinical symptoms consistent with this syndrome mandates immediate discontinuation of abacavir. Hypersensitivity to abacavir is an absolute contraindication to subsequent treatment with any formulation that includes this agent.


Asunto(s)
Didesoxinucleósidos/efectos adversos , Hipersensibilidad a las Drogas/etiología , Inhibidores de la Transcriptasa Inversa/efectos adversos , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Didesoxinucleósidos/uso terapéutico , Hipersensibilidad a las Drogas/epidemiología , Hipersensibilidad a las Drogas/mortalidad , Quimioterapia Combinada , Infecciones por VIH/tratamiento farmacológico , VIH-1/efectos de los fármacos , Humanos , Incidencia , Vigilancia de Productos Comercializados , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Tasa de Supervivencia
12.
JAMA ; 285(9): 1155-63, 2001 Mar 07.
Artículo en Inglés | MEDLINE | ID: mdl-11231744

RESUMEN

CONTEXT: Abacavir, a nucleoside analogue, has demonstrated suppression of human immunodeficiency virus (HIV) replication alone and in combination therapy. However, the role of abacavir in a triple nucleoside combination regimen has not been evaluated against a standard protease inhibitor-containing regimen for initial antiretroviral treatment. OBJECTIVE: To evaluate antiretroviral equivalence and safety of an abacavir-lamivudine-zidovudine regimen compared with an indinavir-lamivudine-zidovudine regimen. DESIGN AND SETTING: A multicenter, phase 3, randomized, double-blind trial with an enrollment period from August 1997 to June 1998, with follow-up through 48 weeks at 73 clinical research units in the United States, Canada, Australia, and Europe. PATIENTS: Five hundred sixty-two antiretroviral-naive, HIV-infected adults with a plasma HIV RNA level of at least 10 000 copies/mL and a CD4 cell count of at least 100 x 10(6)/L. INTERVENTIONS: Patients were stratified by baseline HIV RNA level and randomly assigned to receive a combination tablet containing 150 mg of lamivudine and 300 mg of zidovudine twice daily plus either 300 mg of abacavir twice daily and indinavir placebo or 800 mg of indinavir every 8 hours daily plus abacavir placebo. After 16 weeks, patients with confirmed HIV RNA levels greater than 400 copies/mL were eligible to continue receiving randomized treatment or receive open-label therapy. MAIN OUTCOME MEASURE: Virologic suppression, defined as HIV RNA concentration of 400 copies/mL or less at week 48. RESULTS: The proportion of patients who met the end point of having an HIV RNA level of 400 copies/mL or less at week 48 was equivalent in the abacavir group (51% [133/262]) and in the indinavir group (51% [136/265]) with a treatment difference of -0.6% (95% confidence interval [CI], -9% to 8%). In patients with baseline HIV RNA levels greater than 100 000 copies/mL, the proportion of patients achieving less than 50 copies/mL was greater in the indinavir group than in the abacavir group with 45% (45/100) vs 31% (30/96) and a treatment diference of -14% (95% CI, -27% to 0%). The 2 treatments were comparable with respect to their effects on CD4 cell count. There was no difference between groups in the frequency of treatment-limiting adverse events or laboratory abnormalities. One death in the abacavir group was attributed to hypersensitivity reaction, which occurred following rechallenge with abacavir, approximately 3 weeks after initiating study treatment. CONCLUSIONS: In this study of antiretroviral-naive HIV-infected adults, the triple nucleoside regimen of abacavir-lamivudine-zidovudine was equivalent to the regimen of indinavir-lamivudine-zidovudine in achieving a plasma HIV RNA level of less than 400 copies/mL at 48 weeks.


Asunto(s)
Fármacos Anti-VIH/uso terapéutico , Didesoxinucleósidos/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Inhibidores de la Proteasa del VIH/uso terapéutico , Indinavir/uso terapéutico , Lamivudine/uso terapéutico , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Zidovudina/uso terapéutico , Adulto , Anciano , Fármacos Anti-VIH/administración & dosificación , Terapia Antirretroviral Altamente Activa , Recuento de Linfocito CD4 , Didesoxinucleósidos/administración & dosificación , Método Doble Ciego , Farmacorresistencia Microbiana/genética , Femenino , Genotipo , VIH/enzimología , VIH/genética , Inhibidores de la Proteasa del VIH/administración & dosificación , Transcriptasa Inversa del VIH/genética , Humanos , Indinavir/administración & dosificación , Lamivudine/administración & dosificación , Masculino , Persona de Mediana Edad , Mutación , Inhibidores de la Transcriptasa Inversa/administración & dosificación , Análisis de Supervivencia , Equivalencia Terapéutica , Carga Viral , Zidovudina/administración & dosificación
13.
Pediatrics ; 107(1): E4, 2001 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-11134468

RESUMEN

OBJECTIVES: Abacavir (ABC) is a potent inhibitor of human immunodeficiency virus type 1 (HIV-1) reverse transcriptase. We compared the efficacy, safety, and tolerability of combination therapy with ABC, lamivudine (3TC), and zidovudine (ZDV) versus 3TC and ZDV in antiretroviral experienced HIV-1-infected children over 48 weeks. METHODS: Two hundred five HIV-1-infected children who had received previous antiretroviral therapy and had CD4(+) cell counts >/=100 cells/mm(3) were stratified by age and by previous treatment. Participants were randomly assigned to receive ABC (8 mg/kg twice daily [BID]) plus 3TC (4 mg/kg BID) and ZDV (180 mg/m(2) BID; ABC/3TC/ZDV group) or ABC placebo plus 3TC (4 mg/kg BID) and ZDV (180 mg/m(2); 3TC/ZDV group). Participants who met a protocol-defined switch criteria (plasma HIV-1 RNA >0.5 log(10) copies/mL above baseline at week 8 or >10 000 copies/mL after week 16) had the option to switch to open-label ABC plus any antiretroviral combination or continue randomized therapy or withdraw from the study. RESULTS: The Kaplan-Meier estimates (95% confidence interval) of the proportion of participants who maintained HIV-1 RNA levels 10 000 copies/mL, a significantly higher proportion of participants in the ABC/3TC/ZDV group had HIV-1 RNA

Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Fármacos Anti-VIH/uso terapéutico , Didesoxinucleósidos/administración & dosificación , Lamivudine/administración & dosificación , Zidovudina/administración & dosificación , Adolescente , Fármacos Anti-VIH/efectos adversos , Recuento de Linfocito CD4 , Niño , Preescolar , Intervalos de Confianza , Progresión de la Enfermedad , Método Doble Ciego , Esquema de Medicación , Quimioterapia Combinada , Femenino , Crecimiento/efectos de los fármacos , VIH-1/genética , Humanos , Lactante , Masculino , ARN Viral/análisis , ARN Viral/efectos de los fármacos
14.
Clin Infect Dis ; 32(1): 36-43, 2001 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-11112678

RESUMEN

Empiric oral antibiotic therapy for febrile neutropenic cancer patients has been suggested as a means to decrease hospitalization, but the safety of this approach has not been adequately studied in children. We compared continued iv antibiotic therapy with switching treatment to orally administered cefixime in a group of selected febrile neutropenic children for whom blood cultures were sterile after 48 h of incubation. Two hundred episodes of febrile neutropenia were studied (156 patients), and 100 episodes were randomized to receive each treatment. Failure to respond to therapy was defined by documented or suspected bacterial infection, recurrent fever, or discontinuation of assigned therapy for any reason before neutropenia resolved. Rates of treatment failure were similar in the oral cefixime group (28%) and in the iv antibiotic group (27%; P=1.0). Results support the safety of oral cefixime therapy for low-risk febrile neutropenic children, a therapeutic approach that would facilitate earlier outpatient management and decrease the costs of treatment.


Asunto(s)
Cefixima/uso terapéutico , Cefalosporinas/uso terapéutico , Fiebre/complicaciones , Neoplasias/complicaciones , Neutropenia/tratamiento farmacológico , Administración Oral , Adolescente , Adulto , Antibacterianos/administración & dosificación , Cefixima/administración & dosificación , Cefixima/efectos adversos , Cefalosporinas/administración & dosificación , Cefalosporinas/efectos adversos , Niño , Preescolar , Seguridad de Productos para el Consumidor , Femenino , Humanos , Lactante , Inyecciones Intravenosas , Masculino , Neutropenia/complicaciones , Insuficiencia del Tratamiento
15.
AIDS Read ; 11(12): 620-2, 2001 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-11806176

RESUMEN

Abacavir sulfate is an inhibitor of HIV-1 reverse transcriptase. Approximately 5% of patients given abacavir develop a hypersensitivity reaction, a clinical syndrome thought to be immune-mediated and described previously with many different drugs, including other antiretroviral agents. Although rare, fatal reactions have occurred. Actions aimed at reducing morbidity and risk of fatality with hypersensitivity reactions include patient education, early identification and evaluation of symptoms suggestive of hypersensitivity, and prompt discontinuation of abacavir once the diagnosis has been established.


Asunto(s)
Didesoxinucleósidos/efectos adversos , Hipersensibilidad a las Drogas/etiología , Inhibidores de la Transcriptasa Inversa/efectos adversos , Hipersensibilidad a las Drogas/diagnóstico , Hipersensibilidad a las Drogas/fisiopatología , Humanos
16.
Pediatrics ; 103(4): e47, 1999 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-10103339

RESUMEN

OBJECTIVES: To evaluate the pharmacokinetic features, safety, and tolerance of abacavir, given alone and in combination with other nucleoside antiretroviral agents, in symptomatic human immunodeficiency virus (HIV)-infected children. METHODS: HIV-infected children discontinued prior antiretroviral therapy and were given abacavir orally, 4 mg/kg every 12 hours for 6 weeks, followed by 8 mg/kg every 12 hours for 6 weeks (n = 39); or 8 mg/kg every 12 hours for 12 weeks (n = 8). Children then were randomized to receive a second nucleoside antiretroviral agent (zidovudine, stavudine, didanosine, or lamivudine), plus abacavir. Pharmacokinetics, safety, tolerance, CD4(+) lymphocyte counts, and plasma HIV RNA concentrations were evaluated. RESULTS: At a dose of 8 mg/kg every 12 hours, area under the plasma concentration-versus-time curves and plasma half-life values were comparable with those reported for adults receiving abacavir at a dose of 300 mg twice daily. One case each of hypersensitivity reaction and peripheral neuropathy occurred during abacavir monotherapy. Three children experienced neutropenia while receiving abacavir in combination with another antiretroviral agent. Mean CD4(+) lymphocyte count and plasma HIV RNA concentration did not change when prior antiretroviral therapy was changed to abacavir monotherapy. CONCLUSIONS: Abacavir therapy is associated with good short-term tolerance and safety in HIV-infected children. Phase III studies are in progress to assess the antiviral activity of abacavir in children and adults.


Asunto(s)
Fármacos Anti-VIH/administración & dosificación , Didesoxinucleósidos/administración & dosificación , Didesoxinucleósidos/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Adolescente , Fármacos Anti-VIH/efectos adversos , Fármacos Anti-VIH/farmacocinética , Recuento de Linfocito CD4/efectos de los fármacos , Niño , Preescolar , Didesoxinucleósidos/efectos adversos , Didesoxinucleósidos/farmacocinética , Quimioterapia Combinada , Femenino , VIH/aislamiento & purificación , Humanos , Lactante , Masculino , ARN Viral/sangre
17.
Antimicrob Agents Chemother ; 43(3): 603-8, 1999 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-10049274

RESUMEN

Abacavir (1592U89) is a nucleoside analog reverse transcriptase inhibitor that has been demonstrated to have selective activity against human immunodeficiency virus (HIV) in vitro and favorable safety profiles in mice and monkeys. A phase I study was conducted to evaluate the safety and pharmacokinetics of abacavir following oral administration of single escalating doses (100, 300, 600, 900, and 1,200 mg) to HIV-infected adults. In this double-blind, placebo-controlled study, subjects with baseline CD4+ cell counts ranging from < 50 to 713 cells per mm3 (median, 315 cells per mm3) were randomly assigned to receive abacavir (n = 12) or placebo (n = 6). The bioavailability of the caplet formulation relative to that of the oral solution was also assessed with the 300-mg dose. Abacavir was well tolerated by all subjects; mild to moderate asthenia, abdominal pain, headache, diarrhea, and dyspepsia were the most frequently reported adverse events, and these were not dose related. No significant clinical or laboratory abnormalities were observed throughout the study. All doses resulted in mean abacavir concentrations in plasma that exceeded the mean 50% inhibitory concentration (IC50) for clinical HIV isolates in vitro (0.07 microgram/ml) for almost 3 h. Abacavir was rapidly absorbed following oral administration, with the time to the peak concentration in plasma occurring at 1.0 to 1.7 h postdosing. Mean maximum concentrations in plasma (Cmax) and the area under the plasma concentration-time curve from time zero to infinity (AUC0-infinity) increased slightly more than proportionally from 100 to 600 mg (from 0.6 to 4.7 micrograms/ml for Cmax; from 1.0 to 15.7 micrograms.h/ml for AUC0-infinity) but increased proportionally from 600 to 1,200 mg (from 4.7 to 9.6 micrograms/ml for Cmax; from 15.7 to 32.8 micrograms.h/ml for AUC0-infinity. The elimination of abacavir from plasma was rapid, with an apparent elimination half-life of 0.9 to 1.7 h. Abacavir was well absorbed, with a relative bioavailability of the caplet formulation of 96% versus that of an oral solution (drug substance in water). In conclusion, this study showed that abacavir is safe and is well tolerated by HIV-infected subjects and demonstrated predictable pharmacokinetic characteristics when it was administered as single oral doses ranging from 100 to 1,200 mg.


Asunto(s)
Didesoxinucleósidos/efectos adversos , Didesoxinucleósidos/farmacocinética , Infecciones por VIH/metabolismo , Transcriptasa Inversa del VIH/antagonistas & inhibidores , VIH-1 , Inhibidores de la Transcriptasa Inversa/efectos adversos , Inhibidores de la Transcriptasa Inversa/farmacocinética , Adulto , Área Bajo la Curva , Cromatografía Líquida de Alta Presión , Didesoxinucleósidos/administración & dosificación , Método Doble Ciego , Femenino , Semivida , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de la Transcriptasa Inversa/administración & dosificación , Espectrofotometría Ultravioleta
18.
Antimicrob Agents Chemother ; 43(3): 609-15, 1999 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-10049275

RESUMEN

Abacavir (formerly 1592U89) is a potent 2'-deoxyguanosine analog reverse transcriptase inhibitor that has been demonstrated to have a favorable safety profile in initial clinical trials with adults with human immunodeficiency virus (HIV) type 1 infection. A phase I study was conducted to evaluate the pharmacokinetics and safety of abacavir following the administration of two single oral doses (4 and 8 mg/kg of body weight) to 22 HIV-infected children ages 3 months to 13 years. Plasma was collected for analysis at predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, and 8 h after the administration of each dose. Plasma abacavir concentrations were determined by high-performance liquid chromatography, and data were analyzed by noncompartmental methods. Abacavir was well tolerated by all subjects. The single abacavir-related adverse event was rash, which occurred in 2 of 22 subjects. After administration of the oral solution, abacavir was rapidly absorbed, with the time to the peak concentration in plasma occurring within 1.5 h postdosing. Pharmacokinetic parameter estimates were comparable among the different age groups for each dose level. The mean maximum concentration in plasma (Cmax) and the mean area under the curve from time zero to infinity (AUC0-infinity) increased by 16 and 45% more than predicted, respectively, as the abacavir dose was doubled from 4 to 8 mg/kg (Cmax increased from 1.69 to 3.94 micrograms/ml, and AUC0-infinity increased from 2.82 to 8.09 micrograms.h/ml). Abacavir was rapidly eliminated, with a mean elimination half-life of 0.98 to 1.13 h. The mean apparent clearance from plasma decreased from 27.35 to 18.88 ml/min/kg as the dose increased. Neither body surface area nor creatinine clearance were correlated with pharmacokinetic estimates at either dose. The extent of exposure to abacavir appears to be slightly lower in children than in adults, with the comparable unit doses being based on body weight. In conclusion, this study showed that abacavir is safe and well tolerated in children when it is administered as a single oral dose of 4 or 8 mg/kg.


Asunto(s)
Didesoxinucleósidos/efectos adversos , Didesoxinucleósidos/farmacocinética , Infecciones por VIH/metabolismo , Transcriptasa Inversa del VIH/antagonistas & inhibidores , VIH-1 , Inhibidores de la Transcriptasa Inversa/efectos adversos , Inhibidores de la Transcriptasa Inversa/farmacocinética , Adolescente , Área Bajo la Curva , Niño , Preescolar , Cromatografía Líquida de Alta Presión , Didesoxinucleósidos/administración & dosificación , Método Doble Ciego , Femenino , Semivida , Humanos , Lactante , Masculino , Inhibidores de la Transcriptasa Inversa/administración & dosificación , Espectrofotometría Ultravioleta
19.
Res Nurs Health ; 21(3): 239-50, 1998 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-9609509

RESUMEN

The purpose of this study was to test the effectiveness of an AIDS education intervention for methadone-dependent, African American women. The women were randomly assigned to experimental (n=107) or control (n=97) group. The experimental group participated in a peer counseling and leadership training program conducted by two experienced nurse counselors over an 8-week period, followed by 8 weeks of reinforcement. The program was designed to reduce AIDS high-risk sexual behavior, increase self-esteem, decrease depressive affect, and increase the women's community-based AIDS prevention communication activities. A total of 130 women completed all phases of the study, including longitudinal Posttests at 2, 4, and 7 months after enrollment. Compared to the control group, there were statistically significant differences in three of the outcomes for the experimental group: The experimental group reported an increased number of safer sexual behaviors (p=.029), showed decreases in depression (p=.001), and reported engaging in more AIDS-related, community-based communication activities regarding prevention (p=.005).


Asunto(s)
Negro o Afroamericano/psicología , Infecciones por VIH/prevención & control , Conductas Relacionadas con la Salud , Educación del Paciente como Asunto/métodos , Asunción de Riesgos , Trastornos Relacionados con Sustancias/prevención & control , Adulto , Femenino , Infecciones por VIH/complicaciones , Infecciones por VIH/psicología , Humanos , Metadona/uso terapéutico , Narcóticos/uso terapéutico , Grupo Paritario , Evaluación de Programas y Proyectos de Salud , Autoimagen , Conducta Sexual , Trastornos Relacionados con Sustancias/complicaciones , Trastornos Relacionados con Sustancias/psicología
20.
Oecologia ; 117(1-2): 194-200, 1998 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28308487

RESUMEN

Bracken (Pteridium aquilinum) is aggressively displacing heather (Calluna vulgaris) on many moorlands in Britain. We investigated the use of lignin derivatives to identify the distribution of soil organic matter (SOM) derived from bracken in moorland soil profiles formed under heather. Phenylpropanoids extracted from recently senesced litters, roots and SOM, using alkaline CuO oxidation, showed distinct signatures for bracken and heather, with vanillyl moieties dominating bracken litter extracts and vanillyl and syringyl dominating heather litter extracts. Ratios of vanillyl and syringyl concentrations characterised the SOM derived from heather and bracken better than the concentrations of the individual moieties. The analysis showed up to a depth of 5 cm under pure bracken cover, and at the interface between heather and bracken, the SOM was largely derived from bracken litter but below that depth SOM was apparently derived from heather. The use of these methods to identify the plant origin of SOM not only enables understanding the effects of changing vegetation cover on organic matter dynamics in moorland soils but could also facilitate management techniques in moorland/heathland restoration which involve the removal of comparatively nutrient-rich SOM derived from bracken.

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