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1.
BMC Health Serv Res ; 22(1): 1326, 2022 Nov 08.
Artículo en Inglés | MEDLINE | ID: mdl-36348369

RESUMEN

BACKGROUND: In 2019 daily liquid methadone and sublingual buprenorphine-naloxone were primary opioid agonist treatments for correctional centres in New South Wales, Australia. However, both had significant potential for diversion to other patients, and their daily administration was resource intensive. An alternative treatment in the form of subcutaneous depot buprenorphine became a viable option following a safety trial in 2020 - the UNLOC-T study. Depot preparation demonstrated advantages over current treatments as more difficult to divert and requiring fewer administrations. This paper reports the results of economic modelling of staffing costs in medication administration comparing depot buprenorphine, methadone, and sublingual buprenorphine provision in UNLOC-T trial facilities. METHODS: The costing study adopted a micro-costing approach involving the synthesis of cost data from the UNLOC-T clinical trial as well as data collected from Justice Health and Forensic Mental Health Network records. Labour and materials data were collected during site observations and interviews. Costs were calculated from two payer perspectives: a) the New South Wales (state) government which funds custodial and health services; and b) the Australian Commonwealth government, which pays for medications. The analysis compared the monthly-per-patient cost for each of the three medications in trial-site facilities during July 2019. This was followed by simulation of depot buprenorphine implementation across the study population. Costs associated with medical assessment and reviews were excluded. RESULTS: The monthly-per-patient New South Wales government service costs of depot buprenorphine, methadone and sublingual buprenorphine were: $151, $379 and $1,529 respectively while Commonwealth government medication costs were $434, $80 and $525. The implementation simulation found that service costs of depot buprenorphine declined as patients transitioned from weekly to monthly administration. Costs of treatment using the other medications increased as patient numbers decreased alongside fixed costs. At 12 months, monthly-per-patient service costs for depot buprenorphine, methadone and sublingual buprenorphine-which would be completely phased out by month 13-were $92, $530 and $2,162 respectively. CONCLUSIONS: Depot buprenorphine was consistently the least costly of the treatment options. Future modelling could allow for dynamic patient populations and downstream impacts for participants and the state health system. TRIAL REGISTRATION: ACTRN12618000942257 . Registered 4 June 2018.


Asunto(s)
Buprenorfina , Trastornos Relacionados con Opioides , Humanos , Buprenorfina/uso terapéutico , Analgésicos Opioides/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Nueva Gales del Sur , Australia , Metadona/uso terapéutico
3.
Surg Endosc ; 35(3): 1108-1115, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-32124059

RESUMEN

BACKGROUND: Minimally invasive techniques have been broadly introduced to liver surgery during the last couple of years. In this study, we aimed to report the incidence and potential risk factors for incisional hernia (IH) as well as health-related quality of life (HRQoL) after laparoscopic liver resections (LLR). METHODS: All patients undergoing LLR between January 2014 and June 2017 were contacted for an outpatient hernia examination. In all eligible patients, photo documentation of the scar was performed and IH was evaluated by clinical examination and by ultrasound. Patients also completed a questionnaire to evaluate IH-specific symptoms and HRQoL. Obtained results were retrospectively analyzed with regard to patients' characteristics, perioperative outcomes and applied minimally invasive techniques, such as multi-incision laparoscopic liver surgery or hand-assisted/single-incision laparoscopic surgery (HALS/SILS). RESULTS: Of 184 patients undergoing surgery, 161 (87.5%) met the inclusion criteria and 49 patients (26.6%) participated in this study. After a median time of 26 months (range 19-50 months) after surgery, we observed an overall incidence of IH of 12%. Five of 6 patients were overweight or obese (BMI ≥ 25) and 5 of 6 hernias were located at the umbilical site. Univariate analysis suggested the performance status at time of operation (ASA score ≥ 3; HR 5.616, 95% CI 1.012-31.157, p = 0.048) and the approach (HALS/SILS, HR 6.571, 95% CI 1.097-39.379, p = 0.039) as potential risk factors for IH. A higher frequency of hernia-related physical restrictions (HRR; p = 0.058) and a decreased physical functioning (p = 0.17) were noted in patients with IH; however, both being short of statistical significance. CONCLUSION: Advantages of laparoscopic surgery with regard to low rates of IH can be translated to minimally invasive liver surgery. Even though there are low rates of IH, patients with poor performance status at the time of operation should be monitored closely. While patients' characteristics are hard to influence, it might be worth focusing on surgical factors such as the approach and the closure of the umbilical site to further minimize the rate of IH.


Asunto(s)
Hepatectomía/efectos adversos , Hernia Incisional/epidemiología , Hernia Incisional/etiología , Laparoscopía/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Laparoscópía Mano-Asistida/efectos adversos , Hepatectomía/métodos , Humanos , Incidencia , Laparoscopía/métodos , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Calidad de Vida , Estudios Retrospectivos , Factores de Riesgo
4.
Surg Endosc ; 35(5): 2021-2028, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-32347389

RESUMEN

BACKGROUND AND AIM: The implications of multi-incision (MILS) and hand-assisted (HALS) laparoscopic techniques for minimally invasive liver surgery with regard to perioperative outcomes are not well defined. The purpose of this study was to compare MILS and HALS using propensity score matching. METHODS: 309 patients underwent laparoscopic liver resections (LLR) between January 2013 and June 2018. Perioperative outcomes were analyzed after a 1:1 propensity score match. Subgroup analyses of matched groups, i.e., radical lymphadenectomy (LAD) as well as resections of posterosuperior segments (VII and/or VIII), were performed. RESULTS: MILS was used in 187 (65.2%) and HALS in 100 (34.8%) cases, with a significant decrease of HALS resections over time (p = 0.001). There were no significant differences with regard to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) Score, previous abdominal surgery and cirrhosis between both groups. Patients scheduled for HALS were characterized by a significantly higher rate of malignant tumors (p < 0.001) and major resections (p < 0.001). After propensity score matching (PMS), 70 cases remained in each group and all preoperative variables as well as resection extend were well balanced. A significantly higher rate of radical LAD (p = 0.039) and posterosuperior resections was found in the HALS group (p = 0.021). No significant differences between the matched groups were observed regarding operation time, conversion rate, frequency of major complications, length of intensive care unit (ICU) stay, overall hospital stay and R1 rate. CONCLUSION: Our analysis suggests MILS and HALS to be equivalent regarding postoperative outcomes. HALS might be particularly helpful to accomplish complex surgical procedures during earlier stages of the learning curve.


Asunto(s)
Hepatectomía/métodos , Laparoscopía/métodos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Femenino , Laparoscópía Mano-Asistida/efectos adversos , Laparoscópía Mano-Asistida/métodos , Hepatectomía/efectos adversos , Humanos , Laparoscopía/efectos adversos , Tiempo de Internación , Neoplasias Hepáticas/cirugía , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Tempo Operativo , Complicaciones Posoperatorias/etiología , Puntaje de Propensión , Estudios Retrospectivos , Adulto Joven
5.
Ann Oncol ; 31(11): 1553-1560, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32801017

RESUMEN

BACKGROUND: This multicentre, randomised, double-blinded, placebo-controlled, phase II/III trial aimed to evaluate an oral THC:CBD (tetrahydrocannabinol:cannabidiol) cannabis extract for prevention of refractory chemotherapy-induced nausea and vomiting (CINV). Here we report the phase II component results. PATIENTS AND METHODS: Eligible patients experienced CINV during moderate-to-high emetogenic intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Study treatment consisted of one cycle of 1-4 self-titrated capsules of oral THC 2.5 mg/CBD 2.5 mg (TN-TC11M) three times daily, from days -1 to 5, and 1 cycle of matching placebo in a crossover design, then blinded patient preference for a third cycle. The primary end point was the proportion of participants with complete response during 0-120 h from chemotherapy. A total of 80 participants provided 80% power to detect a 20% absolute improvement with a two-sided P value of 0.1. RESULTS: A total of 81 participants were randomised; 72 completing two cycles were included in the efficacy analyses and 78 not withdrawing consent were included in safety analyses. Median age was 55 years (range 29-80 years); 78% were female. Complete response was improved with THC:CBD from 14% to 25% (relative risk 1.77, 90% confidence interval 1.12-2.79, P = 0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE). Thirty-one percent experienced moderate or severe cannabinoid-related adverse events such as sedation, dizziness, or disorientation, but 83% of participants preferred cannabis to placebo. No serious adverse events were attributed to THC:CBD. CONCLUSION: The addition of oral THC:CBD to standard antiemetics was associated with less nausea and vomiting but additional side-effects. Most participants preferred THC:CBD to placebo. Based on these promising results, we plan to recruit an additional 170 participants to complete accrual for the definitive, phase III, parallel group analysis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001036404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370473&isReview=true.


Asunto(s)
Antieméticos , Antineoplásicos , Cannabidiol , Cannabis , Náusea , Vómitos , Adulto , Anciano , Anciano de 80 o más Años , Antieméticos/uso terapéutico , Antineoplásicos/uso terapéutico , Australia , Cannabidiol/uso terapéutico , Estudios Cruzados , Método Doble Ciego , Dronabinol/uso terapéutico , Combinación de Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Extractos Vegetales/uso terapéutico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico
6.
Langenbecks Arch Surg ; 404(4): 469-475, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31065781

RESUMEN

INTRODUCTION: Cost efficiency is important for hospitals in order to provide high-quality health care for all patients. As hemihepatectomies are increasingly being performed laparoscopically, the aims of this study were to evaluate the costs of laparoscopic hemihepatectomy and to compare them to conventional open techniques. PATIENTS AND METHODS: This is a retrospective analysis of clinical outcomes and financial calculations of all patients who underwent hemihepatectomy between January 2015 and December 2016 at the Department of Surgery, Campus Charité Mitte and Campus Charité Virchow-Klinikum, Berlin, Germany, being allocated to the DRG (diagnosis-related group) H01A (complex operations of the liver and pancreas with complex intensive care treatment) or H01B (operations of the liver and pancreas without complex intensive care treatment). To overcome selection bias, a 1:1 propensity score matching (PSM) analysis was performed. RESULTS: After PSM, a total of 64 patients were identified; 32 patients underwent laparoscopic hemihepatectomy (LH); and 32 patients received open hemihepatectomy (OH). After PSM, no significant differences were observed in clinical baseline characteristics. The duration of surgery was significantly longer for patients undergoing LH compared to OH (LH, 334 min, 186-655 min; OH, 274 min, 176-454 min; p = 0.005). Patients in the LH group had a significantly shortened median hospital stay of 5 d, when compared to OH (LH, 9.5 d, 3-35 d; OH, 14.5 d, 7-37d; p = 0.005). We observed a significant higher rate of postoperative complication in the OH group (p = 0.022). Cost analysis showed median overall costs of 17,369.85€ in the LH group and 16,103.64€ in the OH group (p = 0.390). CONCLUSION: Our data suggest that higher intraoperative costs of laparoscopic liver surgery, e.g., for surgical devices and due to longer operation times, are compensated by fewer postoperative complications and consecutive shorter length of stay when compared with OH.


Asunto(s)
Análisis Costo-Beneficio , Hepatectomía/economía , Laparoscopía/economía , Hepatopatías/cirugía , Humanos , Tiempo de Internación/economía , Tempo Operativo , Complicaciones Posoperatorias/epidemiología , Puntaje de Propensión , Estudios Retrospectivos
7.
Eur J Clin Nutr ; 71(1): 103-106, 2017 01.
Artículo en Inglés | MEDLINE | ID: mdl-27460262

RESUMEN

BACKGROUND/OBJECTIVES: The aim of the study was to measure the relative bioavailability of labeled pteroylglutamic acid (13C5-PteGlu) from a pectin-coated fortified rice in vivo to measure any effect of the edible coating on folic acid bioavailability. SUBJECTS/METHODS: Healthy volunteers (N=26) aged 18-39 years received three test meals in three randomized short-term cross-over trials: Trial 1: aqueous 400 µg 13C5-PteGlu, Trial 2: 200 g cooked white rice+400 µg 13C5-PteGlu,Trial 3: 200 g fortified cooked white rice with pectin-coated premix containing 400 µg 13C5-PteGlu. Blood samples were drawn at 0,1,2,5 and 8 h postprandial. The concentration of 13C5-5 methyl-tetrahydrofolate appearing in plasma was quantified using high performance liquid chromatography-mass spectrometry (MS)/MS. For 24 h before baseline estimation and during the area under the curve (AUC) study, the subjects were placed on a low folate diet (∼100 µg/day). The relative bioavailability of the folic acid following Trial 3 was measured by comparing the 13C5-5 methyl-tetrahydrofuran (THF) AUC with Trials 1 and 2. RESULTS: The bioavailability of folic acid in a pectin-coated rice premix was 68.7% (range 47-105) and 86.5% (range 65-115) in uncoated fortified rice relative to aqueous folic acid. CONCLUSION: This study is the first demonstration of the bioavailability of folate in pectin-coated fortified rice in humans.


Asunto(s)
Ácido Fólico/farmacocinética , Alimentos Fortificados , Oryza , Tetrahidrofolatos/sangre , Complejo Vitamínico B/farmacocinética , Adolescente , Adulto , Área Bajo la Curva , Disponibilidad Biológica , Estudios Cruzados , Femenino , Ácido Fólico/análogos & derivados , Voluntarios Sanos , Humanos , Marcaje Isotópico/métodos , Masculino , Pectinas , Análisis Espectral/métodos , Adulto Joven
8.
Intern Med J ; 46(11): 1259-1268, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27813358

RESUMEN

Alcohol use disorders are common in Australia and are often unrecognised. Alcohol places a significant burden on our healthcare system by increasing the risk of injuries as well as many chronic medical conditions. Diagnosis requires a high index of suspicion and can be aided by the use of specific questionnaires, such as the Alcohol Use Disorder Identification Test-C. The current available laboratory tests are of limited sensitivity and specificity, but can nevertheless aid in the diagnosis in some circumstances. Newer tests, such as ethyl-glucuronide and phosphatidylethanol, are more sensitive and specific but are costly and not widely available. The effective management of alcohol use disorder entails psychosocial or pharmacological treatments or a combination of both. In those who cannot reduce alcohol consumption, harm reduction strategies can be applied to reduce the burden of harm to the drinkers as well as the community at large.


Asunto(s)
Alcoholismo/diagnóstico , Alcoholismo/epidemiología , Alcoholismo/terapia , Australia/epidemiología , Biomarcadores , Quimioterapia/métodos , Glucuronatos/sangre , Glicerofosfolípidos/sangre , Humanos , Tamizaje Masivo/economía , Psicoterapia/métodos
9.
Intern Med J ; 46(7): 852-4, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27405894

RESUMEN

Liver disease develops in one-third of patients with cystic fibrosis (CF). It is rare for liver disease to have its onset after 20 years of age. Lung disease, however, is usually more severe in adulthood. A retrospective analysis was performed on nine patients. Three patients required lung transplantation approximately a decade after liver transplant, and another underwent combined liver and lung transplants. Four additional patients with liver transplants are awaiting assessment for lung transplants. One patient is awaiting combined liver and lung transplants. With increased survival in CF, several patients may require more than single organ transplantation.


Asunto(s)
Fibrosis Quística/complicaciones , Fibrosis Quística/cirugía , Hepatopatías/cirugía , Trasplante de Hígado , Trasplante de Pulmón , Adolescente , Adulto , Australia , Niño , Femenino , Humanos , Pruebas de Función Hepática , Masculino , Pruebas de Función Respiratoria , Estudios Retrospectivos , Adulto Joven
10.
Alcohol Alcohol ; 51(4): 402-9, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-26672793

RESUMEN

AIM: To assess the effectiveness of a 12 week specialized, integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting. METHODS: Out of 86 patients meeting the inclusion criteria for alcohol dependence with suspicion of comorbid anxiety and/or depressive disorder, 57 completed a 3-week stabilization period (abstinence or significantly reduced consumption). Of these patients, 37 (65%) met a formal diagnostic assessment of an anxiety and/or depressive disorder and were randomized to either (a) integrated intervention (cognitive behavioural therapy) for alcohol, anxiety and/or depression, or (b) usual counselling care for alcohol problems. RESULTS: Intention-to-treat analyses revealed a beneficial treatment effect of integrated treatment relative to usual counselling care for the number of days to relapse (χ(2) = 6.42, P < 0.05) and lapse (χ(2) = 10.73, P < 0.01). In addition, there was a significant interaction effect of treatment and time for percentage days of abstinence (P < 0.05). For heavy drinking days, the treatment effect was mediated by changes in DASS anxiety (P < 0.05). There were no significant treatment interaction effects for DASS depression or anxiety symptoms. CONCLUSIONS: These results provide support for integrated care in improving drinking outcomes for patients with alcohol dependence and comorbid depression/anxiety disorder. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01941693.


Asunto(s)
Alcoholismo/terapia , Ansiedad/terapia , Depresión/terapia , Adulto , Alcoholismo/complicaciones , Alcoholismo/psicología , Ansiedad/complicaciones , Terapia Cognitivo-Conductual , Consejo , Depresión/complicaciones , Femenino , Hospitales Públicos , Humanos , Masculino , Resultado del Tratamiento
11.
J Viral Hepat ; 22(11): 914-25, 2015 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-25996567

RESUMEN

Among people who inject drugs (PWID) with chronic HCV, the association between HCV treatment willingness and intent, and HCV specialist assessment and treatment were evaluated. The Enhancing Treatment for Hepatitis C in Opioid Substitution Settings (ETHOS) is a prospective observational cohort. Recruitment was through six opioid substitution treatment clinics, two community health centres and one Aboriginal community controlled health organisation in Australia. Analyses were performed using logistic regression. Among 415 participants (mean age 41 years, 71% male), 67% were 'definitely willing' to receive HCV treatment and 70% reported plans to initiate therapy 12 months postenrolment. Those definitely willing to receive HCV treatment were more likely to undergo specialist assessment (64% vs 32%, P < 0.001) and initiate therapy (36% vs 9%, P < 0.001), compared to those with lower treatment willingness. Those with early HCV treatment plans were more likely to undergo specialist assessment (65% vs 27%, P < 0.001) and initiate therapy (36% vs 5%, P < 0.001), compared to those without early plans. In adjusted analyses, HCV treatment willingness independently predicted specialist assessment (aOR 3.06, 95% CI 1.90, 4.94) and treatment uptake (aOR 4.33, 95% CI 2.14, 8.76). In adjusted analysis, having early HCV treatment plans independently predicted specialist assessment (aOR 4.38, 95% CI 2.63, 7.29) and treatment uptake (aOR 9.79, 95% CI 3.70, 25.93). HCV treatment willingness was high and predicted specialist assessment and treatment. Strategies for enhanced HCV care should be developed with an initial focus on people willing to receive treatment and to increase treatment willingness among those less willing.


Asunto(s)
Hepatitis C Crónica/diagnóstico , Hepatitis C Crónica/tratamiento farmacológico , Aceptación de la Atención de Salud , Abuso de Sustancias por Vía Intravenosa/complicaciones , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Australia , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven
12.
Nutr Diabetes ; 5: e154, 2015 Apr 27.
Artículo en Inglés | MEDLINE | ID: mdl-25915743

RESUMEN

BACKGROUND: Alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD) are highly prevalent liver diseases that may coexist and contribute significantly to liver disease-related mortality. Obesity is a common underlying risk factor for both disorders. There has been little research investigating the combined effects of high fat diet (HFD) and alcohol. Current mouse models of alcohol- or fat-rich diet alone do not lead to severe liver injury. There is a need to develop animal models recapitulating human settings of drinking and diet to study the mechanisms of liver injury progression. METHODS: C57BL6 male mice were fed either chow or HFD ad libitum for 12 weeks. A sub-set of mice from each group were also given alcohol (2 g kg(-)(1) body weight) twice a week via intra-gastric lavage. Animals were monitored progressively for weight gain and blood and livers were harvested at termination. The extent of liver injury was examined by histopathology as well as by liver and serum biochemistry. The expression of lipid metabolism, inflammation and fibrogenesis-related molecules was examined by quantitative reverse transcription PCR (Q-PCR) and immunofluorescence staining. RESULTS: HFD significantly increased total body weight, triglyceride and cholesterol, whereas alcohol increased liver weight. Alcohol+HFD in combination produced maximum hepatic steatosis, increased micro- and macro-vesicular lipid droplets, increased de novo lipogenesis (steroid response-element binding protein 1 (SREBP-1) and stearoyl-CoA desaturase-1 (SCD-1)) and proliferation peroxisome activated receptor alpha (PPARα), and decreased fatty acid ß-oxidation (Acyl-CoA oxidase 1 (ACOX1)). Alcohol+HFD treatment also increased the inflammation (CD45+, CD68+, F4/80+ cells; tumour necrosis factor-alpha (TNF-α), F4/80 mRNAs) and fibrogenesis (vimentin+ activated stellate cells, collagen 1 (Col1) production, transforming growth factor-beta (TGF-ß) and Col-1 mRNAs) in mice livers. CONCLUSIONS: We report a novel mouse model with more severe liver injury than either alcohol or HFD alone recapitulating the human setting of intermittent alcohol drinking and HFD.

13.
Alcohol Alcohol ; 49(6): 654-60, 2014 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-25246489

RESUMEN

AIM: To conduct a double-blind, placebo-controlled randomized clinical trial of baclofen in the treatment of alcohol dependence. METHODS: Out of 69 participants consecutively screened, 42 alcohol-dependent patients were randomized to receive placebo, baclofen 30 mg/day or baclofen 60 mg/day for 12 weeks. All subjects were offered BRENDA, a structured psychosocial therapy for alcohol dependence that seeks to improve motivation for change, enhance strategies to prevent relapse and encourage compliance with treatment. RESULTS: Intention-to-treat analyses revealed that alcohol consumption (heavy drinking days, drinks per drinking day) significantly reduced across all three groups during the treatment period. There were no statistically significant advantages to treatment on time to first heavy drinking day (relapse) (P = 0.08), nor time to first drink (lapse) (P = 0.18). A post hoc analysis stratifying according to whether there had been a comorbid anxiety disorder, revealed a beneficial effect of baclofen 30 mg/day versus placebo on time to lapse and relapse (P < 0.05). There was also a beneficial effect for baclofen 60 mg/day relative to placebo on time to relapse in this comorbid group (P < 0.05). Both doses of baclofen were well tolerated. There were no serious adverse events. CONCLUSIONS: In spite of the small sample for a 3-arm clinical trial, this study suggests a specific role of baclofen in alcohol-dependent individuals with comorbid anxiety. Replication in larger, fully-powered studies is required.


Asunto(s)
Alcoholismo/tratamiento farmacológico , Ansiedad/complicaciones , Baclofeno/uso terapéutico , Agonistas de Receptores GABA-B/uso terapéutico , Adulto , Abstinencia de Alcohol/estadística & datos numéricos , Alcoholismo/complicaciones , Alcoholismo/psicología , Ansiedad/psicología , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Resultado del Tratamiento
14.
Intern Med J ; 44(1): 57-64, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24450521

RESUMEN

AIM: Considerable concern has been expressed about overprescribing of benzodiazepines and related harms. Past analyses have relied on World Health Organization-defined daily doses (DDD) which are sometimes out of keeping with clinical usage. This study examines 20-year (1992-2011) trends of benzodiazepine dispensing in Australia using both DDD and Ashton equivalent dose. METHODS: Data from the Drug Utilisation Sub-Committee and the Pharmaceutical Benefits Scheme (PBS) website were analysed. Trends in number of prescriptions, DDD/1000 people/day and DDD/prescription were examined over time, and between states/territories. RESULTS: In the 20-year period, 174 080 904 scripts were recorded, with temazepam the most dispensed benzodiazepine (35% of scripts), followed by diazepam (23%). Overall recorded utilisation fell from 27.7 DDD/1000 people/day in 1992 to 20.8 in 2011 (24.9% decrease). There were striking changes in use of individual benzodiazepines over time, with reductions in oxazepam and flunitrazepam and dramatic increases in alprazolam. Since 1998, there has been a steady increase, albeit modest, in per script DDD. The DDD/1000 people/day for items dispensed through PBS/Repatriaton-PBS was highest in Tasmania and lowest in Northern Territory. CONCLUSION: Despite a modest overall decline in the amount of benzodiazepine dispensed, the level of use is still likely to reflect relative over-prescribing given the paucity of accepted indications for long-term use. Since 1998, there was a polynomial increase in quantity dispensed per script. The WHO-defined DDD for clonazepam seems inappropriate and could impede monitoring of its abuse. Other problems include lack of national data for medications not subsidised on PBS/Repatriation PBS. A broad policy approach is required, not one which targets only one particular benzodiazepine.


Asunto(s)
Benzodiazepinas/uso terapéutico , Prescripciones de Medicamentos/estadística & datos numéricos , Utilización de Medicamentos/tendencias , Australia , Humanos , Prescripción Inadecuada/estadística & datos numéricos , Seguro de Servicios Farmacéuticos/estadística & datos numéricos , Estudios Retrospectivos , Equivalencia Terapéutica
15.
Herz ; 39(1): 98-104, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23649317

RESUMEN

Moderate persistent elevation of the γ-glutamyltransferase (γGT) level is a frequent finding during long-term follow-up of patients with total cavopulmonary connection (TCPC) for palliation of functionally univentricular hearts. Serial intraindividual data revealed a significant increase in the γGT level within a minimum 4-year interval in more than 80 % of cases. The level of γGT elevation showed a significant correlation to hemodynamic parameters such as systemic ventricular end diastolic pressure and mean pulmonary artery pressure, but did not strongly correlate with duration of follow-up or other liver function parameters, which were less frequent and less impressively deranged. None of the patients had signs of synthetic dysfunction. With increasing postoperative follow-up, abnormalities of sonographic hepatic texture including increased echogenicity, inhomogeneity, or liver surface nodularity were found. All 17 patients with liver surface nodularity had a follow-up period of over 10 years. Structural abnormalities did not correlate with biochemical or hemodynamic parameters. Doppler evaluation revealed inspiratory dependence of hepatic vein flow in more than 90 % as a relevant finding after TCPC; a decrease in portal vein flow velocity was observed in many patients. Since long-term survivors after Fontan procedure are at an increased risk of cardiac hepatopathy and cirrhosis, detailed routine investigation and monitoring of hepatic morphology are needed.


Asunto(s)
Procedimiento de Fontan/efectos adversos , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/fisiopatología , Hepatopatías/etiología , Hepatopatías/fisiopatología , Pruebas de Función Hepática , Hígado/fisiopatología , Adolescente , Niño , Preescolar , Femenino , Cardiopatías Congénitas/diagnóstico , Cardiopatías Congénitas/fisiopatología , Cardiopatías Congénitas/cirugía , Insuficiencia Cardíaca/diagnóstico , Humanos , Lactante , Hepatopatías/diagnóstico , Masculino , Estudios Retrospectivos , Resultado del Tratamiento
16.
Contemp Clin Trials ; 36(2): 348-55, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23939511

RESUMEN

BACKGROUND: Effective treatments for alcohol use disorders in those with significant liver disease are critically lacking. The primary aim of the current study is to explore the effectiveness and biobehavioural basis of low and high dose baclofen in improving treatment outcomes for alcohol dependence in people with alcoholic liver disease (The BacALD study). METHODS: This double-blind, placebo-controlled study will randomize 180 participants to a 12-week regime of either baclofen (30 mg/day baclofen, 75 mg/day baclofen) or placebo. Participants must meet the ICD-10 criteria for alcohol dependence in addition to alcoholic liver disease (ALD) defined as the presence of symptoms and/or signs referable to liver disease or its complications with or without cirrhosis. Primary outcome measures will include total abstinence duration, and time to lapse and relapse. Furthermore, 60 of the ALD patients enrolled in the trial will also participate in a pharmacokinetic and cue-reactivity component, along with an additional 30 healthy volunteers matched for age and gender randomised to a 1 week regime of either 30 mg/day baclofen or 75 mg/day baclofen. At week 1, plasma levels of baclofen and ß-p-chlorophenol-γ-hydroxybutric acid will be measured at 0, 1 and 4 h following baclofen administration and psychophysiological responses to alcohol-associated stimuli will be assessed in a cue reactivity paradigm. Recruitment commenced in late March 2013. CONCLUSIONS: This trial will demonstrate the efficacy and safety of two doses of baclofen in patients with alcoholic liver disease and will explore the biobehavioural mechanisms of the treatment effect.


Asunto(s)
Baclofeno/uso terapéutico , Agonistas de Receptores GABA-B/uso terapéutico , Hepatopatías Alcohólicas/tratamiento farmacológico , Consumo de Bebidas Alcohólicas/epidemiología , Alcoholismo/tratamiento farmacológico , Baclofeno/administración & dosificación , Baclofeno/farmacocinética , Protocolos Clínicos , Método Doble Ciego , Esquema de Medicación , Agonistas de Receptores GABA-B/administración & dosificación , Agonistas de Receptores GABA-B/farmacocinética , Humanos , Hepatopatías Alcohólicas/psicología , Resultado del Tratamiento
18.
Drug Alcohol Depend ; 107(2-3): 244-9, 2010 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-19926405

RESUMEN

Despite that the majority of hepatitis C virus (HCV) infection occurs among injection drug users (IDUs), little is known about HCV treatment uptake in this group, particularly during recent infection. We evaluated uptake of treatment for recent HCV infection, including associated factors, within a population predominantly made up of IDUs. The Australian Trial in Acute Hepatitis C was a study of the natural history and treatment of recent HCV infection. All participants with detectable HCV RNA at screening were offered HCV treatment, assessed for eligibility and those initiating treatment were identified. Logistic regression analyses were used to identify predictors of HCV treatment uptake. Between June 2004 and February 2008, 163 were enrolled, with 146 positive for HCV RNA at enrolment. The mean age was 35 years, 77% (n=113) participants had ever injected illicit drugs and 23% (n=34) reported having ever received methadone or buprenorphine treatment. The uptake of HCV treatment was 76% (111 of 146) among those who were eligible on the basis of positive HCV RNA. Estimated duration of HCV infection (OR=1.03 per week, 95% CI=1.00-1.06, P=0.035) and log(10) HCV RNA (OR=1.92 per log(10) increase, 95% CI=1.36-2.73, P<0.001) were independently associated with treatment uptake whereas injection drug use was not. This study demonstrates that a high uptake of HCV treatment can be achieved among participants with recently acquired HCV infection. Decisions about whether to initiate treatment for recently acquired HCV were mainly driven by clinical factors, rather than factors related to sociodemographics or injecting behaviors.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis C/tratamiento farmacológico , Interferón-alfa/uso terapéutico , Polietilenglicoles/uso terapéutico , Abuso de Sustancias por Vía Intravenosa/complicaciones , Enfermedad Aguda , Adulto , Australia/epidemiología , Estudios de Cohortes , Femenino , Hepacivirus/genética , Hepacivirus/aislamiento & purificación , Hepatitis C/diagnóstico , Hepatitis C/epidemiología , Humanos , Interferón alfa-2 , Modelos Logísticos , Masculino , Metadona/uso terapéutico , Narcóticos/uso terapéutico , Cooperación del Paciente , ARN Viral/genética , ARN Viral/aislamiento & purificación , Proteínas Recombinantes , Factores Socioeconómicos , Abuso de Sustancias por Vía Intravenosa/tratamiento farmacológico , Abuso de Sustancias por Vía Intravenosa/epidemiología , Trastornos Relacionados con Sustancias/tratamiento farmacológico , Trastornos Relacionados con Sustancias/epidemiología , Factores de Tiempo , Resultado del Tratamiento
19.
J Urol ; 182(4): 1561-8, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19683760

RESUMEN

PURPOSE: Minimally invasive procedures are increasingly important in pediatric urology. However, experience is still limited with minimally invasive operations on the upper urinary tract in infants. We analyzed 3 minimally invasive procedures (pyeloplasty, heminephroureterectomy and nephrectomy) in children younger than 1 year. MATERIALS AND METHODS: We analyzed 67 children (mean +/- SD age 5.1 +/- 2.9 months) undergoing minimally invasive pyeloplasty in 26 patients (group 1), heminephroureterectomy in 18 (group 2) or nephrectomy in 23 (group 3) with regard to technical aspects, surgical outcome and complications. Preoperative and postoperative ultrasound and mercaptoacetyltriglycine renal scan were statistically evaluated in groups 1 and 2. RESULTS: Mean +/- SD patient weight was 6.4 +/- 1.8 kg and mean +/- SD operative time was 113.2 +/- 41.6 minutes. Conversion to open surgery was necessary in 1 pyeloplasty. One complication (missed intraoperative bowel perforation) occurred. No blood transfusion was required in any child. After pyeloplasty there were improved tracer clearances (mercaptoacetyltriglycine scan) and improved morphologies of the pyelon (ultrasound) in all patients. In groups 1 and 2 there was no statistical difference between preoperative and postoperative partial function of the affected kidney. Mean +/- SD followup was 32.5 +/- 19.8 months. CONCLUSIONS: Minimally invasive procedures on the upper urinary tract in children younger than 1 year are technically challenging, and require expertise of the surgeon and the entire team. Given these assumptions, such procedures can be safely performed with excellent functional outcomes.


Asunto(s)
Pelvis Renal/cirugía , Laparoscopía , Nefrectomía/métodos , Uréter/cirugía , Humanos , Lactante , Estudios Retrospectivos , Resultado del Tratamiento , Procedimientos Quirúrgicos Urológicos/métodos
20.
Intern Med J ; 39(10): 676-81, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19460051

RESUMEN

BACKGROUND: Opioid prescribing is controversial with evidence of both significant under-utilization and over-utilization. There is some evidence to support efficacy for chronic non-malignant pain, but community and individual harms are increasingly reported. AIMS: To review availability of opioid preparations and prescription patterns of opioids through the subsidized Pharmaceutical Benefits Scheme in Australia from 1992 to 2007. METHODS: Interrogation of the Health Insurance Commission database from 1992 to 2007. Item numbers for all available opioid preparations were identified, and frequency of dispensing was collected and collated. RESULTS: The number of opioids on the Pharmaceutical Benefits Scheme (PBS) increased from 11 preparations of four medications to 70 preparations of eight medications during this period. The total number of PBS opioid prescriptions increased from 2 397 006 in 1992 to 6 998 556 in 2007. We identified a dramatic and continuing increase in prescription of oxycodone in all dose ranges. Fentanyl prescribing is increasing to a lesser degree. Morphine and tramadol prescribing appears to have plateaued. CONCLUSION: Opioid use is increasing. There is a pressing need for co-ordinated assessment of efficacy and harms to facilitate quality usage of opioids.


Asunto(s)
Analgésicos Opioides/uso terapéutico , Prescripciones de Medicamentos/normas , Australia/epidemiología , Bases de Datos Factuales/tendencias , Utilización de Medicamentos/normas , Utilización de Medicamentos/tendencias , Humanos , Dolor/tratamiento farmacológico , Dolor/epidemiología
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