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1.
BMJ Open ; 12(8): e049644, 2022 08 26.
Artigo em Inglês | MEDLINE | ID: mdl-36028279

RESUMO

OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries. DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation. SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan. PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472). INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence. PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping. RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm. CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS. TRIAL REGISTRATION NUMBER: ISRCTN43811467.


Assuntos
Alcaloides , Abandono do Hábito de Fumar , Tuberculose Pulmonar , Adolescente , Adulto , Azocinas , Análise Custo-Benefício , Humanos , Quinolizinas
2.
Obes Rev ; 22 Suppl 5: e13352, 2021 10.
Artigo em Espanhol | MEDLINE | ID: mdl-34708538

RESUMO

En el 2019, en seguimiento a un taller dirigido por el Global Health Studies del Fogarty International Center sobre el tema de la prevención de la obesidad infantil y las sinergias de investigación que surgen a través de las colaboraciones transfronterizas, convocamos a un grupo de expertos de Estados Unidos y Latinoamérica para que realizaran una revisión narrativa de la literatura epidemiológica sobre el papel obesogénico de los químicos disruptores endócrinos (EDC, por sus siglas en inglés) en la etiología de la obesidad infantil entre la juventud latina de Estados Unidos y Latinoamérica. Además de resumir y sintetizar los resultados de las investigaciones sobre este tema publicados en la última década, contextualizamos los hallazgos dentro de un marco bioconductual de curso de vida para identificar relaciones exposición-desenlace impulsadas por resultados de investigación, identificar inconsistencias y deficiencias de la literatura actual, y discutir el papel de las regulaciones políticas, todo con el objetivo de identificar posibles vías para la prevención temprana de la obesidad en las poblaciones hispanas/latinas.


Assuntos
Azocinas , Hispânico ou Latino , Humanos , Estudos Retrospectivos
3.
Sci Rep ; 10(1): 17936, 2020 10 21.
Artigo em Inglês | MEDLINE | ID: mdl-33087766

RESUMO

The main causes of acute pancreatitis (AP) are biliary disease, alcohol consumption, hypertriglyceridaemia (HTG) and endoscopic retrograde cholangiopancreatography (ERCP). The aim of this meta-analysis was to evaluate the effects of these aetiological factors on the severity and outcome of AP. Pubmed and Embase were searched between 01/01/2012 and 31/05/2020. Included articles involved adult alcoholic, biliary, HTG- or post-ERCP AP (PAP) patients. Primary outcome was severity, secondary outcomes were organ failures, intensive care unit admission, recurrence rate, pancreatic necrosis, mortality, length of hospital stay, pseudocyst, fluid collection and systematic inflammatory response syndrome. Data were analysed from 127 eligible studies. The risk for non-mild (moderately severe and severe) condition was the highest in HTG-induced AP (HTG-AP) followed by alcoholic AP (AAP), biliary AP (BAP) and PAP. Recurrence rate was significantly lower among BAP vs. HTG-AP or AAP patients (OR = 2.69 and 2.98, 95% CI 1.55-4.65 and 2.22-4.01, respectively). Mortality rate was significantly greater in HTG-AP vs. AAP or BAP (OR = 1.72 and 1.50, 95% CI 1.04-2.84 and 0.96-2.35, respectively), pancreatic necrosis occurred more frequently in AAP than BAP patients (OR = 1.58, 95% CI 1.08-2.30). Overall, there is a potential association between aetiology and the development and course of AP. HTG-AP is associated with the highest number of complications. Furthermore, AAP is likely to be more severe than BAP or PAP. Greater emphasis should be placed on determining aetiology on admission.


Assuntos
Hipertrigliceridemia/complicações , Pancreatite/etiologia , Consumo de Bebidas Alcoólicas/efeitos adversos , Azocinas , Doenças Biliares/complicações , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Feminino , Humanos , Masculino , Pancreatite/epidemiologia , Pancreatite/mortalidade , Pancreatite Necrosante Aguda/epidemiologia , Pancreatite Necrosante Aguda/etiologia , Recidiva , Índice de Gravidade de Doença
4.
Addiction ; 114(5): 923-933, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30589984

RESUMO

BACKGROUND AND AIMS: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline. DESIGN: Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment. SETTING: Australian population-based study. PARTICIPANTS: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services. INTERVENTION AND COMPARATOR: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions). MEASUREMENTS: Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview. COMMENTS: If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide.


Assuntos
Alcaloides/economia , Alcaloides/uso terapêutico , Abandono do Hábito de Fumar/economia , Abandono do Hábito de Fumar/métodos , Vareniclina/economia , Vareniclina/uso terapêutico , Adulto , Alcaloides/efeitos adversos , Austrália , Azocinas/efeitos adversos , Azocinas/economia , Azocinas/uso terapêutico , Análise Custo-Benefício , Método Duplo-Cego , Estudos de Equivalência como Asunto , Feminino , Humanos , Masculino , Quinolizinas/efeitos adversos , Quinolizinas/economia , Quinolizinas/uso terapêutico , Resultado do Tratamento , Vareniclina/efeitos adversos
5.
Addiction ; 114(2): 344-352, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30276931

RESUMO

BACKGROUND AND AIMS: Cytisine, a nicotinic acetylcholine receptor partial agonist (like varenicline) found in some plants, is a low-cost, effective smoking cessation medication that may appeal to Maori [the indigenous people of New Zealand (NZ)]. The RAUORA trial aims to determine the effectiveness, safety and cost-effectiveness of cytisine (Tabex® ) versus varenicline (Champix® ) for smoking cessation in Maori and the whanau (extended family) of Maori. DESIGN: Pragmatic, community-based, open-label randomized non-inferiority trial. SETTING: Lakes District Health Board region, NZ. PARTICIPANTS: Daily smokers (n = 2140) who self-identify as Maori or whanau of Maori, and are: aged ≥ 18 years, motivated to quit smoking in the next 2 weeks, eligible for subsidized varenicline, able to provide verbal consent and have daily access to a mobile phone/internet. Recruitment uses multi-media advertising. INTERVENTION AND COMPARATOR: Participants are randomized (1 : 1 ratio) to receive a prescription for 12 weeks of cytisine tablets [following the manufacturer's dosing regimen for 25 days, then one 1.5-mg tablet every 6 hours (two per day) until 12 weeks] or varenicline tablets (following the manufacturer's dosing regimen). Both groups receive brief stop-smoking advice from the prescribing doctor and withdrawal-orientated behavioural support via community-based stop-smoking counselling services (frequency, duration and mode of delivery tailored for participants) or a research assistant (six weekly 10-15-minute calls). Participants are advised to reduce their smoking over the first 4 days of treatment, with day 5 as their designated quit-date. MEASUREMENTS: The primary outcome is carbon monoxide-verified continuous abstinence at 6 months post-quit date. Secondary outcomes at 1, 3, 6 and 12 months post-quit date include: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance, treatment acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life. COMMENTS: This trial compares cytisine and varenicline when used by the indigenous people of NZ and their extended family for smoking cessation.


Assuntos
Alcaloides/uso terapêutico , Estudos de Equivalência como Asunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Agentes de Cessação do Hábito de Fumar/uso terapêutico , Abandono do Hábito de Fumar/métodos , Vareniclina/uso terapêutico , Azocinas/uso terapêutico , Dióxido de Carbono/análise , Aconselhamento , Família , Humanos , Havaiano Nativo ou Outro Ilhéu do Pacífico/etnologia , Nova Zelândia/etnologia , Segurança do Paciente , Quinolizinas/uso terapêutico
7.
Health Technol Assess ; 18(33): 1-120, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24831822

RESUMO

BACKGROUND: Tobacco smoking is one of the leading causes of deaths worldwide. Nearly one-fifth of adults in the UK regularly smoke cigarettes. The ill-health associated with smoking costs the NHS over £3B every year. A number of pharmacological interventions are available that can help people to quit smoking. These include nicotinic receptor partial agonists such as varenicline or cytisine. Varenicline is a synthetic product licensed for use in the UK, while cytisine is derived naturally from the seeds of the plant Cytisus laborinum L. (golden rain acacia). OBJECTIVES: To review the evidence on the clinical effectiveness and safety of cytisine from smoking cessation compared with varenicline; to develop an economic model to estimate the cost-effectiveness of cytisine and varenicline; and to provide recommendations based on value of information analyses as to whether or not a head-to-head trial of cytisine and varenicline would represent effective use of resources. DATA SOURCES: Efficacy and adverse events data were sourced from a recent Cochrane review. These data were supplemented with an updated search of twelve electronic databases, including MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library, for the period from December 2011 to January 2013. The review included randomised controlled trials (RCTs) of adult smokers attempting to quit using varenicline or cytisine. Further interventions were considered (placebo, nicotine replacement therapy, bupropion) to allow an indirect comparison between varenicline and cytisine. The primary outcome was abstinence at a minimum of 6 months' follow-up. Secondary outcomes were common adverse events such as abnormal dreams, headache, nausea, insomnia and serious adverse events. REVIEW METHODS: A systematic review and network meta-analysis of the clinical evidence was undertaken. A random-effects model was used to allow for heterogeneity between studies. The economic model structure was based on a published model. Probabilistic sensitivity analyses were undertaken to estimate the treatment expected to be most cost-effective given current information. Formal expected value of perfect information, perfect partial information and of sample information were performed. RESULTS: Twenty-three (RCTs) were included in the systematic review, comprising a total of 10,610 participants. Twenty-one trials of varenicline of differing dosing schedules and two trials of cytisine at standard dose met the inclusion criteria. No head-to-head trials comparing varenicline with cytisine were identified. The methodological quality of the studies was judged to be moderate to good. Cytisine was more efficacious than placebo [hazard ratio (HR) 4.27, 95% credible interval (CrI) 2.05 to 10.05], as was standard-dose varenicline (HR 2.58, 95% Crl 2.16 to 3.15). Standard-dose varenicline treatment was associated with significantly higher rates of headache, insomnia and nausea than placebo; there was no significant difference in the rates of abnormal dreams. There were no significant differences in the rates of headache or nausea between cytisine and placebo; data were identified for neither abnormal dreams nor insomnia. Using expected values, cytisine is anticipated to dominate varenicline, in that it produces more quality-adjusted life-years at a lower associated cost. This occurred in approximately 90% of the scenarios performed. However, owing to the large number of people who wish to quit smoking (estimated to be 3 million over a 10-year period), the implications of making an incorrect decision is large. The expected value of sample information indicated that conducting a head-to-head trial of cytisine and varenicline was worthwhile, and that 1000 smokers per arm was an appropriate number to recruit. CONCLUSIONS: On the basis of the evidence included in this review, varenicline and cytisine are both effective interventions to aid smoking cessation when compared with placebo. Cytisine is estimated to be both more clinically effective and cost-effective than varenicline. However, there is uncertainty in the decision, and a head-to-head trial of cytisine and varenicline would appear to be an effective use of resources. STUDY REGISTRATION: The study was registered as PROSPERO CRD42012003455. FUNDING DETAILS: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Alcaloides/uso terapêutico , Benzazepinas/uso terapêutico , Agonistas Nicotínicos/uso terapêutico , Quinoxalinas/uso terapêutico , Abandono do Hábito de Fumar/métodos , Adulto , Idoso , Alcaloides/efeitos adversos , Alcaloides/economia , Azocinas/efeitos adversos , Azocinas/economia , Azocinas/uso terapêutico , Benzazepinas/efeitos adversos , Benzazepinas/economia , Análise Custo-Benefício , Humanos , Pessoa de Meia-Idade , Agonistas Nicotínicos/efeitos adversos , Agonistas Nicotínicos/economia , Anos de Vida Ajustados por Qualidade de Vida , Quinolizinas/efeitos adversos , Quinolizinas/economia , Quinolizinas/uso terapêutico , Quinoxalinas/efeitos adversos , Quinoxalinas/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fumar/economia , Abandono do Hábito de Fumar/economia , Medicina Estatal , Reino Unido , Vareniclina
9.
Nicotine Tob Res ; 14(4): 463-71, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22232061

RESUMO

INTRODUCTION: The popularity of smoking cost-effectiveness (CE) analysis has grown rapidly. Differences in models and inputs mean results may not be comparable, and researchers may have to take them on trust because the methods are beyond their expertise and not always transparent. We describe a direct method and tables of results for researchers without specialist knowledge. METHODS: We estimate the health benefit to an individual attributed to an intervention and compute tables of incremental cost-effectiveness ratios (ICERs) for interventions with varying incremental intervention effects and costs. Estimates of life years gained come from the longest epidemiological study. After discounting, adjustments are made for future cessation and relapse. The method is described in simple steps, and conservative inputs are used throughout. RESULTS: To look up an ICER, the user needs only to know the cost of the intervention per smoker and the effect as measured by the percentage of ex-smokers attributable to the intervention at either 6- or 12-month follow-up. Reanalysis of authoritative reports indicates that these ICERs are comparable to those from decision-analytic simulation models. CONCLUSIONS: Researchers can now obtain immediate estimates of the CE of interventions in general populations. The method is easily programmed in a spreadsheet. ICERs are from the payer perspective and exclude offset and societal costs. Interventions in subpopulations will require inputs specific to those populations. Readers who wish to include an adjustment for quality of life can easily do so. The tables might promote a standard approach, with interventions compared on a consistent and transparent basis.


Assuntos
Promoção da Saúde/economia , Expectativa de Vida , Tábuas de Vida , Modelos Estatísticos , Abandono do Hábito de Fumar/economia , Fumar/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Alcaloides/administração & dosagem , Azocinas/administração & dosagem , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nicotina/antagonistas & inibidores , Anos de Vida Ajustados por Qualidade de Vida , Quinolizinas/administração & dosagem , Fumar/tratamento farmacológico , Abandono do Hábito de Fumar/métodos
10.
Ecotoxicol Environ Saf ; 58(3): 300-13, 2004 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15223256

RESUMO

Explosives are released into the environment at production and processing facilities, as well as through field use. These compounds may be toxic at relatively low concentrations to a number of ecological receptors. A toxicity assessment was carried out on soils from an explosive-contaminated site at a Canadian Forces Area Training Center. Toxicity studies on soil organisms using endpoints such as microbial processes (potential nitrification activity, dehydrogenase activity, substrate-induced respiration, basal respiration), plant seedling and growth (Lactuca sativa and Hordeum vulgare), and earthworm (Eisenia andrei) growth and reproduction were carried out. Results showed that 1,3,5,7-tetranitro-1,3,5,7-tetrazacyclooctane (HMX) was the principal polynitro-organic compound measured in soils. Soils from the contaminated site decreased microbial processes and earthworm reproduction; whereas plant growth was not significantly reduced. Toxicity to aquatic organisms and genotoxicity were also assessed on soil elutriates using Microtox (Vibrio fischeri), growth inhibition of algae (Selenastrum capricornutum), and SOS Chromotest (Escherichia coli). Results indicated that soil elutriates were generally not toxic to bacteria (Microtox) and algae. However, genotoxicity was found in a number of soil elutriate samples. Thus, the explosive-contaminated soils from the antitank firing range may represent a hazard for the soil organisms. Nevertheless, the global toxicity might have partially resulted from HMX as well as from other (not identified) contaminants such as heavy metals.


Assuntos
Ecologia , Armas de Fogo , Ciência Militar , Poluentes do Solo/toxicidade , Animais , Azocinas/análise , Canadá , Clorófitas/efeitos dos fármacos , Clorófitas/crescimento & desenvolvimento , Escherichia coli/efeitos dos fármacos , Escherichia coli/genética , Compostos Heterocíclicos com 1 Anel/análise , Concentração Inibidora 50 , Testes de Mutagenicidade , Nível de Efeito Adverso não Observado , Oligoquetos/efeitos dos fármacos , Oligoquetos/fisiologia , Desenvolvimento Vegetal , Plantas/efeitos dos fármacos , Reprodução/efeitos dos fármacos , Medição de Risco , Solo/análise , Poluentes do Solo/análise , Vibrio/efeitos dos fármacos
11.
Ann N Y Acad Sci ; 829: 326-40, 1997 Nov 21.
Artigo em Inglês | MEDLINE | ID: mdl-9472327

RESUMO

Umatilla Army Depot Activity (UMDA) near Hermiston, Oregon was the location of the first production-level bioremediation of explosives-contaminated soil in the U.S. Soil from munitions washout lagoons contained high concentrations of TNT (2,4,6-Trinitrotoluene) and RDX (Hexahydro-1,3,5-trinitro-1,3,5- triazine) as well as HMX (Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine). In addition to these primary contaminants, laboratory tests were performed for Tetryl (Methyl-2,4,6-trinitrophenylnitramine), 4-Am-DNT (4-Amino-2,6-dinitrotoluene), 2-Am-DNT (2-Amino-4,6-dinitrotoluene), 2,4 DNT (2,4-Dinitrotoluene), 2,6 DNT (2,6-Dinitrotoluene), 1,3,5-TNB (1,3,5-Trinitrobenzene), 1,3,-DNB (1,3-Dinitrobenzene) and NB (Nitrobenzene) during the pilot-scale treatability tests. The clean-up goal established by the Record of Decision (ROD) was 30 mg/kg each for TNT and RDX. Degradation progress was monitored using immunoassay field screening Methods SW 846,4050 and 4051. Confirmational analysis consisted of EPA Method 8330. Treatment time on a 2,700 cubic yard batch (810 cubic yards of soil) was 10-12 days. A composting technique developed by the Army Environmental Center and implemented by Bioremediation Service, Inc., Portland, Oregon was used at the site. Agricultural waste products (or amendments including cow manure, chicken manure, potato waste, sawdust and alfalfa) were blended with the contaminated soil during treatment. Specialized soil turning equipment mixed the compost for optimum biological action and homogeneity. Homogeneity of the compost mix ensured rapid degradation of all contaminants. Physical and chemical properties were closely monitored to ensure that thermophilic bacteria played a dominant role in the degradation process. Nearly 5,000 cubic yards of soil have been successfully treated, and more than 70% of all analyses indicate non-detectable levels of both TNT and RDX. The U.S. Army Corps of Engineers estimates that over $2.6 million is being saved using bioremediation at Umatilla.


Assuntos
Biodegradação Ambiental , Resíduos Perigosos , Poluentes do Solo/metabolismo , Poluentes Químicos da Água/metabolismo , Azocinas/metabolismo , Custos e Análise de Custo , Compostos Heterocíclicos com 1 Anel/metabolismo , Nitrocompostos/metabolismo , Plantas/metabolismo , Triazinas/metabolismo , Trinitrotolueno/metabolismo
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