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1.
Appl Ergon ; 42(5): 710-8, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21163464

RESUMO

Sixty one percent of respondents to a questionnaire survey of occupational stress (Phase I) returned follow-up questionnaires twelve months later (Phase II). The Phase I questionnaire measured psychological strain resulting from exposure to occupational stressors, and measured the presence of stress buffers and demographic, psychological and lifestyle-related confounding factors, including age, rank and gender, mood state and the occurrence of stressful life events outside of work. The prevalence of strain was 31% at Phase I and 33% at Phase II. Fifty percent of personnel had no strain on either occasion, 15% had strain on both occasions and the remainder had strain on one occasion. The main stressor associated with strain at Phase I was an inability to disengage from work and this stressor accounted for a greater proportion of the variance in strain in personnel serving on ships than those serving ashore. The twelve-month follow-up questionnaire (Phase II) re-assessed psychological strain. A multiple linear regression analysis was conducted to identify factors measured at Phase I that predicted strain at Phase II in previously strain-free individuals. A lack of autonomy and control and dissatisfaction with living conditions predicted strain twelve months later in those serving on ships. Of the living conditions assessed, lack of privacy was the most strongly associated with strain twelve months later in those serving on ships. These stressors were not associated with strain twelve months later in those serving ashore. The findings suggest that improvements to the design of the environment on ships may have benefits for the psychological health of personnel.


Assuntos
Satisfação no Emprego , Militares/psicologia , Medicina Naval , Saúde Ocupacional , Navios , Estresse Psicológico/psicologia , Adaptação Psicológica , Adulto , Feminino , Inquéritos Epidemiológicos , Humanos , Modelos Lineares , Estudos Longitudinais , Masculino , Modelos Psicológicos , Exposição Ocupacional/efeitos adversos , Prevalência , Psicometria , Inquéritos e Questionários , Fatores de Tempo , Reino Unido , Adulto Jovem
2.
Occup Med (Lond) ; 59(7): 454-8, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19783756

RESUMO

BACKGROUND: Previous surveys have shown that there is a greater prevalence of psychological strain in Naval personnel than in the general population and have described the main psychosocial stressors associated with strain. AIMS: To determine the prevalence of acute strain and of repeated episodes of strain over 6- and 12-month periods. METHODS: Six and twelve months after completing a Phase I Work and Well-Being questionnaire, 2596 personnel were reassessed using a follow-up General Health Questionnaire-12. RESULTS: The response rates at 6 and 12 months ranged from 51 to 60%. There was no evidence of response bias at follow-up. The prevalence of acute strain was 31% at Phase I. After 6 months, approximately half of strain cases had recovered. Only 10% had strain over the entire period. Change in strain was linked to change in work role. CONCLUSIONS: Accumulation of strain and recovery occur within 6 months depending on change in work role. Management of strain might best be achieved by management of work demands and deployment length. Further studies will investigate the rate of accumulation of strain over the course of demanding deployments. Exposure to psychosocial stressors such as effort reward imbalance accounted for much of the difference between chronic strain sufferers and those with no strain.


Assuntos
Militares/psicologia , Doenças Profissionais/epidemiologia , Estresse Psicológico/epidemiologia , Doença Aguda , Adulto , Doença Crônica , Estudos de Coortes , Humanos , Doenças Profissionais/psicologia , Prevalência , Estresse Psicológico/etiologia , Inquéritos e Questionários , Reino Unido/epidemiologia
3.
Occup Med (Lond) ; 58(8): 534-9, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-18974071

RESUMO

BACKGROUND: Previous surveys of psychological strain in the Naval Service (NS) have shown higher than expected levels of strain when compared to the general population. AIM: To repeat the survey last carried out in 2004 and to obtain further information on the nature of the occupational stressors associated with strain. METHODS: General Health Questionnaire-12 strain rates and job/life stressors were measured using a Work and Well-Being Questionnaire. Models of strain were developed for male and female personnel in the Royal Navy (RN) and males in the Royal Marines (RM). RESULTS: The response rate was 57%. The psychological strain rate was 31.5% overall. Personnel suffering from strain tended to be 'overcommitted' to work, had low levels of commitment to the NS and had suffered stressful life events (SLEs) in the previous 12 months. Strain rates declined with age and rank in males, but not in females. Strain was significantly positively correlated with levels of overcommitment, effort-reward imbalance (ERI), role conflict, work-family conflict, organizational commitment and exposure to SLEs. Models of strain in the males and females in the RN and in the RM accounted for between 37 and 44% of the variance in strain. CONCLUSIONS: The survey provides evidence for both the demand control and ERI models-components of these models contribute independently to strain. High levels of commitment to the organization were associated with lower strain and exposure to SLEs to higher strain.


Assuntos
Militares/psicologia , Doenças Profissionais/diagnóstico , Estresse Psicológico/diagnóstico , Adulto , Estudos Transversais , Feminino , Humanos , Acontecimentos que Mudam a Vida , Masculino , Doenças Profissionais/psicologia , Escalas de Graduação Psiquiátrica , Análise de Regressão , Fatores Sexuais , Inquéritos e Questionários , Reino Unido , Tolerância ao Trabalho Programado , Carga de Trabalho , Adulto Jovem
4.
Educ Health (Abingdon) ; 20(1): 6, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17647174

RESUMO

INTRODUCTION: There is a need to improve the validity of performance assessments and to develop better ways of identifying and assessing what students actually do in practice. Incorporating patients' assessments into OSCEs has the potential to offer both an expert assessment of aspects of the doctor-patient interaction and improve validity. Therefore, we held a trial using simulated patient (SP) assessments in history-taking, explaining and communication skills stations in third year OSCEs. METHODS: SPs made two separate ratings of each student they saw in the OSCE. Examiners graded students using checklists and an overall 'borderline' grade. SP and examiners' marks were subject to statistical analysis. RESULTS: The reliability of the SP ratings was .77. The reliability of the SP borderline grades was .68. The reliability of the ratings and grades combined was .86. SPs reached consensus on the characteristics of high and low performing students. CONCLUSIONS: SP assessments are reliable. Statistical analysis demonstrated that SPs and clinicians are assessing different aspects of students' performance. We concluded that, due to our approach to working with SPs, their assessments increased validity.


Assuntos
Educação Médica , Avaliação Educacional/métodos , Anamnese , Simulação de Paciente , Relações Médico-Paciente , Humanos , Reprodutibilidade dos Testes , Reino Unido
5.
Occup Med (Lond) ; 57(2): 92-7, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17082519

RESUMO

BACKGROUND: Surveys of occupational stress were undertaken in 1999 and 2004. OBJECTIVE: To measure the prevalence of psychological strain and exposure to work-related stressors in personnel. METHOD: A cross-sectional survey using a validated, reliable questionnaire was undertaken in 1999 and was replicated in 2004. The data were combined and models of stress-strain were developed for male and female personnel in the Royal Navy (RN) and males in the Royal Marines (RM). RESULTS: The response rates were 78% in 1999 and 67% in 2004. Strain prevalence was 32% in 1999 and 33.5% in 2004. Strain rates were higher in females than in males and in personnel serving at sea. Reduced organizational commitment was associated with strain in males and females. Dissatisfaction with the physical work environment was associated with strain in RN females and RM. Role conflict was associated with strain in all groups. Work-family conflict was associated with strain in males, but not in females. The models accounted for 20-30% of the variance in strain. CONCLUSION: The strain rate in the Naval Service appeared to be similar to that in the other service occupations such as the UK Police, as did the sex difference in strain. The strain rate and stressor exposure ratings were remarkably stable over the period. Role conflict was found to be a generic stressor associated with strain.


Assuntos
Militares/estatística & dados numéricos , Saúde Ocupacional , Estresse Psicológico/epidemiologia , Inglaterra/epidemiologia , Família , Feminino , Humanos , Masculino , Prevalência , Inquéritos e Questionários
6.
Neurol Sci ; 25 Suppl 3: S276-8, 2004 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-15549559

RESUMO

The aim of the study was to design and test a new, easy to use, assessment tool, the Migraine Assessment of Current Therapy (Migraine-ACT), for identifying patients who require a change in their acute treatment. A 27-item questionnaire was developed by an international advisory board including questions formulated in four domains: headache impact, global assessment of relief, consistency of response and emotional response. Migraine patients entered a multinational, prospective study to investigate the test-retest reliability and construct validity of the tool, which was completed by the patients on two occasions. Test-retest reliability was assessed by Pearson's and by Spearman correlation coefficients. Construct validity was assessed by correlating patients' answers to the 27-item questionnaire with those of well-reported measures: SF-36, MIDAS and Migraine Therapy Assessment Questionnaire (MTAQ). The test-retest reliability of the 27 initial questions ranged from good to excellent. Correlations of all items with SF-36, MIDAS and MTAQ scores--assessed by discriminatory t-tests--indicated that the following 4 were the most discriminating items: Does your migraine medication work consistently, in the majority of your attacks? Does the headache pain disappear within 2 hours? Are you able to function normally within 2 hours? Are you comfortable enough with your medication to be able to plan your daily activities? The 4-item Migraine-ACT is a brief, simple, and reliable assessment tool to identify patients who require a change in their acute migraine treatment, and can be recommended for primary care physicians, neurologists and headache clinicians.


Assuntos
Transtornos de Enxaqueca/diagnóstico , Transtornos de Enxaqueca/tratamento farmacológico , Inquéritos e Questionários , Doença Aguda , Humanos , Itália , Idioma , Transtornos de Enxaqueca/psicologia , Reprodutibilidade dos Testes
7.
Curr Med Res Opin ; 20(7): 1125-35, 2004 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15265257

RESUMO

BACKGROUND: Currently available measures of the efficacy of acute migraine medications are not frequently used in primary care. They may be too burdensome and complicated for routine use. OBJECTIVES: To design and test a new, easy to use, 4-item assessment tool, the Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire for use by clinicians, to quickly evaluate how a recently prescribed acute medication is working, and to identify patients who require a change of their current acute treatment. METHODS: A 27-item Migraine-ACT questionnaire was developed by an international advisory board of headache specialists. Questions were formulated in four domains: headache impact, global assessment of relief, consistency of response and emotional response. All these are clinically important measures of migraine severity and treatment outcome. All questions were dichotomous and answered by yes or no. Patients (n = 185) attending secondary care headache clinics who were diagnosed with migraine according to International Headache Society criteria entered a multinational, prospective, observational study to investigate the test-retest reliability and construct validity of the 27-item Migraine-ACT. Patients completed the Migraine-ACT on two occasions, separated by a 1-week interval, and test-retest reliability was assessed by Pearson product moment and Spearman rank measures. Construct validity was assessed by correlating patients' answers to the 27-item Migraine-ACT with those to other questionnaires (individual domains and total scores) conceptually related to it; the Short-Form 36 quality of life questionnaire (SF-36), the Migraine Disability Assessment (MIDAS) questionnaire and the Migraine Therapy Assessment Questionnaire (MTAQ). Discriminatory t-tests were used to identify the four Migraine-ACT questions (one in each domain) which discriminated best between the domains of the SF36, MIDAS, and MTAQ. These four items constituted the final 4-item Migraine-ACT. RESULTS: The test-retest reliability of the 27 Migraine-ACT questions ranged from good to excellent, and correlation coefficients were highly significant for all items. The consistency of reporting the yes and no answers was also excellent. Correlations of Migraine-ACT items with SF-36 and MIDAS items and SF-36, MIDAS and MTAQ total scores indicated that the following were the most discriminating items, in the respective four domains, and constitute the final Migraine-ACT questionnaire: Consistency of response: Does your migraine medication work consistently, in the majority of your attacks? Global assessment of relief: Does the headache pain disappear within 2 h? IMPACT: Are you able to function normally within 2 h? Emotional response: Are you comfortable enough with your medication to be able to plan your daily activities? The 4-item Migraine-ACT was shown to be highly reliable (Spearman/Pearson measure r = 0.82). The individual questions, and the total 4-item Migraine-ACT score, showed good correlation with items of the SF-36, MIDAS and MTAQ questionnaires, particularly with the total MTAQ and SF-36 scores. CONCLUSIONS: The 4-item Migraine-ACT questionnaire is an assessment tool for use by primary care physicians to identify patients who require a change in their current acute migraine treatment. It is brief and simple to complete and score, and has demonstrated reliability, accuracy and simplicity. Migraine-ACT can therefore be recommended for everyday clinical use by clinicians.


Assuntos
Analgésicos/farmacologia , Transtornos de Enxaqueca/tratamento farmacológico , Medição da Dor , Psicometria/instrumentação , Perfil de Impacto da Doença , Inquéritos e Questionários , Resultado do Tratamento , Doença Aguda , Adulto , Analgésicos/uso terapêutico , Monitoramento de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/fisiopatologia , Transtornos de Enxaqueca/psicologia , Estudos Prospectivos , Qualidade de Vida
8.
Br J Clin Pharmacol ; 53(1): 43-7, 2002 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-11849194

RESUMO

AIMS: To discover whether a new infra-red laser method could detect a change in pain threshold after as mild an analgesic as paracetamol and whether an effervescent liquid formulation produced a faster onset of action than tablets. METHODS: This double-blind, placebo controlled randomized study used a portable, infra-red laser to measure "first pain" thresholds on the nondominant forearm in 12 normal volunteers before and after 1 g of paracetamol or placebo. The mean of six recordings was determined three times before dosing, the first being used as a familiarization procedure, and 14 times after dosing. RESULTS: We detected a small (2%), statistically significant difference in pain threshold between a liquid formulation of paracetamol and placebo at 30 and 60 min (P = 0.004 and P = 0.001), but not between tablets and placebo. Liquid also increased the threshold significantly compared with tablets at 60 min (P = 0.01). CONCLUSIONS: To detect such a small increase in pain threshold requires a highly consistent measure and the coefficient of variation was 2% for the study overall, surprisingly low for a subjective phenomenon. The reasons for this include minimizing reflectance by blacking the skin, using a nonhairy site, averaging six data points at each sample time and controlling closely the ambient conditions and the subjects' preparation for studies.


Assuntos
Acetaminofen/administração & dosagem , Analgésicos não Narcóticos/administração & dosagem , Lasers , Limiar da Dor/efeitos dos fármacos , Acetaminofen/farmacocinética , Adolescente , Adulto , Idoso , Analgésicos não Narcóticos/farmacocinética , Análise de Variância , Cápsulas , Química Farmacêutica , Intervalos de Confiança , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Raios Infravermelhos/efeitos adversos , Lasers/efeitos adversos , Masculino , Pessoa de Meia-Idade , Soluções Farmacêuticas/administração & dosagem , Soluções Farmacêuticas/farmacocinética , Comprimidos , Equivalência Terapêutica
9.
Med Educ ; 35(5): 437-43, 2001 May.
Artigo em Inglês | MEDLINE | ID: mdl-11328513

RESUMO

OBJECTIVES: To evaluate the effects of introducing specialised ward based teachers (WBTs) who had a broad remit to improve third year medical undergraduates' clinical experience. DESIGN: Quantitative and qualitative methods including interviews with WBTs, participating consultants and SIFT co-ordinator; student questionnaire and evaluations; analysis of Objective Structured Clinical Examination (OSCE) scores to ascertain if exposure to WBTs affected OSCE scores. SETTING: Two university teaching hospitals. PARTICIPANTS: Third year undergraduate medical students from one school of medicine; four WBTs; 25 consultants; SIFT co-ordinator. MAIN OUTCOME MEASURES: Student evaluations. Student questionnaires. Student OSCE scores. Interview data. RESULTS: WBTs had a demonstrable effect on student performance in OSCE examinations. 94% of students either agreed or strongly agreed that WBTs had helped them develop their examination skills and 87% either agreed or strongly agreed that WBTs had helped them develop their history taking skills. Interview data indicated that the consultants and SIFT co-ordinator considered that WBTs made an important contribution to clinical teaching. CONCLUSIONS: This study suggests that specialised WBTs are one way to manage clinical experience and enhance learning of undergraduate medical students. As clinical teaching moves into earlier parts of the undergraduate curriculum and into the community there is potential for this role to be developed.


Assuntos
Competência Clínica , Educação de Graduação em Medicina/métodos , Ensino/métodos , Currículo , Avaliação Educacional , Inglaterra , Humanos , Medicina Estatal , Inquéritos e Questionários
10.
Med Educ ; 34(10): 827-40, 2000 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-11012933

RESUMO

CONTEXT: Clinical supervision has a vital role in postgraduate and, to some extent, undergraduate medical education. However it is probably the least investigated, discussed and developed aspect of clinical education. This large-scale, interdisciplinary review of literature addressing supervision is the first from a medical education perspective. PURPOSE: To review the literature on effective supervision in practice settings in order to identify what is known about effective supervision. CONTENT: The empirical basis of the literature is discussed and the literature reviewed to identify understandings and definitions of supervision and its purpose; theoretical models of supervision; availability, structure and content of supervision; effective supervision; skills and qualities of effective supervisors; and supervisor training and its effectiveness. CONCLUSIONS: The evidence only partially answers our original questions and suggests others. The supervision relationship is probably the single most important factor for the effectiveness of supervision, more important than the supervisory methods used. Feedback is essential and must be clear. It is important that the trainee has some control over and input into the supervisory process. Finding sufficient time for supervision can be a problem. Trainee behaviours and attitudes towards supervision require more investigation; some behaviours are detrimental both to patient care and learning. Current supervisory practice in medicine has very little empirical or theoretical basis. This review demonstrates the need for more structured and methodologically sound programmes of research into supervision in practice settings so that detailed models of effective supervision can be developed and thereby inform practice.


Assuntos
Educação Médica/métodos , Preceptoria/normas , Estágio Clínico/métodos , Educação de Pós-Graduação em Medicina , Humanos
11.
Med Educ ; 34(10): 841-50, 2000 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-11012934

RESUMO

BACKGROUND: The 1999 Cambridge Conference was held in Northern Queensland, Australia, on the theme of clinical teaching and learning. It provided an opportunity for groups of academic medical educators to consider some of the challenges posed by recent changes to health care delivery and medical education across a number of countries. PURPOSE: This paper describes the issues raised by the practical challenges posed by the current environment and how they might be addressed in ways that could promote more effective learning in clinical settings. METHOD: A SWOT analysis is a tool that can help in forward planning by identifying the strengths, weaknesses, opportunities and threats presented by any situation. Our SWOT analysis was used to generate a list of items, from which we chose those most feasible and most likely to promote positive change. RESULTS: Twenty different issues were identified, with four of them chosen by consensus for further elaboration. The discussion gave rise to four main recommended strategies: ensuring that clinical teachers thoroughly understand the purpose and process of learning in clinical settings; equipping learners with 'survival skills'; making the best use of learning resources within different clinical environments and making judicious use of information technology to enhance learning efficiency. CONCLUSIONS: The four strategies were selected not only because of their inherent importance, but also because of their feasibility. Modest changes can motivate students to feel part of a clinical team and a 'community of practice' and enhance their capacity for self-regulated practice.


Assuntos
Estágio Clínico/métodos , Aprendizagem , Computação em Informática Médica , Modelos Educacionais , Humanos
12.
Med Educ ; 34(10): 858-61, 2000 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-11012936

RESUMO

CONTEXT: In-training assessment (ITA) has established its place alongside formative and summative assessment at both the undergraduate and postgraduate level. In this paper the authors aimed to identify those characteristics of ITA that could enhance clinical teaching. METHODS: A literature review and discussions by an expert working group at the Ninth Cambridge Conference identified the aspects of ITA that could enhance clinical teaching. RESULTS: The features of ITA identified included defining the specific benefits to the learner, teacher and institution, and highlighting the patient as the context for ITA and clinical teaching. The 'mapping' of a learner's progress towards the clinical teaching objectives by using multiple assessments over time, by multiple observers in both a systematic and opportunistic way correlates with the incremental nature of reaching clinical competence. CONCLUSIONS: The importance of ITA based on both direct and indirect evidence of what the learner actually does in the real clinical setting is emphasized. Particular attention is given to addressing concerns in the more controversial areas of assessor training, ratings and documentation for ITA. Areas for future research are also identified.


Assuntos
Estágio Clínico/organização & administração , Competência Clínica/normas , Avaliação Educacional/métodos , Humanos , Aprendizagem , Mentores , Estudantes de Medicina
13.
Stroke ; 30(9): 1869-74, 1999 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-10471438

RESUMO

BACKGROUND AND PURPOSE: S-100 protein promises to be a valuable surrogate end point for cerebral injury. This is of particular interest within the context of cardiac surgery. We sought to explore the relationship between change in neurospychological performance attributable to cardiopulmonary bypass and the release of brain-specific S-100 protein. METHODS: In an observational comparative study in a University Hospital Cardiac Surgical Unit, S-100 protein release during and 5 hours after the onset of cardiopulmonary bypass was compared with change (from preoperative to 6 to 8 weeks postoperative) in neuropsychological tests in 130 patients undergoing the full range of cardiac surgical procedures. RESULTS: Neuropsychological performance usually improved, being significantly so in 10 of 25 parameters. S-100 area under the curve (AUC) protein release correlated with age (r=0.24, P<0.008) and bypass time (r=0.17, P<0.02). S-100 Cmax correlated with bypass times (r=0.29, P<0.0001). Bypass times correlated with memory performance (Rey R5; r=-0.21, P<0.03). Less S-100 protein release was associated with better neuropsychological performance, as indexed by significant correlations with the Rey Auditory Verbal Learning memory test, descending Critical Flicker Fusion thresholds, and the Hospital Anxiety and Depression rating scales, typically around r=0.2. Multiple regression models showed that neuropsychological tests accounted for 23% of the variance associated with S-100 AUC release, after partialing out the effects of age and bypass time. CONCLUSIONS: The correlation between S-100 protein release and neuropsychological function supports the belief that it is a measure of brain injury, which may be useful in future studies of mechanisms and prevention.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Saúde Mental , Sistema Nervoso/fisiopatologia , Proteínas S100/metabolismo , Afeto , Idoso , Envelhecimento/metabolismo , Cognição , Ponte de Artéria Coronária , Humanos , Período Intraoperatório , Pessoa de Meia-Idade , Testes Neuropsicológicos , Período Pós-Operatório , Fatores de Tempo
14.
Clin Drug Investig ; 16(2): 93-9, 1998.
Artigo em Inglês | MEDLINE | ID: mdl-18370526

RESUMO

OBJECTIVE: To evaluate the impact of cyclical low-dose micronised medroxyprogesterone (5 mg/day for the last 12 days of each 28-day cycle) in combination with 17-beta estradiol (2 mg/day continuously) on lipid profiles in postmenopausal women treated for 12 months. DESIGN AND SETTING: Open, noncomparative, prospective study carried out in general practice. PATIENTS AND RESULTS: 98 female patients were enrolled; seven failed to meet entry criteria, 20 withdrew after developing adverse events, three were lost to follow up and one withdrew for personal reasons; 67 (67.3%) completed 12 months' treatment. Levels of total cholesterol (6.42 mmol/L at baseline) fell 8.4% (p = 0.0001) after 12 months' treatment, while total triglycerides (1.39 mmol/L at baseline) increased by 12.2% (p = 0.007), low density lipoprotein cholesterol (4.27 mmol/L at baseline) fell 18.3% (p = 0.0001) and high density lipoprotein (HDL) cholesterol (1.59 mmol/L at baseline) increased by 6.9% (p = 0.0001). The most frequently reported adverse events were menorrhagia, breast tenderness, cervical polyps or cysts, bloating, fatigue or lethargy, influenza or influenza-like syndrome, back pain and headaches. CONCLUSIONS: Treatment with oral micronised 17-beta estradiol 2 mg/day continuously and medroxyprogesterone 5 mg/day for 12 days of each 28-day cycle lead to changes in lipid profiles in postmenopausal women that had favourable implications for the risk of development of coronary heart disease. The 17-beta estradiol-induced increase in the level of HDL cholesterol was maintained during combination with low-dose cyclical medroxyprogesterone for 12 months.

15.
J Clin Pharmacol ; 37(3): 222-8, 1997 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-9089424

RESUMO

Metoclopramide, a drug used for the relief of nausea and emesis, is currently under development as a radio- and chemosensitizing agent. Its usefulness in high doses, however, is limited by its central nervous system side effects. Neu-metoclopramide (Neu-Sensamide), a novel, concentrated, phosphate-buffered, pH-adjusted (pH = 6.5-7.0) formulation of metoclopramide, has been shown to have an improved side-effect profile in animal studies. The present double-blind, four-way crossover study compared the central nervous system effects and pharmacokinetics of neu-metoclopramide (intravenously and intramuscularly at 1.8 mg/kg) with intravenous metoclopramide and intramuscular placebo in 19 healthy male volunteers. Eight participants withdrew from the study, one because of noncompliance and seven because of adverse events. A total of 28 central nervous system events were observed with intravenous metoclopramide administration, whereas 16, 15, and 6 such events were attributed to intravenous neu-metoclopramide, intramuscular neu-metoclopramide, and placebo, respectively. Extra-pyramidal effects occurred on 10 occasions: 7 after intravenous metoclopramide, 2 after intravenous neu-metoclopramide, and 1 after intramuscular neu-metoclopramide. No significant differences were observed in the pharmacokinetic profiles of the three formulations of metoclopramide. It may be speculated, therefore, that the molecular conformational changes inherent to neu-metoclopramide result in a reduced side-effect profile compared with conventional metoclopramide formulations.


Assuntos
Antieméticos/farmacocinética , Sistema Nervoso Central/efeitos dos fármacos , Metoclopramida/farmacocinética , Adulto , Idoso , Antieméticos/efeitos adversos , Estudos Cross-Over , Método Duplo-Cego , Humanos , Masculino , Metoclopramida/efeitos adversos , Metoclopramida/análogos & derivados , Pessoa de Meia-Idade
16.
Eur J Clin Pharmacol ; 52(5): 365-9, 1997.
Artigo em Inglês | MEDLINE | ID: mdl-9272405

RESUMO

OBJECTIVE: Otilonium is a smooth muscle spasmolytic with greater affinity for receptors in the smooth muscle of distal than proximal gut in rats. This study was the first to compare distal and proximal GI transit effects in human subjects. METHODS: Using an increasing dose design for the safe exploration of clinical and supraclinical single dose levels, two groups of eight volunteers received either 40, 120 and 200 mg or 80, 160 and 240 mg otilonium. Gastric emptying of 400 ml 10% glucose solution was assessed by epigastric impedance (EI), orocaecal transit time (OCTT) by the lactulose breath-hydrogen method and whole gut transit time (WGTT) by the method of Hinton et al. [1]. Potential anticholinergic effects were assessed via visual accommodation using the RAF rule and saliva flow in response to sucking a sweet. RESULTS: Median WGTT after 120 mg significantly increased by 4.1 h relative to placebo, but at higher doses median changes relative to placebo were not significant due to wide increases in group variance. The EI t50% was delayed by 1.4 min when results from the two highest doses were combined and compared with placebo; this small difference was statistically significant but seems unlikely to achieve physiological or clinical significance. OCTT, visual accommodation and saliva flow were unaltered. Otilonium bromide was well tolerated at all doses, due mainly to low systemic absorption.


Assuntos
Trânsito Gastrointestinal/efeitos dos fármacos , Parassimpatolíticos/farmacologia , Compostos de Amônio Quaternário/farmacologia , Acomodação Ocular/efeitos dos fármacos , Adolescente , Adulto , Relação Dose-Resposta a Droga , Humanos , Pessoa de Meia-Idade , Parassimpatolíticos/administração & dosagem , Parassimpatolíticos/efeitos adversos , Compostos de Amônio Quaternário/administração & dosagem , Compostos de Amônio Quaternário/efeitos adversos , Saliva/efeitos dos fármacos , Saliva/metabolismo
17.
Psychopharmacology (Berl) ; 95(2): 245-9, 1988.
Artigo em Inglês | MEDLINE | ID: mdl-2901122

RESUMO

Acebutolol (400 mg once daily), atenolol (100 mg once daily) and placebo were self administered to 12 healthy male volunteers in a double-blind crossover study. Each drug treatment was administered for 4 days so that subjects' plasma levels of the drug were at steady state. Subjects were tested on the 4th day. On each of the 3 test days subjects underwent an anxiety induction procedure involving both easy and difficult versions of the Stroop test and syntactic reasoning. Measures of state anxiety were taken during the difficult task, an easy version of the task and after a period of quiet relaxation. High, medium and low levels of anxiety corresponded to the three levels of task difficulty. Highly significant differences were exhibited in state anxiety between high, medium and low anxiety induction procedures with both Stroop test and syntactic reasoning. This was shown by highly significant main effects for task difficulty with both tasks. There was no significant anxiolytic action of either acebutolol or atenolol when compared to placebo (there were no drug effects or any interaction of drugs with task difficulty). There were no significant drug effects upon any of the cognitive test measures. Overall, there was no evidence of either anxiolysis or sedation with either of these two relatively hydrophilic drugs.


Assuntos
Acebutolol/farmacologia , Ansiolíticos , Ansiedade/induzido quimicamente , Atenolol/farmacologia , Adulto , Ansiedade/psicologia , Humanos , Masculino , Desempenho Psicomotor/efeitos dos fármacos
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