RESUMO
BACKGROUND: The National Child Measurement Programme (NCMP) records weight and height and assesses overweight-obesity patterns in English children using body mass index (BMI), which tends to underestimate body fatness in South Asian children and overestimate body fatness in Black children of presumed African ethnicity. Using BMI adjustments to ensure that adjusted BMI was similarly related to body fatness in South Asian, Black and White children, we reassessed population overweight and obesity patterns in these ethnic groups in NCMP. METHODS: Analyses were based on 2012-2013 NCMP data in 582 899 children aged 4-5 years and 485 362 children aged 10-11 years. Standard centile-based approaches defined weight status in each age group before and after applying BMI adjustments for English South Asian and Black children derived from previous studies using the deuterium dilution method. FINDINGS: Among White children, overweight-obesity prevalences (boys, girls) were 23% and 21%, respectively, in 4-5 year olds and 33% and 30%, respectively, in 10-11 year olds. Before adjustment, South Asian children had lower overweight-obesity prevalences at 4-5 years (19%, 19%) and slightly higher prevalences at 10-11 years (42%, 34%), whereas Black children had higher overweight-obesity prevalences both at 4-5 years (31%, 29%) and 10-11 years (42%, 45%). Following adjustment, overweight-obesity prevalences were markedly higher in South Asian children both at 4-5 years (39%, 35%) and at 10-11 years (52%, 44%), whereas Black children had lower prevalences at 4-5 years (11%, 12%); at 10-11 years, prevalences were slightly lower in boys (32%) but higher in girls (35%). INTERPRETATION: BMI adjustments revealed extremely high overweight-obesity prevalences among South Asian children in England, which were not apparent in unadjusted data. In contrast, after adjustment, Black children had lower overweight-obesity prevalences except among older girls. FUNDING: British Heart Foundation, NIHR CLAHRC (South London), NIHR CLAHRC (North Thames).
Assuntos
Povo Asiático/estatística & dados numéricos , População Negra/estatística & dados numéricos , Índice de Massa Corporal , Sobrepeso/epidemiologia , Obesidade Infantil/epidemiologia , Tecido Adiposo/fisiologia , Povo Asiático/etnologia , População Negra/etnologia , Peso Corporal/etnologia , Peso Corporal/fisiologia , Criança , Pré-Escolar , Estudos de Coortes , Inglaterra/epidemiologia , Feminino , Humanos , Masculino , Sobrepeso/etnologia , Obesidade Infantil/etnologiaRESUMO
Head and neck cancer (HNC) caregivers are especially vulnerable to poor outcomes because the HNC patients are at high risk for physical and functional impairments. This study examines contextual and stress process variables potentially associated with HNC caregivers' physical and psychological well-being. Patient-caregiver variables included socio-demographics, primary stressors (caregiving, patient clinical characteristics, HNC-related symptoms/dysfunction), secondary stressors (caregiver employment, childcare responsibilities and sleep duration <7 hr), appraisal, and response (physical activity). General linear models modeled caregiver well-being, along with depression and anxiety. A total of 33 patient-caregiver dyads were included. Most caregivers were female (81.8%) and patient spouses/partners (72.7%). Factors significantly associated with better caregiver physical well-being included caregiver older age, <2 comorbidities, ≥7 hr of sleep, ≥3 days/week physical activity, and patient swallowing and speech dysfunction. Factors significantly associated with better caregiver mental health functioning were less patient social dysfunction and less perceived caregiving burden. Short nighttime sleep, higher caregiver burden, and <3 days/week physical activity were also significantly related to caregivers' depression and anxiety. Results suggested caregiver behaviors and perceived burden, along with patient HNC concerns are linked with caregiver well-being. These behavioral, cognitive, and patient factors should be incorporated into caregiver screening tools or targeted with behavioral interventions to improve caregiver well-being.
Assuntos
Cuidadores/psicologia , Neoplasias de Cabeça e Pescoço/psicologia , Estresse Psicológico/etiologia , Adaptação Psicológica , Ansiedade/etiologia , Efeitos Psicossociais da Doença , Estudos Transversais , Depressão/etiologia , Exercício Físico/psicologia , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , North Carolina , AutorrelatoRESUMO
BACKGROUND/OBJECTIVES: Body mass index (BMI) (weight per height2) is the most widely used marker of childhood obesity and total body fatness (BF). However, its validity is limited, especially in children of South Asian and Black African origins. We aimed to quantify BMI adjustments needed for UK children of Black African and South Asian origins so that adjusted BMI related to BF in the same way as for White European children. METHODS: We used data from four recent UK studies that made deuterium dilution BF measurements in UK children of White European, South Asian and Black African origins. A height-standardized fat mass index (FMI) was derived to represent BF. Linear regression models were then fitted, separately for boys and girls, to quantify ethnic differences in BMI-FMI relationships and to provide ethnic-specific BMI adjustments. RESULTS: We restricted analyses to 4-12 year olds, to whom a single consistent FMI (fat mass per height5) could be applied. BMI consistently underestimated BF in South Asians, requiring positive BMI adjustments of +1.12 kg m-2 (95% confidence interval (CI): 0.83, 1.41 kg m-2; P<0.0001) for boys and +1.07 kg m-2 (95% CI: 0.74, 1.39 kg m-2; P<0.0001) for girls of all age groups and FMI levels. BMI overestimated BF in Black Africans, requiring negative BMI adjustments for Black African children. However, these were complex because there were statistically significant interactions between Black African ethnicity and FMI (P=0.004 boys; P=0.003 girls) and also between FMI and age group (P<0.0001 for boys and girls). BMI adjustments therefore varied by age group and FMI level (and indirectly BMI); the largest adjustments were in younger children with higher unadjusted BMI and the smallest in older children with lower unadjusted BMI. CONCLUSIONS: BMI underestimated BF in South Asians and overestimated BF in Black Africans. Ethnic-specific adjustments, increasing BMI in South Asians and reducing BMI in Black Africans, can improve the accuracy of BF assessment in these children.
Assuntos
Tecido Adiposo , Adiposidade/etnologia , Povo Asiático , População Negra , Índice de Massa Corporal , Obesidade Infantil/prevenção & controle , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Obesidade Infantil/diagnóstico , Padrões de Referência , Reprodutibilidade dos Testes , Reino UnidoRESUMO
AIM: To examine whether low circulating vitamin C concentrations and low fruit and vegetable intakes were associated with insulin resistance and other Type 2 diabetes risk markers in childhood. METHODS: We conducted a cross-sectional, school-based study in 2025 UK children aged 9-10 years, predominantly of white European, South-Asian and black African origin. A 24-h dietary recall was used to assess fruit, vegetable and vitamin C intakes. Height, weight and fat mass were measured and a fasting blood sample collected to measure plasma vitamin C concentrations and Type 2 diabetes risk markers. RESULTS: In analyses adjusting for confounding variables (including socio-economic status), a one interquartile range higher plasma vitamin C concentration (30.9 µmol/l) was associated with a 9.6% (95% CI 6.5, 12.6%) lower homeostatic model assessment of insulin resistance value, 0.8% (95% CI 0.4, 1.2%) lower fasting glucose, 4.5% (95% CI 3.2, 5.9%) lower urate and 2.2% (95% CI 0.9, 3.4%) higher HDL cholesterol. HbA1c concentration was 0.6% (95% CI 0.2, 1.0%) higher. Dietary fruit, vegetable and total vitamin C intakes were not associated with any Type 2 diabetes risk markers. Lower plasma vitamin C concentrations in South-Asian and black African-Caribbean children could partly explain their higher insulin resistance. CONCLUSIONS: Lower plasma vitamin C concentrations are associated with insulin resistance and could partly explain ethnic differences in insulin resistance. Experimental studies are needed to establish whether increasing plasma vitamin C can help prevent Type 2 diabetes at an early stage.
Assuntos
Ácido Ascórbico/administração & dosagem , Ácido Ascórbico/sangue , Glicemia/metabolismo , Ingestão de Alimentos/fisiologia , Frutas , Resistência à Insulina , Verduras , Criança , Estudos Transversais , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/etiologia , Dieta , Feminino , Humanos , Masculino , Fatores de Risco , Fatores Socioeconômicos , Reino Unido/epidemiologiaRESUMO
Guidelines are presented for the organisational and clinical peri-operative management of anaesthesia and surgery for patients who are obese, along with a summary of the problems that obesity may cause peri-operatively. The advice presented is based on previously published advice, clinical studies and expert opinion.
Assuntos
Anestesia , Obesidade , Assistência Perioperatória , Feminino , Humanos , Masculino , Anestesia/métodos , Anestesiologia , Medicina Bariátrica , Irlanda , Obesidade/cirurgia , Assistência Perioperatória/métodos , Sociedades Médicas , Reino UnidoRESUMO
AIMS/HYPOTHESIS: Physical inactivity is implicated in unfavourable patterns of obesity and cardiometabolic risk in childhood. However, few studies have quantified these associations using objective physical activity measurements in children from different ethnic groups. We examined these associations in UK children of South Asian, black African-Caribbean and white European origin. METHODS: This was a cross-sectional study of 2,049 primary school children in three UK cities, who had standardised anthropometric measurements, provided fasting blood samples and wore activity monitors for up to 7 days. Data were analysed using multilevel linear regression and allowing for measurement error. RESULTS: Overall physical activity levels showed strong inverse graded associations with adiposity markers (particularly sum of skinfold thicknesses), fasting insulin, HOMA insulin resistance, triacylglycerol and C-reactive protein; for an increase of 100 counts of physical activity per min of registered time, levels of these factors were 12.2% (95% CI 10.2-14.1%), 10.2% (95% CI 7.5-12.8%), 10.2% (95% CI 7.5-12.8%), 5.8% (95% CI 4.0-7.5%) and 19.2% (95% CI 13.9-24.2%) lower, respectively. Similar increments in physical activity levels were associated with lower diastolic blood pressure (1.0 mmHg, 95% CI 0.6-1.5 mmHg) and LDL-cholesterol (0.04 mmol/l, 95% CI 0.01-0.07 mmol/l), and higher HDL-cholesterol (0.02 mmol/l, 95% CI 0.01-0.04 mmol/l). Moreover, associations were broadly similar in strength in all ethnic groups. All associations between physical activity and cardiometabolic risk factors were reduced (albeit variably) after adjustment for adiposity. CONCLUSIONS/INTERPRETATION: Objectively measured physical activity correlates at least as well with obesity and cardiometabolic risk factors in South Asian and African-Caribbean children as in white European children, suggesting that efforts to increase activity levels in such groups would have equally beneficial effects.
Assuntos
Adiposidade/fisiologia , Atividade Motora/fisiologia , Obesidade/epidemiologia , Povo Asiático , População Negra , Doenças Cardiovasculares/fisiopatologia , Criança , Proteção da Criança , Estudos Transversais , Inglaterra/epidemiologia , Feminino , Humanos , Resistência à Insulina , Masculino , Obesidade/fisiopatologia , Risco , Fatores de Risco , Dobras Cutâneas , Classe Social , População BrancaRESUMO
In the UK, South Asian adults have increased risks of CHD, type 2 diabetes and central obesity. Black African-Caribbeans, in contrast, have increased risks of type 2 diabetes and general obesity but lower CHD risk. There is growing evidence that these risk differences emerge in early life and that nutritional factors may be important. We have therefore examined the variations in nutritional composition of the diets of South Asian, black African-Caribbean and white European children, using 24 h recalls of dietary intake collected during a cross-sectional survey of cardiovascular health in eighty-five primary schools in London, Birmingham and Leicester. In all, 2209 children aged 9-10 years took part, including 558 of South Asian, 560 of black African-Caribbean and 543 of white European ethnicity. Compared with white Europeans, South Asian children reported higher mean total energy intake; their intakes of total fat, polyunsaturated fat and protein (both absolute and as proportions of total energy intake) were higher and their intakes of carbohydrate as a proportion of energy (particularly sugars), vitamin C and D, Ca and haem Fe were lower. These differences were especially marked for Bangladeshi children. Black African-Caribbean children had lower intakes of total and saturated fat (both absolute and as proportions of energy intake), NSP, vitamin D and Ca. The lower total and saturated fat intakes were particularly marked among black African children. Appreciable ethnic differences exist in the nutritional composition of children's diets, which may contribute to future differences in chronic disease risk.
Assuntos
População Negra , Dieta/etnologia , Comportamento Alimentar/etnologia , População Branca , Ásia Ocidental/etnologia , Região do Caribe/etnologia , Criança , Dieta/estatística & dados numéricos , Humanos , Avaliação Nutricional , Reino UnidoAssuntos
Anestesia Geral/efeitos adversos , Anestesia Geral/psicologia , Anestesiologia/legislação & jurisprudência , Sedação Consciente/efeitos adversos , Sedação Consciente/psicologia , Consciência no Peroperatório/epidemiologia , Consciência no Peroperatório/psicologia , Feminino , Humanos , Masculino , GravidezRESUMO
Enophthalmos has many causes, and serious post-traumatic cases indicate the need for operation. Such diagnoses should be made objectively, and a robust method for quantifying the degree to which the globe has been displaced is key. Current methods of measurement, however, have long been considered unreliable and inconsistent, in particular with regard to interobserver variability. The aim of this paper therefore was to review all these methods systematically, to analyse their reliability, and to compare them with others. The paper also includes a proposed protocol for the accurate and reliable measurement of protrusion of an eye, which aims to standardise the assessment of patients and to create a uniform approach that will enable the selection of those who are most likely to benefit from surgical treatment. Analysis of the data showed that computed tomographic (CT) exophthalmometry is the most reliable, followed by the Mourits' exophthalmometer, which performed better than the other clinical methods. In the acute phase of orbital blowout fractures, the measurement of herniated tissue through a fracture defect may give a good prediction of the degree of enophthalmos that is likely to occur without surgical correction. Measurement of the herniated volume and CT exophthalmometry should be the foundation for diagnosis and the planning of treatment. Three-dimensional imaging or Mourits' exophthalmometers (which are reliable non-radiological methods) could be used in a follow-up protocol.
Assuntos
Enoftalmia , Exoftalmia , Fraturas Orbitárias , Enoftalmia/diagnóstico , Enoftalmia/cirurgia , Exoftalmia/diagnóstico , Exoftalmia/cirurgia , Olho , Ossos Faciais/lesões , Ossos Faciais/cirurgia , Humanos , Órbita , Fraturas Orbitárias/diagnóstico , Fraturas Orbitárias/cirurgia , Reprodutibilidade dos TestesRESUMO
The objective of this study was to evaluate a premium program for very high quality milk in a US cooperative. Data were available on a monthly basis from a large US milk cooperative from April 1998 through December 2005. The data set consisted of 36,930 observations representing producer-months. The actual amount of the low bulk tank somatic cell count (BTSCC) premium varied from $0.15 per hundred pounds (cwt.) of milk to $1.00/cwt. with steps in between of $0.50 and $0.60 per cwt. of milk during the data collection period. Data analysis was done to evaluate the impact of the premium program on average BTSCC and on the probability of a producer to ship milk with <100,000 cells/mL in a given month. The results showed a strong effect of the premium program on both the average BTSCC and the probability of producing milk with very low BTSCC. On average, the BTSCC of all the milk in the cooperative was reduced by 22,000 cells during the high premium period. The probability of producing milk with BTSCC <100,000 doubled during some months of the high premium period from 4 to 8%, and an associated 10% increase in probability to produce milk below 200,000 cells/mL was observed. The data clearly indicate that premium offerings for very high quality milk affect the overall milk quality in the population affected by the premium. Producers responded to the high premiums and the overall impact on milk quality was substantial. We argue that the combination of a penalty program for high BTSCC milk with a premium program for very high quality milk (low BTSCC) provides a strong incentive for improvement of milk quality.
Assuntos
Leite/economia , Leite/normas , Controle de Qualidade , Animais , Contagem de Células , Custos e Análise de Custo , Modelos Logísticos , Leite/citologia , Estações do Ano , Estados UnidosRESUMO
In addition to bactericidal activity, macrolide antibacterials possess clinically relevant properties such as immunomodulatory activity. Whether such activity extends to novel antibacterials that are structurally related to macrolides, such as the ketolides, remains largely unknown. The objective of this study was to evaluate the in vivo immunomodulatory profile of the first ketolide antibacterial - telithromycin in a murine neutropenic thigh infection model. Specific pathogen-free, female ICR mice were rendered transiently neutropenic with intraperitoneal cyclophosphamide. Thighs were inoculated with 10(6) colony-forming units of a single clinical isolate of Streptococcus pneumoniae. Once inoculated, mice (n=500) received single oral doses of telithromycin (10, 25 or 50 mg/kg of body weight) or no treatment (control). Blood was obtained via cardiac puncture prior to and at 2, 4, 8, and 24 h after dose administration for determination of cytokine concentrations. Significant post-inoculation elevations of interleukin (IL)-1beta, IL-6, and IL-10 were noted in untreated controls over 24 h. Telithromycin attenuated these increases and the suppression of both IL-6 and IL-10 release was observed to be dose dependent. Systemic concentrations of IL-2 and tumor necrosis factor alpha showed an upward trend over the initial 8-h post-inoculation period in the telithromycin group. These data therefore reveal novel in vivo immunomodulatory effects of telithromycin. Further studies are warranted to determine whether such effects contribute to the therapeutic efficacy of the drug in patients with acute respiratory tract infections.
Assuntos
Fatores Imunológicos , Cetolídeos/farmacologia , Infecções Pneumocócicas/imunologia , Animais , Feminino , Interleucina-1/sangue , Interleucina-10/sangue , Interleucina-2/sangue , Interleucina-6/sangue , Camundongos , Camundongos Endogâmicos ICR , Infecções Pneumocócicas/sangue , Fator de Necrose Tumoral alfa/metabolismoRESUMO
OBJECTIVE: Little is known about levels of physical fitness in children from different ethnic groups in the UK. We therefore studied physical fitness in UK children (aged 9-10â years) of South Asian, black African-Caribbean and white European origin. DESIGN: Cross-sectional study. SETTING: Primary schools in the UK. PARTICIPANTS: 1625 children (aged 9-10â years) of South Asian, black African-Caribbean and white European origin in the UK studied between 2006 and 2007. OUTCOME MEASURES: A step test assessed submaximal physical fitness from which estimated VO2 max was derived. Ethnic differences in estimated VO2 max were estimated using multilevel linear regression allowing for clustering at school level and adjusting for age, sex and month as fixed effects. RESULTS: The study response rate was 63%. In adjusted analyses, boys had higher levels of estimated VO2 max than girls (mean difference 3.06â mL O2/min/kg, 95% CI 2.66 to 3.47, p<0.0001). Levels of estimated VO2 max were lower in South Asians than those in white Europeans (mean difference -0.79â mL O2/min/kg, 95% CI -1.41 to -0.18, p=0.01); levels of estimated VO2 max in black African-Caribbeans were higher than those in white Europeans (mean difference 0.60â mL O2/min/kg, 95% CI 0.02 to 1.17, p=0.04); these patterns were similar in boys and girls. The lower estimated VO2 max in South Asians, compared to white Europeans, was consistent among Indian, Pakistani and Bangladeshi children and was attenuated by 78% after adjustment for objectively measured physical activity (average daily steps). CONCLUSIONS: South Asian children have lower levels of physical fitness than white Europeans and black African-Caribbeans in the UK. This ethnic difference in physical fitness is at least partly explained by ethnic differences in physical activity.
Assuntos
Povo Asiático/estatística & dados numéricos , População Negra/estatística & dados numéricos , Aptidão Física , População Branca/estatística & dados numéricos , Criança , Estudos Transversais , Inglaterra/etnologia , Teste de Esforço , Feminino , Humanos , Modelos Lineares , Masculino , Consumo de Oxigênio , Instituições AcadêmicasRESUMO
In an attempt to determine the influence of administration time on cisplatin-induced emesis, 20 adults previously untreated with cisplatin were enrolled into this double-blind study. Twenty patients were randomly assigned to receive high-dose cisplatin (greater than 100 mg/m2) either by a one-hour infusion or by an eight-hour infusion. All patients received antiemetic therapy with metoclopramide 2 mg/kg intravenously one-half hour before cisplatin administration, and 1 1/2, 3 1/2, 5 1/2, and 8 1/2 hours after cisplatin administration. Patients in the eight-hour infusion group experienced significantly fewer emesis episodes than did patients in the one-hour infusion group. The median of emesis episodes in the eight-hour group was one (range, 0 to 2) and in the one-hour group was three (range, 0 to 8). In patients receiving high-dose cisplatin plus metoclopramide, increasing the administration time from one hour to eight hours resulted in a small but significant decrease in emesis episodes. The cisplatin infusion rate should be considered as a variable in cisplatin-antiemetic trials.
Assuntos
Cisplatino/efeitos adversos , Náusea/induzido quimicamente , Vômito/induzido quimicamente , Adulto , Idoso , Cisplatino/administração & dosagem , Cisplatino/uso terapêutico , Ensaios Clínicos como Assunto , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Infusões Parenterais , Masculino , Metoclopramida/administração & dosagem , Metoclopramida/uso terapêutico , Pessoa de Meia-Idade , Náusea/prevenção & controle , Neoplasias/tratamento farmacológico , Distribuição Aleatória , Fatores de Tempo , Vômito/prevenção & controleRESUMO
Streamlining of antibiotic therapy from a more complex to a less complex regimen should reduce hospital costs. Utilizing the expertise of an infectious disease physician and clinical pharmacists, an antibiotic-streamlining program was implemented by (1) daily collection of data on patients receiving two or more parenteral antibiotics, (2) formulation of recommendations of cost-effective alternative therapy when clinically appropriate, (3) oral and/or written communication of the reasons for the recommendation to the patient's physician, (4) follow-up monitoring, and (5) determination of the cost savings by subtracting the actual cost of antibiotic therapy (including labor and supplies) from the cost of the initial regimen if it had been continued without alteration. Streamlining recommendations were made in 340 of 625 patients who were reviewed during the initial seven months. Cases that necessitated streamlining recommendations decreased from 98.6% during the first month to 54.4% during the seventh month, reflecting the educational impact of the program on prescribing habits. Recommendations were followed in 82.6% of the cases, of which 97.2% completed therapy with the streamlined regimen. The projected annual savings of the program was +107,637.
Assuntos
Antibacterianos/administração & dosagem , Controle de Custos/métodos , Infecção Hospitalar/tratamento farmacológico , Infecção Hospitalar/economia , Infecção Hospitalar/prevenção & controle , Quimioterapia Combinada/economia , Estudos de Avaliação como Assunto , Humanos , Auditoria Médica , Padrões de Prática Médica/economia , Estudos Prospectivos , Estudos RetrospectivosRESUMO
The effectiveness of a ten-day course of either oral bacitracin or oral vancomycin hydrochloride for treatment of Clostridium difficile-induced antibiotic-associated diarrhea was compared in a randomized double-blind study. Bacitracin was as effective as vancomycin in resolving diarrhea; most patients responded within five days of therapy with either drug. Three patients receiving bacitracin worsened during therapy; two of these were considered treatment failures. Neither C difficile nor its toxin was detected in stool samples collected on the final day of therapy in 71% of patients (10/14) receiving vancomycin and in 30% (3/10) receiving bacitracin. Five patients receiving bacitracin and three receiving vancomycin had at least one recurrence. Low but nontoxic concentrations of bacitracin were detected in serum samples collected from 11 patients. Oral bacitracin at this dosage level was as effective as vancomycin in resolving the symptoms of C difficile-induced antibiotic-associated diarrhea in most patients but was less effective in eradicating C difficile and its toxin from patients' stools.
Assuntos
Bacitracina/uso terapêutico , Infecções por Clostridium/tratamento farmacológico , Diarreia/tratamento farmacológico , Vancomicina/uso terapêutico , Idoso , Bacitracina/sangue , Ensaios Clínicos como Assunto , Clostridium/isolamento & purificação , Infecções por Clostridium/microbiologia , Diarreia/etiologia , Diarreia/microbiologia , Método Duplo-Cego , Fezes/microbiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Distribuição Aleatória , Recidiva , Fatores de TempoRESUMO
Oropharyngeal candidiasis is frequently a complication of patients with altered immune states. Clotrimazole troches are effective in the treatment of Candida and were evaluated in this study in a prophylaxis regimen. Patients with malignant neoplasms who were receiving chemotherapy and renal transplant recipients who were receiving immunosuppressives were randomized to receive either clotrimazole (10 mg) or placebo troches three times a day in a prospective, double-blinded study. Eighty-four patients were randomized into the study, 18 patients with leukemia, 19 patients with malignant neoplasms, and 47 patients with renal transplants. Among all patients, thrush developed in 57% while receiving placebo compared with 13% while receiving clotrimazole prophylaxis. Prophylaxis showed significant benefit for the renal transplant recipients and for patients with solid malignant neoplasms, but not for the leukemic patients. Clotrimazole troches are effective in preventing oral candidiasis in a select group of patients.
Assuntos
Candidíase Bucal/prevenção & controle , Clotrimazol/administração & dosagem , Imidazóis/administração & dosagem , Administração Oral , Adulto , Antineoplásicos/efeitos adversos , Candidíase Bucal/etiologia , Ensaios Clínicos como Assunto , Método Duplo-Cego , Feminino , Humanos , Terapia de Imunossupressão , Imunossupressores/efeitos adversos , Transplante de Rim , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológicoRESUMO
OBJECTIVE: This study compared the quality of 65 generic clarithromycin products manufactured in 18 countries with that of the innovator product. DESIGN: To assess quality, the generic products were examined visually, assayed by high-pressure liquid chromatography for clarithromycin content and impurities, tested for dissolution properties, and compared with the innovator product manufactured by Abbott Laboratories. RESULTS: This survey found that many generic clarithromycin products were not equivalent to the innovator product and many of these generic products fell short of the approved specifications developed for the innovator product. Overall, 9% (6 of 65) of all generic tablets tested failed to contain between 95% and 105% of the clarithromycin claimed in the label, thus falling short of the approved registered specification for the innovator product. Seventeen percent (1 of 6) of tablets from Latin America (LA), 8% (3 of 38) of tablets from the Asia, Africa, Pacific (AAP) region, and 10% (2 of 21) of tablets from Europe did not contain the amount of clarithromycin drug content claimed in the label. A total of 34% (17 of 50) of the generic products tested released less drug in 30 minutes than did the innovator tablets. Although the majority of these generic products met the dissolution specification requiring that 80% of the drug must dissolve in 30 minutes, one generic product failed to meet this specification with 68% of drug dissolving in 30 minutes. Moreover, 19% (12 of 65) of all the generic products tested exceeded the Abbott Laboratories' 3% limit for total impurities in bulk drug, and 30% (20 of 65) exceeded the Abbott Laboratories' 0.8% limit for the known impurity 6,11 di-O-methyl erythromycin A. CONCLUSIONS: These results demonstrated that generic tablets are often not comparable in vitro to the innovator product. These findings suggest that results achieved with branded clarithromycin (Abbott Laboratories) should not be extrapolated to generic products. In vivo studies would be needed to determine the clinical relevance of these findings.
RESUMO
Disopyramide hemodialysis and kinetics after 200 mg orally in six patients receiving long-term hemodialysis were examined. Mean volume of distribution (area) was 66.5 +/- 13 l. Mean times of the peak serum concentration and mean peak serum concentration were 2.3 +/- 0.9 hr and 3.1 +/- 0.9 microgram/ml. Mean absorption half-life (t 1/2) was 21.6 +/- 12.5 min. Mean disopyramide elimination t 1/2 during dialysis was 16.8 +/- 11.9 hr, not significantly different from mean elimination t 1/2 without dialysis of 16.1 +/- 5.2 hr. End-dialysis bath concentrations of disopyramide showed that not more than 2.4% of the dose was dialyzed during a 2-hr dialysis period. Our data indicate that at therapeutic concentrations disopyramide was not appreciably dialyzed.