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1.
J Nutr ; 151(7): 2043-2050, 2021 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-33880554

RESUMEN

BACKGROUND: Measures that better describe "healthy" and sustainable recovery during nutritional treatment of children with moderate acute malnutrition (MAM) are needed. OBJECTIVES: We compared changes to body composition among children receiving 1 of 4 specialized nutritious food (SNFs) during treatment of MAM and by recovery and relapse outcomes. METHODS: The study was nested within a prospective, cluster-randomized, community-based, cost-effectiveness trial assessing 4 SNFs to treat children aged 6-59 mo with MAM [midupper arm circumference (MUAC) ≥11.5 cm and <12.5 cm without bipedal edema] in Sierra Leone. Biweekly SNF rations (1 of 3 fortified-blended foods or a lipid-based nutrient supplement) were given until children recovered (MUAC ≥12.5 cm), or up to 7 rations (∼12 wk). Deuterium dilution was used to estimate fat-free mass (FFM) and fat mass (FM) at enrollment and after 4 wk of treatment to ensure similar treatment exposure among the participants. Another MUAC measurement was performed among recovered children 4 wk after program exit to determine whether recovery was sustained. ANOVA, paired t tests, and linear regression models were used to determine significant differences in changes from baseline to 4 wk. RESULTS: Among 312 analyzed participants, mean baseline weight comprised ∼80% FFM; mean weight gained after 4 wk comprised ∼82% FFM. Changes in FM and FFM among 4 SNFs were similar. Children who recovered gained more weight (241%), FFM (179%), and weight-for-height z score (0.44 compared with 0) compared with those who did not recover; sustainers gained 150% more weight. FM gains were positive among recovered children and sustainers, as well as negative among those who did not recover or sustain recovery, but not significantly different. CONCLUSIONS: Four SNFs had similar effects on body composition in children after 4 wk of treatment for MAM, showing a healthy pattern of weight gain, the majority being FFM. Differential responses to treatment underscore a need for further research to provide targets for healthy, sustainable recovery. This trial was registered at clinicaltrials.gov as NCT03146897.


Asunto(s)
Desnutrición , Composición Corporal , Niño , Suplementos Dietéticos , Humanos , Lactante , Estudios Prospectivos , Sierra Leona
2.
Oncologist ; 25(3): e512-e519, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32162815

RESUMEN

BACKGROUND: In a global, phase III, open-label, noninferiority trial (REFLECT), lenvatinib demonstrated noninferiority to sorafenib in overall survival and a statistically significant increase in progression-free survival in patients with unresectable hepatocellular carcinoma (HCC). Recently, lenvatinib became the first agent in more than 10 years to receive approval as first-line therapy for unresectable HCC, along with the previously approved sorafenib. The objective of this study was to determine the comparative cost-effectiveness of lenvatinib and sorafenib as a first-line therapy of unresectable HCC. MATERIALS AND METHODS: A state-transition model of unresectable HCC was developed in the form of a cost-utility analysis. The model time horizon was 5 years; the efficacy of the model was informed by the REFLECT trial, and costs and utilities were obtained from published literature. Probabilistic sensitivity analyses and subgroup analyses were performed to test the robustness of the model. RESULTS: Lenvatinib dominated sorafenib in the base case analysis. A probabilistic sensitivity analysis indicated that lenvatinib remains a cost-saving measure in 64.87% of the simulations. However, if the cost of sorafenib was reduced by 57%, lenvatinib would no longer be the dominant strategy. CONCLUSION: Lenvatinib offered a similar clinical effectiveness at a lower cost than sorafenib, suggesting that lenvatinib would be a cost-saving alternative in treating unresectable HCC. However, lenvatinib may fail to remain cost-saving if a significantly cheaper generic sorafenib becomes available. IMPLICATIONS FOR PRACTICE: This analysis suggests an actionable clinical policy that will achieve cost saving. This cost-utility analysis showed that lenvatinib had a similar clinical effectiveness at a lower cost than sorafenib, indicating that lenvatinib may be a cost-saving measure in patients with unresectable HCC, in which $23,719 could be saved per patient. The introduction of a new therapeutic option for the first time in 10 years in Canada provides an important opportunity for clinicians, researchers, and health care decision-makers to explore potential modifications in recommendations and practice guidelines.


Asunto(s)
Antineoplásicos , Carcinoma Hepatocelular , Neoplasias Hepáticas , Antineoplásicos/uso terapéutico , Canadá , Carcinoma Hepatocelular/tratamiento farmacológico , Análisis Costo-Beneficio , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Compuestos de Fenilurea/uso terapéutico , Quinolinas , Sorafenib/uso terapéutico
3.
Artículo en Inglés | MEDLINE | ID: mdl-29445299

RESUMEN

BACKGROUND: Recent trials in early-stage breast cancer support hypofractionated whole-breast radiotherapy (WBRT) as part of breast-conserving therapy (BCT). Evidence also suggests that radiotherapy (RT) omission may be reasonable for some patients over 70 years. Among radiation-delivery techniques, intensity-modulated RT (IMRT) is more expensive than 3-dimensional conformal RT (3DCRT). Based on this evidence, in 2013, the American Society for Radiation Oncology (ASTRO) recommended hypofractionated schedules for women aged ≥50 years with early-stage breast cancer and avoiding routine use of IMRT for WBRT. To assess response to level I evidence and adherence to ASTRO recommendations, we evaluated the pattern of RT use for early-stage breast cancer at our National Comprehensive Cancer Network institution from 2006 to 2008 and 2011 to 2013 and compared the results with national trends. METHODS: Data from a prospective database were extracted to include patients treated with BCT, aged ≥50 years, with histologic findings of invasive ductal carcinoma, stage T1-T2N0M0, estrogen receptor-positive, and HER2 normal. We retrospectively reviewed the medical records and estimated costs based on 2016 Hospital Outpatient Prospective Payment System (technical fees) and Medicare Physician Fee Schedule (professional fees). RESULTS: Among 55 cases from 2006 to 2008, treatment regimens were 11% hypofractionated, 69% traditional schedule, and 20% RT omission (29% of patients were aged >70 years). Among 83 cases from 2011 to 2013, treatment regimens were 54% hypofractionated, 19% traditional schedule, and 27% RT omission (48% of patients were aged >70 years). 3DCRT was used for all WBRT treatments. Direct medical cost estimates were as follows: 15 fractions 3DCRT, $7,197.87; 15 fractions IMRT, $11,232.33; 25 fractions 3DCRT, $9,731.39; and 25 fractions IMRT, $16,877.45. CONCLUSION: Despite apparent resistance to shorter radiation schedules in the United States, we demonstrate that rapid practice change in response to level I evidence is feasible. Wider adoption of evidence-based guidelines in early-stage breast cancer may substantially lower health care costs and improve convenience for patients without sacrificing oncologic outcomes.

4.
Crit Rev Oncol Hematol ; 103: 86-98, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27247118

RESUMEN

Recurrent squamous cell carcinoma of the head and neck (SCCHN) carries a poor prognosis. Tumor hypoxia (TH) has been implicated as one of many factors contributing to SCCHN recurrence. TH leads to radiation resistance by reversing radiation-induced DNA damage. Effective strategies to overcome TH may improve outcomes in patients with SCCHN. We searched the English literature on PubMed and reviewed the reference sections of key articles related to TH (publications spanning from the early 1900s to the present). We summarized the underlying theory of TH in SCCHN, methods for quantifying it, and the numerous therapies developed to modulate it. We included articles that set the foundation of TH as a theory and the most relevant articles published within the last 15 years related to TH quantification and therapeutic targeting. Despite extensive research, targeting TH in SCCHN has not become a part of routine clinical practice in North America, and we analyze the pitfalls in hypoxia research that have led to this failure. We propose that future studies should test a combined approach of targeting the immune system in addition to cellular pathways rendered aberrant in TH and should include development of novel surrogate markers of TH and/or TH imaging.


Asunto(s)
Carcinoma de Células Escamosas/complicaciones , Neoplasias de Cabeza y Cuello/complicaciones , Hipoxia Tumoral , Animales , Carcinoma de Células Escamosas/irrigación sanguínea , Carcinoma de Células Escamosas/terapia , Eritropoyetina/agonistas , Neoplasias de Cabeza y Cuello/irrigación sanguínea , Neoplasias de Cabeza y Cuello/terapia , Humanos , Hipertermia Inducida , Oxígeno/metabolismo , Carcinoma de Células Escamosas de Cabeza y Cuello
5.
Breast Cancer Res Treat ; 150(1): 169-80, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25694355

RESUMEN

5-fluorouracil, epirubicin, cyclophosphamide â†’ docetaxel (FEC-D) has been associated with higher-than-expected rates of febrile neutropenia (FN) that meet the current guideline threshold of 20 % for primary prophylaxis (PP) with granulocyte colony-stimulating factor (G-CSF). We examined the cost-effectiveness of FEC-D with varying strategies of G-CSF prophylaxis from the perspective of the public payer in Ontario, Canada. A state-transition model was developed to compare three strategies: FEC-D with secondary prophylaxis (SP) only, PP starting with the first cycle of D, and PP starting with the first cycle of FEC. Analysis was conducted for a hypothetical cohort of 50-year-old early-stage breast cancer patients undergoing adjuvant chemotherapy, at a 10-year horizon. Results were expressed in quality-adjusted life-years (QALYs) and 2013 Canadian dollars. Costs and benefits were discounted at 5 %. Event rates, costs, and utilities were derived from the literature. One-way and probabilistic sensitivity analyses were conducted. Using filgrastim, the incremental cost-effectiveness ratios (ICERs) for starting PP with the first cycle of D and starting PP with the first cycle of FEC, compared to using SP only, were $57,886/QALY and $116,186/QALY, respectively. With pegfilgrastim, the ICERs for the same strategies were $90,735/QALY and $149,483/QALY. Compared to using filgrastim SP only, starting PP with D had a 24 % chance of being cost-effective at a willingness-to-pay (WTP) threshold of $50,000/QALY, and a 99 % chance at a WTP threshold of $100,000/QALY. Results were sensitive to FN-related parameters, such as the risk of FN per cycle with D and the associated mortality, but were robust to uncertainty in parameters related to breast cancer, such as the utilities and hazard of relapse. FEC-D with PP starting with the first cycle of D is most likely to be cost-effective, especially with increased risk of FN and mortality from FN.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/complicaciones , Análisis Costo-Beneficio , Neutropenia Febril/etiología , Neutropenia Febril/prevención & control , Factor Estimulante de Colonias de Granulocitos/uso terapéutico , Premedicación/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Canadá , Quimioterapia Adyuvante/economía , Ciclofosfamida/administración & dosificación , Docetaxel , Epirrubicina/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Costos de la Atención en Salud , Humanos , Años de Vida Ajustados por Calidad de Vida , Taxoides/administración & dosificación
6.
J Urol ; 190(2): 521-6, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23415964

RESUMEN

PURPOSE: We evaluate long-term disease control and chronic toxicities observed in patients treated with intensity modulated radiation therapy for clinically localized prostate cancer. MATERIALS AND METHODS: A total of 302 patients with localized prostate cancer treated with image guided intensity modulated radiation therapy between July 2000 and May 2005 were retrospectively analyzed. Risk groups (low, intermediate and high) were designated based on National Comprehensive Cancer Network guidelines. Biochemical control was based on the American Society for Therapeutic Radiology and Oncology (Phoenix) consensus definition. Chronic toxicity was measured at peak symptoms and at last visit. Toxicity was scored based on Common Terminology Criteria for Adverse Events v4. RESULTS: The median radiation dose delivered was 75.6 Gy (range 70.2 to 77.4) and 35.4% of patients received androgen deprivation therapy. Patients were followed until death or from 6 to 138 months (median 91) for those alive at last evaluation. Local and distant recurrence rates were 5% and 8.6%, respectively. At 9 years biochemical control rates were 77.4% for low risk, 69.6% for intermediate risk and 53.3% for high risk cases (log rank p = 0.05). On multivariate analysis T stage and prostate specific antigen group were prognostic for biochemical control. At last followup only 0% and 0.7% of patients had persistent grade 3 or greater gastrointestinal and genitourinary toxicity, respectively. High risk group was associated with higher distant metastasis rate (p = 0.02) and death from prostate cancer (p = 0.0012). CONCLUSIONS: This study represents one of the longest experiences with intensity modulated radiation therapy for prostate cancer. With a median followup of 91 months, intensity modulated radiation therapy resulted in durable biochemical control rates with low chronic toxicity.


Asunto(s)
Neoplasias de la Próstata/radioterapia , Radioterapia de Intensidad Modulada/métodos , Anciano , Anciano de 80 o más Años , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Neoplasias de la Próstata/patología , Dosificación Radioterapéutica , Radioterapia de Intensidad Modulada/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
7.
Menopause ; 20(4): 443-7, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23211877

RESUMEN

OBJECTIVE: The purpose of this study was to assess the effect of soy isoflavone supplementation on quality of life in postmenopausal women. METHODS: A multicenter, randomized, double-blind, placebo-controlled 24-month trial was conducted to assess the effect of 80 or 120 mg of daily aglycone hypocotyl soy isoflavone supplementation on quality of life in 403 postmenopausal women using a validated Menopause-Specific Quality of Life questionnaire. RESULTS: Menopause-Specific Quality of Life domain scores at 1 year and 2 years were similar to baseline. There were no differences in domain scores among treatment groups. CONCLUSIONS: Soy isoflavone supplementation offers no benefit to quality of life in postmenopausal women.


Asunto(s)
Isoflavonas/administración & dosificación , Menopausia , Calidad de Vida , beta-Glucanos/administración & dosificación , Adulto , Suplementos Dietéticos , Método Doble Ciego , Endometrio/diagnóstico por imagen , Femenino , Humanos , Isoflavonas/efectos adversos , Persona de Mediana Edad , Placebos , Encuestas y Cuestionarios , Resultado del Tratamiento , Ultrasonografía , beta-Glucanos/efectos adversos
8.
Am J Clin Nutr ; 95(6): 1487-94, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22552034

RESUMEN

BACKGROUND: Isoflavones, having chemical structures similar to estrogens, are believed to stimulate nitric oxide production and thus lower blood pressure. The efficacy of soy isoflavone supplementation to stimulate nitric oxide production and lower blood pressure in menopausal women with high normal blood pressure remains unknown. OBJECTIVE: The objective was to test the effect of soy isoflavone supplementation on nitric oxide production and blood pressure in menopausal women with high normal blood pressure. DESIGN: A randomized, double-blind, parallel, placebo-controlled 6-wk trial was conducted to assess the effects of daily supplementation with 80 mg soy hypocotyl isoflavones (in aglycone units) on nitric oxide metabolism and blood pressure in 24 menopausal women with 12 women per group. Changes in nitric oxide metabolism were assessed via a primed, constant-infusion protocol with [15N]arginine and [13C]- and [2H]citrulline. Changes in blood pressure and associated vascular hemodynamics were assessed via office and 24-h ambulatory blood pressure monitoring, forearm blood flow, and indexes of arterial compliance. RESULTS: When compared with placebo and after control for pretreatment values, soy isoflavone supplementation had no effect on arginine flux, citrulline flux, nitric oxide synthesis, blood pressure, forearm blood flow, or estimates of arterial stiffness. CONCLUSION: Daily supplementation with 80 mg soy hypocotyl isoflavones over a 6-wk period had no effect on nitric oxide metabolism or blood pressure and associated vascular hemodynamics in menopausal women with high normal blood pressure.


Asunto(s)
Presión Sanguínea/efectos de los fármacos , Suplementos Dietéticos , Glycine max/química , Isoflavonas/farmacología , Menopausia/efectos de los fármacos , Óxido Nítrico/metabolismo , Extractos Vegetales/farmacología , Método Doble Ciego , Femenino , Humanos , Hipocótilo , Menopausia/fisiología , Persona de Mediana Edad
9.
Am J Clin Nutr ; 93(2): 356-67, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-21177797

RESUMEN

BACKGROUND: Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety. OBJECTIVE: Our aim was to evaluate the clinical outcomes of soy hypocotyl isoflavone supplementation in healthy menopausal women as a secondary outcome of a trial on bone health. DESIGN: A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg aglycone equivalent soy hypocotyl isoflavones plus calcium and vitamin D on the health of 403 postmenopausal women. At baseline and after 1 and 2 y, clinical blood chemistry values were measured and a well-woman examination was conducted, which included a mammogram and a Papanicolaou test. A cohort also underwent transvaginal ultrasound measurements to assess endometrial thickness and fibroids. RESULTS: The baseline characteristics of the groups were similar. After 2 y of daily isoflavone exposure, all clinical chemistry values remained within the normal range. The only variable that changed significantly was blood urea nitrogen, which increased significantly after 2 y (P = 0.048) but not after 1 y (P = 0.343) in the supplementation groups. Isoflavone supplementation did not affect blood lymphocyte or serum free thyroxine concentrations. No significant differences in endometrial thickness or fibroids were observed between the groups. Two serious adverse events were detected (one case of breast cancer and one case of estrogen receptor-negative endometrial cancer), which was less than the expected population rate for these cancers. CONCLUSION: Daily supplementation for 2 y with 80-120 mg soy hypocotyl isoflavones has minimal risk in healthy menopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.


Asunto(s)
Nitrógeno de la Urea Sanguínea , Suplementos Dietéticos , Glycine max/química , Isoflavonas/farmacología , Fitoestrógenos/farmacología , Extractos Vegetales/farmacología , Posmenopausia/efectos de los fármacos , beta-Glucanos/farmacología , Método Doble Ciego , Femenino , Humanos , Hipocótilo , Isoflavonas/efectos adversos , Persona de Mediana Edad , Fitoestrógenos/efectos adversos , Extractos Vegetales/efectos adversos , beta-Glucanos/efectos adversos
10.
Am J Clin Nutr ; 90(5): 1433-9, 2009 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-19759166

RESUMEN

BACKGROUND: Isoflavones are naturally occurring plant estrogens that are abundant in soy. Although purported to protect against bone loss, the efficacy of soy isoflavone supplementation in the prevention of osteoporosis in postmenopausal women remains controversial. OBJECTIVE: Our aim was to test the effect of soy isoflavone supplementation on bone health. DESIGN: A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg of soy hypocotyl aglycone isoflavones plus calcium and vitamin D on bone changes in 403 postmenopausal women. Study subjects were tested annually and changes in whole-body and regional bone mineral density (BMD), bone mineral content (BMC), and T scores were assessed. Changes in serum biochemical markers of bone metabolism were also assessed. RESULTS: After study site, soy intake, and pretreatment values were controlled for, subjects receiving a daily supplement with 120 mg soy isoflavones had a statistically significant smaller reduction in whole-body BMD than did the placebo group both at 1 y (P < 0.03) and at 2 y (P < 0.05) of treatment. Smaller decreases in whole-body BMD T score were observed among this group of women at 1 y (P < 0.03) but not at 2 y of treatment. When compared with the placebo, soy isoflavone supplementation had no effect on changes in regional BMD, BMC, T scores, or biochemical markers of bone metabolism. CONCLUSION: Daily supplementation with 120 mg soy hypocotyl isoflavones reduces whole-body bone loss but does not slow bone loss at common fracture sites in healthy postmenopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.


Asunto(s)
Densidad Ósea/efectos de los fármacos , Suplementos Dietéticos , Isoflavonas/farmacología , Posmenopausia , beta-Glucanos/farmacología , Adulto , Calcio/farmacología , Relación Dosis-Respuesta a Droga , Femenino , Hormona Folículo Estimulante/sangre , Humanos , Isoflavonas/administración & dosificación , Persona de Mediana Edad , Placebos , Posmenopausia/efectos de los fármacos , Factores de Tiempo , Vitamina D/farmacología , beta-Glucanos/administración & dosificación
11.
Cancer ; 115(23): 5596-606, 2009 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-19670452

RESUMEN

BACKGROUND: In the current study, the effects of dose escalation for localized prostate cancer treatment with intensity-modulated radiotherapy (IMRT) or permanent transperineal brachytherapy (BRT) in comparison with conventional dose 3-dimensional conformal radiotherapy (3D-CRT) were evaluated. METHODS: This study included 853 patients; 270 received conventional dose 3D-CRT, 314 received high-dose IMRT, 225 received BRT, and 44 received external beam radiotherapy (EBRT) + BRT boost. The median radiation doses were 68.4 grays (Gy) for 3D-CRT and 75.6 Gy for IMRT. BRT patients received a prescribed dose of 144 Gy with iodine-125 (I-125) or 120 Gy with palladium-103 (Pd-103), respectively. Patients treated with EBRT + BRT received 45 Gy of EBRT plus a boost of 110 Gy with I-125 or 90 Gy with Pd-103. Risk group categories were low risk (T1-T2 disease, prostate-specific antigen level or=2 factors). RESULTS: With a median follow-up of 58 months, the 5-year biochemical control (bNED) rates were 74% for 3D-CRT, 87% for IMRT, 94% for BRT, and 94% for EBRT + BRT (P <.0001). For the intermediate-risk group, high-dose IMRT, BRT, or EBRT + BRT achieved significantly better bNED rates than 3D-CRT (P <.0001), whereas no improvement was noted for the low-risk group (P = .22). There was no increase in gastrointestinal (GI) toxicity from high-dose IMRT compared with conventional dose 3D-CRT, although there was more grade 2 genitourinary (GU) toxicity (toxicities were graded at the time of each follow-up visit using a modified Radiation Therapy Oncology Group [RTOG] scale). BRT caused more GU but less GI toxicity, whereas EBRT + BRT caused more late GU and GI toxicity than IMRT or 3D-CRT. CONCLUSIONS: The data from the current study indicate that radiation dose escalation improved the bNED rate for the intermediate-risk group. IMRT caused less acute and late GU toxicity than BRT or EBRT + BRT.


Asunto(s)
Braquiterapia/métodos , Neoplasias de la Próstata/radioterapia , Radioterapia de Intensidad Modulada/métodos , Braquiterapia/efectos adversos , Estudios de Seguimiento , Humanos , Masculino , Dosificación Radioterapéutica , Radioterapia de Intensidad Modulada/efectos adversos , Riesgo
12.
J Nutr ; 139(5): 981-6, 2009 May.
Artículo en Inglés | MEDLINE | ID: mdl-19321587

RESUMEN

Soy isoflavones have functional similarity to human estrogens and may protect against breast cancer as a result of their antiestrogenic activity or increase risk as a result of their estrogen-like properties. We examined the relation between isoflavone supplementation and mammographic density, a strong marker for breast cancer risk, among postmenopausal women. The Osteoporosis Prevention Using Soy (OPUS) study, a multi-site, randomized, double-blinded, and placebo-controlled trial assigned 406 postmenopausal women to 80 or 120 mg/d of isoflavones each or a placebo for 2 y. Percent densities were assessed in digitized mammograms using a computer-assisted method. The mammogram reader did not know the treatment status and the time of mammograms. We applied mixed models to compare breast density by treatment while considering the repeated measures. The mammographic density analysis included 358 women, 88.2% of the OPUS participants; 303 had a complete set of 3 mammograms, 49 had 2, and 6 had only 1 mammogram. At baseline, the groups were similar in age, BMI, and percent density, but mean breast density differed by study site (P = 0.02). A model with all mammograms did not show a treatment effect on any mammographic measure, but the change over time was significant; breast density decreased by 1.6%/y across groups (P < 0.001). Stratification by age and BMI did not reveal any effects in subgroups. In this randomized 2-y trial, isoflavone supplements did not modify breast density in postmenopausal women. These findings offer reassurance that isoflavones do not act like hormone replacement medication on breast density.


Asunto(s)
Mama/efectos de los fármacos , Glycine max/química , Isoflavonas/administración & dosificación , Mamografía , Posmenopausia , Adulto , Índice de Masa Corporal , Densidad Ósea , Mama/patología , Neoplasias de la Mama/patología , Método Doble Ciego , Femenino , Humanos , Isoflavonas/efectos adversos , Persona de Mediana Edad , Osteoporosis Posmenopáusica/prevención & control , Placebos , Factores de Riesgo
13.
Int J Comput Biol Drug Des ; 2(1): 58-80, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-20054986

RESUMEN

We describe the use of our Vector Space Model Molecular Descriptor (VSMMD), based on a Vector Space Model (VSM) that is suitable for kernel studies in Quantitative Structure-Activity Relationship (QSAR) modelling. Our experiments provide convincing comparative empirical evidence that this kernel method can provide sufficient discrimination to predict various biological activities of a molecule with reasonable accuracy. Furthermore, together with a kernel feature space algorithm, experiments also provide convincing empirical evidence that our VSMMD can provide sufficient information to identify different binding modes with high accuracy.


Asunto(s)
Relación Estructura-Actividad Cuantitativa , Algoritmos , Sitios de Unión , Biología Computacional , Bases de Datos Factuales , Diseño de Fármacos , Evaluación Preclínica de Medicamentos/estadística & datos numéricos , Ligandos , Modelos Biológicos , Unión Proteica , Interfaz Usuario-Computador
14.
J Nutr ; 137(7): 1828-33, 2007 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-17585038

RESUMEN

The effect of different energy densities of complementary foods on breast milk consumption is not well understood. In this study, we tested the hypothesis that provision of fortified spread (FS), a micronutrient fortified, energy-dense (22 kJ/g), ready-to-use food, to Malawian infants would not decrease their breast milk intake more than a traditional corn + soy blended flour (CSB). Forty-four healthy 6-mo-old infant and mother pairs were enrolled in a prospective, parallel group, investigator-blinded, randomized controlled complementary feeding trial. Infants were randomized to receive 25 g/d of FS, 50 g/d of FS, or 72 g/d of CSB. The primary outcome was the difference in breast milk intake after 1 mo of complementary feeding as measured by the dose-to-mother deuterium oxide dilution technique. Outcomes were compared using repeated measures ANOVA. A total of 41 mother-infant pairs completed the study. At enrollment, 88% of the infants had received corn porridge. At baseline, the infants consumed 129 +/- 18 g.kg body wt(-1) x d(-1) (mean +/- SD) of breast milk. After 1 mo of complementary feeding with 25 g/d FS, 50 g/d FS, or 72 g/d CSB, their breast milk consumption was 115 +/- 18 g.kg body wt(-1) x d(-1), a significant reduction; however, the effects of the complementary foods did not differ from one another (F-value model = 4.33, P = 0.0008 for effect of time and P = 0.69 for effect of type of food). The results suggest that complementary feeding of Malawian infants with FS has the same effect on their breast milk intake as complementary feeding with traditional CSB porridge.


Asunto(s)
Ingestión de Alimentos/fisiología , Alimentos , Alimentos Infantiles , Leche Humana , Valor Nutritivo , Adulto , Femenino , Harina , Alimentos Fortificados , Humanos , Lactante , Malaui , Masculino , Glycine max , Zea mays
15.
Am J Clin Nutr ; 85(1): 90-5, 2007 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-17209182

RESUMEN

BACKGROUND: A better understanding of the associations of early infant nutrition and growth with adult health requires accurate assessment of body composition in infancy. OBJECTIVE: This study evaluated the performance of an infant-sized air-displacement plethysmograph (PEA POD Infant Body Composition System) for the measurement of body composition in infants. DESIGN: Healthy infants (n = 49; age: 1.7-23.0 wk; weight: 2.7-7.1 kg) were examined with the PEA POD system. Reference values for percentage body fat (%BF) were obtained from a 4-compartment (4-C) body-composition model, which was based on measurements of total body water, bone mineral content, and total body potassium. RESULTS: Mean (+/- SD) reproducibility of %BF values obtained with the PEA POD system was 0.4 +/- 1.3%. Mean %BF obtained with the PEA POD system (16.9 +/- 6.5%) did not differ significantly from that obtained with the 4-C model (16.3 +/- 7.2%), and the regression between %BF for the 4-C model and that for the PEA POD system (R2 = 0.73, SEE = 3.7%BF) did not deviate significantly from the line of identity (y = x). CONCLUSIONS: The PEA POD system provided a reliable, accurate, and immediate assessment of %BF in infants. Because of its ease of use, good precision, minimum safety concerns, and bedside accessibility, the PEA POD system is highly suitable for monitoring changes in body composition during infant growth in both the research and clinical settings.


Asunto(s)
Tejido Adiposo/metabolismo , Composición Corporal , Recién Nacido/crecimiento & desarrollo , Modelos Biológicos , Pletismografía/métodos , Absorciometría de Fotón/métodos , Agua Corporal/metabolismo , Agua Corporal/fisiología , Huesos/metabolismo , Femenino , Humanos , Lactante , Fenómenos Fisiológicos Nutricionales del Lactante , Recién Nacido/metabolismo , Masculino , Potasio/metabolismo , Valores de Referencia , Reproducibilidad de los Resultados , Sensibilidad y Especificidad
16.
Ann Thorac Surg ; 81(6): 2031-6, 2006 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-16731125

RESUMEN

BACKGROUND: The role of electroacupuncture in postthoracotomy pain control is uncertain. We conducted a pilot study to evaluate the role of electroacupuncture in the management of early postthoracotomy wound pain. METHODS: A total of 27 patients with operable non-small cell lung carcinoma who received thoracotomy were recruited and randomized to receive either electroacupuncture or sham acupuncture in addition to routine oral analgesics and patient-controlled intravenous analgesia for postoperative pain control. All patients received acupuncture twice daily with visual analog pain score recorded for the first 7 postoperative days. Specific chest acupoints (LI 4, GB 34, GB 36, and TE 8) were targeted. Patient-controlled analgesia was used for the first 3 postoperative days in all patients, and the cumulative dosage used was recorded. RESULTS: Two patients were excluded after randomization because of complications unrelated to acupuncture. Interventions and data collection were completed for the remaining 25 patients (13 in the electroacupuncture group; 12 in the sham acupuncture group). There was a trend for lower visual analog scale pain scores in the electro-acupuncture group between postoperative days 2 and 6, although this did not reach statistical significance. The cumulative dose of patient-controlled analgesia morphine used on postoperative day 2 was significantly lower in the electroacupuncture group (7.5 +/- 5 mg versus 15.6 +/- 12 mg; p < 0.05). Such delay of onset of pain control may be related to the frequency of electroacupuncture used. CONCLUSIONS: Electroacupuncture may reduce narcotic analgesic usage in the early postoperative period. A prospective randomized controlled trial using different electroacupuncture frequency is warranted to verify this benefit.


Asunto(s)
Electroacupuntura , Dolor Postoperatorio/terapia , Toracotomía , Estimulación Eléctrica Transcutánea del Nervio , Acetaminofén/administración & dosificación , Acetaminofén/uso terapéutico , Administración Oral , Anciano , Analgesia Controlada por el Paciente , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/cirugía , Dextropropoxifeno/administración & dosificación , Dextropropoxifeno/uso terapéutico , Método Doble Ciego , Diseño de Equipo , Femenino , Humanos , Neoplasias Pulmonares/cirugía , Masculino , Persona de Mediana Edad , Morfina/administración & dosificación , Morfina/uso terapéutico , Narcóticos/administración & dosificación , Narcóticos/uso terapéutico , Dimensión del Dolor , Dolor Postoperatorio/tratamiento farmacológico , Proyectos Piloto , Placebos , Neumonectomía/métodos , Estudios Prospectivos
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