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1.
Oper Dent ; 45(6): 664-676, 2020 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-32997740

RESUMEN

CLINICAL RELEVANCE: When a resin nanoceramic inlay is cemented using self-adhesive cement, a universal dentin adhesive can be applied to the prepared cavity. The application of the adhesive before self-adhesive cement placement provides similar or better interfacial adaptation than without the adhesive. SUMMARY: Purpose: The first objective of this study was to determine whether the luting material used for computer-aided design and computer-aided manufacture resin nanoceramic inlays affected interfacial adaptation. The second objective was to investigate whether application of a universal dentin adhesive before cementation affected interfacial adaptation. The final objective was to compare the inlay-side and dentin-side interfaces in the cement space.Methods and Materials: Seventy-four class I cavities were prepared on extracted human third molars. Cavities were optically scanned, and resin nanoceramic inlays were milled using Lava Ultimate blocks (3M ESPE). For the control groups, the fabricated inlays were cemented using Panavia V5 (Kuraray Noritake) or FujiCem 2 (GC). For the experimental groups, the teeth were randomly divided into groups I and II. Group I contained four subgroups using different luting materials; in all subgroups, the inlays were cemented and dual cured without pretreatment. Group II contained six subgroups in which inlays were cemented and dual cured after application of a universal dentin adhesive. After thermocycling, interfacial adaptation was measured using swept-source optical coherence tomography (SS-OCT) imaging and statistically compared among groups.Results: Interfacial adaptation was different depending on the luting material used (p<0.05). After application of a universal adhesive, some subgroups showed improved interfacial adaptation (p<0.05). In the comparison of inlay-side and dentin-side interfaces, no difference was found in interfacial adaptation (p>0.05).Conclusions: Interfacial adaptation for resin nanoceramic inlays differed with luting material. For some self-adhesive cements, application of a universal adhesive before cementation improved interfacial adaptation.


Asunto(s)
Incrustaciones , Tomografía de Coherencia Óptica , Resinas Compuestas , Diseño Asistido por Computadora , Preparación de la Cavidad Dental , Porcelana Dental , Humanos , Ensayo de Materiales , Cementos de Resina
2.
Public Health ; 182: 143-150, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-32305513

RESUMEN

OBJECTIVES: The problem of uneven distribution of medical services and inequitable distribution of physicians is drawing much attention worldwide. Revealing how changes in the specialty training system in Japan have affected the distribution of doctors could help us understand this problem. In 2018, a new and standardized specialty training system was implemented by the Japanese Medical Specialty Board, which is recognized by the Ministry of Health, Labor and Welfare. The purpose of this study was to investigate how this new system has affected the geographical distribution of doctors commencing specialty training (trainees) and choice of specialty in Japan. STUDY DESIGN: Retrospective observational study. METHODS: The change in the number of trainees between the control period (2012-2014) and 2018 was investigated, taking into account the prefecture and specialty selected. Population, the proportion of residents aged 65 years or older (aging rate), and the total number of overall doctors in each prefecture were considered as the background characteristics of each prefecture. We created a Lorenz curve and calculated the Gini coefficient for the distribution of trainees. RESULTS: In 2018, the number of trainees per 100,000 population increased to 6.6 nationwide compared with 5.5 during the control period. The number of trainees per 100,000 population in 2018 increased in prefectures with a large population of ≧ 2,000,000, a low aging rate (<27%), and a high doctor density (≧ 250 doctors per 100,000 population). The Gini coefficient showed an increase to 0.226 in 2018 compared with only 0.160 during the control period. CONCLUSIONS: After the implementation of the new training system, there was an increase in the number of doctors enrolling in specialty programs, and the specialties other than internal medicine and surgery have attracted more trainees. Inequality in the distribution of doctors between urban and rural prefectures worsened. This indicates the need to explore new ways of balancing distribution while maintaining optimal opportunities for specialist training.


Asunto(s)
Educación de Postgrado en Medicina/estadística & datos numéricos , Médicos/provisión & distribución , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Japón , Persona de Mediana Edad , Médicos/estadística & datos numéricos , Densidad de Población , Estudios Retrospectivos , Población Rural , Especialización , Población Urbana
3.
Radiat Environ Biophys ; 59(2): 185-209, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-32146555

RESUMEN

Tissue reactions and stochastic effects after exposure to ionising radiation are variable between individuals but the factors and mechanisms governing individual responses are not well understood. Individual responses can be measured at different levels of biological organization and using different endpoints following varying doses of radiation, including: cancers, non-cancer diseases and mortality in the whole organism; normal tissue reactions after exposures; and, cellular endpoints such as chromosomal damage and molecular alterations. There is no doubt that many factors influence the responses of people to radiation to different degrees. In addition to the obvious general factors of radiation quality, dose, dose rate and the tissue (sub)volume irradiated, recognized and potential determining factors include age, sex, life style (e.g., smoking, diet, possibly body mass index), environmental factors, genetics and epigenetics, stochastic distribution of cellular events, and systemic comorbidities such as diabetes or viral infections. Genetic factors are commonly thought to be a substantial contributor to individual response to radiation. Apart from a small number of rare monogenic diseases such as ataxia telangiectasia, the inheritance of an abnormally responsive phenotype among a population of healthy individuals does not follow a classical Mendelian inheritance pattern. Rather it is considered to be a multi-factorial, complex trait.

4.
Ann Oncol ; 31(1): 88-95, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31912801

RESUMEN

BACKGROUND: The phase II J003 (N = 169) and phase III RECOURSE (N = 800) trials demonstrated a significant improvement in survival with trifluridine (FTD)/tipiracil (TPI) versus placebo in patients with refractory metastatic colorectal cancer. This post hoc analysis investigated pharmacokinetic data of FTD/TPI exposure and pharmacodynamic markers, such as chemotherapy-induced neutropenia (CIN) and clinical outcomes. PATIENTS AND METHODS: A total of 210 patients from RECOURSE were enrolled in this substudy. A limited sampling approach was used, with three pharmacokinetic samples drawn on day 12 of cycle 1. Patients were categorized as being above or below the median area under the plasma concentration-time curve (AUC) for FTD and TPI. We conducted a post hoc analysis using the entire RECOURSE population to determine the correlations between CIN and clinical outcome. We then carried out a similar analysis on the J003 trial to validate the results. RESULTS: In the RECOURSE subset, patients in the high FTD AUC group had a significantly increased CIN risk. Analyses of the entire population demonstrated that FTD/TPI-treated patients with CIN of any grade in cycles 1 and 2 had significantly longer median overall survival (OS) and progression-free survival (PFS) than patients who did not develop CIN and patients in the placebo group. Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN. Similar results were obtained in the J003 cohort. CONCLUSIONS: In RECOURSE, patients with higher FTD drug exposure had an increased CIN risk. FTD/TPI-treated patients who developed CIN had improved OS and PFS versus those in the placebo group and those who did not develop CIN. Similar findings were reported in the J003 cohort, thus validating the RECOURSE results. The occurrence of CIN may be a useful predictor of treatment outcomes for FTD/TPI-treated patients. CLINICALTRIALS. GOV IDENTIFIER: NCT01607957 (RECOURSE). JAPAN PHARMACEUTICAL INFORMATION CENTER NUMBER: JapicCTI-090880 (J003).

6.
Nutr Metab Cardiovasc Dis ; 29(5): 518-526, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30935764

RESUMEN

BACKGROUND AND AIMS: Gastric bypass is known to have larger effects on weight and metabolism than gastric banding. However, scarce data exist as to whether the differences are translated into differential risks of cardiovascular disease (CVD)-related morbidities. The objective was to examine whether adults with obesity and CVD who underwent gastric bypass have a lower rate of acute care use (emergency department [ED] visit or unplanned hospitalization) for CVD than those with gastric banding. METHODS AND RESULTS: We performed a comparative effectiveness study of gastric bypass versus banding among adults with obesity and CVD who underwent either surgery, using population-based [ED] and inpatient samples in California, Florida, and Nebraska from 2005 through 2011. The primary outcome was acute care use for CVD during a two-year postoperative period. We constructed negative binomial regression models to compare the event rate during sequential 6-month periods, using gastric banding group as the reference. We identified 11,229 adults with obesity and CVD who underwent gastric bypass and 3896 adults who had gastric banding. Patients with gastric bypass had significantly lower rate of the outcome compared to those with banding in the 7-12 months postoperative period (adjusted rate ratio [aRR] 0.77; 95% confidence interval [CI], 0.61-0.98; P = 0.03). The significant reduction in the rate persisted during 13-18 months (aRR 0.71; 95% CI, 0.57-0.90; P = 0.005) and 19-24 months (aRR 0.66; 95% CI, 0.52-0.82; P < 0.001) after bariatric surgery. CONCLUSION: In this population-based comparative effectiveness study of adults with obesity and CVD, the rate of acute care use for CVD was lower after gastric bypass compared to gastric banding.


Asunto(s)
Enfermedades Cardiovasculares/terapia , Derivación Gástrica , Gastroplastia , Obesidad/cirugía , Adulto , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Investigación sobre la Eficacia Comparativa , Femenino , Derivación Gástrica/efectos adversos , Gastroplastia/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Obesidad/diagnóstico , Obesidad/epidemiología , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiología
7.
Br J Oral Maxillofac Surg ; 57(3): 260-264, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30910414

RESUMEN

Bilateral sagittal split ramus osteotomy (BSSRO) is commonly used in orthognathic surgery. Although abnormal sensation in areas that are innervated by the inferior alveolar nerve is a well-known neurological complication of mandibular osteotomy, facial palsy is rare postoperatively. We present a case of peripheral facial palsy that developed the day after BSSRO to correct a mandibular protrusion in a 42-year-old man. Oral prednisolone was begun on the second day postoperatively, and was gradually tapered off over time. One month after operation, he had gradually recovered all movements in his right facial muscle and, after two months, had completely recovered without residual asymmetry. Possible causes of the palsy were compression of the facial nerve as a result of the insertion of a retractor around the posterior border of the ramus, and postoperative oedema. Peripheral facial palsy after BSSRO should be considered a rare, but possible, complication and as such, should be mentioned in consent forms.


Asunto(s)
Parálisis Facial , Osteotomía Sagital de Rama Mandibular , Adulto , Parálisis Facial/etiología , Humanos , Masculino , Mandíbula , Nervio Mandibular , Osteotomía Mandibular , Osteotomía Sagital de Rama Mandibular/efectos adversos
8.
Osteoporos Int ; 29(12): 2659-2665, 2018 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-30105400

RESUMEN

We compared the effectiveness of promoting bone healing between two teriparatide preparations for atypical femoral fracture (AFF). A total of 45 AFFs were included in this study, and we compared the duration of bone union. Teriparatide administered by daily injection enhanced bone union more than weekly administration in complete AFFs. INTRODUCTION: The efficacy of teriparatide for atypical femoral fracture (AFF) has been recently reported. Although two different teriparatide preparations can be used to treat osteoporosis in Japan, daily or weekly injection, all previous reports on the effectiveness of teriparatide for AFF only examined daily injection formulations. Therefore, we compared the promotion of bone healing between the two teriparatide preparations for AFF. METHODS: A total of 45 consecutive AFFs in 43 Japanese patients were included in this study. They received either a daily 20-µg teriparatide injection (daily group; n = 32) or a once-a-week 56.5-µg teriparatide injection (weekly group; n = 13). We compared the clinical background and duration of bone union between these two groups. RESULTS: When all patents were included, the fracture healing time was not significantly different between the two groups. Only patients with complete AFFs had significantly fewer daily bisphosphonate or denosumab injections than the weekly group (P < 0.05). The fracture healing time in the daily group (6.1 ± 4.1 months) was significantly shorter than that in the weekly group (10.1 ± 4.2 months) (P < 0.05). Even if the influence of bisphosphonate or denosumab usage was excluded, a similar significant difference was observed in the fracture healing time (P < 0.05). There was no significant difference between the two groups among patients with incomplete AFFs. CONCLUSIONS: Daily teriparatide injections enhance bone union more than weekly injections in complete AFF patients.


Asunto(s)
Conservadores de la Densidad Ósea/administración & dosificación , Fracturas del Fémur/tratamiento farmacológico , Curación de Fractura/efectos de los fármacos , Fracturas Osteoporóticas/tratamiento farmacológico , Teriparatido/administración & dosificación , Anciano , Anciano de 80 o más Años , Conservadores de la Densidad Ósea/uso terapéutico , Terapia Combinada , Esquema de Medicación , Femenino , Fracturas del Fémur/fisiopatología , Fracturas del Fémur/cirugía , Fijación Interna de Fracturas/métodos , Humanos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Fracturas Osteoporóticas/fisiopatología , Fracturas Osteoporóticas/cirugía , Estudios Retrospectivos , Teriparatido/uso terapéutico
11.
J Hosp Infect ; 99(1): 31-35, 2018 May.
Artículo en Inglés | MEDLINE | ID: mdl-29258919

RESUMEN

BACKGROUND: Several reports have been published regarding cost increases attributable to surgical site infections (SSIs) in Europe and the USA. However, such studies have been limited in Japan. AIM: To evaluate the economic burden of colorectal SSIs on hospitals in Japan. METHODS: This study was undertaken at a Japanese university hospital. Amongst 265 patients who had undergone colorectal surgery in the Department of Coloproctological Surgery between November 2014 and March 2016, 16 patients who developed SSIs and could be allocated a diagnosis procedure combination code were selected as SSI cases. Individual SSI cases were matched to non-SSI cases based on a combination of surgical category, age band, sex, wound class, presence of stoma and risk index. Median length of stay (LOS) and piecework reference cost were compared between SSI episodes and non-SSI episodes. FINDINGS: The median LOS for patients with SSI and without SSI was 25.5 [interquartile range (IQR) 21.5-39.3] and 16.5 (IQR 12.5-18.5) days, respectively (P<0.01). The median piecework reference cost for patients with SSI and without SSI was ¥842,155 (IQR ¥716,423-1,388,968) and ¥575,795 (IQR ¥529,638-680,105), respectively (P<0.01). CONCLUSION: SSIs led to a significant increase in LOS and economic burden. Although the SSI episodes appear to be more profitable than the non-SSI episodes, the economic profit for SSI episodes was less than that for non-SSI episodes in the observation period, when opportunity costs were taken into account.


Asunto(s)
Cirugía Colorrectal/efectos adversos , Costos de Hospital , Hospitales Universitarios , Infección de la Herida Quirúrgica/economía , Infección de la Herida Quirúrgica/epidemiología , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Japón/epidemiología , Tiempo de Internación , Masculino , Persona de Mediana Edad
12.
Osteoporos Int ; 28(11): 3153-3160, 2017 11.
Artículo en Inglés | MEDLINE | ID: mdl-28785980

RESUMEN

This study compared spinal alignment, muscular strength, and quality of life (QOL) between women with postmenopausal osteoporosis and healthy volunteers. The results indicated that lower QOL in osteoporosis patients may be associated with increased thoracic kyphosis, reduced lean muscle mass, and generalized muscle weakness. INTRODUCTION: Increased spinal kyphosis is common in patients with osteoporosis and negatively impacts quality of life (QOL). Muscular strength is also important for QOL in patients with osteoporosis. However, spinal kyphosis and muscle weakness also occur in healthy individuals with advancing age. The purposes of this study were thus to compare spinal alignment, muscular strength, and QOL between women with postmenopausal osteoporosis and healthy volunteers. METHODS: Participants comprised 236 female patients with postmenopausal osteoporosis (mean age, 68.7 years) and 93 healthy volunteer women (mean age, 71.0 years). Body mass index (BMI), angles of spinal kyphosis, back extensor strength, grip strength, and QOL were compared between groups. RESULTS: BMI, back extensor strength, and grip strength were significantly higher in the volunteer group than in the osteoporosis group (p < 0.01). Both thoracic kyphosis and lumbar lordosis were significantly greater in the osteoporosis group than in the volunteer group (p < 0.01). With regard to QOL, the 36-Item Short-Form Health Survey (SF-36) subscale scores of role physical, bodily pain, general health, and role emotional were all significantly lower in the osteoporosis group than in the volunteer group (p < 0.05 each). SF-36 physical component summary (PCS) score was significantly lower in the osteoporosis group than in the volunteer group (p < 0.001). SF-36 PCS score correlated positively with thoracic kyphosis and negatively with BMI only in the osteoporosis group (p < 0.05 each). CONCLUSIONS: These results indicated that lower QOL in osteoporosis patients may be associated with increased thoracic kyphosis, reduced lean muscle mass, and generalized muscle weakness.


Asunto(s)
Cifosis/etiología , Fuerza Muscular/fisiología , Osteoporosis Posmenopáusica/complicaciones , Calidad de Vida , Anciano , Estudios de Casos y Controles , Femenino , Fuerza de la Mano/fisiología , Humanos , Cifosis/patología , Lordosis/etiología , Lordosis/patología , Persona de Mediana Edad , Osteoporosis Posmenopáusica/fisiopatología , Osteoporosis Posmenopáusica/rehabilitación , Psicometría , Vértebras Torácicas/patología
13.
J Dent Res ; 96(9): 992-998, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28521113

RESUMEN

The aims of this study were to observe the behavior of composite and formation of gaps during and immediately after light polymerization using swept source optical coherence tomography (OCT) and to compare the interfacial integrity of adhesives in cavities through 3-dimensional (3D) image analysis. Forty tapered cylindrical cavities (4-mm diameter, 2-mm depth) were prepared in bovine incisors and restored using Bond Force (BF), Scotchbond Universal Adhesive (SBU), OptiBond XTR (XTR), or Clearfil SE Bond 2 (SE2), followed by Estelite Flow Quick flowable composite. Real-time imaging was performed at the center of restoration by the OCT system (laser center wavelength: 1,330 nm; frequency: 30 KHz) during and up to 10 min after light curing. The 3D scanning was performed 0, 1, 3, 5, and 10 min after light curing. The percentages of sealed enamel and dentin interface area (E%, D%) were calculated using Amira software. In real-time videos, the initial gaps appeared as a bright scattered area mainly on dentin floor and rapidly progressed along the cavity floor. The timing, rate, and extent of gap formation were different among the specimens. From 3D visualization, gap progress could be seen on both enamel and dentin even after irradiation; furthermore, typical toroidal gap patterns appeared at the dentin floor of BF and SBU. XTR and SE2 showed nearly perfect sealing performance on the dentin floor up to the 10 min that images were recorded. From quantitative analysis, SE2 and XTR showed significantly higher E% and D% than other groups. SBU showed the smallest E% and BF showed a significantly smaller D% than other groups ( P < 0.05). In conclusion, real-time observation of composite placement and 3D quantification of interfacial gaps were implemented within the experimental limitations. Interfacial gap formation during polymerization of the composite depended on the adhesive system used. The formed gaps continued to propagate after composite light curing finished.


Asunto(s)
Resinas Compuestas/química , Curación por Luz de Adhesivos Dentales , Tomografía de Coherencia Óptica , Animales , Bovinos , Luces de Curación Dental , Esmalte Dental , Dentina , Imagenología Tridimensional , Incisivo , Ensayo de Materiales , Polimerizacion , Cementos de Resina , Programas Informáticos , Propiedades de Superficie , Grabación en Video
16.
J Forensic Odontostomatol ; 35(2): 97-108, 2017 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-29384741

RESUMEN

BACKGROUND: The nature of differences in the timing of tooth formation between ethnic groups is important when estimating age. AIM: To calculate age of transition of the mandibular third (M3) molar tooth stages from archived dental radiographs from sub-Saharan Africa, Malaysia, Japan and two groups from London UK (Whites and Bangladeshi). MATERIALS AND METHODS: The number of radiographs was 4555 (2028 males, 2527 females) with an age range 10-25 years. The left M3 was staged into Moorrees stages. A probit model was fitted to calculate mean ages for transitions between stages for males and females and each ethnic group separately. The estimated age distributions given each M3 stage was calculated. To assess differences in timing of M3 between ethnic groups, three models were proposed: a separate model for each ethnic group, a joint model and a third model combining some aspects across groups. The best model fit was tested using Bayesian and Akaikes information criteria (BIC and AIC) and log likelihood ratio test. RESULTS: Differences in mean ages of M3 root stages were found between ethnic groups, however all groups showed large standard deviation values. The AIC and log likelihood ratio test indicated that a separate model for each ethnic group was best. Small differences were also noted between timing of M3 between males and females, with the exception of the Malaysian group. These findings suggests that features of a reference data set (wide age range and uniform age distribution) and a Bayesian statistical approach are more important than population specific convenience samples to estimate age of an individual using M3. CONCLUSION: Some group differences were evident in M3 timing, however, this has some impact on the confidence interval of estimated age in females and little impact in males because of the large variation in age.


Asunto(s)
Determinación de la Edad por los Dientes/métodos , Grupos de Población Continentales , Tercer Molar/diagnóstico por imagen , Tercer Molar/crecimiento & desarrollo , Adolescente , Adulto , Niño , Femenino , Humanos , Funciones de Verosimilitud , Masculino , Mandíbula/diagnóstico por imagen , Adulto Joven
17.
J Dent Res ; 96(3): 308-314, 2017 03.
Artículo en Inglés | MEDLINE | ID: mdl-27872333

RESUMEN

The aim of this study was to nondestructively analyze enamel crack behavior on different areas of teeth using 3D swept source-optical coherence tomography (SS-OCT). Ten freshly extracted human teeth of each type on each arch ( n = 80 teeth) were inspected for enamel crack patterns on functional, contact and nonfunctional, or noncontact areas using 3D SS-OCT. The predominant crack pattern for each location on each specimen was noted and analyzed. The OCT observations were validated by direct observations of sectioned specimens under confocal laser scanning microscopy (CLSM). Cracks appeared as bright lines with SS-OCT, with 3 crack patterns identified: Type I - superficial horizontal cracks; Type II - vertically (occluso-gingival) oriented cracks; and Type III - hybrid or complicated cracks, a combination of a Type I and Type III cracks, which may or may not be confluent with each other. Type II cracks were predominant on noncontacting surfaces of incisors and canines and nonfunctional cusps of posterior teeth. Type I and III cracks were predominant on the contacting surfaces of incisors, cusps of canines, and functional cusps of posterior teeth. Cracks originating from the dental-enamel junction and enamel tufts, crack deflections, and the initiation of new cracks within the enamel (internal cracks) were observed as bright areas. CLSM observations corroborated the SS-OCT findings. We found that crack pattern, tooth type, and the location of the crack on the tooth exhibited a strong correlation. We show that the use of 3D SS-OCT permits for the nondestructive 3D imaging and analysis of enamel crack behavior in whole human teeth in vitro. 3D SS-OCT possesses potential for use in clinical studies for the analysis of enamel crack behavior.


Asunto(s)
Esmalte Dental/lesiones , Imagenología Tridimensional , Tomografía de Coherencia Óptica/métodos , Fracturas de los Dientes/diagnóstico , Síndrome de Diente Fisurado/diagnóstico , Esmalte Dental/patología , Humanos , Técnicas In Vitro , Microscopía Confocal/métodos
18.
Ann Oncol ; 27(8): 1601-6, 2016 08.
Artículo en Inglés | MEDLINE | ID: mdl-27358385

RESUMEN

BACKGROUND: There has been no phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy (HEC). PATIENTS AND METHODS: Patients with a malignant solid tumor who would receive HEC containing 50 mg/m(2) or more cisplatin were randomly assigned to either palonosetron (0.75 mg) arm (Arm P) or granisetron (1 mg) arm (Arm G), on day 1, both arms with dexamethasone (12 mg on day 1 and 8 mg on days 2-4) and aprepitant (125 mg on day 1 and 80 mg on days 2-3). The primary end point was complete response (CR; no vomiting/retching and no rescue medication) at the 0-120 h period and secondary end points included complete control (CC; no vomiting/retching, no rescue medication, and no more than mild nausea) and total control (TC; no vomiting/retching, no rescue medication, and no nausea). RESULTS: Between July 2011 and June 2012, 842 patients were enrolled. Of 827 evaluable, 272 of 414 patients (65.7%) in Arm P had a CR at the 0-120 h period when compared with 244 of 413 (59.1%) in Arm G (P = 0.0539). Both arms had the same CR rate of 91.8% at the acute (0-24 h) period, while at the delayed (24-120 h) period, Arm P had a significantly higher CR rate than Arm G (67.2% versus 59.1%; P = 0.0142). In secondary end points, Arm P had significantly higher rates than Arm G at the 0-120 h period (CC rate: 63.8% versus 55.9%, P = 0.0234; TC rate: 47.6% versus 40.7%, P = 0.0369) and delayed periods (CC rate: 65.2% versus 55.9%, P = 0.0053; TC rate: 48.6% versus 41.4%, P = 0.0369). CONCLUSION: The present study did not show the superiority of palonosetron when compared with granisetron in the triplet regimen regarding the primary end point. CLINICAL TRIAL REGISTRY IDENTIFIER: UMIN000004863.


Asunto(s)
Cisplatino/administración & dosificación , Granisetrón/administración & dosificación , Isoquinolinas/administración & dosificación , Neoplasias/tratamiento farmacológico , Quinuclidinas/administración & dosificación , Adulto , Anciano , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Cisplatino/efectos adversos , Método Doble Ciego , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Femenino , Granisetrón/efectos adversos , Humanos , Isoquinolinas/efectos adversos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Náusea/patología , Neoplasias/patología , Palonosetrón , Quinuclidinas/efectos adversos , Antagonistas de la Serotonina/administración & dosificación , Antagonistas de la Serotonina/efectos adversos , Vómitos/inducido químicamente , Vómitos/patología
19.
Ann Oncol ; 27(4): 673-9, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26747859

RESUMEN

BACKGROUND: The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. PATIENTS AND METHODS: Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m(2)) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. RESULTS: Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. CONCLUSION: In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. CLINICALTRIALSGOV: NCT01170663.


Asunto(s)
Adenocarcinoma/tratamiento farmacológico , Anticuerpos Monoclonales/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias Esofágicas/tratamiento farmacológico , Paclitaxel/administración & dosificación , Adenocarcinoma/patología , Adulto , Anciano , Anticuerpos Monoclonales Humanizados , Supervivencia sin Enfermedad , Neoplasias Esofágicas/patología , Unión Esofagogástrica/efectos de los fármacos , Unión Esofagogástrica/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Resultado del Tratamiento
20.
Radiat Prot Dosimetry ; 168(1): 61-71, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-25669653

RESUMEN

Since diagnostic reference levels (DRLs) for children are not currently established in Japan, the authors determined local DRLs for the full range of paediatric CT examinations in a single tertiary care children's hospital. A retrospective review of 4801 CT performance records for paediatric patients (<15 y old) who had undergone CT examinations from 2008 to 2011 was conducted. The most frequent examinations were of the head (52 %), followed by cardiac (15 %), temporal bone (9 %), abdomen (7 %), chest (6 %) and others (11 %). Approximately one-third of children received two or more CT scans. The authors' investigation showed that mean CTDIvol and DLP for head, chest and abdomen increased as a function of age. Benchmarking of the results showed that CTDIvol, DLP and effective dose for chest and abdomen examinations in this hospital were below average, whereas those for the head tended to be at or slightly above average of established DRL values from five countries. The results suggest that CT examinations as performed in a tertiary children's hospital in Japan are well optimised.


Asunto(s)
Pediatría , Tomografía Computarizada por Rayos X/normas , Adolescente , Niño , Preescolar , Femenino , Hospitales Pediátricos , Humanos , Lactante , Japón , Masculino , Dosis de Radiación , Radiometría , Valores de Referencia , Estudios Retrospectivos , Centros de Atención Terciaria
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