The potential role of imaging techniques in avoiding neck dissection during salvage surgery after head and neck carcinoma treated with bioradiotherapy.

OBJECTIVE: This study aimed to evaluate the effectiveness of computed tomography and positron emission tomography-computed tomography prior to salvage surgery after head and neck carcinoma treated with bioradiotherapy and to look at the role of neck dissection in this setting. METHOD: This study was a retrospective chart review of a series of consecutive patients with locally advanced head and neck squamous cell carcinoma treated with bioradiotherapy. Radiological and pathological stages were compared to evaluate the accuracy of computed tomography and positron emission tomography-computed tomography in detecting occult neck metastasis in the context of recurrence of primary tumour. In order to assess the impact of neck dissection on survival, Kaplan-Meier survival curves after salvage surgery with and without neck dissection were derived. RESULTS: A total of 268 patients were identified, of which 22 underwent salvage surgery. The negative predictive value of computed tomography and positron emission tomography-computed tomography was excellent. Neck dissection did not represent an improvement on overall, disease specific and regional recurrence free survival (p = 0.67, p = 0.91 and p = 0.62, respectively) amongst clinically and radiologically negative necks. CONCLUSION: Conservative treatment of the neck should be considered when dealing with patients with primary site recurrence or persistent disease after bioradiotherapy without evidence of neck disease.

Effects of preoperative dexamethasone on postoperative pain, nausea, vomiting and respiratory function in women undergoing conservative breast surgery for cancer: Results of a controlled clinical trial.

The objective was to evaluate whether preoperative administration of dexamethasone improved postoperative nausea and vomiting (PONV), pain and respiratory function tests in women undergoing conservative surgery for breast cancer. This was a controlled clinical trial conducted between June 2013 and October 2014. Eighty patients were evaluated. Patients received a preoperative dose of 8 mg of dexamethasone (n = 40) or placebo (n = 40). The data on PONV and pain intensity was obtained and forced spirometry tests were performed, 1 hr before and at 1, 6, 12 and 24 hr after surgery. Any use of additional analgesic/antiemetic drugs was recorded. Patients were followed until 30 days after surgery for any surgical or medical complications. The pain intensity was lower in the treatment group for all periods; PONV was lower at 6, 12 and 24 hr; Additional analgesics/antiemetics were required less frequently (all p < .05). Both groups exhibited a restrictive ventilatory pattern immediately after surgery, which was reversed in the following hours. However, spirometric values were higher in the dexamethasone group. There were no pulmonary or metabolic complications after surgery. Our conclusions were that dexamethasone significantly reduced the incidences of PONV, pain and improved respiratory parameters, and reduced the need for additional postoperative analgesic and antiemetic drugs.

Body weight changes after adjuvant chemotherapy of patients with breast cancer: results of a Mexican cohort study.

Weight gain is observed in breast cancer patients receiving chemotherapy and is a well-known complication. Several factors that contributing to weight gain have been identified. However, there is a lack of information about factors associated with weight changes following adjuvant chemotherapy. A retrospective cohort of 200 pre- and post-menopausal Mexican patients treated for breast cancer was made. Anthropometric variables were measured before/after treatment. Biomarkers, cellular differentiation and chemotherapy were similar between groups. Weight gain occurred in 85.6% of pre-menopausal and 72.6% of post-menopausal women (p = .03). At the end of chemotherapy, weight and body mass index (BMI) did not differ significantly between pre-menopausal (69.3 ± 12.6 kg; 26.6 ± 4.8 kg/m2 ) and post-menopausal women (69.5 ± 10.9 kg; 27.3 ± 4.4 kg/m2 ) (p = .91 and 0.34). Dexamethasone doses were higher in pre-menopausal (85.7 ± 39.1 g) than post-menopausal patients (79.2 ± 22.5 g; p = .13). Weight loss was observed in 9.2% of pre-menopausal and 20.2% of post-menopausal patients (p = .04). A multivariate analysis revealed that age (OR = 2.7; 95% CI = 1.26-5.79; p = .01), menopausal status (OR = 2.29; 95% CI = 1.09-4.80; p = .03), dexamethasone dosage (OR = 2.1; 95% CI = 1.04-4.23; p = .03) and daily caloric intake (OR = 2.3; 95% CI = 1.12-5.10; p = .02) were independent variables that inducted weight gain. Pre- and post-menopausal women gained weight, but more pre-menopausal patients showed gain. An effort should be made to administer lower steroid doses to reduce weight gain.

A genome-wide association study identifies a new locus associated with the response to anti-TNF therapy in rheumatoid arthritis.

Anti-Tumor Necrosis Factor (anti-TNF) drugs are biologic agents commonly used to treat rheumatoid arthritis (RA). However, anti-TNFs are not effective in approximately one out of four treated patients. We conducted a Genome-Wide Association Study (GWAS) to identify the genetic variation associated with the response to anti-TNF therapy in RA. In the discovery stage, 372 RA patients treated with an anti-TNF agent (infliximab, adalimumab or etanercept) were analyzed and treatment response was defined at 12 weeks of therapy. We found a genome-wide significant association in the MED15 gene with the response to etanercept (P<1.5e-8). Using an independent cohort of 245 RA patients, we performed a replication study of the most significant GWAS associations. We replicated the association at the MED15 locus and found suggestive evidence of association in the previously associated MAFB locus. The results of this study suggest novel mechanisms associated with the response to anti-TNF therapies.

Experiencia a largo plazo con condroitín sulfato sódico en pacientes con síndrome de vejiga dolorosa / Long-Term Experience With Sodium Chondroitin Sulfate in Patients With Painful Bladder Syndrome

Objetivo: Valorar la respuesta de pacientes diagnosticadas de síndrome vesical doloroso al tratamiento con instilaciones de condroitín sulfato sódico. Material y métodos: Presentamos una serie de casos de pacientes con síndrome vesical doloroso, que siguieron un protocolo de instilación vesical con condroitín sulfato sódico, según el esquema de nuestro centro. Se evaluó la respuesta al tratamiento en lo que respecta a dolor, según la escala de Downie; frecuencia urinaria, según diario miccional y mejoría subjetiva, según la escala de Impresión Mejoría Global de paciente (PGI- I ). Resultados: Veintiocho pacientes con una mediana de edad de 59 años (rango: 22-90) siguieron este protocolo. Entre los antecedentes clínicos el 19,4% había padecido alguna infección del tracto urinario, el 3,8% tuberculosis urinaria, el 7,6% recibió radioterapia pélvica y el 26,9% había tomado anticolinérgicos por vejiga hiperactiva. Evaluamos la respuesta al tratamiento a los 0-3-6 y 12 meses, encontrando que al final del tratamiento el 72,3% había mejorado del dolor vesical y el 75% de los pacientes se encontraba mucho mejor. Conclusiones: El tratamiento con condroitín sulfato sódico en instilación endovescial en el síndrome de vejiga dolorosa produce mejora del dolor, de la frecuencia miccional y de la calidad de vida a largo plazo (AU)

Objective: To assess the response of patients diagnosed with painful bladder syndrome to treatment with instillations of sodium chondroitin sulfate. Material and methods: We present a series of cases of patients with painful bladder syndrome who followed a bladder instillation protocol with sodium chondroitin sulfate, according to our centre's regimen. The response to treatment was assessed with respect to pain, according to the Downie scale; urinary frequency, according to the voiding diary; and subjective improvement, according to the Patient Global Impression of Improvement (PGI- I ) scale. Results: A total of 28 patients with a median age of 59 years (range 22-90) followed this protocol. From the medical histories, 19.4% had suffered an infection of the urinary tract, 3.8% had suffered urinary tuberculosis, 7.6% received pelvic radiation therapy and 26.9% had taken anticholinergic drugs for overactive bladder syndrome. We evaluated the response to treatment at 0, 3, 6 and 12 months and found that at the end of treatment 72.3% of the patients had improved bladder pain and 75% were significantly better. Conclusions: Treatment with sodium chondroitin sulfate through endovesical instillation in painful bladder syndrome improves pain, voiding frequency and quality of life in the long term (AU)

Long-term experience with sodium chondroitin sulfate in patients with painful bladder syndrome.

OBJECTIVE: To assess the response of patients diagnosed with painful bladder syndrome to treatment with instillations of sodium chondroitin sulfate. MATERIAL AND METHODS: We present a series of cases of patients with painful bladder syndrome who followed a bladder instillation protocol with sodium chondroitin sulfate, according to our centre's regimen. The response to treatment was assessed with respect to pain, according to the Downie scale; urinary frequency, according to the voiding diary; and subjective improvement, according to the Patient Global Impression of Improvement (PGI-I) scale. RESULTS: A total of 28 patients with a median age of 59 years (range 22-90) followed this protocol. From the medical histories, 19.4% had suffered an infection of the urinary tract, 3.8% had suffered urinary tuberculosis, 7.6% received pelvic radiation therapy and 26.9% had taken anticholinergic drugs for overactive bladder syndrome. We evaluated the response to treatment at 0, 3, 6 and 12 months and found that at the end of treatment 72.3% of the patients had improved bladder pain and 75% were significantly better. CONCLUSIONS: Treatment with sodium chondroitin sulfate through endovesical instillation in painful bladder syndrome improves pain, voiding frequency and quality of life in the long term.

Decoherence cross-section in NO + Ar collisions: experimental results and a simple model.

Quantum decoherence can be viewed as the mechanism responsible for the quantum-to-classical transition as the initially prepared quantum state interacts with its environment in an irreversible manner. One of the most common mechanisms responsible for the macroscopically observed decoherence involves collisions of an atom or molecule, initially prepared in a coherent superposition of states, with gas particles. In this work, a coherent superposition of quantum internal states of NO molecules is prepared by the interaction between the molecule with both a static and a radiofrequency electric field. Subsequently, NO + Ar collision decoherence experiments are investigated by measuring the loss of coherence as a function of the number of collisions. Data analysis using a model based on the interaction potential of the collisional partners allowed to unravel the molecular mechanism responsible for the loss of coherence in the prepared NO quantum superposition of internal states. The relevance of the present work relies on several aspects. On the one hand, the use of radio-waves introduces a new way for the production of coherent beams. On the other hand, the employed methodology could be useful in investigating the Stereodynamics of chemical reactions with coherent reagents.

Vibrational excitation of adsorbed molecules by photoelectrons of very low energy: acrylonitrile on Cu(100).

In this study, we report on a powerful method of primary photoelectron scattering by adsorbed species. Specifically, threshold-energy (E(kin,max) < 0.5 eV) two-photon photoelectrons (2PPE) are used to probe acrylonitrile (ACN) molecules chemisorbed onto a Cu(100) substrate, held at room temperature. This has proven to constitute a perfect tool to reveal the ACN vibrational modes in the chemisorbed state. From the dynamics of the directional (perpendicular to the copper surface) electron energy loss we conclude that only a few fundamental vibrational motions of adsorbed ACN are excited, namely the C=C, C≡N and C-H stretch modes. From the excitation probability spectra threshold energies, E(th), of these modes was extracted: E(th)(C=C) = 182(15) meV, E(th)(C≡N) = 248(16) meV--which are shifted noticeably from the equivalent gas phase values; and E(th)(C-H) ∼360-380 meV--which varies only marginally from the gas phase value. The interpretation of the excitation spectra suggests that the di-σ adsorption configuration of the terminal C- and N-atoms dominates, which agrees well with the orientation and bindings predicted in Density Functional Theory (DFT) calculations. Consistent with this is the observation that the contribution to the 2PPE excitation spectra from the C-H stretch motion is by far the largest, which are not directly affected by chemisorption bonding.

[Clinical and economic repercussions of the use of tunneled haemodialysis catheters in a health area]. / Repercusiones clínicas y económicas del uso de catéteres tunelizados de hemodiálisis en un área sanitaria.

INTRODUCTION: Tunneled catheters in hemodialysis are associated with poor prognosis, however, few prospective studies have been designed to specifically evaluate this aspect. The objective has been evaluate the impact of tunneled catheter in patient mortality and costs attributable to this procedure. METHODS: A seven years prospective cohort study was performed in all patients starting hemodialysis in our health care area adjusting for comorbidity and albumin. The study comprised 260 patients with Charlson index 7.05 +/- 2.8 (age 65.5 years, 62.3% males, 25% with diabetes mellitus and 37.7% with a previous cardiovascular event. RESULTS: The first vascular access was a catheter in 47.3%, PTFE in 11.2% and native arteriovenous fistula in 41.5%. Minimum follow-up was one year, with an average of 2.31 years/patient. The mortality risk adjusted for comorbidity was greater among the patients that started with catheterization, HR: 1.86 [1.11-3.05]. This negative effect was observed in 57.30% of those subjected to catheterization at any stage (HR: 1.68 [1.00-2.84] and proved to be time dependent, i.e., the longer catheterization, the greater the risk: HR: 7.66 [3.34-17.54] third versus first tertil. The cost directly attributable to catheter use was 563.31 euros/month. All poor prognosis groups showed lower albumin and hemoglobin levels, without differences in efficacy. CONCLUSION: Tunneled catheter use at any time is associated with an increased risk of death. This effect increases with the duration of catheterization, both circumstances are independent of patient comorbidity at time start of hemodialysis and implies a higher net cost.

Repercusiones clínicas y económicas del uso de catéteres tunelizados de hemodiálisis en un área sanitaria / No disponible

Introducción: el uso de catéteres en hemodiálisis se asocia a un gran número de complicaciones. Sin embargo, se han realizado pocos estudios diseñados específicamente para evaluar este problema. Los objetivos del estudio han sido conocer el impacto en la supervivencia del paciente y el gasto económico que implica la utilización de catéteres. Métodos: estudio observacional y prospectivo histórico de siete años de duración en 260 pacientes incidentes en hemodiálisis en nuestra área de salud, ajustado a la comorbilidad y albúmina al inicio de la hemodiálisis. La media de edad fue de 65,5 ± 15,2 años, 62,3% varones, 25% diabéticos. La media del índice de comorbilidad de Charlson fue de 7,05 ± 2,8. Resultados: el 47,3% de los pacientes inicia hemodiálisis con catéter, el 41,5% con FAV-auto y 11,2% con FAV-PTFE. El seguimiento medio fue 2,31 años/paciente. El riesgo de mortalidad ajustado por comorbilidad fue mayor para los que inician hemodiálisis con un catéter, HR:1,86 (1,11-3,05). Este efecto negativo también se observó en el 57,3% de pacientes que a lo largo del seguimiento requirieron un catéter, HR: 1,68 (1,00-2,84) y, además, fue tiempo dependiente; a mayor tiempo con catéter, mayor mortalidad: HR 7,66 (3,34-17,54), tertil 3 vs. tertil 1. El coste del empleo mes/catéter fue de 561,31 euros. Conclusiones: el uso de catéteres tunelizados es un factor independientemente asociado con la mortalidad de los pacientes, tanto al inicio como a lo largo del seguimiento, es tiempo dependiente y conlleva un elevado coste económico (AU)

Introducction: Tunneled catheters in hemodialysis are associated with poor prognosis, however, few prospective studies have been designed to specifically evaluate this aspect. The objective has been evaluate the impact of tunneled catheter inpatient mortality and costs attributable to this procedure. Methods: A seven years prospective cohort study was performed in all patients starting hemodialysis in our health care area adjusting for comorbidity and albumin. The study comprised 260patients with Charlson index 7.05 ± 2.8 (age 65.5 years, 62.3%males, 25% with diabetes mellitus and 37.7% with a previous cardiovascular event. Results: The first vascular access was a catheter in 47.3%, PTFE in 11.2% and native arteriovenous fistula in 41.5%. Minimum follow-up was one year, with an average of 2.31 years/patient. The mortality risk adjusted for comorbidity was greater among the patients that started with catheterization, HR: 1.86 [1.11-3.05]. This negative effect was observed in 57.30% of those subjected to catheterization at any stage (HR: 1.68 [1.00-2.84] and proved to be time dependent, i.e., the longer catheterization, the greater the risk: HR:7.66 [3.34-17.54] third versus first tertil. The cost directly attributable to catheter use was 563.31 euros/month. All poor prognosis groups showed lower albumin and hemoglobin levels, without differences in efficacy. Conclusion: Tunneled catheter use at any time is associated with an increased risk of death. This effect increases with the duration of catheterization, both circumstances are independent of patient comorbidity at time start of hemodialysisand implies a higher net cost (AU)

[Complications after regional anesthesia]. / Complicaciones tras técnicas de anestesia regional.

In recent years, there has been a considerable increase in the number of procedures carried out under regional anesthesia. The techniques used can be associated with a number of complications, which should be understood so that they can be recognized and managed appropriately. The overall incidence of reported complications associated with these techniques is low and therefore, with currently available data, we can only have an approximate idea of their incidence. The objective of this study is to systematically describe the complications that may arise from the use of neuraxial and peripheral regional anesthesia techniques.

Complicaciones tras técnicas de anestesia regional / Complications after regional anesthesia

En los últimos años se ha producido un incrementoconsiderable del número de procedimientos llevados acabo con técnicas de anestesia regional. Dichas técnicaspueden llevar asociadas una serie de complicacionescuyo conocimiento es importante para la identificación ycorrecto manejo de las mismas. La incidencia global decomplicaciones asociadas a la realización de dichas técnicases baja y por ello, y con los datos de que disponemosen la actualidad, sólo podemos aproximar su incidenciaexacta.En el presente trabajo se pretende ordenar esquemáticamentey describir las posibles complicaciones que sederivan de la realización de técnicas regionales tantoneuroaxiales como periféricas (AU)

In recent years, there has been a considerableincrease in the number of procedures carried out underregional anesthesia. The techniques used can beassociated with a number of complications, which shouldbe understood so that they can be recognized andmanaged appropriately. The overall incidence ofreported complications associated with these techniquesis low and therefore, with currently available data, wecan only have an approximate idea of their incidence.The objective of this study is to systematically describethe complications that may arise from the use ofneuraxial and peripheral regional anesthesia techniques (AU)

Factores predictivos del cumplimiento del tratamiento diario con Raloxifeno y Alendronato / Predictive factors of compliance with daily Raloxifene and Alendronate treatment

El cumplimiento del tratamiento prescrito para la osteoporosis a menudo es inadecuado en la práctica clínica. El objetivo de este análisis fue evaluar los factores predictivos asociados con el cumplimiento del tratamiento diario con raloxifeno y alendronato en la práctica clínica. La influencia de diferentes factores se evaluó como un objetivo secundario en un estudio comparativo, abierto, multicéntrico, con un período de seguimiento de 12 meses. Se incluyeron 902 mujeres posmenopáusicas. Únicamente dos de las variables analizadas se mostraron como predictivas del cumplimiento terapéutico: el tratamiento prescrito (68,7% en las pacientes tratadas con raloxifeno frente al 54,0% en las tra - tadas con alendronato; p < 0,00019) y el tipo de especialidad médica (66,7% de aquellas tratadas por reumatólogos frente al 57,5% en las tratadas por traumatólogos; p < 0,0059). La especialidad del médico y la elección del tratamiento constituyen probablemente el enfoque principal para el problema del cumplimiento terapéutico

Patient compliance to prescribed osteoporosis treatment is often poor in clinical practice and reasons for non-compliance are multifactorial. The aim of this analysis was to evaluate predictive factors associated with compliance to daily treatment with raloxifene and alendronate in clinical practice. The influence of different factors upon the degree of treatment compliance was evaluated as a secondary objective in a comparative, multicentre, open-label study with a 12- month follow-up period. Nine hundred and two postmenopausal women were included in the study. Only two of the variables were found to be predictive of treatment compliance: type of treatment (68,7% of patients administered raloxifene, versus 54,0% treated with alendronate; p < 0.00019) and the type of medical specialist attended (66,7% of the patients treated by rheumatologists, versus 57,5% treated by orthopaedic surgeons; p < 0.0059). The speciality of the physician and the selection of appropriate treatment for each patient are probably the primary approach to the issue of treatment compliance (AU)

[Development of nephrectomy during the nineteenth century and its introduction into Spain]. / Desarrollo de la nefrectomía durante el siglo XIX y su introducción en España.

INTRODUCTION AND OBJECTIVES: After first nephrectomy lumbar made by Dr. Simon in 1869, the surgical technique was established and the procedure access was followed by several surgeons with initial controversy between the use of the intra or extraperitoneal access. We carried out a review about the evolution of this surgical procedure among XIX century and of those who were pioneers with this Kind of technique in our country. MATERIAL AND METHODS: We have reviewed books of history of the Urology, the chapters of surgery in classic urology volumes and the oral presentations to the Spanish Medical congresses, until beginning of XX century and the published nephrectomy procedures in medical literature of that time. RESULTS: We analyzed different statistical studies appeared at the time about results of the operation, the decrease of mortality in the nephrectomies made by extraperitoneal access demonstrated its advantage soon. We found out 35 kidney removal performing the lumbar access, carried out in Spain in the last third of the XX century, three by Dr Federico Rubio and Gall in Madrid, in Barcelona by the urologist Dr. Victor Azcárreta Colán and Jose Pages and by the surgeons Drs. Esquerdo and Salvador Cardinal, from Sevilla, Dr Antonio Solano and the canary urologist Dr. Jose Hernández Perez, who were pioneers performing this procedure in our country. CONCLUSIONS: The introduction of nephrectomy by lumbar access in Spain was delayed in relation to the rest of Europe, due to the secular delay that we dragged, only when adequate conditions of the operating rooms, as much as anaesthesia and asepsis and surgical devices tools, guaranteed the success operation, the main surgeon begun to perform it.

Síndrome de pre-excitación tipo Wolff-Parkinson-White / Wolff-Parkinson-White pre-extitation syndrome

No disponible

Eficacia y seguridad de las inyecciones intraarticulares de ácido hialurónico en la artrosis de rodilla. Evaluación clínica y ecográfica / Efficacy and safety of intraarticular injections of hyaluronic acid in knee osteoarthritis: clinical and ultrasonographic evaluations

Objetivos: Evaluar la eficacia y seguridad del ácido hialurónico (AH) intraarticular en pacientes con artrosis de rodilla. Pacientes y métodos: Estudio prospectivo, multicéntrico, no controlado con 6 meses de seguimiento. Se incluyó a 111 pacientes ambulatorios diagnosticados de artrosis de rodilla según criterios clínicos y radiológicos (excepto grado IV de Kellgren). A los pacientes se les administraron 5 inyecciones intraarticulares de AH (Adant®, Tedec-Meiji Farma S.A.) con cadencia semanal. La eficacia se evaluó a las 2, 12 y 24 postratamiento respecto del dolor global (EVA), índice Lequesne, índice WOMAC, valoración global por el paciente y el investigador (escala tipo Likert), rango de movimiento de flexión y extensión, y consumo de analgésicos. Se realizó ecografía de rodilla al inicio y al final del estudio. La seguridad se valoró mediante registro sistemático de acontecimientos adversos. Resultados: Los pacientes mostraron mejoría estadísticamente significativa en todos los parámetros respecto a los valores basales (p d 0,01). A los 6 meses, el 68% de los pacientes valoró su situación como mejor o mucho mejor. La presencia y cantidad de derrame sinovial en la articulación de la rodilla disminuyó de forma considerable tras el tratamiento. Los acontecimientos adversos fueron, sobre todo, locales y debidos mayoritariamente a la técnica de administración, y aparecieron reacciones por inyección en el 2,4% de los casos. Conclusión: La administración de AH intraarticular es una alternativa eficaz y bien tolerada para el tratamiento de la artrosis de rodilla leve a moderada, con mejoría sintomática de hasta 6 meses(AU)

Objectives: To evaluate the efficacy and safety of hyaluronic acid (HA) therapy in patients with osteoarthritis of the knee. Materials and methods: We performed a prospective, multicenter, noncontrolled study with a 6-month followup. One hundred eleven outpatients with a diagnosis of knee osteoarthritis based on clinical and radiological criteria (except for Kellgren grade IV) were enrolled in the four participating centers. Five sequential intraarticular injections of HA (Adant®, Tedec-Meiji Farma, S.A.) were administered over a 4-week period. Efficacy was evaluated at the follow-up visits (2, 12 and 24 weeks after the final injection) by comparing posttreatment with baseline scores for the following variables: overall knee pain on a visual analog scale, Lequesne Index, WOMAC Index, patient and investigator overall assessment of efficacy on a 5-point Likert scale, knee range of movement, and analgesic consumption. Knee ultrasonography was performed at baseline and at the end of the study. Safety was evaluated by systematic recording of adverse events (AE). Results: A statistically significant improvement in all the efficacy variables analyzed (p d 0.01) compared with baseline values was found at each of the follow-up visits. At 24 weeks, more than 68% of the patients rated their status as better or much better. The presence and amount of intraarticular fluid in the knee joint, assessed by ultrasonography, diminished dramatically after HA treatment. Most of the adverse events were local and were mainly due to the administration technique; the incidence of AEs due to injection was 2.4%. Conclusion: Intraarticular administration of HA is an effective, safe and well-tolerated alternative in the treatment of mild-to-moderate osteoarthritis with symptomatic improvement lasting up to 6 months(AU)

Patient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial.

OBJECTIVE: To compare patient reported measures of function, health related quality of life (QoL), and satisfaction with medication among patients with rheumatoid arthritis (RA) treated with methotrexate (MTX), etanercept, or both for up to 1 year. METHODS: In a 52 week, double blind, clinical trial, patients with active RA were randomised to receive etanercept 25 mg twice weekly, methotrexate up to 20 mg weekly, or combination therapy. The Health Assessment Questionnaire (HAQ) disability index, EuroQoL health status visual analogue scale (EQ-5D VAS), patient global assessment, and patient general health VAS were administered at baseline and weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52. Satisfaction with the medication was compared at 52 weeks. RESULTS: Of 682 enrolled patients, 522 completed 52 weeks of treatment. Mean improvement from baseline in HAQ score was 0.65, 0.70, and 1.0 for MTX, etanercept, and the combination, respectively. The mean percentage and absolute improvement in the HAQ was significantly higher (p<0.01) for combination therapy than for either of the monotherapies. Combination therapy produced significantly more rapid achievement of HAQ < or =0.5 sustained for 6 months than either of the monotherapies (p<0.01). Compared with patients receiving monotherapy, those receiving combination therapy achieved a significantly better (p<0.05) health state as measured by the EQ-5D VAS (mean (SD) 63.7 (3.2), 66.8 (3.2), 72.7 (3.1) for MTX, etanercept, and the combination, respectively). Results were similar for other assessments (p<0.01). Patients in combination and etanercept groups were significantly more likely (p<0.0001, p = 0.0009, respectively) to report satisfaction with the medication. CONCLUSIONS: Combination therapy with etanercept and methotrexate improved function, QoL, and satisfaction with the medication significantly more than monotherapy.

[Efficacy and safety of intraarticular injections of hyaluronic acid in knee osteoarthritis: clinical and ultrasonographic evaluations]. / Eficacia y seguridad de las inyecciones intraarticulares de ácido hialurónico en la artrosis de rodilla. Evaluación clínica y ecográfica.

OBJECTIVES: To evaluate the efficacy and safety of hyaluronic acid (HA) therapy in patients with osteoarthritis of the knee. MATERIALS AND METHODS: We performed a prospective, multicenter, noncontrolled study with a 6-month followup. One hundred eleven outpatients with a diagnosis of knee osteoarthritis based on clinical and radiological criteria (except for Kellgren grade IV) were enrolled in the four participating centers. Five sequential intraarticular injections of HA (Adant(®), Tedec-Meiji Farma, S.A.) were administered over a 4-week period. Efficacy was evaluated at the follow-up visits (2, 12 and 24 weeks after the final injection) by comparing posttreatment with baseline scores for the following variables: overall knee pain on a visual analog scale, Lequesne Index, WOMAC Index, patient and investigator overall assessment of efficacy on a 5-point Likert scale, knee range of movement, and analgesic consumption. Knee ultrasonography was performed at baseline and at the end of the study. Safety was evaluated by systematic recording of adverse events (AE). RESULTS: A statistically significant improvement in all the efficacy variables analyzed (p≤0.01) compared with baseline values was found at each of the follow-up visits. At 24 weeks, more than 68% of the patients rated their status as better or much better. The presence and amount of intraarticular fluid in the knee joint, assessed by ultrasonography, diminished dramatically after HA treatment. Most of the adverse events were local and were mainly due to the administration technique; the incidence of AEs due to injection was 2.4%. CONCLUSION: Intraarticular administration of HA is an effective, safe and well-tolerated alternative in the treatment of mild-to-moderate osteoarthritis with symptomatic improvement lasting up to 6 months.