Oral Platelet Gel Supernatant Plus Supportive Medical Treatment Versus Supportive Medical Treatment in the Management of Radiation-induced Oral Mucositis: A Matched Explorative Active Control Trial by Propensity Analysis.

OBJECTIVES: In this active control trial, the rate of radio-induced WHO grade 3/4 oral mucositis and the change in quality of life, assessed by OMWQ-HN, were measured in subjects with head and neck cancer treated by platelet gel supernatant (PGS) and supportive medical treatment versus subjects treated by supportive medical treatment alone. MATERIALS AND METHODS: Eighty patients with nonmetastatic head and neck cancer underwent curative or adjuvant radiotherapy. All patients underwent supportive medical treatment and/or PGS at the beginning and during radiotherapy. Sixteen patients received PGS in association with supportive medical treatment. To obtain 2 groups virtually randomized for important clinical characteristics subjects were matched, by propensity analysis, with a group of subjects (64 patients) treated with supportive medical treatment alone. RESULTS: Subjects treated with standard supportive treatment experienced significant higher WHO grade 3/4 toxicity (55%; 35/64) than subjects treated by PGS (13%; 3/16). The reduced toxicity found in PGS group paralleled with the evidence that they developed later symptoms with respect to controls. The Cox proportional hazard model indicated that patients treated with standard supportive medical treatment experienced 2.7-fold increase (hazard ratio=2.7; 95% confidence interval, 1.3-5.7) in the occurrence of WHO grade 3/4 toxicity. PGS group significantly experienced higher quality of life than control groups as measured by OMWQ-HN. A significant decrease in the opioid analgesics usage was found in the PGS group. CONCLUSIONS: These preliminary data should be interpreted with caution and could serve as a framework around which to design future trials.

Fingolimod: efectividad y seguridad en la práctica clínica habitual. Estudio observacional, retrospectivo y multicéntrico en Asturias y Cantabria / Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Asturias and Cantabria

Objetivo. Evaluar la efectividad y seguridad del fingolimod en la práctica clínica habitual en la región de Asturias y Cantabria (España). Pacientes y métodos. Estudio retrospectivo y multicéntrico de pacientes con esclerosis múltiple recurrente remitente tratados con fingolimod, según la ficha técnica. La efectividad se evaluó en los pacientes con al menos un año de tratamiento. Se calculó la tasa anualizada de brotes (TAB), el porcentaje de pacientes libres de brotes y libres de lesiones captantes de gadolinio, y los que mejoraron/mantuvieron la puntuación en la escala expandida del estado de discapacidad (EDSS). Se analizó la población total y según el tratamiento previo: inmunomodulador (interferón beta-1 o acetato de glatiramero) o natalizumab. Resultados. Un total de 138 pacientes iniciaron tratamiento con fingolimod; el 60% recibió previamente inmunomodulador; el 28%, natalizumab; y el 9%, ningún tratamiento. Noventa y nueve pacientes estuvieron al menos un año en tratamiento con fingolimod. Después de un año de tratamiento, el fingolimod disminuyó la TAB en un 67% (1,26 a 0,42; p < 0,0001), aumentó el porcentaje de pacientes libres de brotes de un 24% a un 69% (p < 0,0001), y el porcentaje de pacientes libres de lesiones captantes de gadolinio de un 70% a un 85% (p < 0,0106). El 77% de los pacientes mejoró/mantuvo la puntuación en la EDSS. Resultados similares se observaron en pacientes tratados previamente con inmunomodulador. La efectividad de los pacientes tratados previamente con natalizumab se mantuvo tras el tratamiento con fingolimod. Conclusiones. La práctica clínica habitual en las regiones de Asturias y Cantabria muestra que el fingolimod tiene resultados similares a los observados en los ensayos clínicos, al comparar las variables clinicorradiológicas utilizadas en estos últimos (AU)

Aim. To evaluate the effectiveness and safety of fingolimod in routine clinical practice in the region of Asturias and Cantabria (Spain). Patients and methods. We conducted a retrospective multicentre study of patients with relapsing-remitting multiple sclerosis treated with fingolimod, in accordance with the product data sheet. Effectiveness was evaluated in patients with at least one year’s treatment. The following were calculated: annualised relapse rate (ARR), the percentage of patients free from relapses and free from gadolinium-enhancing lesions, and those who improved/maintained their score on the Expanded Disability Status Scale (EDSS). Both total population and according to previous treatment: immunomodulator (interferon beta-1 or glatiramer acetate) or natalizumab, were analysed. Results. A total of 138 patients started treatment with fingolimod; 60% previously received an immunomodulator; 28% were given natalizumab; and 9% had no treatment. Ninety-nine patients were treated with fingolimod for at least one year. After one year of treatment, fingolimod decreased the ARR by 67% (1.26 to 0.42; p < 0.0001), increased the percentage of patients free from relapses from 24% to 69% (p < 0.0001) and the percentage of patients free from gadoliniumenhancing lesions from 70% to 85% (p < 0.0106). Altogether, 77% of the patients improved/maintained their score on the EDSS. Similar results were observed in patients previously treated with an immunomodulator. The effectiveness of the patients previously treated with natalizumab remained the same following treatment with fingolimod. Conclusions. Routine clinical practice in the regions of Asturias and Cantabria shows that fingolimod yields similar results to those observed in clinical trials, on comparing the clinicoradiological variables used in them (AU)

Treatment of Solitary Painful Osseous Metastases with Radiotherapy, Cryoablation or Combined Therapy: Propensity Matching Analysis in 175 Patients.

PURPOSE: aim of this study was to identify outcomes in pain relief and quality of life in patients with a solitary painful osseous metastasis treated by radiotherapy, cryoablation or the combination using a propensity score matching study design. MATERIALS AND METHODS: 175 patients with painful bone metastases were included in the study. Twenty-five of them underwent a radiation course (20 Gy in five daily fractions) 15 days after the cryoablation. These subjects were retrospectively matched by propensity analysis with a group of subjects treated by radiotherapy (125 subjects) and with a group treated byCryoablation (25 subjects). The pain relief in terms of complete response, rate of subjects requiring analgesics after treatments and the changes in self-rated quality of life were measured. Informed consent was obtained from the subject and the study was approved by the local Ethical Committee. RESULTS: An higher proportion of subjects treated by cryoablation (32%) or cryoablation followed by RT (72%;) experienced a complete response compared with patients treated by radiotherapy alone (11.2%). After Bonferroni correction strategy, the addition of radiotherapy to cryoablation significantly improved the rate of complete response compared with cryoablation alone (p = 0.011) and this paralleled with an improved self-rated quality of life. Seventeen subjects (13.6%) of patients in the radiotherapy group, 9 (36%) in the cryoablation group, and 19 (76)% in the cryoablation- radiotherapy group did not require narcotic medications. CONCLUSIONS: The addition of radiotherapy to cryoablation favorably impacts on perceived pain, with a favorable toxicity profile. However, our data should be interpreted with caution and could serve as a framework around which to design future trials.

Long-term outcome after microendoscopic diskectomy for lumbar disk herniation: a prospective clinical study with a 5-year follow-up.

BACKGROUND: Several authors have reported results obtained with the microendoscopic diskectomy (MED) technique, but the long-term outcome has not been described. This report summarizes our clinical experience with the lumbar MED technique with a long-term follow-up period. OBJECTIVE: To evaluate the efficacy of the MED for lumbar disk herniation and to report long-term outcome and complications (5-year follow-up). METHODS: One hundred twenty consecutive patients with lumbar disk herniation were treated with the METRx system.We included all types of lumbar herniated disks: contained, not contained, foraminal, and migrated disk herniations. The results were evaluated with the Visual Analog Scale (VAS) pain score, Oswestry Disability Index score, patient satisfaction questionnaire, and modified Macnab criteria. RESULTS: The average age of patients was 41 years; 65 were men and 55 were women. The most commonly affected level was L5-S1 (54.2%). The follow-up time after surgery was 5 years in all cases. We obtained good or excellent results in 75% of patients and regular results in 18%. Good subjective satisfaction was observed with surgery in 92% of patients. The mean decrease in the Oswestry Disability Index score was 52.8 ± 21.6; the mean decrease in leg VAS score was 6.1 ± 2.3; and the mean decrease in lumbar VAS score was 1.9 ± 3.3. Adjusted mean differences were statistically significant in all cases (P < .05). CONCLUSION: MED not only reduces the incision, tissue damage, and postoperative period of incapacity but also offers long-term results comparable to those of conventional techniques.

Trastornos cardiovasculares en la enfermedad de Parkinson / Cardiovascular disorders in Parkinson’s disease

Introducción. En la enfermedad de Parkinson (EP) existe una denervación simpática cardiaca posganglionar que ya está presente desde fases presintomáticas de la enfermedad y que puede demostrarse mediante la maniobra de Valsalva y la gammagrafía cardiaca con [123]I-metaiodobencilguanidina. Objetivo. Describir las técnicas de estudio de la función noradrenérgica cardiaca y las principales manifestaciones cardiovasculares en pacientes con EP. Desarrollo. La hipotensión ortostática es la disfunción autonómica más incapacitante en pacientes con EP y se relaciona con un aumento de la morbilidad por caídas y traumatismos. En su origen se ha implicado una pérdida de neuronas en las columnas intermediolaterales de la médula, la disfunción autonómica cardiaca y la presencia de cuerpos de Lewy en los plexos vegetativos. Los pacientes afectados pueden beneficiarse de una serie de medidas dietéticas y posturales, y en caso necesario pueden utilizarse fármacos como la fludrocortisona, la midodrina y la piridostigmina. La hipertensión supina es una complicación potencialmente grave que puede verse en pacientes que reciben tratamiento para la hipotensión ortostática con fludrocortisona o midodrina. Conclusiones. El reconocimiento y tratamiento adecuado de las complicaciones cardiovasculares de la EP, especialmente la hipotensión ortostática, puede mejorar de forma significativa la calidad de vida de estos pacientes (AU)

Introduction. In Parkinson’s disease (PD) there is a post-gangliar cardiac sympathetic denervation that is present from the pre-symptomatic phases of the disease onwards and which can be demonstrated by means of the Valsalva manoeuvre and cardiac scintigraphy with [123]I-meta-iodobenzylguanidine. Aim. To describe the techniques for studying the cardiac noradrenergic function and the main cardiovascular manifestations in patients with PD. Development. Orthostatic hypotension is the most disabling autonomic dysfunction in patients with PD and is related with an increase in morbidity due to falls and traumatic injuries. Loss of neurones in the intermediolateral columns of the spinal cord, cardiac autonomic dysfunction and the presence of Lewy bodies in the vegetative plexuses have all been related with its origin. Affected patients can benefit from a series of dietetic and postural measures and, if necessary, can use medication, such fludrocortisone, midodrine and pyridostigmine. Supine hypertension is a potentially serious complication that can appear in patients being treated for orthostatic hypotension with fludrocortisone or midodrine. Conclusions. Suitable recognition and treatment of the cardiovascular complications of PD, especially orthostatic hypotension, can improve these patients’ quality of life to a significant extent (AU)

Midterm outcome after microendoscopic decompressive laminotomy for lumbar spinal stenosis: 4-year prospective study.

OBJECTIVE: To evaluate the efficacy of radicular decompression in lumbar spinal stenosis using a microendoscopic technique. METHODS: This was a longitudinal prospective study of 50 patients with a diagnosis of lumbar spinal stenosis who were treated by microendoscopic decompression using an 18-mm METRx tubular retractor according to the METRx technique (Medtronic Sofamor Danek, Memphis, TN). Twenty of the patients had an additional disc prolapse, and a microendoscopic discectomy was associated with decompressive laminectomy. The results were evaluated using the visual analog scale pain score, Oswestry Disability Index score, patient satisfaction questionnaire, and modified Macnab classification. RESULTS: The average age of the patients was 56 years; 29 (58%) were men and 21 (42%) were women. The most commonly affected level was L4-L5 (64%). The mean surgical intervention time was 94.3 (+/- 14.3) minutes. Mean postoperative hospital stay was 3.16 (+/- 2.3) days. The follow-up time after surgery was 4 years (48 +/- 6.6 months; range, 24-72 months). We obtained good or excellent results in 72% of patients, achieving good subjective satisfaction in 68% of the patients. The mean decrease in the Oswestry Disability Index score was 30.23 (+/- 24.29), the mean decrease in the leg pain visual analog scale score was 6.02 (+/- 2.57), and the mean decrease in the lumbar pain visual analog scale score was 0.84 (+/- 2.06). Adjusted mean differences were in all cases statistically significant (P < 0.05). CONCLUSION: Data indicate that, in our experience, on midterm follow-up, microendoscopic laminectomy decompression is an effective technique for the treatment of lumbar spinal stenosis.

Meningitis aséptica recurrente asociada a la toma de amoxicilina-ácido clavulánico / Recurrent aseptic meningitis associated to amoxyciline-clavulanic acid

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