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International audience; IntroductionThe growing number of oral antineoplastic agents delivered by French community pharmacies has modified the job and roles of community pharmacists. Coordination between hospitals (oncology centers) and community pharmacies has become essential for a quality work in this field. The goal of this work was to obtain information about the feeling of the community pharmacies teams in a French county (Aveyron) regarding the communication tools offered by various hospitals with an oncology service (when receiving a beginning prescription for an oral antineoplastic drug), and to evaluate the impact of these tools on their practice.MethodsA declarative survey was submitted to the 109 community pharmacies of this county to evaluate their relationship with their nearest oncology centers (including communication tools) and collect their opinion on the quality of the coordination and their pharmaceutical exercise.ResultsThe response rate was of 54% (59 community pharmacies). Communication between the oncology centers and the pharmacies was limited (only 50% of the pharmacies received information complementary to the prescription), the available tools were not used very frequently (44% of pharmacies didn’t use shared medical records) and there was a strong feeling of rupture between the pharmacies and the oncology centers, impacting the quality of their work (46% of respondents indicated being little or incapable of correctly validating the indication of the anticancer drug).DiscussionThis study illustrates the under-use of the available hospital-community pharmacy communication tools and the fact that the pharmacies feel difficulties to correctly deliver oral antineoplastic medications due to a lack of information.

The trial was financed by Ministerio de Sanidad y Consumo Español through their call for independent clinical research, Orden Ministerial SAS/2377, 2010 (EC10-115, EC10-116, EC10-117, EC10-119, EC10-122); CAIBER—Spanish Clinical Research Network, Instituto de Salud Carlos III (ISCIII) (CAI08/010044); and Gerencia Asistencial de Atención Primaria de Madrid. This study is also supported by the Spanish Clinical Research Network (SCReN), funded by ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, project number PT13/0002/0007, within the National Research Program I+D+I 2013-2016 and co-funded with European Union ERDF funds (European Regional Development Fund). This project received a grant for the translation and publication of this article from the Foundation for Biomedical Research and Innovation in Primary Care (FIIBAP) Call 2017 for grants to promote research programs. Objectives To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. Design Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. Interventions The IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. Main outcomes Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. Results The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. Conclusions Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low. Publisher PDF

Aims Real-world data on treatment persistence, safety and effectiveness of non-Vitamin K antagonist oral anticoagulants (NOACs) play an important role in the assessment of risks and benefits of these drugs. Our aim was to evaluate persistence on treatment, incidence of major bleeding and incidence of a composite endpoint of major events, including all-cause death, myocardial infarction, stroke and systemic thromboembolism, during treatment with apixaban in a cohort of patients with nonvalvular atrial fibrillation (NVAF). Methods In this multicentre retrospective observational study, we retrieved data from medical records of five Italian hospitals on patients with a diagnosis of NVAF who initiated apixaban between 1 January 2014 and 31 March 2016 and had a first subsequent visit at the same hospital. Results We studied 766 patients with mean age of 74.2 (standard deviation 11.1) years and median CHADS2 and CHA2DS2VASc scores of 2.0 and 4.0, respectively. Over a median follow-up period of 339 days, persistence on treatment was 83.5% [95% confidence interval (95% CI) 75.5-89.1%]. The rate of major bleeding (per 100 person-years) was 1.15 (95% CI 0.39-1.90 per 100 person-years), while the cumulative incidence was 4.4% (95% CI 1.6-12.0). The rate of major events was 1.97 (95% CI 1.08-2.86) per 100 patient-years, with a cumulative incidence over the entire follow-up period of 7.7% (95% CI 4.6-12.8). Conclusion In real-life conditions, NVAF patients treated with apixaban show rates of treatment discontinuation and major bleedings, which are comparable to those found in the ARISTOTLE pivotal study, thus supporting its external validity.

Introduction The management of anxious patients undergoing dental procedures is still a challenge in clinical practice. Despite a wide variety of drugs for oral sedation in adult patients, there are relatively few systematic reviews that compare the effectiveness and safety of different drugs administered via this route. Thus, this study will evaluate the effectiveness and safety of oral sedation with benzodiazepines and other agents to patients undergoing dental surgical procedures. Method/design We will conduct a systematic review and, if appropriate, a meta-analysis of randomised controlled clinical trials that will evaluate the use of conscious sedation administered orally to adult patients undergoing oral surgery. The search will be conducted using electronic databases, such as the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), CINAHL (via Ovid), Lilacs (SciELO) and Capes database, without restriction of languages or date of publication. Primary outcomes include anxiety, sedation, treatment satisfaction, pain and adverse effects. Secondary outcomes include vital parameters (heart rate, respiratory rate and blood pressure) and patient cooperation during intervention. A team of reviewers will independently assess each citation for eligibility and in duplicates. For eligible studies, the same reviewers will perform data extraction, risk of bias assessment and determination of the overall quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation classification system. Ethics and dissemination The evidence gathered from this study should provide dental surgeons with knowledge on the effectiveness and safety of oral sedation in adults requiring dental surgical procedures. This in turn should contribute towards the decision-making process in dental practice, minimising the risks of anxiety and ineffective pain control in clinical procedures, as well as possible side effects. Ethics approval is not required in protocols for systematic reviews. The systematic review will be published in a peer-reviewed journal and presented at conferences. PROSPERO registration number CRD42017057142.

Trabajo fin de grado en Enfermería, Introducción: Los pacientes con tumores de cabeza y cuello van a tener dificultades a la hora de alimentarse motivados por las características inherentes de la patología tumoral y por los efectos del tratamiento, lo cual puede implicar que presenten un estado de malnutrición. Objetivo: Revisar la evidencia científica disponible acerca de la utilización de la alimentación enteral de estos pacientes y cuidados enfermeros más adecuados, e identificar las vías de acceso enteral más prevalentes y las complicaciones que presentan. Método: Se realizó una revisión narrativa en las siguientes bases de datos: Pubmed, Cinahl, Cochrane, Scielo, PsycINFO, la Biblioteca Virtual de Salud y Cuiden. Se encontraron un total de 21 artículos. Resultados: Los accesos enterales más utilizados en estos pacientes son la sonda nasogástrica (SNG) y la gastrostomía, concretamente la gastrostomía endoscópica percutánea (PEG). La elección va a depender del tiempo en que los pacientes necesiten el soporte nutricional. Existen factores predictores que pueden prever quién de estos pacientes tienen un riesgo mayor de sufrir complicaciones respecto a la nutrición. Una de las complicaciones graves a pesar de su poca frecuencia son los casos de metástasis en el lugar de inserción de la PEG. Las intervenciones enfermeras en relación la alimentación enteral y los cuidados a estos pacientes presentan buenos resultados. Conclusiones: Destaca el beneficio del uso profiláctico de la PEG en pacientes que van a ser sometidos al tratamiento contra el cáncer. La enfermera tiene un papel fundamental en la prevención de las complicaciones y realización de los cuidados., Introduction: Patients with head and neck tumors will have feeding difficulties due to the inherent characteristics of the tumor pathology and the effects of the treatments, which may imply that these patients present a state of malnutrition. Objective: To review the available scientific evidence about the use of enteral feeding of these patients and the most appropriate nursing care, to identify the most prevalent enteral access roads and their complications. Method: A narrative review was made in the following databases: Pubmed, Cinahl, Cochrane, Scielo, PsycINFO, Biblioteca Virtual de Salud and Cuiden. 21 articles were found. Results: The most commonly used enteral access in these patients are the nasogastric tube (NGT) and gastrostomy, specifically the percutaneous endoscopic gastrostomy (PEG). The choice will depend on the time in which patients need nutritional support. There are predictive factors that can predict who of these patients have a higher risk of complications with respect to nutrition. Despite its low frequency, a serious complication is the metastasis in the place of insertion of the PEG. Nursing interventions in relation to enteral feeding and care to these patients have good results. Conclusions: Highlights the benefit of prophylactic use of the PEG in patients who are going to be undergoing cancer treatment. The nurse has a fundamental role in the prevention of complications and realization of care.

BACKGROUND Following the potent efficacy of β-D-mannuronic acid (M2000) in phase I/II trial in ankylosing spondylitis patients, the present clinical trial was conducted to evaluate the efficacy, safety, and tolerability of this novel drug in rheumatoid arthritis (RA) patients who had inadequate response to conventional therapy. METHOD The study was a 12-week randomized, controlled, phase I/II clinical trial with two treatment arms: M2000 and conventional treatment. Patients who had RA according to the modified American College of Rheumatology (ACR) criteria, with active disease at baseline also inadequate response to conventional therapy, were enrolled in this study. M2000 was administrated at a dose of two capsules (500 mg) per day orally during a period of 12 weeks. The primary endpoint was the proportion of patients fulfilling the ACR 20% improvement criteria after 12 weeks of M2000 therapy. Moreover, the patients were also followed up for safety. RESULTS There were no statistically significant differences between treatment and conventional groups at baseline characteristics. The ACR20 response rate was significantly higher among M2000-treated patients than conventional-treated control, so that 74% of patients in treatment group showed an ACR20 response after 12 weeks of M2000 therapy (74 versus 16%; P = 0.011). 10% of M2000-treated patients and 57.1% of conventional-treated patient's adverse events occurred during this study. CONCLUSION Treatment with M2000 in combination with conventional therapy showed a significantly superior efficacy along with a high safety profile compared to conventional-treated patients. Thereby, M2000 might be suggested as a suitable option in the treatment of RA.

Resumen: Introducción: La adherencia al tratamiento es esencial para el éxito terapéutico. En los niños, la palatabilidad de las medicaciones orales condiciona su aceptación y cumplimentación terapéutica. El objetivo fue estimar los sabores de las soluciones de rehidratación oral (SRO) que más gustan a los niños y analizar la relación entre los gustos del niño y la elección de un determinado sabor de SRO. Material y métodos: Ensayo clínico multicéntrico, aleatorizado y simple ciego. Ciento dieciséis niños cataron 4 sueros, 2 a 2, y puntuaron el sabor de cada uno de ellos como muy bueno, bueno, malo o muy malo, y en cada cata eligieron el preferido. Previamente se había encuestado sobre los gustos del niño. Resultados: Los sabores que más gustaron a los niños fueron el sabor a cola (puntuado como bueno o muy bueno por el 87,9%) y el sabor a fresa (62,1%). En 97 de las catas el sabor preferido fue el de cola y en 62 fue el de fresa, en 26 fue el de frutas y en 39 fue el sabor neutro. Hubo asociación entre los niños a los que les gustan los refrescos de cola y la preferencia de la SRO de cola (odds ratio ajustada: 10,3; intervalo de confianza del 95%: 3,1-34,6), y no se encontró relación entre la SRO de fresa y otros gustos. De los 7 niños a los que no les gustaban ni los refrescos de cola ni los caramelos de fresa, 5 prefirieron la solución neutra. Conclusiones: Existen grandes variaciones en la aceptación de los distintos sabores de las SRO. Preguntar a los niños por sus gustos puede orientar hacia la aceptación de los sueros. Abstract: Introduction: Patient adherence to therapeutic regimens is extremely important to successful treatment. Among paediatric patients medication palatability of oral solutions is essential for patient acceptance, therapeutic compliance and successful outcome. The objective was to assess the palatability of different oral rehydration solutions (ORS), which flavour the children preferred and the relationship between the tastes of the child and the flavour chosen. They had been asked previously about their likings. Material and methods: Randomised, multicentre, single blind clinical trial. A total of 116 children tasted four solutions, two at a time, and scored each flavour as really good, good, bad or really bad, and in each of the two tastings chose their preferred choice. Results: The flavours that children preferred were cola (rated as good or really good by 87.9%) and strawberry (62.1%). In 97 of tastings, the flavour of choice was cola and in 62 strawberry, fruit in 26 and in 39 the neutral taste. There was an association between children who liked cola drinks and preferred the ORS cola flavoured (aOR: 10.3; 95%CI: 3.1-34.6). No relationship was found between children who preferred the strawberry flavoured ORS and their likings. Of the 7 children who did not like either cola drinks or strawberry sweets, 5 preferred the neutral solution. Conclusions: There are large variations in the acceptance of different flavours of ORS. Asking for children's tastes can lead towards the acceptance of the solutions.

Inflammation is fundamentally a protective cellular response aimed at removing injurious stimuli and initiating the healing process. However, when prolonged, it can override the bounds of physiological control and becomes destructive. Inflammation is a key element in the pathobiology of chronic pain, neurodegenerative diseases, stroke, spinal cord injury, and neuropsychiatric disorders. Glia, key players in such nervous system disorders, are not only capable of expressing a pro-inflammatory phenotype but respond also to inflammatory signals released from cells of immune origin such as mast cells. Chronic inflammatory processes may be counteracted by a program of resolution that includes the production of lipid mediators endowed with the capacity to switch off inflammation. These naturally occurring lipid signaling molecules include the N-acylethanolamines, N-arachidonoylethanolamine (an endocannabinoid), and its congener N-palmitoylethanolamine (palmitoylethanolamide or PEA). PEA may play a role in maintaining cellular homeostasis when faced with external stressors provoking, for example, inflammation. PEA is efficacious in mast cell-mediated models of neurogenic inflammation and neuropathic pain and is neuroprotective in models of stroke, spinal cord injury, traumatic brain injury, and Parkinson disease. PEA in micronized/ultramicronized form shows superior oral efficacy in inflammatory pain models when compared to naive PEA. Intriguingly, while PEA has no antioxidant effects per se, its co-ultramicronization with the flavonoid luteolin is more efficacious than either molecule alone. Inhibiting or modulating the enzymatic breakdown of PEA represents a complementary therapeutic approach to treat neuroinflammation. This review is intended to discuss the role of mast cells and glia in neuroinflammation and strategies to modulate their activation based on leveraging natural mechanisms with the capacity for self-defense against inflammation.

In the light of some new information based on clinical evidence, current therapeutic approach to patients with acute coronary syndrome especially focusing on oral therapy is being considered. The initial stage of treatment does not differ greatly among patients with unstable angina pectoris (UA), non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI). It is necessary to simultaneously resolve a series of problems within the first twenty minutes upon admission, i.e. risk assessment, selection of treatment strategy (conservative, invasive), relief of ischemic pain, determination of hemodynamic status and elimination of any undesired complications (hypertension, tachycardia, heart failure), and administration of antithrombotic therapy. Patients suffering from STEMI require reperfusion treatment, and the method of choice is primary percutaneous coronary intervention (PCI) where available. Fibrinolytic reperfusion therapy is limited exclusively to STEMI within the first three hours from the onset of pain. Unlike this, in patients suffering from UA/NSTEMI it is necessary to make risk assessment in the early stage of disease, and thus select the patients that will certainly benefit from invasive treatment through PCI. For pain relief, the patient should be immediately administered nitroglycerin along with oxygen. Beta-blockers that are reasonably used in the initial stage of treatment during the first 24 hours, if not contraindicated, are still underused. Clopidogrel becomes an obligatory drug not only in patients having undergone PCI, but also in those treated conservatively following fibrinolysis., U svjetlu nekih novih podataka zasnovanih na kliničkim dokazima razmatra se terapijski pristup bolesnicima s akutnim koronarnim sindromom koji se osobito oslanja na oralnu terapiju. U početnoj fazi liječenja nema većih razlika u pristupu bolesnicima s nestabilnom pektoralnom anginom, infarktom miokarda bez povišenja ST segmenta (NSTEMI) ili infarktom miokarda s povišenjem ST segmenta (STEMI). Istodobno treba razriješiti niz problema unutar prvih dvadesetak minuta od prijma bolesnika: procjenu rizika, odabir strategije liječenja (konzervativno, invazivno), ublažavanje ishemijske boli, određivanje hemodinamskog statusa i uklanjanje neželjenih komplikacija (hipertenzija, tahikardija, srčano zatajenje), te davanje antitrombotske terapije. Bolesnici koji imaju STEMI zahtijevaju liječenje reperfuzijom, a metoda izbora je primarna perkutana koronarna intervencija (PCI) tamo gdje je dostupna. Fibrinolitička reperfuzijska terapija je ograničena isključivo na STEMI unutar prva tri sata od nastupa boli. Za razliku od toga, kod bolesnika s nestabilnom pektoralnom anginom/NSTEMI treba procijeniti rizik u ranom stadiju bolesti te tako odabrati one bolesnike kod kojih će invazivno liječenje pomoću PCI zasigurno biti korisno. Uz kisik bolesniku treba smjesta dati nitroglicerin radi ublažavanja boli. Primjena beta blokatora je razumna u početnoj fazi liječenja tijekom prva 24 sata, ako nisu kontraindicirani, no oni se još uvijek nedostatno primjenjuju. Klopidogrel postaje obvezatan lijek ne samo u bolesnika podvrgnutih PCI, nego isto tako u bolesnika koji se liječe konzervativno nakon fibrinolize.

In the light of some new information based on clinical evidence, current therapeutic approach to patients with acute coronary syndrome especially focusing on oral therapy is being considered. The initial stage of treatment does not differ greatly among patients with unstable angina pectoris (UA), non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI). It is necessary to simultaneously resolve a series of problems within the first twenty minutes upon admission, i.e. risk assessment, selection of treatment strategy (conservative, invasive), relief of ischemic pain, determination of hemodynamic status and elimination of any undesired complications (hypertension, tachycardia, heart failure), and administration of antithrombotic therapy. Patients suffering from STEMI require reperfusion treatment, and the method of choice is primary percutaneous coronary intervention (PCI) where available. Fibrinolytic reperfusion therapy is limited exclusively to STEMI within the first three hours from the onset of pain. Unlike this, in patients suffering from UA/NSTEMI it is necessary to make risk assessment in the early stage of disease, and thus select the patients that will certainly benefit from invasive treatment through PCI. For pain relief, the patient should be immediately administered nitroglycerin along with oxygen. Beta-blockers that are reasonably used in the initial stage of treatment during the first 24 hours, if not contraindicated, are still underused. Clopidogrel becomes an obligatory drug not only in patients having undergone PCI, but also in those treated conservatively following fibrinolysis.

The objective of this study was to assess the effectiveness and safety of levosulpiride in patients with dysmotility-like functional dyspepsia including nonerosive reflux esophagitis in conditions of daily practice. The study was conducted as a prospective, open-label, multicenter design in 342 patients with dysmotility-like functional dyspepsia (n=279) and nonerosive reflux disease (n=63), who received levosulpiride 25 mg 3 times daily orally for 4 weeks. Individual symptoms (pain/discomfort, fullness, bloating, early satiety, pyrosis, regurgitation, and nausea/vomiting) and a global symptom score were assessed at 15, 30, and 60 days after starting treatment. Adverse events also were recorded. There were 151 men and 191 women (mean age 38.8 years) who referred dyspeptic symptoms for a mean of 10.2 (10.7) months. A total of 66.4% patients were treated with 75 mg/day levosulpiride and 33.6% with 50 mg/day. At the 15-day visit, a decrease greater than 50% in the global symptom score was observed. The frequency and intensity of individual symptoms showed a statistically significant decrease (p

Primidone oral suspension is used as an antiepileptic and anticonvulsive. The quantitative determination of primidone oral suspension may be carried out, according to the literature review, by the gaseous chromatography method and by the Kejldhal method. The results are reproducible and accurate in both; however, the first requires an expensive equipment, which is not always available in our small laboratories, and the second one is long and laborious. Therefore, it was developed a simpler and less laborious method able to quantify the amount os primidone in the suspension and to meet the industry's requirements. To this end, it was created a method of potentiometric residual assessment, and a basic hydrolisis with sodium hydroxide 0.5 mol/L was previously carried out. The factibility of the method proposed was checked and it proved to be specific, precise and exact. The analytical results were compared with those obtained by the methods reported in literature. A statistical study was conducted and the equivalence between both methods was demonstrated.

BACKGROUND: The aim of this analysis is to evaluate the costs of 72-hour postoperative pain treatment in patients undergoing major abdominal, orthopedic and thoracic procedures in nine different Italian hospitals, defined as the cumulative cost of drugs, consumable materials and time required for anesthesiologists, surgeons and nurses to administer each analgesic technique. METHODS: Nine Italian hospitals have been involved in this study through the administration of a questionnaire aimed to acquire information about the Italian clinical practice in terms of analgesia. This study uses activity-based costing (ABC) analysis to identify, measure and give value to the resources required to provide the therapeutic treatment used in Italy to manage the postoperative pain patients face after surgery. A deterministic sensitivity analysis (DSA) has been performed to identify the cost determinants mainly affecting the final cost of each treatment analyzed. Costs have been reclassified according to three surgical macro-areas (abdominal, orthopedic and thoracic) with the aim to recognize the cost associated not only to the analgesic technique adopted but also to the type of surgery the patient faced before undergoing the analgesic pathway. RESULTS: Fifteen different analgesic techniques have been identified for the treatment of moderate to severe pain in patients who underwent a major abdominal, orthopedic or thoracic surgery. The cheapest treatment actually employed is the oral administration "around the clock" (€ 8.23), whilst the most expensive is continuous peripheral nerve block (€ 223.46). The intravenous patient-controlled analgesia costs € 277.63. In terms of resources absorbed, the non-continuous administration via bolus is the gold standard in terms of cost-related to the drugs used (€ 1.28), and when administered pro re nata it also absorbs the lowest amount of consumables (€0.58€) compared to all other therapies requiring a delivery device. The oral analgesic administration pro re nata is associated to the lowest cost in terms of health professionals involved (€ 6.25), whilst intravenous PCA is the most expensive one (€ 245.66), requiring a massive monitoring on the part of physicians and nurses. CONCLUSIONS: The analysis successfully collected information about costs of 72-hour postoperative pain treatment in patients undergoing major abdominal, orthopedic and thoracic procedures in all the nine different Italian hospitals. The interview showed high heterogeneity in the treatment of moderate to severe pain after major abdominal, orthopedic and thoracic surgeries among responding anesthesiologists, with 15 different analgesic modalities reported. The majority of the analgesic techniques considered in the analysis is not recommended by any guideline and their application in real life can be one of the reasons for the high incidence of uncontrolled pain, which is still reported in the postoperative period. Health care costs have become more and more important, although the choice of the best analgesic treatment should be a compromise between efficacy and economic considerations.