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Background: The aim of this open label phase II study (NCT00407459) was to assess the activity of the vascular endothelial growth factor (VEGF) inhibitor bevacizumab combined with pemetrexed and carboplatin in patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). Methods: Eligible patients received pemetrexed 500 mg m −2 , carboplatin area under the plasma concentration–time curve (AUC) 5 mg ml −1 per minute and bevacizumab 15 mg kg −1 , administered intravenously every 21 days for six cycles, followed by maintenance bevacizumab. The primary end point of the study was progression-free survival (PFS). A 50% improvement in median PFS in comparison with standard pemetrexed/platinum combinations (from 6 to 9 months) was postulated. Results: Seventy-six patients were evaluable for analysis. A partial response was achieved in 26 cases (34.2%, 95% CI 23.7–46.0%). Forty-four (57.9%, 95% CI 46.0–69.1%) had stable disease. Median PFS and overall survival were 6.9 and 15.3 months, respectively. Haematological and non-haematological toxicities were generally mild; however, some severe adverse events were reported, including grade 3–4 fatigue in 8% and bowel perforation in 4% of patients. Three toxic deaths occurred. Conclusion: The primary end point of the trial was not reached. However, due to the limitation of a non-randomised phase II design, further data are needed before drawing any definite conclusion on the role of bevacizumab in MPM.

Background: The incidence of malignant pleural mesothelioma (MPM) in elderly patients is increasing. There are no specific guidelines for their management. Methods: The clinical records of elderly patients (⩾70 years old) with MPM referred from January 2005 to November 2011 to six Italian Centres were reviewed. Age, gender, histology, International Mesothelioma Interest Group (IMIG) stage, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), Charlson Comorbidity Index (CCI) and treatment modalities were analysed and correlated to overall survival (OS). Results: In total, 241 patients were identified. Charlson Comorbidity Index was ⩾1 in 92 patients (38%). Treatment was multimodality therapy including surgery in 18, chemotherapy alone in 180 (75%) and best supportive care in 43 cases (18%). Chemotherapy was mainly pemetrexed based. Median OS was 11.4 months. Non-epithelioid histology (HR 2.32; 95% CI 1.66–3.23, P <0.001), age ⩾75 years (HR 1.44; 95% CI 1.08–1.93, P =0.014), advanced (III–IV) stage (HR 1.47; 95% CI 1.09–1.98, P =0.011) and CCI⩾1 (HR 1.38; 95% CI 1.02–1.85, P =0.034) were associated to a shorter OS. Treatment with pemetrexed was associated with improved OS (HR 0.40; 95% CI 0.28–0.56, P <0.001). Conclusions: Non-epithelioid histology, age ⩾75 years, advanced IMIG stage and presence of comorbidities according to CCI were significant prognostic factors in elderly patients with MPM. Treatment with pemetrexed-based chemotherapy was feasible in this setting. Prospective dedicated trials in MPM elderly patients selected according to prognostic factors including comorbidity scales are warranted.

The effects of UV irradiation (at λ>380 nm and λ>265 nm) on spore suspensions of a European strain of Arthrobotrys oligospora (hyphomycete) have been investigated and compared with those on a strain of the Antarctic species, A. ferox. Emission and excitation spectra of control and irradiated spore suspensions of both strains suggest a higher vulnerability of A. oligospora, which would be consistent with changes in membrane permeability and a lower amount of UV-protecting substances. Germination tests on UV-B irradiated spores confirm the higher resistance of A. ferox, which seems better adapted to the high UV radiation levels characterizing Antarctic environments.[PUBLICATION ABSTRACT]

Background Dysphagia is a symptom whose prevalence can be higher than 30% in the older. It is related to higher disability, longer hospital stay and more malnutrition and mortality. The Eating Assessment Tool (EAT-10) is a practical, analogical and easy dysphagia evaluation instrument. Purpose Determine the prevalence of dysphagia in the older. Evaluate if it was previously detected by the physician and if he established corrective actions. Assess the nutritional status in patients with dysphagia. Materials and methods 50 patients, 18 male and 32 female, were randomly selected in an older patient unit. Medium age was 78. Dysphagia was measured with EAT-10, a 10 question questionnaire (each scored from 0 to 4). If total score is ≥3, dysphagia may be present. The type of diet as well as gelatin and thickeners intake was registered. Nutritional status was assessed by CONUT (COntrol NUTritional) system. Unlike Nutritional Risk Screening (NRS-2002) which is a screening tool based on weight loss, Body Mass Index, food intake diminution and disease severity, CONUT is an automatic validated tool that classifies nutritional status in normal, mild, moderate or serious malnutrition, based on serum albumin, cholesterol and lymphocytes. Results EAT-10 was ≥3 in 10 patients (20%) (mean =11,7; range 3-31). Average realisation time was 4 min. Four patients (40%) with EAT-10 ≥3 had corrective actions. All had crushed diet, and 3 had thickeners. None had gelatins. Eight patients out of ten with dysphagia had malnutrition (5 mild, 3 moderate). All patients with moderate malnutrition had nutritional supplements. Conclusions 20% of patients had dysphagia, but only 40% had corrective actions. Malnutrition prevalence was high (80%) in patients with dysphagia. EAT-10 is an easy and fast dysphagia detecting scale and could avoid malnutrition and other associated problems. So, it would be advisable its routine realisation in older so that corrective actions are established.

Background Etanercept is a soluble tumour necrosis factor receptor fusion protein used in a variety of arthropathies. A new administration device (pen) has recently been marketed. Purpose To evaluate pain differences and preference between the etanercept syringe and pen as well as the relation between pain and demographic and anthropometric factors. Materials and Methods All patients with the etanercept pen from 1 January 2012 to 31 March 2012 who had previously used the syringe were chosen. Gender, age, Body Mass Index (BMI), diagnosis, self-administration, pain perception (0 = no pain; 10 = maximum pain) and device preference were recorded. Statistical analysis: Student’s t-test and variance analysis were used for comparisons of means, chi-square and Fisher’s test for proportions, and non-parametric tests for pain. Results109 patients (43% men; 57% women) met inclusion criteria. Mean age was 54 ± 13.5 years and mean BMI 26.5 ± 4.8 kg/m². 58.7% had Rheumatoid Arthritis, 19.3% Ankylosing Spondylitis, 1.8% Juvenile Idiopathic Arthritis, 16.5% Psoriatic Arthritis and 3.7% Psoriasis. 82% self-administrated the pen, and 71% the syringe. The median pain with the syringe was 3 [interquartile range (IQR): 2–6] and with the pen was 4 [IQR: 2–5] (P = 0.008). 65% reported the same pain with both devices. 35% reported differences in pain and most of them (71%) had much pain (>5) with the pen and little pain (<5) with the syringe. There was a statistically significant association of pain with gender: women had more pain with the pen (P = 0.03), but less with the syringe (p > 0.05). There was no association with BMI, age or diagnosis. 59% preferred the pen, 25% the syringe, and 16% did not mind. Conclusions An association of pain with pen device and female gender was found. However there was no association with BMI, age or diagnosis. Acceptance of the pen and self-administration were higher even though pain was greater, so it is necessary to maintain both devices to assure adherence. No conflict of interest.

Background The Spanish Nephrology Society and the Spanish Enteral and Parenteral Nutrition Society issued a consensus statement about indications, contraindications and the composition of intradialyticparenteral nutrition (IDPN) in 2010. Table 1 Criteria Patients Albumin <3.5 g/dL and/or prealbumin <20 mg/dL 14 (57%) Creatinine < 8 mg/dL 18 (86%) BMI <18.5 (or SGA* score C) 1 (5%) Weight loss (10-20%) 6 (29%) Caloric intake control (<25-26 Kcal/Kg/day) Not recorded Protein intake control (<0.75 g/Kg/day) Not recorded *SGA was not recorded >3 criteria fulfilment 4 (19%) > 2 criteria fulfilment 8 (43%) Purpose To find out whether these guidelines are being followed. Materials and methods Patients who started IDPN during 2010 were included. Medical histories were revised retrospectively. The start and end date, subjective global assessment (SGA), intake of food, body mass index (BMI), age, creatinine, albumin and prealbumin were recorded. Results 21 patients were included. Median age was 63. Start criteria: all had found supplementary oral intake impossible and had rejected a nasogastric tube according to the consensus. In addition, 3 criteria referred to in the table had to be present. Composition criteria: All patients had Oliclinomel N7-1000 ml (Baxter). It complied with the recommendations except that: ▶It had 40 grams of protein, which corresponded to 0.5-0.8 g/kg/day (consensus 0.8-1.2/kg/day) ▶It had no vitamins, no added insulin and no phosphorus ▶Carnitine was not added in dyslipidaemic patients Discontinuation criteria: Only albumin was assayed. No patients were discontinued because of complications or intolerance. Four patients complied with the discontinuation criteria (albumin >3.8 g/dl). Conclusions 19% of patients fulfilled the start criteria, 43% the discontinuation criteria and the composition did not fully fit the consensus. Initial screening should be improved by recording caloric and protein intake and SGA. It would be desirable to choose an IDPN better adapted to protein needs, and consider the addition of vitamins and carnitine in dyslipidaemic patients, as well as individualising phosphorus and insulin requirements.

Background Malnutrition among hospital inpatients is very high (30-50%). It has important consequences in patients' clinical course and in hospitalisation costs so early detection and establishment of corrective action is crucial. Vitamin D deficiency is also common in the older, and leads to decreased bone mass and increased fractures and healthcare costs. Purpose Evaluate the nutritional status and vitamin D levels in an older medical unit. Evaluate whether corrective actions such as nutritional supplements or vitamin D prescription were established. Materials and methods Nutritional status was assessed in 50 randomly selected patients using CONUT (COntrol NUTritional) system, a validated tool that determines nutritional status according to serum albumin, cholesterol and lymphocytes. 25-OH vitamin D levels (deficiency <12 ng/mL; insufficiency 12-30 ng/mL; normal 30-80 ng/mL) were also measured. Prescription of nutritional or vitamin D supplements was registered. Results Medium age was 78.8 years. 22 were male and 28 female. Prevalence of malnutrition was very high (68%): It was mild in 19 patients (38%), moderate in 13 (26%) and serious in 2 (4%). Nutritional supplements were prescribed to just 6 patients (17,6%) with malnutrition. Forty-six patients (92%) had vitamin D levels below recommendations: 15 (30%) had vitamin D insufficiency (mean= 17.8; range 12.1-25.8 ng/mL) and 31 (62%) had deficiency (mean= 7.5; range 3-11.4 ng/mL). Calcium + vitamin D supplements were prescribed in eight (17.4%) patients with insufficiency or deficiency, three (7%) prescribed before admission and five (10.9%) during admission. Conclusions Due to the high prevalence of malnutrition and hypovitaminosis D in the older, it would be advisable to establish a nutritional screening system and to measure vitamin D levels at admission, so that corrective action such as prescription of vitamin D or nutritional supplements prescription can be established. In addition, general practitioners should continue monitoring malnutrition and vitamin D after patients are discharged.

Background One of the clinical pharmacist’s main functions in parenteral nutrition is to ensure the quality and safety of the solutions prepared. It is too laborious to do this with each preparation. So in our hospital it was decided to design 21 standard Total Parenteral Nutrition (TPN) protocols. Purpose To analyse the prescriptions for TPN and their compliance with the standard protocols available. Materials and Methods A retrospective study was conducted over a period of one year (October 2011–October 2012). The composition of all TPN administered to adults was recorded, as well as the addition of various drugs such as insulin or somatostatin. Data were obtained from the pharmacy service’s nutritional database. Results 629 adult patients were treated with TPN and received 8342 bags of TPN; 3129 (37.5%) fitted the standard protocols. The changes in the composition of TPN in non-standard TPN bags were: glucose added to 117 (2.3%) bags, lipids in quality 2276 (44.4%) and in quantity 374 (7.5%), nitrogen to 223 (4.3%); electrolytes: sodium to 238 (4.6%), calcium to 7 (0.1%), magnesium to 181 (3.5%), potassium to 3054 (59.6%) and phosphorus to 245 (4.8%); volume to 117 (2.3%), somatostatin to 545 (10.6%) and insulin to 862 (16.8%). Composition of protocols ranged from: nitrogen: 6 to 20 g, increasing the amount of nitrogen from 2 by 2 g, glucose: 150–200–250–300 g, lipids 0–50–75–100 g, kcal non-protein/g nitrogen from 87.5 to 187.5 and volume 1350–2000–3000 mL. All protocols contained the same amount of electrolytes (sodium: 75 mEq, potassium: 60 mEq, calcium: 15 mEq, magnesium: 15 mEq, chloride: 90 mEq, acetate: 75 mEq and phosphorus: 10–20 mMol), vitamins and trace elements. Conclusions 61% of administered TPN needed to be modified with respect to standard protocols in order to meet the nutritional requirements of individual patients. So we are considering revising the protocols regarding the quality of lipids and amount of potassium. No conflict of interest.

BackgroundPercutaneous radiologic gastrostomy (PRG) consists of inserting a long-term catheter in the gastric cavity through the anterior abdominal wall. The catheter is replaced every 6 months (180 days). However, it can often require a replacement in advance due to obstruction or bad management of the catheter.PurposeTo analyse the most common causes of PRG replacement and its frequency.Material and methodsAn observational retrospective study was conducted. All patients with PRG were included. Also analysed was PRG indication, number of replacements and its causes, the average duration of catheter placement and the reason of removing it. All the data havw been collected from electronic medical records and have been processed through the Stata statistics program.ResultsA total number of 63 patients that had a 16 Fr catheter in place were included; 42 were males and 21 females with a mean age of 65.5±11.8. The median follow-up was 113 days. PRG indications were: 46% (29) head and neck tumour, 17.5% (11) amyotrophic lateral sclerosis (ALS), 16% (10) cerebrovascular accident, 1.5% (one) dementia and 19% (12) others.Ninety-four catheters were replaced, from which 79% (74) were not programmed due to: 34% (32) catheter came out, 17% (16) broken catheter, 9.5% (nine) medicines obstruction, 5.5% (five) obstruction due to liquid diet, 3.5% (three) leak, 1% (one) infected stoma and 8.5% (eight) others. The average duration of PRG before being replaced was 205±190 days in those patients that were programmed, whereas 78±66 days in those non-programmed.The average duration for a gastrostomy was 170 days. Results vary depending on the pathology: 263±164 days for ALS, 173±179 days for head and neck tumour and 134±123 days for cerebrovascular accidents.In 52 patients the catheter was removed, due to recovery (32%) or death (68%).ConclusionOnly one-fifth of the catheter replacements were programmed. The most common causes were because they came out or they were broken. In order to prevent these complications it is necessary to develop standard operational procedures and patient information leaflets on catheter management by a multidisciplinary team including nursing, medical and pharmacy staff.

BackgroundThe therapeutic strategy for chronic hepatitis C (CHC) in our health system established that in mono- or co-infected HCV/HIV patients in whom prioritised therapy with glecaprevir/pibrentasvir is contraindicated, their chronic medication (CM) will be changed and/or an alternative therapy for HCV will be used: sofosbubir/velpatasvir (+7% cost per patient) or elbasvir/grazoprevir (+64% cost per patient).PurposeTo analyse the influence of pharmacological interactions in the selection of HCV treatment in opiate-dependent patients.Material and methodsAll treatments started in a Mental Health Network (which opiate-dependent patients attend) from 1 January 2018 to 31 August 2018 were analysed.Prior to the approval of hepatitis C treatment by the CHC committee, the pharmacist reviewed the treatment and looked for possible pharmacological interactions of the HCV prioritised therapy with the CM. If there was a significant interaction, the pharmacist recommended either to change/stop the CM or to choose an alternative HCV treatment.ResultsApproved treatments by the CHC committee: 96. Completed treatments: 73, 98% monoinfected. HCV genotype: 1a: 31 (42%), 3: 22 (30%), 4: 11 (15%), 1b: seven (10%) and 2: two (3%). Forty-seven (64%) patients were ≤F3, 21 (29%) F4 and five (7%) were unknown.64/73 (88%) patients were treated with glecaprevir/pibrentasvir. A CM change was needed in 14/64 (22%) patients: to avoid metamizole, delay proton-pump inhibitor administration time, to switch to another statin and stop oxcarbazepine.Only 9/73 patients (12%) received a non-prioritised treatment with sofosbuvir/velpatasvir. In eight of them due to interactions with their CM: antipsychotics (five), HIV protease inhibitor (one), anti-platelet (one) and ethinylestradiol (one). In another patient the reason was that he was Child-Pugh B.The sustained viral response is available only in 20% of patients, so the effectiveness has been measured as viral response at the end of treatment (VRE), being 96% (70/73) up to date. Three patients are pending to be determined.ConclusionThe review of pharmacological interactions has allowed the treating of 88% of patients with the prioritised therapy, with an effectiveness in VRE of 96%, according to the results of the clinical trials.The pharmacological interactions evaluation and pharmaceutical interventions optimize the risk benefit ratio and contribute to the efficient use of HCV therapies.References and/or acknowledgementsNo acknowledgements.No conflict of interest.