Objective: The aim of the present study is to investigate the effect of antioxidant polyphenol-rich pomegranate juice (PJ) supplementation for 5 weeks on patients with stable chronic obstructive pulmonary disease (COPD), since the oxidative stress plays a major role in the evolution and pathophysiology of COPD. Design: A randomized, double-blind, placebo-controlled trial was conducted. Subjects: A total of 30 patients with stable COPD were randomly distributed in two groups (15 patients each). Interventions: Both groups consumed either 400 ml PJ daily or matched placebo (synthetic orange-flavoured drink) for 5 weeks. Trolox Equivalent Antioxidant Capacity (TEAC) of PJ, blood parameters (14 haematological and 18 serobiochemical), respiratory function variables, bioavailability of PJ polyphenols (plasma and urine) and urinary isoprostane (8-iso-PGF 2a ) were evaluated. Results: The daily dose of PJ (containing 2.66 g polyphenols) provided 4 mmol/l TEAC. None of the polyphenols present in PJ were detected in plasma or in urine of volunteers. The most abundant PJ polyphenols, ellagitannins, were metabolized by the colonic microflora of COPD patients to yield two major metabolites in both plasma and urine (dibenzopyranone derivatives) with no TEAC. No differences were found (P40.05) between PJ and placebo groups for any of the parameters evaluated (serobiochemical and haematological), urinary 8-iso-PGF 2a , respiratory function variables and clinical symptoms of COPD patients. Conclusions: Our results suggest that PJ supplementation adds no benefit to the current standard therapy in patients with stable COPD. The high TEAC of PJ cannot be extrapolated in vivo probably due to the metabolism of its polyphenols by the colonic microflora. The understanding of the different bioavailability of dietary polyphenols is critical before claiming any antioxidantrelated health benefit. Sponsorship: 'Fundació n Séneca' (Murcia, Spain), Project PB/18/FS/02 and Spanish CICYT, Project AGL2003-02195.
BackgroundThromboembolic disease (TED) is a complex condition in which the interaction between genetic, acquired and environmental factors determines the onset of an episode.PurposeThis study aimed to assess the risk factors (RF) associated with TED in hospitalised patients.Material and methodsA retrospective, descriptive study was conducted in which hospitalised patients with TED from January 2015 to June 2015 were included. Variables included: age, sex, type of TED, previous events, hospitalisation duration, D-dimer elevation, obesity, renal impairment, tabaquism, cardiac and respiratory comorbidities, recent immobilisation or major surgery, family history/genetic predisposition, oncohaematologic history, and treatment with chemotherapy regimens, hormonal therapy, angiogenic agents or erythropoiesis stimulating factors (ESF).Data were obtained from electronic prescription software (APD-Prisma) and medical records.Results108 patients were analysed. There were 6.8 new cases per 1000 admitted patients during the study period. 55% were women. Mean age was 71 years (18–97). 20.3% presented previous TED. Median time of hospitalisation was 8 days (1–91). D-dimer elevation was observed in 63.8% with an average value of 6926.91 (2-48453) (26% absent data).Of 108 patients, 40.7% presented tabaquism, 22% respiratory complications, 21% cardiac comorbidities, 14.8% obesity and 11% renal impairment. Recent immobilisation or major surgery was noted in 27.8% and 4.6% of cases, respectively. A family history of TED or genetic predisposing mutations were present in 7.4%. Oncohaematologic history was observed in 24%. 8.3% received chemotherapy, 6.5% hormonal therapy and 6.5% ESF. No patient received angiogenic therapy. 28 days mortality was 7.4%.ConclusionAmong our studied population, the incidence of TED was an important issue that grew according to genetic, acquired or environmental factors, consistent with published data. RF evaluation is an essential measure during hospitalisation to minimise these events. Multidisciplinary active programmes for TED prevention should be available.No conflict of interest
Background As the result of Resolution SC 0403/10 of December 22, 2010 in the region of Andalucia (Spain) some medicines for outpatient treatment are no longer dispensed in community pharmacies but in hospital pharmacies, given that they require special surveillance, supervision and control. Purpose To determine the savings made by dispensing oral cytostatic drugs in a third-level hospital. Materials and methods Descriptive observational study of the oral cytostatics dispensed between December 2010 and March 2013. Data were collected from APD software. We determined: The total expenditure on dispensing cytostatics for out-patients, The percentage of this expenditure relative to the total expenditure on all oral medicines for outpatients, The cost savings, The most expensive active ingredients. Results The value of oral cytostatics totalled 6,731,547.87 € during the period of study. This meant 6.37% of the total amount of out-patient prescriptions for oral medicines for the same period. These prescriptions would have cost € 7,141,037.52 if they had been made at community pharmacies. Therefore, these results equate to a saving of € 409,489.64. The active ingredients that affected the cost most were imatinib and sunitinib. Conclusions Hospital dispensing of oral cytostatics led to a cost saving of 5.73% when compared to community pharmacy dispensing. Two factors explain this cost saving: The Avoidance of Any Commercial Expenditure Undertaken by Community Pharmacies The Optimisation of Resources Driven by Patients Taking the Exact Amount Needed of the Drug as They Are Required to Return Any Untaken Medicine When Completing or Changing Their Treatment No conflict of interest.
A57and disability prevalence by age group through national databases of healthcare attentions. A systematic literature search and a modified Delphi were performed to obtain other necessary information like mortality, disability distribution by severity, and duration of sequelae. These data were then used to estimate CVD burden of disease for Colombia. DALY estimation considered recent methodological changes introduced in Global Burden of Disease 2010 study. Updated life expectancy tables, no discount rate, and absence of age-weighting are the main changes from previous methodology. Sensitivity analysis was performed to evaluate the impact of changing these parameters. CVD burden of disease was also estimated for the five year period 2009-2013. Results: We estimated 1.31 incident cases of CVD/1,000 for Colombia in 2014. DALY, years of life lost due to premature death (YLL) and years lost due to disability (YLD) were 14/1,000, 7.1/1,000 and 6.9/1,000, respectively. Sensitivity analyses showed important differences in the estimation, when parameters of the estimation changed. ConClusions: CVD incidence, mortality and burden of disease estimations performed in this study agree with data from other studies. CVD is a relevant cause of disability and mortality in Colombia. This disease is a priority for Colombian health policy. Identifying the most vulnerable groups is essential to create effective prevention and promotion programs. PCV100The UPTake of NoN-ViTamiN k oral aNTiCoagUlaNTs iN irelaNd: BalaNCiNg CosT-effeCTiVeNess aNalysis aNd BUdgeT imPaCT
BackgroundTransplantation-associated thrombotic microangiopathy (TMA) is a feared complication of allogeneic hematopoietic stem cell transplantation (HSCT) owing to its high rate of mortality. The use of calcineurin inhibitors or sirolimus for graft-versus-host disease (GVHD) prophylaxis has been suggested as a potential risk factor.PurposeTo analyse the incidence of TMA in patients undergoing HSCT who received ciclosporin as prophylaxis against GVHD; to investigate the cause of this phenomenon.Material and methodsRetrospective observational study that reviewed the medical records of patients who had suffered from TMA after allogeneic HSCT in the haematology service of a tertiary hospital from 2010 to 2014. To obtain the results, the diagnostic criteria associating TMA with the bone marrow transplant of the International Working Group were measured.ResultsOf the 50 patients undergoing allogeneic HSCT, 10 suffered ciclosporin-associated TMA. In 4 TMA emerged with the addition of ciclosporin to sirolimus and in 6 when sirolimus was added to ciclosporin. The reason for the addition of these immunosuppressants was acute GVHD in 3 patients and in 7 due to chronic GVHD. The response to TMA was to suspend ciclosporin and maintain sirolimus and corticosteroids in 4 patients whereas in 6 both ciclosporin and sirolimus were suspended. In 4 patients phenytoin was added, in 2 haemodialysis was performed, in 3 plasmapheresis was done and in 1 rituximab was administered. In all the cases the duration of active levels of basal ciclosporin after it had been suspended was about two or four months.ConclusionThe appearance of TMA in patients undergoing allogeneic HSCT is a concern. All cases present moderate to severe haemolytic anaemia, negative direct Coombs, thrombocytopenia, elevated LDH and creatinine, schistocytes >4% and kidney disorders. The cause of the sustained increase in the time of ciclosporin levels is still unknown, it is thought that an ABCB1 genetic polymorphism can produce this phenomenon.References and/or acknowledgementsPharmacogeneticsNo conflict of interest.
Background The use of intracameral cefuroxime is becoming more widely accepted for endophthalmitis prophylaxis (EP) after cataract surgery. Recently, the European Medicines Agency approved a single, sterile, unit dose of intracameral cefuroxime in a few countries of Europe. Purpose To evaluate the cost saving resulting from the implementation of an optimisation protocol for the preparation of ready-to-use (RTU) intracameral cefuroxime syringes from 1500 mg vials of cefuroxime. Materials and methods A review of the literature was conducted when we planned to change the protocol. To evaluate the cost savings, the cost generated by the use of cefuroxime 1500 mg vials in the preparation of RTU syringes since the implementation of the protocol was compared to the costs if the marketed unit dose of intracameral cefuroxime had been used. Results A total of 200 RTU syringes are prepared from a single vial of cefuroxime 1500 mg in each batch at the Pharmacy. 40 syringes are sent weekly to the OR, the rest are stored frozen in Pharmacy (stability three months). Between January and July 2013 five vials of cefuroxime 1500 mg were used to prepare 1000 RTU cefuroxime syringes, with a cost of 14.56 € (PVP: 145.6 €/50 vials). If we had used the marketed unit dose, for the same treatment the cost would have been 12164 € (PVP: 121.64 €/10 vials); meaning a 99.8% reduction in costs. Conclusions The implementation of the optimisation protocol for the preparation of RTU intracameral cefuroxime syringes has led to a significant cost saving without compromising patient health. No conflict of interest.
Background Haematological toxicity (HT) is a well-known side effect of chemotherapy. Neutropenia and thrombocytopenia are common reasons for dose reductions and treatment delays in chemotherapy treatment. Correct management of chemotherapy-induced HT is essential to achieve optimal treatment outcomes. Purpose To assess the incidence and review the management of HT in ambulatory patients with gastrointestinal cancer receiving intravenous chemotherapy. Material and methods Haematological parameters which had been measured before the application of chemotherapy were retrospectively collected for 121 patients treated in 2012. In patients with HT (defined as leukopenia, neutropenia, thrombocytopenia or anaemia) dose reductions and treatment delays were reviewed and compared to available international guidelines for the management of HT. Results HT occurred in 73 (60.3%) patients. 41 (33.9%) patients presented with leukopenia, 33 (27.3%) with neutropenia, 25 (20.6%) with thrombocytopenia and 52 (42.9%) with anaemia. According to international guidelines, treatment adjustments were required in 24 patients (19.8%) and altogether in 64 chemotherapy cycles. Dose reductions were required in 18/64 (28.1%) cycles, and treatment delays in 58/64 (90.6%) cycles. Actual dose reductions were lower than stated in the guidelines in 7 (38.9%) cycles; treatment dates were not rescheduled in 21 (36.2%) out of 58 cycles in which treatment delays were required. Overall, treatment adjustments were not suitable in 9/24 (37.5%) patients. Higher dose reductions or longer treatment delays than stated in the guidelines were not considered inappropriate, since these may have occurred due to other conditions, not related to HT. Conclusion Incidence of thrombocytopenia and anaemia in gastrointestinal cancer patients was comparable, while incidence of neutropenia was lower than in similar previous studies. The high number of incorrectly adjusted treatments demonstrated the necessity for a clinical pharmacist to review chemotherapy prescriptions together with laboratory parameters and to create hospital guidelines for the management of HT. References and/or Acknowledgements No conflict of interest.
BackgroundSoybean lipid emulsions in parenteral nutrition (PN) are associated with liver disease. This has led to the development of alternative intravenous lipid emulsions (ILEs).PurposeTo compare the effects of two new ILEs: Lipoplus (soybean with fish oil) and Clinoleic (soybean with olive oil).Material and methodsRetrospective observational study using pharmacotherapeutic records of premature infants who started PN between December 2012 and May 2014 in a tertiary care hospital. We included infants requiring ≥5 days of PN with a gestational age <34 weeks and birth weight between 0.5 and 2 kg. Clinical information included gender, gestational age and body weight. Laboratory data recorded included total (TB), conjugated (CB) and unconjugated bilirubin (UB) (mg/dL). Either Lipoplus or Clinoleic was used as the clinician requested. Comparisons were done using t-tests.Results24 children were included (16 male and 8 female); 17 (70.8%) treated with Lipoplus and 7 (29.2%) with Clinoleic. Mean gestational age was 29 weeks for both treatments. Average weight at the beginning of PN was 1.23 kg for Lipoplus and 1.32 kg for Clinoleic.No differences were detected in bilirubin levels between groups at baseline (Lipoplus: CB: 0.9; UB: 8.7; TB: 8.7. vs. Clinoleic: CB: 0.3; UB: 7.8; TB: 9.0; p = n.s.) or at completion of treatment (Lipoplus: CB: 0.7; UB: 9.8; TB: 8.7 vs. Clinoleic: CB: 0.5; UB: 9.2; TB: 9.4; p = n.s.). No decrease in TB, CB or UB vs. baseline was observed for either treatment.ConclusionWe found no significant difference in benefit or less persistent hyperbilirubinaemia between infants treated with Lipoplus or Clinoleic. Treatment with soybean emulsion vs. new ILEs has resulted in a significant decrease in total/conjugated bilirubin vs. baseline.1 However previous studies also showed no significant differences in total/conjugated bilirubin levels between the new ILE treatments.2 References and/or AcknowledgementsM. Rayyan, et al. 2012J. Pichler, et al. 2014No conflict of interest.
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