during the past 5 years. Collected variables: age, sex, ECOG, adjuvant chemotherapy, treatment line, dose reduction and adverse events (AE). Efficacy endpoints were progression-free survival (PFS) and overall survival (OS) obtained by the Kaplan-Meier method. Adverse effects (AE) were collected for safety profile assessment. Descriptive statistical analysis was performed using the SPSS Statistics program V22.0. Results Forty-seven patients (30 men and 17 women) were included. The median age was 59 years . At the beginning of the treatment, more than 80% presented ECOG 0-1: 23.4% had received previous adjuvant chemotherapy (gemcitabine and/or fluoropyrimidines). They were treated with nab-paclitaxel 125 mg/m 2 and gemcitabine 1000 mg/m 2 on days 1, 8 and 15 every 28 days. In 89.4% of the patients it was prescribed as first-line treatment. Dose reduction was performed in 68.1%. The median duration of treatment was 4.5 months (0.5-22.9), with four long survivors (longer than 15 months). The median PFS was 9.1 months (95% CI 8.36 to 9.73) and the median OS was 9.11 months (95% CI 4.0 to 14.2). Eighty-three per cent of patients (n=39) had AE of some grade and 17% (n=8) of grade 3-4. The most common AE were: asthaenia (n=17), neutropaenia (n=16), thrombocytopaenia (n=15), neuropathy (n=13), alopecia (n=5), diarrhoea (n=7), mucositis (n=3), vomiting (n=3), oedema (n=3) and dermatitis (n=2). These were grade 3-4: neutropaenia (n=7), thrombocytopaenia (n=4), mucositis (n=1), alopecia (n=1) and neuropathy (n=1). The causes of treatment discontinuation were mainly due to progression in 42.6% and deterioration of general health in 29.8%. At the end of the study, five patients continued treatment. ConclusionThe PFS obtained in our study is greater than those described in the pivotal trial MPACT or CA046. This difference may be due to the four patients with a considerably longer treatment than the average and a small sample. Regarding OS, there are no significant differences with the pivotal trial. The AE described were similar to those published in the literature REFERENCE AND/OR ACKNOWLEDGEMENTS BMC Cancer 2016;16:817. No conflict of interest.
Background and Importance The opening of a pharmaceutical care service for onco-haematology patients (OHP) in the midst of the health care crisis caused by the COVID19 pandemic, made it possible to maintain the healthcare activity, avoid the collapse and provide the opportunity to implement Comprehensive Medication Management (CMM). Aim and Objectives To investigate the pharmacotherapeutic experience of OHP in outpatient therapy with CMM services; to know important aspects perceived for the identification of barriers/facilitators that determine the quality of the service and proposals for improvement. Material and Methods Descriptive observational design with a qualitative approach, using informal and semi-structured indepth interviews (participant observation and peer review) during January-June 2021. ATLAS.ti software was used for content analysis. Oncohaematology patients in outpatient therapy with any medication-related problem and who received CMM services were interviewed. Those who, due to cognitive limitation, could not be interviewed or who did not have a caregiver/family member available were excluded. Results 19 interviews were conducted: 57.89% patients and 42.10% caregivers; 57.89% were women. All patients were very satisfied with the care received, the vast majority preferred to be attended by a pharmacist, and valued telepharmacy as an alternative or complementary option. The vision of the pharmacy professional as an expert in medicines improves. They suggest improvement related to location, waiting times and greater accessibility of the pharmacist. After the researchers' reflective process, were identified as barriers: care pressure, limited time/resources, lack of interlevel coordination, and facilitators: prioritisation of interventions, integration of pharmacist in the multidisciplinary team, trust in the pharmacist and the new model of care. Improvement strategies: provision of human/material resources with release of pharmacist's time to provide the CMM, extension of hours, information management with the development of personal learning environment and use of programs for recording/integration of information and interventions. Conclusion and RelevanceDelving into patients' experiences can be key to improving the quality of care. In our case, the implementation of the CMM service in OHP has been a challenge and an opportunity in the current context of the COVID-19 pandemic. The pharmacy adapted to the needs and implemented a new model of care with excellent acceptance by users.
BackgroundThe antibiotic lock therapy (ALT) technique that involves the instillation of a highly concentrated antimicrobial solution with additives such as anticoagulants into the catheter lumen, is an option for treatment of catheter-related bloodstream infections when the central venous catheter is retained. An important limitation is the frequent incompatibility between the components, causing great controversy in the literaure. The ALT with gentamicin is one of the most requested ALT for treating bacteriemias by Gram(-). The anticoagulant that is studied more is unfractioned heparin. It can be used in haemodialysis patients, however, other anticoagulants such as citrate whose data are limited regarding compatibility should be used for patients with a history of heparin-induced trombocytopenua (HIT) or active HIT.PurposeTo study the stability of the catheter lock solution that combines gentamicin 2.5 mg/ml and heparin 2500UI/mL or citrate 2% as anticoagulant.Material and methodsEight solutions of catheter lock were prepared at fixed concentrations: four solutions of gentamicin 2.5 mg/ml+heparin 2500UI/ml (A1,B1,C1,D1) and four of gentamicin 2.5 mg/ml+citrate 2% (A2,B2,C2,D2). Physical and chemical stability were measured on days 0 (A1,A2), 2 (B1,B2), 3 (C1,C2) and 7 (D1,D2) after the preparation. Two aliquots were prepared from solutions B1, B2 and C1, C2. One aliquot of each one (B1a,B2a,C1a,C2a) were stored in the refrigerator (2°C–8°C) to test the stability of the preparation of ALT extemporaneously prior to its use, and another (B1b,B2b,C1b,C2b) in the oven (35°C–37°C) to simulate the temperatures that are reached once installed in the catheter. Chemical stability was defined as concentrations of gentamicin at least 90% measured by the colourimetric technique. For the analysis the samples were diluted to a gentamycin concentration of 5 mcg/ml. Physical stability was considered as the absence of precipitate or appearance of particles.ResultsNone of the ALT precipitated during the study nor did they showed variations in colour. The concentrations of gentamicin were stable in the different selected storage conditions: A1:5.31 mcg/mL; A2:5.46 mcg/mL; B1a:5.88 mcg/mL; B1b:5.8 mcg/mL; B2a:5.1 mcg/mL; B2b:4.97 mcg/mL; C1a:5.9 mcg/mL; C1b:5.47 mcg/mL; C2a:5.08 mcg/mL; C2b:5.21 mcg/mL; D1:5.46 mcg/mL; and D2:5.04 mcg/mL. The mean was 5.39±0,32 mcg/mL.ConclusionThe ALT with gentamicin 2.5 mg/ml and heparin 2500UI/ml or citrate 2% are chemically and physically stable. More studies are needed to address areas of uncertainty of great clinical relevance, such as the stability of ALT with other concentrations of gentamicin and ALT that combines other antibiotic with citrate.No conflict of interest
BackgroundThe appropriate dose and frequency of omalizumab in patients with severe asthma was determined in clinical trials based on body weight (kg) and baseline IgE (IU/mL). However, in clinical practice a conversion chart promoted by stakeholders is used for dose determination.PurposeTo assess the correlation between omalizumab´s estimated dose calculated from the formula used in pivotal clinical trials (PCT) and prescribed omalizumab dose in clinical practice. We also aimed to analyse the effectiveness of omalizumab based on FEV modifications from baseline.Material and methodsAsthmatic patients treated with omalizumab up to July 2015 were evaluated retrospectively. Demographic data (gender and age), body weight, posology (dose and frequency), duration of treatment, baseline and current IgE level, and baseline and current FEV were recorded. Omalizumab estimated dose was calculated according to the PVT formula at baseline: 0.016*weight*IgE (UI/mL) every 4 weeks or 0.008*weight*IgE (UI/mL) every 2 weeks. For patients treated with omalizumab for 3 or more years current weight and IgE was used instead of baseline data to assess omalizumab´s estimated dose. Also, to analyse the effectiveness of treatment, we calculated the difference in FEV from baseline. Statistical analysis were performed using SPSS15.Results60 patients met the inclusion criteria. 68.3% were female and mean age was 51.8 years (range 16–80). Mean FEV improvement from baseline was 9.69% (range -25%-51.1%). This meant that 56.9% of patients developed an improvement in FEV but 25% had worsening FEV and in 18.3% of patients these data were missing. Comparison between the prescribed dose and estimated dose from the PCT formula showed a concordance of doses in only 20% of cases. Based on these data, 46.3% of patients would benefit from omalizumab dose reduction. Also, 36.7% of patients had a lower prescribed dose than omalizumab’s estimated dose based on the PCT formula. Nevertheless, 61.1% of these patients would not need an increase in dose based on FEV improvement from baseline.ConclusionWe found a great discrepancy between estimated omalizumab dose by the PCT formula and the prescribed omalizumab dose in clinical practice. By using the formula we optimised the efficiency of treatment with omalizumab.No conflict of interest.
combination presented benefit in terms of OS and PFS in untreated metastatic squamous NSCLC (mSNSCLC), regardless of PD-L1 expression. No randomised clinical trials (RCTs) of Pb-CT versus Pb alone have been done. Aim and objectives To assess the comparative efficacy of Pb and Pb-CT in untreated mSNSCLC patients with PD-L1 !50% using an adjusted indirect treatment comparison (ITC). Material and methods A bibliographic search was conducted in the Pubmed database (2 October 2019). Inclusion criteria were phase III RCTs, Pb and Pb-CT treatments, similar mSNSCLC population (with PD-L1 !50%), follow-up period and end points(OS or PFS). Exclusion criteria were mSNSCLC population with EGFR or ALK mutations. An ITC was developed using Bucher's method. Delta value (D), maximum acceptable difference as a clinical criterion of no inferiority, was set at 0.70 (and its inverse, 1.43), used to calculate the sample size in the Pb-CT trial. The Shakespeare method was used to estimate the probability of the results out of the D margins. Results Two studies, one for each regimen, 1 2 were found in the literature search. Limitations found between Pb-CT and Pb trials included populations (all patients vs only patients with PD-L1 !50%, respectively, subgroup data used for ITC) and small size of the squamous subgroup. No OS data were available for the squamous subgroup in the Pb trial. PFS was taken as the primary end point for ITC. Results of RCTs and ITC are shown in table 1. No significant differences in PFS between Pb-CT and Pb were found. The 95% CI exceeded D on both sides (high level of uncertainty). The probability of a result out of D were 24.14% below and 16.54% above. Conclusion and relevance ITC did not show significant differences in PFS between Pb-CT and Pb. No evidence of clinically relevant benefit from one or other regimen was found. Considering the toxicity related to the addition of CT, Pb monotherapy would be preferable in untreated mSNSCLC with PD-L1 !50%.
Aim and objectives To study the impact of a strategy to improve safe handling procedures for HDs and to review medical prescriptions. Material and methods A prospective multicentre study was conducted in 25 nursing homes (NH), 18 day care centres (DC) and 13 centres for people with intellectual disabilities (CPID), with 2500 healthcare professionals serving 7501 users. The intervention consisted of creating standardised work procedures and developing two training sessions for doctors and managers. Subsequently, HD treatments were reviewed according to INFOMEP (a Spanish HDs database) and different interventions were developed to withdraw, replace or reduce HD manipulation. Interventions were compiled and their acceptance was calculated. Results A total of 58 656 lines of treatment were analysed, resulting in 2732 HDs (4.7%) in 2394 users without the ability to self-administer their medicines: 7.6% HDs in group 1, 43.1% HDs in group 2 and 49.3% HDs in group 3. For HDs, 41.1% required handling for preparation and administration: 8.5% in group 1, 36.7% in group 2 and 54.8% in group 3. The most frequent drugs were risperidone (22.6%), acenocoumarol (22.3%), valproic acid (8.9%), clonazepam (7.4%), spironolactone (7.0%), carbamazepine (4.7%) and paroxetine (4.3%) which accounted for 75.0%. A total of 584 interventions were made (percentage acceptance): 86 (69.8%) withdrawn as not need, 103 (29.1%) replaced, 369 (39.0%) switched to another drug presentation which required less manipulation, 9 (55.5%) optimised administration frequency, 9 (33.3%) optimised drug schedule and 8 (0.0%) changed pharmaceutical form. Global acceptance was 42.0%. After the intervention there were 1924 HDs: 9.0% in group 1, 25.5% in group 2 and 65.5% in group 3. HDs were reduced by 29.6% due to risperidone and paliperidone which were no longer considered dangerous by NIOSH during the study period (83.0%), withdrawals (7.4%), lost (5.9%) and replaced with other non-HDs (3.7%). Conclusion and relevance The exclusion of risperidone and paliperidone has meant a significant reduction in the prescription of HDs in nursing homes. This particular prescription review, supported by standardised procedures, individual interventions and training, also contributed to the adequacy of HD prescriptions. The pharmacist is a key advisor in HD safe handling strategies, including in nursing homes.
BackgroundAlthough parenteral nutrition (PN) is a lifesaving therapy in undernourished patients, its use may be associated with metabolic complications.PurposeTo analyse the incidence of metabolic complications associated with PN administration in patients admitted to the intensive care unit (ICU).Material and methodsObservational and retrospective study. All patients who received PN in the ICU between January and March 2017 were included. Demographic, clinic and nutrition information were obtained from Diraya® and Kabisoft®.Demographics, indication, duration, venous access, composition of the nutrition and associated complications were registered.Hyperglycaemia (>200 mg/dl), hypoglycaemia (<60 mg/dl), electrolytic alterations (EA) (sodium and/or potassium), hypertriglyceridaemia (>250 mg/dl), hypercholesterolaemia (>200 mg/dl), creatinine (>3 mg/dl), urea (>60 mg/dl), metabolic acidosis y cholestasis (alkaline phosphatase (AF) >380 UI/L, and glutamic transaminase (GGT) >50 UI/L of bilirubin >1.2 mg/dl) were the parameters considered metabolic complications. Rate and density of incidence (number of episodes per 100 days of parenteral nutrition in case of the most frequent) were determined.ResultsThirty-six patients were included (52.7% males), the average age was 64.75±10.37 years.PN indications were: intestinal resection 30.5%, fistula or perforation 11.1%, intestinal obstruction 16.7%, suture dehiscence 13.9%, paralytic ileus 8.3%, ulcerative colitis 5.6% and others 16.7%.10±10 days was the median duration of the PN and 10±11 days the median of the ICU stay.Central vias channelled were jugular 50%, subclavian 25% and femoral 13.9%.All patients had daily analysis of glucaemia, sodium, potassium, urea, creatinine and pH. 33.3% also had cholesterol and triglycerides determination, and 47.2% had FA, GGT and bilirrubina determinations as well.88.9% of the patients presented metabolic complications associated with the PN: 71% presented more than one complication.Incidence of complications: EA 63.9% (5.01 per 100 days); hyperglycaemia 52.8% (4.14 per 100 days); hyperuricaemia 33.3% (2.6 per 100 days); hypercreatininaemia 16.7% (1.03 per 100 days); metabolic acidosis 31.3% (1.09 per 100 days). None presented hypercholesterolaemia and six presented hypertriglyceridaemia.The alterations presented in those patients whose AF, GGT and bilirubin were determined, were 23.5%, 52.9% and 29.4%, respectively.ConclusionMetabolic complications in patients admitted to the ICU were frequent, underscoring electrolytic alterations and hyperglycaemia. These results were in accord with the consulted bibliography.No conflict of interest
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.