Background Calcinosis is caused by accumulation of calcium salts in the tissues, with subcutaneous nodules, atrophy and ulceration over the affected area. Treatment with intravenous sodium thiosulfate has been used, since it inhibits the precipitation of calcium salts and dissolves calcium deposits. Recently, cases successfully treated with topical 10–25% sodium thiosulfate have been described. Purpose To analyse the efficacy and safety of topical treatment with a formulation of 10% sodium thiosulfate in a paediatric patient with iatrogenic calcinosis. To optimise the preparation of the formulation. Materials and methods Case Male 6 years old with primary hypothyroidism and post-surgical hypoparathyroidism treated with calcium gluconate. In January 2013, he was diagnosed with iatrogenic calcinosis presenting stony in consistency erythematous spot in both arms. Topical 10% sodium thiosulfate was prescribed. A literature search was conducted in PubMed to find a suitable formulation. The first sample was stored to check the stability of the emulsion. After starting treatment, the clinical evolution was followed up during successive visits (January–April 2013). Results To achieve greater occlusivity that allowed adequate absorption and a greater pharmacological effect, a topical W/O emulsion was prepared using a commercial product (’cold cream’) as the oily external phase. It was necessary to dissolve the hydrophilic drug in water prior its incorporation in the external phase. The clinical response to treatment was prompt, gradually reducing visible injuries, subcutaneous calcifications, induration and swelling. After 15 days, the pain disappeared completely and mobility was recovered with the help of rehabilitation. The calcified material was gradually expelled as calcium crystals through ulcers over three months. Tolerance of the cream was adequate, with slight temporary pruritus in the first month. The stored emulsion remained stable for 4 months. Conclusions Topical treatment with a W/O emulsion of 10% sodium thiosulfate was effective, as in the published literature (although in one case the concentration was 25% and in the other one injuries were only subcutaneous) and well tolerated (without topical or systemic adverse reactions). Despite the low compatibility between the ionic drug and ‘cold cream’, the emulsion was stable at least 4 months. No conflict of interest.
Introduction. Comparative “real life” data on the effectiveness and safety of ceftolozane/tazobactam (C/T) versus other regimens (aminoglycosides/colistin/combination), in the treatment of multi-resistant (MDR) and extremely resistant (XDR) Pseudomonas aeruginosa (PA), are needed to establish positions. Material and methods. Observational, retrospective study of patients with microbiological confirmation of MDR and XDR PA from July 2016 up to December 2018 in a tertiary hospital. Variables: age, sex, comorbidities, risk factors for multidrug resistance, variables related to infection, source of infection, microorganism and type of sample, antibiotic treatment, clinical cure, microbiological cure, recurrence, mortality on admission and 30 days post-discharge. Patients were classified according to received antibiotic treatment, C/T or aminoglycosides/colistin/combination Results. A total of 405 patients with PA MDR and XDR infection (73.1% men, mean age 63 ± 15 years) were studied. An 87.1% of PA XDR and a 12.9% MDR were observed. All patients received C/T as targeted therapy and in the aminoglycosides/colistin/combination group were 73.5%. Patients in the C/T group present worse prognostic factors: septic shock (30.0%) and catheterization (90.0%) (p<0.05). There were not statistically significant differences in microbiological cure (p=0.412), recurrence (p=0.880) and clinical cure (p=0.566). There were not statistically significant differences in mortality at admission (p=0.352) or at 30 days after discharge (p=0.231). A 17.2% of the patients with aminoglycosides/colistin/combination had acute kidney injury according to RIFLE criteria and 4.3% with C/T. Conclusions. The data obtained suggest that there have been no differences in effectiveness (clinical or microbiological cure) in favour of C/T, although, in the period studied, it was used in most cases in multitreated patients with a worse prognosis. Randomized and prospective studies would be needed to establish an adequate positioning.
Background Clofarabine is a recently marketed drug used in paediatric patients with refractory acute lymphoblastic leukaemia (ALL) after at least two prior chemotherapy regimens. Its safety and effectiveness have not been evaluated in adults. Purpose To evaluate the effectiveness and safety of clofarabine in adult and paediatric patients in a tertiary hospital and compare the results between the two populations. Materials and methods Retrospective and descriptive study. Inclusion criteria: all patients treated with clofarabine in the hospital. Data collected from clinical history and pharmacy database: patient age, diagnosis, prior relapses and number of cycles of clofarabine received. Efficacy variables: disease remission (complete/partial) and the need for transplantation. Safety variables: all serious adverse reactions observed. Results 16 patients were included: 10 adults and 6 children. Mean age was 33.4 (18–63) and 8 (3.7–13.5) years old, respectively. Diagnoses were ALL (10 patients), acute myelogenous leukaemia (5) and lymphoblastic lymphoma (1). 2 (12.5%) patients received 2 cycles and the rest (87.5%) 1 cycle, all after the second relapse. A complete response was attained in 33.3% of adults and 50% of children. 10% of adults had a partial response and 40% of adults and 33.3% children didn’t respond. 56.25% of patients needed subsequent transplantation. The most significant adverse reactions in children were post-chemotherapy pancytopenia with infections (66.67%) and fulminant hepatic failure (16.67%). In adults pancytopenia (100%), bacteraemia, sepsis and severe infections (70%), hepatotoxicity (40%), central venous thrombosis (20%), severe gastrointestinal toxicity (20%), grade 4 mucositis (10%) and tumour lysis syndrome (10%) were observed. 13 patients died at the end point. 2 adults and 1 child died immediately after clofarabine treatment (due to post-chemotherapy hypovolaemic shock, tumour lysis syndrome and fulminant hepatic failure, respectively). Conclusions Clofarabine effectiveness is low and bears a high risk of severe adverse effects in adults (especially infectious diseases or liver toxicity). In paediatric patients, clofarabine is more effective and better tolerated. No conflict of interest.
improve patient outcome and patient care, in order to support a hospital pharmacy CTF legislation process in the European Union. Material and methods We identified 70 publications based on data up to 2010 from our previous study 1 and were evaluated with indepth assessment regarding pharmacists' qualifications. Results Forty (57%) publications had sufficient information on the qualifications of pharmacists and an additional 7 (10%) papers had partial information. Of the papers with detailed information on pharmacists' qualifications, 30 (43%) defined the pharmacists as 'clinical pharmacists' having additional training. Other qualifications were mentioned, such as intensive care, pain, oncology, paediatric, internal medicine and infectious diseases specialised pharmacists, that also verified the importance of postgraduate training. Further information on the qualifications of pharmacists were included in additional training to highlight their competency in clinical services. The publications provided evidence of the positive effect of pharmaceutical interventions for patient outcomes in many fields, including internal medicine, acute care medicine, oncology, paediatrics and surgery, also demonstrating the economic benefits of the interventions. Conclusion and relevance Clear evidence was provided that only qualified pharmacists with a postgraduate education can provide the correct services to patients and consequently improve their outcomes, similar to other professions (physicians and nurses) in the healthcare system. REFERENCES AND/OR ACKNOWLEDGEMENTS 1. West LM, Vetter-Kerkhoff C, Miljkovic N, Frontini R. Is there a need for a hospital pharmacy common training framework? Review of the literature on the impact of educational interventions on health outcome.
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