Trans-arterial chemoembolization with doxorubicin-eluting particles versus conventional trans-arterial chemoembolization in unresectable hepatocellular carcinoma: A study of effectiveness, safety and costs.

OBJECTIVES: To compare the effectiveness, survival and cost in patients with unresectable hepatic cell carcinoma (HCC) treated with trans-arterial chemoembolization using doxorubicin-eluting beads (DEB-TACE) versus conventional TACE (cTACE) in clinical practice. MATERIAL AND METHODS: This single-centered retrospective observational study compared 60 consecutive HCC unresectable patients: 30 were treated with DEB-TACE and 30 used cTACE. Comparisons were with χ(2) test, Student t-test, and Kaplan Meier method. RESULTS: Of the 60 patients with HCC in non-curative stage, baseline characteristics were similar for both groups of treatment, and of these we observed lower survival in male patients and those who had hepatitis C virus (p=0.014 and p=0.003, respectively). No statistically significant differences were observed as a function of treatment employed with respect to overall survival (OS) at 5 years (29.99 months; 95%CI: 21.38-38.60 versus 30.67 months; 95%CI:22.65-38.70; p=0.626) and progression free survival (PFS) median of 11.57 months (95%CI: 0.97-22.18) versus 12.80 months (95%CI:0.00-32.37; p=0.618). The median length of hospital admission were 2.6 and 5.4 days (p<0.001) for DEB(-)TACE and cTACE, respectively. Toxicities grade 2-4 were higher in cTACE group (54 versus 31; p<0.001). The cost of the treatment was 1581 € for DEB(-)TACE and 514.63 € for cTACE. The overall mean cost of intervention was 3134 € and 3694.35 €, respectively (p=0.173). CONCLUSIONS: Chemoembolization in patients with unresectable HCC achieved OS close to 30 months at 5 years, independent of the technique employed. Similar overall costs but better tolerance of the DEB-TACE justified the higher costs of the procedure.

[The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document]. / 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla.

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: « Does this particular AABT reduce the transfusion rate or not?¼ All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology.

Neutrophil/lymphocyte ratio: Can a non-specific marker of inflammation helps to confirm the inflammatory hypothesis of the serious mental diseases? A case-control study.

BACKGROUND: The hypotheses of autoimmune, allergic or infectious etiology of severe mental illness have been reported in the scientific literature repeatedly. The main objective of this work is to study the relationship of inflammatory, autoimmunity or recent infection markers with the fact of suffering Severe Mental Disorders (SMD). METHODS: In the present case-control study, adult patients with a diagnosis of SMD were compared with controls who underwent routine health checks that included analytical control. Cases with psychosis substance-induced and controls with diagnosis of any psychiatric illness were excluded. In both groups, patients with chronic inflammatory diseases or intercurrent infectious disease were also excluded. A set of common analytical parameters, markers of infectious diseases and inflammatory markers were retrieved for both groups, as well as demographic and clinical data. RESULTS: A total of 212 subjects (81 cases and 131 controls) were recruited. From cases, 70 (86.4%) have a diagnosis of Schizophrenia Disease (SD) and 11 (13.6%) of Schizoaffective Disorder (SAD). In the multivariate model the female sex (OR 0.24, 95% CI 0.12-0.46) and the neutrophil-lymphocyte ratio (OR 3.00, 95% CI 1.91-4.70) were associated with the fact of being case. CONCLUSIONS: Patients with SMD seem to have higher inflammatory markers compared to the general population, being the neutrophil-lymphocyte ratio, the marker associated with more strength. The role of inflammatory processes in the etiology of this type of disorders, if confirmed, opens interesting and innovative therapeutic possibilities.

[Medication errors in a tertiary hospital with three different drug delivery systems]. / Errores de medicación en un hospital terciario con tres sistemas de distribución de medicamentos diferentes.

OBJECTIVE: To estimate the proportion of medication errors in a tertiary hospital, global and for each delivery medication system, to describe the error types and the implied medications, and to analyze the factors associated to the same ones. METHODS: Errors were identified from direct observation of 2,242 opportunities for error (administered doses or prescribed doses not given) by 6 couples of observers. Delivery medication systems were stock in ward, unit dose with electronic prescription and unit dose with computerized transcription. Logistic regression was used to evaluate the association between errors and certain factors. RESULTS: The medication error rate was of 7.2% (CI 95%: 6.1-8.3), and 4.4% (CI 95%: 3.6-5.3) of them reached the patient. For delivery systems, the error rate was of 9.5% (CI 95%: 7.4-11.9) for stock in ward, 7.8% (CI 95%: 5.9-10.0) for electronic prescription and 4.7% (CI 95%: 3.4-6.4) for computerized transcription. The highest error frequency was observed in the administration phase (58.4%) and the omitted dose was the most prevalent error (31.7%). The error rate was associated to the pharmacotherapeutic process, the schedule of administration and the unit of hospitalization. CONCLUSIONS: In one of each 14 opportunities for error a medication error takes place. The different delivery medication systems have different error rates.

[Effectiveness of heparin versus NaCl 0.9% in central venous catheter flushing. A systematic review]. / Heparina frente a cloruro sódico 0,9% para mantener permeables los catéteres venosos centrales. Una revisión sistemática.

OBJECTIVE: To determine the effects of intermittent flushing with heparin versus NaCl 0.9% solution on prevention of thrombotic events and infections in central venous catheters. METHOD: A systematic review of controlled trials, randomized or not, in whose intermittent flushing with heparin versus NaCl 0.9% in central venous catheters were compared was carried out. Any publication was excluded because of patients age, country or language. Studies were identified by computerised searches (MEDLINE and CINAHL 1996-2004, EMBASE Drugs and Pharmacology 1991-2004, Cochrane Library up 2005, ISI Web of knowledge 1990-2004), clinical trials metaregister http://www. controlled-trials.commrct/mrct_info_es.asp, and scanning references. RESULTS: Only two clinical trials, involving 94 patients, fulfilled inclusion criteria for obstruction. Methodological quality of trials was poor and heterogenicity was also very significant. It made impossible meta-analytical combination of results. No studies comparing heparin vs. NaCl 0.9% solution flushing in catheter-related infection prophylaxis were reported. CONCLUSIONS: Poor evidence supports effectiveness of intermittent heparin flushing vs. NaCl 0.9% solution, although methodological limitations and small sample size make these findings very inconsistent. In infection prophylaxis, there is no data allowing us to conclude if heparin flushing is more effective than NaCl 0.9% solution. More randomized clinical trials are needed.

[An analysis of patient information sheets for obtaining informed consent in clinical trials]. / Análisis de las hojas de información al paciente para la obtención de su consentimiento informado en ensayos clínicos.

BACKGROUND: The written information provided to the potential participants in a clinical trial must have certain qualitative and quantitative characteristics to reach the ethical requirements governing the theory of the informed consent. MATERIAL AND METHODS: In a sample of 101 clinical trial protocols approved in two Spanish university general hospitals, the following items were evaluated: a) the amount and quality of the written information given to the patient, in accordance with the established in the Spanish legislation; b) the formal readability of this written forms, by means of the Flesch method, and c) the level of complexity of the vocabulary, by means of the number of non-comprehensible words for two volunteers unaware of the health professions, with high studies. RESULTS: The balance of benefits and risks, the identification and the way of contact with the main investigator, the description of the alternative treatments and the specification of the compensations in case of lesions were the items with highest noncompliance. The mean global readability by means of the index of Flesch was of -12.7 (text with a high level of complexity). The mean percentage of words non-comprehensible for the volunteers that analyzed the texts was 0.3%. CONCLUSIONS: The written form of information provided to the patient in the clinical trials developed in Spain has serious deficiencies, either in their formal readability (complexity of the linguistic structure) or in the amount and quality of the information that provides. These deficiencies could have a wrong influence in the appropriate obtention of the informed consent from the patients.

[3 possible sources of microbiologic contamination in the preparation of formulations for parenteral nutrition]. / Estudio de tres potenciales fuentes de contaminación microbiológica en la elaboración de nutriciones parenterales.

It is well known that the microbiological control of "all in one" nutritional preparations is difficult. In this work we evaluated and compared the potential contaminants that may be present in the process of manufacturing in a Centralized Unit of Parenteral Nutrition. The study has been centered on the microbiological contamination that may be introduced by the technician, by the raw materials, and that existing in the work area. A microbiological contact technique was used. The results obtained showed that the main microbiological contaminants are introduced by the technician when not observing strict aseptic measures. Another source of contamination is represented by PVC bags when they are manipulated in the pre-sterile area and are not sprayed with alcohol 70 degrees. Therefore, PVC contamination arises from the hands of the technician. Significant differences in contamination between hands washed with germicidal soap and sterile gloves and between clean and sterile surgical dressing could not be demonstrated.

[Low-residue diets supplemented with fermentable fiber. Effect on experimental colonic anastomosis]. / Dietas de bajo residuo suplementadas con fibra fermentable. Efecto sobre las anastomosis cólicas experimentales.

Presentation of an experimental study comparing the scarring of colic anastomoses performed in Wistar rats fed with three different types of diet: a standard laboratory diet, an enteral low-residue diet and a low-residue diet supplemented with fermentable fibre in short chain fatty acids (pectin). Scarring in the group fed with the standard laboratory diet showed greater anastomotic complications, and the microscopic appearance was more inflamed. The administration of low-residue diets reduced the level of complications, but also reduced the concentration of collagen and the parietal rupture tension. The addition of pectin to a low-residue diet maintained the complications at a low level, and also significantly increased the pressure parameters and the collagen concentration.

[Therapeutic interchange of drugs not included in the hospitals pharmacotherapeutic guide: a quality program]. / Programa de calidad aplicado a la sustitución de medicamentos no incluidos en la Guía Farmacoterapéutica del hospital.

BACKGROUND: Standardised substitution of those drugs not included in the hospitals formulary constitutes one of several methods used to improve therapeutic efficiency, due to reduction of variability in pharmaceutical practice and prevention of potential medication errors. OBJECTIVES: To evaluate quality of drug substitution procedures in those drugs not included in the hospital's formulary. METHODS: Assessment study in a surgical hospital with 314 beds, using structural, process and outcome criteria from 1998 to 2002. RESULTS: Compliance degree for structure, process and outcome criteria were 100, 89 and 35%, respectively, while the established standards were 100%. Prevalence values for patients with substituted medication, increased from 2.9 (95%CI, 2.4-3.6) in 1998 to 11.1% (95%CI, 10.2-12.1) in 2002. Non-substituted drugs annual cost decreased from 20,199 in 1998 to 12,356 Euro in 2002. Drug substitution made by the pharmacist had an acceptance degree of 82.5%. No interchange errors were found in 126 replaced drugs. CONCLUSIONS: The development of quality programs to improve drug prescription adherence to the hospitals formulary, specially those that promote therapeutic interchange under the Pharmacy Committee guidance, are helpful strategies to make a proficient management of patients pharmacotherapy.

[Assesing the GRDOSIS Software program as a tool to analyse drug usase by DRGs]. / Evaluación del programa informático GRDOSIS como herramienta de análisis de la utilización de medicamentos por GRD.

OBJECTIVE: To validate the GRDOSIS software program as a tool to calculate Spanish drug weights within diagnosis-related groups (DRGs), and to analyse information used in this calculation. MATERIAL AND METHODS: Information corresponding to a 7-hospital sample is analysed after exchanging data between the minimum basic data set processed by the DRG-grouping program Estación Clínica -3M and unit-dose drug consumption. Data are purged by eliminating cases with an unusual (either long or short) length of stay in each DRG, and both weights and pondered weights are calculated. Data from the 5 most prevalent DRGs are analysed by using the different options provided by the software program, with the aim of detecting intervention points in order to improve results. RESULTS: Extreme case elimination noticeably reduces mean cost per DRG. A reduced group of DRGs represents a high percentage of total cost. Similarly, a reduced number of drugs may represent a high percentage of cost within a given DRG. The use of specific therapeutic groups for specific DRGs is demonstrated, as is the correct use of first-choice drugs versus other therapeutic options within therapeutic groups. An unwarranted variability regarding drug administration dosing and frequency is, however, observed. CONCLUSIONS: The GRDOSIS software program proves itself a powerful tool for both the qualitative (drug usage profiles, dosage) and quantitative (costs) analysis of information originating in a Pharmacy Department

[Emergent drugs (III): hallucinogenic plants and mushrooms]. / Drogas emergentes (III): plantas y hongos alucinógenos.

An increase in the consumption of vegetable substances with a hallucinogenic effect has been observed. Some of these substances are associated with ancestral religious ceremonies, while many of them are legal or are partially regulated. Salvia divinorum is a powerful kappa receptor agonist, with dissociative and hallucinogenic properties, which start quickly and have a short duration. Kratom (Mytragyna speciosa) has mitragynine as its principal alkaloid, with stimulating effects at low doses (coke-like effect), and sedative effects (opiate-like effect) at high doses. Several deaths from its consumption have been detected. The consumption of hallucinogenic mushrooms appears in cyclic form, although there has been increase in their online offer. They are consumed in search of their hallucinogenic effects, above all those belonging to the family of psilocybes, which contain tryptamines with a hallucinogenic effect similar to LSD. Peyote (Lophophora psilocybes), a cactus rich in mescaline (trimetoxifeniletilamina), produces hallucinations of the five senses, and forms part of the religious culture of the North American Indians. Daturas, which are ubiquitous, produce anticholinergic symptoms and effects on the central nervous system (delirium, hallucinations, etc.), due to their high atropine and scopolamine content. Other substances used for their hallucinogenic effects include the drink known as ayahuasca, and seeds for preparing infusions like Ololiuqui, Morning Glory (Ipomoea violacea), Hawaian Baby Woodrose (Argyreia nervosa), Syrian Rue (Peganum harmala) and Iboga Rootbark (Tabernanthe iboga).

[The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document]. / 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla.

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: "Does this particular AABT reduce the transfusion rate or not?" All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology.

Tejo (Taxus baccata) y digital (Digitalis spp. ): los principios tóxicos son muy diferentes / Yew (Taxus baccata) and foxglove (Digitalis spp. ): toxic principles are very different

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