Effect of ß-cryptoxanthin plus phytosterols on cardiovascular risk and bone turnover markers in post-menopausal women: a randomized crossover trial.

BACKGROUND AND AIM: Post-menopausal women are at higher risk of cardiovascular disease and bone demineralization. Phytosterols (PS) may be used for hypercholesterolemia in some groups and ß-cryptoxanthin (ß-Cx) displays a unique anabolic effect on bone. Our aim was to assess the changes in cardiovascular and bone turnover markers from the oral intake of ß-Cx and PS in post-menopausal women. METHODS AND RESULTS: A randomized, double-blind, crossover study with ß-Cx (0.75 mg/day) and PS (1.5 g/day), single and combined, was performed in 38 postmenopausal women. Diet was supplemented with 1 × 250 mL milk-based fruit drink/day for 4 weeks with a wash-out period of 4-weeks in between. Serum ß-Cx and PS were determined by UPLC and CG-FID respectively. Outcome variables included markers of bone turnover and cardiovascular risk. Biological effect was assessed by paired t test and generalized estimating equations analysis that included the previous treatment, the order of intervention and the interactions. The intake of beverages containing ß-Cx and PS brought about a significant increase in serum levels of ß-Cx, ß-sitosterol and campesterol. Intervention caused changes in almost all the markers while the order, previous treatment and the interaction did not reach statistical significance. Only the intake of the beverage containing ß-Cx plus PS brought about significant decreases in total cholesterol, c-HDL, c-LDL and bone turnover markers. CONCLUSIONS: ß-Cx improves the cholesterol-lowering effect of PS when supplied simultaneously and this combination may also be beneficial in reducing risk of osteoporosis. CLINICAL TRIAL REGISTRY: ClinicalTrials.gov number NCT01074723.

Incidence and prevalence of multiple sclerosis in Spain: a systematic review.

INTRODUCTION: Greater understanding of the prevalence and incidence of multiple sclerosis in Spain and their temporal trends is necessary to improve the allocation of healthcare resources and to study aetiological factors. METHODS: We performed a systematic search of the MedLine database and reviewed the reference lists of the articles gathered. We collected studies reporting prevalence or incidence rates of multiple sclerosis in any geographical location in Spain, with no time limits. In 70% of cases, data were extracted by 2 researchers (FGL and EAC); any discrepancies were resolved by consensus. RESULTS: We identified 51 prevalence and 33 incidence studies published between 1968 and 2018. In the adjusted analysis, the number of prevalent cases per 100 000 population increased by 26.6 (95% confidence interval [CI], 21.5-31.8) every 10 years. After adjusting for year and latitude, the number of incident cases per 100 000 population increased by 1.34 (95% CI, 0.98-1.69) every 10 years. We observed a trend toward higher prevalence and incidence rates at higher latitudes. CONCLUSIONS: The prevalence of multiple sclerosis in Spain has increased in recent decades, although case ascertainment appears to be incomplete in many studies. Incidence rates have also increased, but this may be due to recent improvements in the detection of new cases.

[Evaluation of training on the programs to optimize antimicrobial use in medical residents of the province of Las Palmas]. / Evaluación de la formación sobre el programa de optimización del uso de antimicrobianos en médicos residentes de la provincia de Las Palmas.

OBJECTIVE: Antibiotic resistance is a threat to global public health. This situation makes essential to establish programs to optimize antimicrobial use (PROA). Training needs are identified in the PROA of resident physicians and the results of the analysis of the associations between study variables and training in the rational and prudent use of antibiotics are presented in this analysis. METHODS: Cross-sectional and analytical study through a self-administered questionnaire to a group of 506 medical residents of the province of Las Palmas. The association between resident's characteristics and PROA training was calculated through logistic regression. RESULTS: The associations between response variance and speciality were observed in most of the core component analysis (opportunity p=0.003, training p=0.007, motivation p=0.055 and hand hygiene p=0.044), followed by variance according to sex (capacity p=0.028, theoretical knowledge p=0.013, hand hygiene p=0.002). Very few differences were associated with age (capacity p=0.051 and hand hygiene p=0.054) or the year of expertise (hand hygiene p=0.032). CONCLUSIONS: The main training needs of resident physicians include one health, motivation, training, hand hygiene and information. The type of speciality followed by sex are the most important determinants on antibiotic use and resistance for resident physicians.

[Does continuous veno-venous hemodiafiltration therapy reduce mortality due to acute renal failure as compared to intermittent hemodialysis?]. / Es la hemodiafiltración veno-venosa continua superior a la hemodiálisis intermitente en términos de supervivencia en los enfermos con fracaso renal agudo? Respuesta mediante una revisión sistemática.

OBJECTIVE: To estimate whether continuous veno-venous hemodiafiltration (CVVHDF) is superior to intermittent hemodialysis (IHD) in terms of survival of adult patients with acute renal failure (ARF) admitted to the Intensive Care Unit. SELECTION OF STUDIES: Controlled clinical trials (CCT) and systematic reviews comparing CWHDF and IHD for managing ARF in adult patients (age > 19 years). Observational and case series were excluded. SEARCH SOURCES: The basic syntax <> was used to search Pub Med and Ovid System databases. A manual search was done by reviewing the references in the corresponding topic of UpToDate. ANALYSIS: Data were extracted by two author and their methodological quality was assessed according to the Cochrane Renal Group recommendations that include the procedure for assigning, blinding, intention to treat analysis, and follow-up. OUTCOMES VARIABLES: All data relating to mortality were extracted, specifying the time of collection, time and circumstances (mortality in the ICU or hospitalization). Values gathered are expressed as mortality rates in both the experimental group (CVVHDF) and the control group (IHD), indicating the absolute risk reduction (ARR) and its 95% confidence interval. OUTCOMES AGGREGATION: Studies meeting clinical and methodological homogeneity criteria were combined with the fix effect model by using the Review Manager tool from Cochrane Collaboration. Methodological heterogeneity was analyzed by using the chi-squared test for n-1 freedom degrees, with an alpha value of 0.05. A sensitivity analysis was done adjusting for methodological quality to confirm the results obtained. RESULTS: Seven clinical trials directly comparing the survival of severe ARF patients in a prospective, randomized, and controlled way were identifiec. Almost all published estudies have quality problems because of being too small to study survival rates, treatment allocation problems and high numbers of loss to follow-up, differences in initial severity levels, or to premature study closure. When combining the results, it was observed that mortality was 64% for IHD and 65% for CVVHDF, with a relative risk of 0.98 (95% CI 0.89-1.07), p = 0.65, with no statistically significant heterogeneity between studies included. When excluding from the analysis the most questionable study due to selection bias, high loss to follow-up (21%), and baseline differences in co-variables influencing the study outcomes, the results are not changed, the observed mortality was 67% for extra-renal intermittent depurative techniques versus 65% for continous ones, with a relative risk of 1.03 (95% CI 0.94-1.14), p = 0.54, again with no statistically significant heterogeneity between studies included. CONCLUSION: CVVHDF does not offer any benefit as compared to IHD in terms of survival and according to available data from the literature. However, continuous techniques bring other potential benefits such as hemodynamic stability, better tolerability of ultrafiltration, and depuration of solutes, which merit a systematic review to estimate and quantify their magnitude, and which would allow for better defining their place in the therapeutic armamentarium available for this high-mortality condition.

[Female paraurethral cysts. Experience of 4 cases]. / Quistes parauretrales femeninos. Experiencia de 4 casos.

Parauthreal cysts are an uncommon pathology. We present 4 cases diagnosed and treated in our hospital during the last 10 years.

Clinical use and tolerability of voriconazole in the treatment of fungal infections in critically ill patients.

The clinical use and tolerability of voriconazole in daily practice for the treatment of fungal infection in critically ill patients was assessed in an open-label, non-comparative, observational study. All patients admitted to medical-surgical Intensive Care Units (ICUs) of 21 hospitals in Spain between February 2003 and January 2004, who were treated with voriconazole because of known or suspected fungal infection, were included. A total of 130 patients received voriconazole (6.2 cases per ICU). Fungal infections were classified as proven in 50 patients (38.5%) and probable in 38 (29.2%). The etiology was established in 103 patients, with Candida albicans and Aspergillus fumigatus as the most common pathogens. In 98 (75.4%) patients, voriconazole was initially administered intravenously. Fifty-three patients (40.8%) were treated with other antifungal agents prior to the use of voriconazole. In 21 patients (16.2%), voriconazole was administered in combination with other antifungal drugs. Clinical responses were cure and improvement in 65 (50%) patients, failure in 26 (20%), and undetermined in 39 (30%). The crude ICU mortality was 49.2%. According to multivariate analysis, ICU mortality was significantly associated with pneumonia (OR = 3.30, 95% CI 1.07-10.18) and infection caused by Aspergillus spp. (OR = 3.70, 95% Cl 1.12-12.28), whereas eradication of the causative microorganisms was inversely associated (OR = 0.13, 95% CI 0.05-0.34). Adverse events were recorded in 65 patients, probably or possibly related to the study drug in 21. In conclusion, in critically ill patients admitted to the ICU, the use of voriconazole was affective in 50% of cases. The drug was well tolerated and discontinuation of voriconazole treatment due to adverse events was not necessary.

[Urinary bacteriologic study prior to endoscopic urologic surgery]. / Estudio bacteriológico de la orina previa a la cirugía urológica endoscópica.

OBJECTIVE: The objectives of this study are to know the incidence of preoperative bacteriuria in patients undergoing endoscopic urologic surgery, to analyze the most frequent microorganisms appearing in the cultures and their resistance to antibiotics in order to select the most appropriate prophylactic one for our population, and to determine the risk factors related to postoperative bacteriuria or sepsis of urologic origin. MATERIAL AND METHODS: 449 patients undergoing endoscopic urologic surgery were included in the study. Urinary samples were collected for culture prior to prophylactic antibiotic administration and again a week after bladder catheter removal once the antibiotic treatment was finished. Variables related to an increase in infectious complications were analyzed. Special attention was paid to postoperatory incidences, mainly those of infectious nature. RESULTS: Preoperative bacteriuria was found in 66 out of 428 patients (15.4%). It was found to be related to age, sex, previous infection episodes, diabetes mellitus, indwelling catheter and to the pathology for which operation was indicated. The most frequently found microorganism was Escherichia Coli. Resistance to prophylactic antibiotic was found in 37.9% of patients with preoperatory bacteriuria. Postoperatory bacteriuria, observed in 22.0% of the patients was exclusively related to preoperatory bacteriuria. 2.9% of patients showed sepsis of urinary origin criteria during hospital staying, and it was found to be exclusively related to length of surgery and neither to preoperatory bacteriuria nor to indwelling catheter time or the "inappropriate" prophylactic antibiotic use in these cases. CONCLUSIONS: A good part of patients who underwent endoscopic surgery showed preoperatory bacteriuria, responsible for postoperative bacteriuria in less than 25% of the cases. The length of surgery seemed to be the only related cause whit sepsis of urinary origin.

A randomized trial comparing cyclosporine and steroids with cyclosporine, azathioprine, and steroids in cadaveric renal transplantation.

BACKGROUND: In renal transplantation, triple-drug therapy (low-dose cyclosporine [CsA] combined with azathioprine plus steroids) has been replacing double-drug therapy (CsA plus steroids) in clinical practice without much evidence in favor of either therapy. Previous trials comparing the two immunosuppressive regimens gave conflicting results. We attempted to determine whether triple therapy is at least equivalent to double therapy. METHODS: A randomized trial was performed in 250 adult cadaveric renal transplant recipients, comparing double therapy (CsA [10 mg/kg/day] plus prednisone) with triple therapy (CsA [6 mg/kg/day] plus azathioprine plus prednisone). The median follow-up time was 930 days. RESULTS: The incidence of acute rejection episodes refractory to treatment was 11% in double therapy and 4% in triple therapy (relative risk reduction: 64%; 95% confidence interval: 5-100%; P=0.035). Patients in the double therapy group required more intensive antirejection treatment, and their pathologic lesions were more severe. The proportion of patients with acute rejection was similar (double therapy: 45% vs. triple therapy: 40%) as was the incidence of chronic renal dysfunction (double therapy: 17% vs. triple therapy: 15.5%), the 4-year graft survival (double therapy: 71% vs. triple therapy: 83%, P=0.089), and patient survival (double therapy: 94% vs. triple therapy: 93%). In 29 patients (23%), 35 episodes of azathioprine-induced leukopenia were recorded, and in 9 of them azathioprine had to be discontinued. The incidence of other adverse events did not differ between the groups. CONCLUSIONS: Triple therapy caused fewer episodes of refractory acute rejection episodes and was as efficacious and safe as double therapy.

Diagnosis of prosthetic vascular graft infection by technetium-99m-HMPAO-labeled leukocytes.

UNLABELLED: The purpose of this study was to determine the usefulness of 99mTc-HMPAO-labeled leukocyte scans in the diagnosis of prosthetic vascular graft infection. METHODS: We performed 75 scans in 61 patients with vascular grafts. Thirty-six patients were evaluated for suspected infection and 25 were control patients. Scintigraphic images were performed at 5 min, 30 min, 3 hr and, occasionally, 24 hr. Persistent increased uptake at 3 hr along the suspected area of the graft was considered evidence of graft infection. RESULTS: All 20 infected grafts were detected with 99mTc-HMPAO leukocyte scan. The sensitivity and specificity of the scan in the detection of infected graft were 100%. We also detected two pelvic abscesses, two infected fistulae, two soft-tissue infections, three cases of ischemic colitis, one acute diverticulitis, one infected hematoma, one septic arthritis and one noninfected hematoma. One patient with a superficial groin infection had a negative scan. The eight pseudoaneurysms did not show scintigraphic evidence of graft infection. Correlative CT studies were performed in 12 cases. CONCLUSION: Technetium-99m-HMPAO-labeled leukocyte scan is an accurate and valuable diagnostic method for evaluation of suspected prosthetic vascular graft infection.

Mammography and 99mTc-MIBI scintimammography in suspected breast cancer.

UNLABELLED: The aim of this work has been to evaluate whether a diagnostic protocol based on the joint use of mammography and 99mTc-methoxyisobutyl isonitrile (MIBI) scintimammography is capable of reducing the number of biopsies required in patients with suspected breast cancer. METHODS: We performed prone scintimammography in 90 patients with suspected breast cancer, involving 97 lesions. In all patients, the diagnosis was established by way of biopsy. On mammography, we evaluated the degree of suspicion of malignancy and the size of the lesion (smaller or larger than 1 cm in diameter). RESULTS: The results of only 41 of the biopsies indicated malignancy. On mammography, 20 lesions (of which 1 was breast cancer) were considered to be of low suspicion of malignancy, 31 (of which 4 were breast cancer) as indeterminate and 46 (of which 36 were breast cancer) as high. Fourteen lesions (2 low probability, 2 indeterminate and 10 high) were smaller than 1 cm, whereas 83 (18 low probability, 29 indeterminate and 36 high) were larger. The sensitivity, specificity, positive predictive value and negative predictive value of scintimammography were 85%, 79%, 74% and 88%, respectively. Scintimammography was positive in all cases of breast cancer that initially had a low or indeterminate suspicion of malignancy according to mammography, as well as in 30 cases of breast cancer that initially were highly suspicious. Six false-negative scintimammography studies were obtained in lesions with a high suspicion of malignancy. CONCLUSION: We propose a diagnostic protocol with a biopsy performed on lesions that have a high suspicion of malignancy as well as those with low or indeterminate suspicion that are smaller than 1 cm or with positive scintimammography results. This would have reduced the total number of biopsies performed by 34%. More importantly, there would have been a 65% reduction in number of biopsies performed in the low and indeterminate mammographic suspicion groups. All 41 cases of breast cancer would have been detected.

The intricate relationship between evidence and clinical practice in kidney transplantation.

Clinical practice is supposed to be evidence-based but it always conveys underlying values, judgements, moral principles or axioms. We explore the evidence-based nature of clinical practice in the fast-changing field of kidney transplantation and its relationship with values in five different interventions: those well supported on evidence, focussed on the use of immunosuppressant drugs like cyclosporine, mycophenolate mofetil and tacrolimus, and the elective withdrawal of cyclosporine or steroids; disputable interventions where evidence, focussed on anti-lymphocyte antibodies, is strong but not strong enough to be applied on the majority of occasions; interventions not supported by randomised controlled trials with focus on primary treatment of vascular graft rejection and rescue treatment for acute graft rejection; interventions not widely applied despite strong evidence from sources other than randomised controlled trials, with focus on HLA-matched kidney transplants in cadaver donor and living donor transplants; and finally, a variety of interventions when evidence is lacking. Being aware of the factors influencing every clinical decision we can make the strength of evidence and the nature of the values underlying them explicit and we will find it easier to improve the process of transferring evidence into practice and openly face and acknowledge the values involved.

Single ectopic ureter opening into blind vagina, with renal dysplasia and associated utero-vaginal duplication.

A rare case of single ectopic ureter opening into a blind vagina with renal dysplasia and associated uterovaginal duplication is reported. The findings are interesting from the clinical diagnostic viewpoint and also contribute to our knowledge of the embryology of the female genitourinary system, especially concerning the origin of the vagina.

Investigation: basis for nursing practice.

The term evidence based nursing signifies a systematic process of search, assessment and application of the most up-to-date investigation for decision taking. In practice the process can be applied in four steps: formulation of the question, a search of the bibliography, a critical analysis of the validity of the results, and putting the obtained findings into practice. Nursing practise must be based on the best available scientific results. Professional nurses are more accustomed to acting according to tradition with scarce scientific rigour. It is necessary to introduce investigation as an instrument to allow resolution of problems with practice and to offer the best possible care alternative. The evidence contributed by investigation is evaluated according to criteria of validity and utility. There are several scales to assess the methodological rigour of investigation studies as well as to recommend a practice or technique as appropriate, or not, according to the scientific evidence available.

Tc-99m HMPAO labeled platelets in the detection of left ventricular thrombosis post acute myocardial infarction.

A left ventricular thrombosis post acute myocardial infarction was detected with Tc-99m HMPAO labeled platelet imaging. The left ventricular thrombosis was already detected on early scans, which allowed for a precise diagnosis during the first 6 hours of the study.

[Chronic obstructive pulmonary disease and lung transplants: results in Spain]. / EPOC y trasplante pulmonar: resultados en España.

OBJECTIVE: To determine the outcome of lung transplantation in patients with chronic obstructive pulmonary disease (COPD) in Spain. METHODS: In all COPD patients transplanted at four Spanish hospitals over a period of seven years, we studied actuarial survival rates retrospectively using the Kaplan Meier test in relation to demographic characteristics, type of transplant, underlying disease, lung function evolution in terms of forced vital capacity (FVC), maximum expiratory flow in 1 second (FEV1) and gasometric evolution (PaO2 and PaCO2). RESULTS: Seventy-four transplants were performed in COPD patients over a five-year period. Mean age was 47 +/- 7 years (26-61) and 77% of the patients were men. A diagnosis of emphysema was made in 58%, alpha-1 antitrypsin deficiency emphysema in 14% and chronic bronchitis in 28%. The likelihood of survival was 75% for the first year, 63% for two years and 41% for the third year. Lung function and blood gases improved significantly by the third month after transplantation: FVC was 1677 +/- 637 ml before transplantation and 2631 +/- 670 ml afterwards; FEV1 was 585 +/- 189 ml before transplantation and 2118 +/- 673 ml afterwards (p < 0.001). Double lung transplants achieved significantly greater improvement in function variables than did single-lung transplants (FVC 2843 +/- 681 ml and FEV1 2543 +/- 620 ml by the third month in DLT patients versus FVC 2402 +/- 587 ml and FEV1 1659 +/- 350 ml for SLT), with no significant differences in blood gases after the two types of transplant. Half the sing-lung transplant patients developed hyperinflation of the native lung and reached maximum lung function values, which tended to be lower than those for patients who did not experience this complication (FEV1 1638 +/- 349 ml versus 1930 +/- 307 ml, p = 0.051). CONCLUSIONS: First-year mortality in patients with COPD undergoing lung transplantation in Spain is similar to that described in the International Transplant Registry. We found no differences between double- and single-lung transplant patients. Functional change is good for both types of transplantation, although this aspect of outcome is significantly better when two lungs are transplanted.

[Survival of lung transplant at the Puerta de Hierro Clinic]. / Análisis de la supervivencia del trasplante pulmonar en la Clínica Puerta de Hierro.

The objective of this study was to analyze patient survival after lung transplants performed at the Puerta de Hierro clinic in Madrid (Spain) between 1991 and 1996. Survival probability was 65% after one year and 50% after three years. We found no significant differences in survival related to sex or type of transplant. Early survival tended to be higher for the last two years analyzed (71%) than for the first two (55%) (p < 0.00001). The rate was 100% for patients with cystic fibrosis and 0% for pulmonary hypertension and lymphangiomyomatosis. Short- and medium-term lung function results were good in surviving patients who did not develop obliterating bronchiolitis. We conclude that actuarial survival after lung transplant in our program is comparable to that reported in the literature. There are no significant differences related to sex, type of transplant or period. Survival varies greatly, however, depending on disease.

[Impact of legal regulations on the quality of clinical trials carried out in Spain]. / Impacto de la normativa legal en la calidad de los ensayos clínicos realizados en España.

BACKGROUND: In Spain since 1982 laws require that clinical trials involving drugs be approved before implementation. We studied the impact of regulations on the quality of published trials. METHODS: Four sets of trials were chosen: trials implemented after 1982 and registered as approved; trials implemented after 1982 but not registered; trials implemented before 1982; and trials conducted outside Spain. Trials were identified via MEDLINE, EMBASE, and Indice Médico Español. Sets were compared with regard to indicators of quality, as obtained from the information in the published reports. The comparison was based on a total of 273 Spanish trials published between 1988 and 1990, 85 approved and 188 unregistered; 97 old trials, published between 1980 and 1982; and 152 non-Spanish trials published between 1988 and 1990. RESULTS: Approved trials, compared to their unregistered and old counterparts, were more often informed randomised, more of their published reports included lists of reasons for exclusions and information on consent and achieved higher scores of a quality index. Approved trials, compared to non-Spanish trials, had lower proportion of sample size justification, greater discrepancies between randomised and analyzed cases and a trend to lower quality scores. Multiple logistic regression analysis of quality scores showed that approved trials had higher scores than unregistered trials when single-centre trials (odds ratio for reaching scores in the upper quartile: 2.90; 95% confidence interval: 1.27 - 6.64) and similar when multicentre trials. CONCLUSIONS: Approved trials achieved better indicators of quality than unregistered trials but did not achieve the standards of quality prevailing in the international community.