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Insuline-Naaïve type 2 diabetic patients: a multidimensional evaluation on the role of glycated albumin Introduction: glycated Albumin (GA) is an innovative glycemic marker, that could be used in the clinical practice, as an add-on strategy, to the traditional glycemic monitoring systems, such as glycated haemoglobin (Hb1Ac) and fasting plasma glucose (FPG). The study aims at presenting the results of a multidimensional analysis conducted in Italy, exploring the main clinical, economic, ethical, social and organizational implications, related to the introduction of GA. Methods: an Health Technology Assessment (HTA) approach was implemented. The analysis considered the Italian National Healthcare Service (NHS) perspective, and assumed a 12-month time horizon, focusing on type 2 diabetes patients insulin-naïve, assuming oral therapy. The 9 HTA dimensions (derived from the Core Model developed by the European Network of HTA – EUnetHTA) were deployed, considering scientific evidence, health economics tools and qualitative approaches, through the administration of specific questionnaires to 15 diabetes experts. Results: literature reported better GA safety and efficacy profiles, thus being a predictor of the relative risk for diabetes complications development, and increasing the therapeutic success after 3 months of therapy (97.0% versus 71.6%). From an economic point of view, GA introduction resulted in an economic advantage of 1.06% and in a better tradeoff between costs sustained and efficacy gained. Considering a 7-item Likert Scale (ranging from -3 to +3), negative perceptions emerged with regard to equity aspects (0.13 versus 0.72) due to GA limited accessibility, whereas it would improve both patients (2.17 versus 1.33) and care givers (1.50 versus 0.83) quality of life. In the short term, GA required training courses and equipment update, whereas, in the long term, it could be considered the preferable solution from an organizational perspective (0.30 Conclusions: the results of this study demonstrated GA strategic relevance, its economic sustainability and feasibility, versus 0.01). as well as the potential clinical pathway improvement.

The issue of the appropriateness in laboratory medicine has been discussed from several years in association to the parallel onset of two aspects: 1) the significant increase in tests demand and utilization, thanks to the development of laboratory automation and information laboratory systems (LIS), that allow to provide timely and reliable results to clinicians; 2) the opportunity, thanks to new pathophysiological knowledge and new technologies to introduce new and more sophisticated tests in clinical practice, providing a relevant support to the clinician in the management of patients, according to the improved vision of personalized medicine. As a consequence, the potential inappropriateness in test utilization and the need to manage demand and to reduce the redundant testing have received increasing concern. Several papers, in the recent literature, demonstrated that the inappropriateness in laboratory test utilization may represent a potential source of errors, and interesting strategies have been proposed and progressively adopted in order to limit this problematic outcome. An essential issue is to assure appropriateness not only in test request, but in all steps of the testing cycle. In particular, some of the more relevant issues has been linked to: rationalization of laboratory test ordering prescription, thanks to development of a computerized clinical decision support systems; implementation of the reflexing tests rule; definition of the minimum retesting interval according to the clinical and pathophysiological criteria; timely revision of the available panel tests in order to delete those considered obsolete from clinical and analytical point-of-view and, finally, improving the education in demand management. The “clinical laboratory stewardship” seems to be the new and shared strategy, that guarantees not only the appropriate utilization and interpretation of laboratory tests improving efficacy and providing efficiency but, more importantly, the future of the discipline and the role of laboratory professionals in the context of new and more complicated clinical and economical scenarios.

Introduction: atherosclerosis is one of the leading causes of death and morbidity worldwide. It consists in the development of plaques in the intima media layers of arteries due to lipid accumulation and oxidation, causing massive inflammation. We aim to better understand the role of Galectin-3 (Gal-3) and Lipoprotein(a) [Lp(a)] as possible peripheral markers of plaque presence. Methods: Gal-3 and Lp(a) were measured in plasma samples from 99 patients undergoing carotid endarterectomy and 78 healthy controls, by immunometric assays. Plaques were classified histologically, according to the American Heart Association (AHA) guidelines as type Va (fibroatheroma), Vb (mainly calcific) and Vl (complicated lesion). Results: Gal-3 and Lp(a) plasma levels are higher in patients compared to controls [19.8 ng/mL (SD 5.8) vs 14.0 ng/mL (3.6)], p

OBJECTIVES: Vitamin D status influences the risk to develop autoimmune diseases affecting the percentage and/or functions of regulatory T cells (Tregs). Since low levels of 25 (OH) D have been decreased in patients with systemic sclerosis (SSc), we aimed to study the effect of Vitamin D3 (cholecalciferol) supplementation on Tregs frequencies and functions. METHODS: Peripheral blood and sera samples were obtained from 45 SSc patients and controls (HC). A number of eighteen SSc patients had consumed Cholecalciferol (orally) at the dose of 25.000 UI/month for 6 months at the time of enrollment. 25(OH)D serum levels were measured and VDR polymorphisms, were genotyped by polymerase chain reaction (PCR). Tregs isolated from peripheral blood mononuclear cells were in vitro expanded and a suppression assay was performed. Flow cytometry analysis was then carried out. Finally, IL-10 production was assayed by ELISA. RESULTS: Low serum levels of 25(OH)D were detected in SSc patients. The percentage of Tregs in SSc patients was similar to controls, but, among SSc patients, it was higher in those patients taking cholecalciferol. Tregs capability to suppress T cell proliferation was impaired in SSc patients and not restored after in vitro pre-treatment with the active form of Vitamin D (1,25(OH)2D3); but at the same time the production of IL-10 was increased in treated samples obtained from patients. The lack of response of Tregs from SSc patients to 1,25(OH)2D3 treatment in vitro was not due to altered Vitamin D/VDR signalling. CONCLUSIONS: Altogether, our results indicate that the increased production of IL-10 by 1,25(OH)2D3 -treated Tregs could provide a "suppressive" cytokine milieu able to modulate immune response but it is not sufficient to restore the immune suppressive functions of Tregs.

Pre-Exposure Prophylaxis (PrEP) is changing the landscape of HIV prevention, and may bring changes in sexual behaviors. The double-blind phase (DBP) and open-label extension (OLE) study of the ANRS-IPERGAY trial allowed us to assess changes in sexual behavior of men who have sex with men (MSM) taking sexual activity-based (i.e., on-demand) PrEP. Generalized Estimating Equation (GEE) models found a significant decrease in the number of sexual partners (Coefficient [CI95%], p value; - 0.37[- 0.70 to - 0.04], p = 0.03) between the DBP and OLE as well as in the number of sexual relations (- 0.25 [- 0.49 to 0.00], 0.04). GEE estimates also showed that respondents' most recent sexual relation was less likely to have been with an unknown casual partner during the OLE than during the DBP (Odds Ratio [CI95%], p value: 0.75[0.62-0.92], 0.005). Furthermore, they showed an increase in the proportion of condomless anal sex in the OLE (1.32[1.04-1.67], 0.02), a decrease in the proportion of 'suboptimal PrEP adherence' over time (0.75[0.58-0.97], p = 0.03), a decrease in PrEP only use (0.73[0.55-0.96], 0.03) and in both PrEP and condom use over time (0.70[0.51-0.95], 0.02) and finally, a decrease in alcohol consumption between the DBP and OLE (0.74[0.61-0.90], 0.002). We observed both protective and risky behaviors in terms of HIV and STI risk after on-demand PrEP uptake in the OLE phase. Our findings are consistent with results from previous PrEP trials.

Objective: This study aimed to identify situational and behavioral factors associated with condomless anal sex without on-demand PrEP in the open-label extension (OLE) study of the ANRS-IPERGAY trial. Methods: Univariable and multivariable modified Poisson regressions with a generalized estimating equation (GEE) were used. The attributable risk percentage for each explanatory variable and for condomless anal sex without PrEP was calculated. Results: In the OLE, 19% of anal intercourses were unprotected (i.e. no PrEP or condom). Of these, 85% were attributable to sexual intercourse with main partners and 47% with HIV-negative partners. The following factors were positively associated with condomless anal sex without PrEP: a depressive episode in the previous 12 months [aR (95% CI),P-value: 1.49 (1.02--2.17), 0.039], a higher number of sexual intercourses during the previous 4 weeks [1.01 [1.002--1.02], 0.014], and sexual intercourses under the influence of alcohol [1.45 (1.10--1.92), 0.008]. By contrast, condomless anal sex without PrEP was less frequent during sexual intercourses with known casual, unknown casual and multiple partners [0.20 (0.14--0.30)

Recent data confirmed the hypothesis suggested by historical studies that the ratio of peripheral blood monocytes to lymphocytes (M/L) is associated with the risk of tuberculosis (TB) disease. We retrospectively analyzed the electronic health records of tuberculosis and HIV-positive patients who had followed day-care programs at the AIDS Center of the University of Palermo, Italy. 261 patients were recruited and divided into 6 groups as follows: healthy control group (HCG: 47 pts), latent HIV negative infected TB group (LIG, 43 pts), active HIV negative tuberculosis (TAG: 61 pts), treated tuberculosis HIV negative (TTG: 44 pts), HIV drug-naive patients tested TST and QFT-IT-negative with negative chest x-Ray (HIVnG: 44 pts), and HIV-tuberculosis coinfection (HIVTB-G: 22 pts). For each group, absolute lymphocyte (L), monocyte (M) and M/L ratio by peripheral blood was calculated. The mean value of monocytes in the TAG group was significant, the highest (0.70±0.37 1x103/μl) in comparison to HGC (0.70>0.44, p-value 0.40, p-value 0.45, p-value0.27, p-value0.29, p-value0.32) and HIVTB-G groups (0.49>0.27, p-value

The aim of this paper is to present the preliminary results of a joint project by SIBioC-AIPO working group on “Body cavities fluids”. The main purpose of the working group is to achieve a harmonized and shared diagnostic pathway related to pleural fluid (PF) analysis. The multistep project begins with a state of the art analysis. A survey, sent to both laboratory medicine personnel and pneumologists, was conducted between October and December 2016. The questionnaire (21 questions) was made available through the web-based SurveyMonkey platform. Overall, 408 replies were collected, 40.4% from laboratory medicine specialists, 3.2% from laboratory technicians, 49.3% from pneumologists and 7.1% from professionals with non-specified qualification. Regarding the pre-analytical phase, the most critical issue resulted to be the clinical query, due to the lack of structured communication between clinicians and laboratory personnel. While over 76% of laboratory professionals stated that the working diagnosis was unavailable, 87% of pneumologists affirmed that the clinical question had been forwarded to the laboratory. An important issue was the widespread use of inappropriate containers for PF collection (60% of inappropriate tubes). Regarding the panel of tests, a satisfactory agreement was reached on the need to perform macroscopic analysis and cytometric evaluation, along with the assessment of pH, glucose, total proteins, lactate dehydrogenase and the respective ratios between PF and serum concentrations. As expected, the availability of verified or validated analytical methods, notably pH analysis, has emerged as a critical point. The layout of the laboratory report also needs improvements and better harmonization. Despite the many critical issues emerged from this survey, a positive feedback was reflected by a notable general interest on PF analysis, leading thus the way to produce a joint consensus document involving clinicians and laboratory personnel, as suggested by more than 30% of responders.

Biomarkers have dramatically impacted the way heart failure (HF) patients are evaluated and managed. A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological or pathogenic processes, or pharmacological responses to a therapeutic intervention. Natriuretic peptides (B-type natriuretic peptide [BNP] and N-terminal proBNP) are the gold standard biomarkers in determining the diagnosis and prognosis of HF, and a natriuretic peptide-guided HF management looks promising. In the last few years, an array of additional biomarkers has emerged, each reflecting different pathophysiological processes in the development and progression of HF: myocardial insult, inflammation, fibrosis and remodeling, but their role in the clinical care of the patient is still partially defined and more studies are needed before to be well validated. Moreover, several new biomarkers have the potential to identify patients with early renal dysfunction and appear to have promise to help the management cardio-renal syndrome. With different biomarkers reflecting HF presence, the various pathways involved in its progression, as well as identifying unique treatment options for HF management, a closer cardiologist-laboratory link, with a multi-biomarker approach to the HF patient, is not far ahead, allowing the unique opportunity for specifically tailoring care to the individual pathological phenotype.

The authors regret that the authors’ names in the original article appear, as reported, in the wrong form, which follows: Bivona Giulia, Agnello Luisa, Scazzone Concetta, Lo Sasso Bruna, Bellia Chiara, Ciaccio Marcello. The correct form is: Giulia (first name) Bivona (last name), Luisa (first name) Agnello (surname), Concetta (first name) Scazzone (surname), Bruna (first name) Lo Sasso (surname), Chiara (first name) Bellia (surname), Marcello (first name) Ciaccio (last name). The authors would like to apologise for any inconvenience caused.

No abstract available.

In this work, we aimed to investigate the bacterial microbiota of the Anadenanthera colubrina seed endosphere, with special focus to the characterization of beneficial traits and to the colonization pattern by coupling for the first time cultivation-dependent and -independent analyses, functional tests and microscopical investigation. We isolated several Methylobacterium and Staphylococcus spp., exhibiting several plant growth promotion and antimicrobial activities. Interestingly, the two taxonomic groups showed complementary traits, which supports a functional selection for these genera. Both genera were detected by high throughput sequencing of 16S rRNA gene from total seed DNA, together with further taxa, some of which (Friedmaniella, Bifidobacterium, Delftia, Anaerococcus and Actinomyces) appeared for the first time as seed endophytes. We were able to visualize bacterial cells and micro-colonies in seed cryosections, by fluorescence in situ hybridization coupled with confocal laser scanning microscopy (FISH-CLSM). Alphaproteobacteria, Firmicutes and other bacteria, were localized in intercellular spaces and transport vessels of the seed endosphere, suggesting acquisition by endophytic translocation. Our work adds new information to shed light onto the diversity, functions and colonization pattern of the seed endophytic microbiota, and confirms the importance of seed-associated endophytes as potentially beneficial plant partners.

In recent decades, the increase in life expectancy stimulated the study of aging processes and the search for candidate genes involved in longevity. The angiotensin converting enzyme (ACE), present in all endothelial cells, plays an essential role in maintaining the homeostasis of blood flow by regulating the production of the vasoconstrictor angiotensin II and inactivating the bradykinin. Some studies reported a possible association between the polymorphism I/D of ACE gene and either hypertension and longevity. The present study was aimed to confirm these data. We studied two large cohorts of nonagenarians and centenarians. One was from Sardinia (200 subjects, 88 males, mean age: 96 years) and their data were compared to a group of 222 subjects (106 males, mean age: 44 years) from the general population of the same geographic area. The latter group of longeve subjects (161 subjects, 71 males, mean age: 97 years) was from Southern Italy. Furthermore, we studied 146 hypertensive patients (98 males, mean age: 51 years) and 172 normotensive subjects (86 males, mean age: 33 years) from Southern Italy. The ACE I/D polymorphism was typed by polymerase chain reaction; the amplified 490 bp (allele I) and 190 bp (allele D) were visualized on 2% agarose gel. Hypertensive subjects had a significantly different distribution of ACE genotypes as compared to normotensive ones (P=0.001) and a higher frequency of the D/D genotype. Long-lived subjects from Sardinia showed a significantly different distribution of ACE genotypes as compared to subjects from the general population of the same geographic area (P

Background: Numerous recent evidence suggests that homocysteine (HC), a putative risk factor for stroke and coronary artery disease [1,2], could play a role in the physiopathology of several neurodegenerative disorders, such as Alzheimer’s Parkinson’s diseases and amyotrophic lateral sclerosis (ALS) [3,4,5]. HC, an aminoacid involved in the methionine metabolism, acts as a neurotoxin through several mechanisms, including free radicals and cytosolic accumulation, mitochondrial dysfunctions, activation of apoptotic pathways, and excitotoxic aminoacid-mediated damage [5]. A recent report showed that plasma HC levels were significantly elevated in ALS, and in particular in those patients with a faster progression of the disease, suggesting that this endogenous molecule might represent a marker of neurodegeneration in this devastating motor neuron disorder [5]. Objectives: Aim of the study was to assay the CSF and plasma levels of HC in ALS patients and controls, and to evaluate the relationship between HC levels and clinical variables of the disease. Methods: Cerebrospinal fluid from sixty-nine (♂45, ♀24) and plasma from sixty-five ALS patients (♂42, ♀23) were taken and stored at -80° C until use. Controls (CSF = 55; plasma = 67) were patients admitted to our hospital for neurological disorders with no known relationship to HC changes. CSF and plasma from ALS patients and controls were obtained as a necessary step of the diagnostic workup. HC levels in CSF and plasma were assayed using a high performance liquid chromatograph (HPLC) and a fluorimetric detector. Results: The median level of total HC in the CSF of ALS patients was 0.46 microM, significantly higher than that of the controls (0.24 microM, +91.6%, P < 0.001). A similar trend was observed when HC was assayed in plasma (ALS, 12.4 microM vs. controls, 7.26 lM, +70.8%, P < 0.001). The CSF and plasma HC levels showed no relationship with the disease progression, age at onset, and the site of onset. Conclusions: CSF and plasma homocysteine levels were significantly increased in patients with ALS compared with controls. This enhancement seems to be independent of the vitamin levels. Our data suggest that homocysteine might represent a biochemical marker in ALS, and it might be related to the pathophysiology of the disease. References 1. Pezzini A, Del Zotto E, Padovani A. Homocysteine and cerebral ischemia: pathogenic and therapeutical implications. Curr Med Chem 2007; 14: 249–263. 2. Humphrey LL, Fu R, Rogers K, et al. Homocysteine level and coronary heart disease incidence: a systematic review and meta-analysis. Mayo Clin Proc 2008; 83: 1203–1212. 3. Tchantchou F, Shea TB. Folate deprivation, the methionine cycle, and Alzheimer_s disease. Vitam Horm 2008; 79:83–97. 4. Postuma RB, Lang AE. Homocysteine and levodopa: should Parkinson disease patients receive preventative therapy? Neurology 2004; 63: 886–891. 5. Zoccolella S, Simone IL, Lamberti P, et al. Elevated plasma homocysteine levels in patients with amyotrophic lateral sclerosis. Neurology 2008; 70: 222–225.