Search

Diabetic retinopathy is a disorder of the retinal blood vessels; vascular alterations can cause neurosensory loss in the retina. These neurosensory losses may predict the progression of the disease in the retina and macula (the small yellow spot in the center of the retina that contains the fovea where central vision takes place). Neurosensory loss may involve macular recovery function; nyctometry is a technique used to measure the recovery function of the macula. The macula is first adapted to bright light, then to darkness, and vision is evaluated as a function of time; following this, the patient's sensitivity to glare is measured. This technique may be useful in predicting the progression of background diabetic retinopathy. A study was undertaken to define the relationship between changes of macular recovery function measured by nyctometry and the status of the retina in diabetic patients with or without early diabetic retinopathy. Macular recovery function was assessed using nyctometry in 234 diabetic patients; 99 patients had no evidence of retinopathy, and 135 patients had early background retinopathy. There was a significant correlation between abnormal nyctometry readings and progression of the retinopathy. Blood sugar levels at the time of macular recovery function evaluation did not influence the nyctometry results. These findings suggest that nyctometry may be a simple, quick, noninvasive test for monitoring the function of the retina in diabetic patients. Nyctometry may provide new information into the understanding of the abnormal physiology involved in diabetic retinopathy. (Consumer Summary produced by Reliance Medical Information, Inc.)

This study evaluates the effects of a Tele-check/Tele-emergency service on the quality of life in the elderly. Through telephone interviews a questionnaire has been repeatedly administered to explore various psychological, somatic, and social aspects in a random sample of 574 subjects aged 65 years and over (mean = 76.8 years). The findings suggest that the elderly helped by the service (in its 'control' functioning) make less demands on health facilities (GPs visits, number of days in hospital) as compared to controls. Implications are presented and discussed. [ABSTRACT FROM AUTHOR]

Objective: To investigate the safety and efficacy of subcutaneous tocilizumab (SC-TCZ) treatment in a long-term extension (LTE) of clinical trials in polyarticular or systemic juvenile idiopathic arthritis (pJIA or sJIA)., Methods: Patients with pJIA or sJIA from two open-label, 52-week phase 1b core trials of SC-TCZ who had adequate response per investigator assessment entered the LTE and continued SC-TCZ treatment according to body weight-based dosing regimens until commercial availability or up to 5 years. Pharmacokinetics, pharmacodynamics, and efficacy were assessed for up to 3 years, and safety for up to 5 years in the LTE., Results: Forty-four patients with pJIA and 38 patients with sJIA entered the LTE. Tocilizumab trough concentrations were maintained within the range expected to provide clinical benefit (mean values: pJIA, ∼10 μg/ml; sJIA, ∼75 μg/ml over 3 years). Pharmacodynamic parameters (interleukin-6, soluble interleukin-6 receptor, erythrocyte sedimentation rate, C-reactive protein) were maintained throughout the LTE at levels achieved in the core trials. Inactive disease per American College of Rheumatology provisional criteria was reported for 90% (17/19) and 53% (8/15) of patients with pJIA and 91% (10/11) and 92% (12/13) of patients with sJIA in the <30 and ≥30 kg body weight groups, respectively. Serious adverse events in the LTE were reported in six patients with pJIA (13.6%; five serious infections) and five patients with sJIA (13.2%; one serious infection)., Conclusion: Patients with pJIA or sJIA experienced long-term disease control with SC-TCZ treatment. Long-term safety was consistent with the known tocilizumab safety profile., Clinical Trial Registration: clinicaltrials.gov, NCT02165345., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objectives: To explore prognostic and predictive markers of SSc-associated interstitial lung disease (SSc-ILD) outcomes in a phase 3 trial (focuSSced) and prognostic markers in a real-world cohort (SMART)., Methods: The focuSSced SSc-ILD subgroup included 68 of 106 placebo-treated and 68 of 104 tocilizumab-treated patients. The SMART cohort included 505 patients with SSc-ILD. Linear mixed-effect models were used to identify factors associated with change in forced vital capacity (FVC). Kaplan-Meier estimation and Cox regression were used for time-to-event analyses., Results: In placebo-treated focuSSced patients, sex was a significant prognostic factor for FVC decline; males had increased risk for absolute decline ≥10% in percent-predicted FVC (ppFVC) and 0.22% faster weekly FVC decline than females (P = 0.0001). FVC was 9.8% lower in patients with CRP >6 mg/ml vs those with CRP ≤6 mg/ml (P = 0.0059). Tocilizumab reduced the risk for ≥10% decline in ppFVC in patients who were male, had earlier disease (<2 years duration), had IL-6 levels <10 pg/ml, or had anti-topoisomerase antibodies (ATA). In the SMART cohort, prognostic factors for ppFVC <70% were male sex, ATA, and low baseline FVC. Males had 3.3% lower FVC 1 year after disease onset (P < 0.001) and 0.6% faster yearly decline (P = 0.03) than females., Conclusion: Prognostic markers in SSc-ILD were similar between focuSSced and SMART. Male sex and inflammatory markers were associated with lower FVC but IL-6 ≥10 pg/ml was not predictive of response to tocilizumab., Trial Registration: ClinicalTrials.gov: NCT02453256., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Background: Subcutaneous tocilizumab (TCZ SC) is approved globally for giant cell arteritis (GCA). This phase Ib study investigated the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of intravenous (IV) TCZ 6 and 7 mg/kg in patients with GCA. This study explored an IV dose resulting in a minimum exposure level within the range of effective trough concentrations achieved with TCZ SC dosing in GCA and not exceeding the exposure of the well-tolerated 8 mg/kg IV every 4 weeks (Q4W) in rheumatoid arthritis (RA)., Methods: Patients with GCA who had received ≥ 5 doses of TCZ IV 8 mg/kg Q4W and achieved remission were enrolled. Patients received 5 doses of TCZ IV 7 mg/kg Q4W in period 1 and, if still in remission, 5 doses of 6 mg/kg Q4W in period 2. Pharmacokinetic endpoints were maximum concentration (C max ), minimum concentration (C trough ), area under the curve over a dosing interval (AUC τ ), and mean concentration (C mean ) of TCZ after the last dose of each period. Other endpoints included pharmacodynamic markers, safety, and exploratory efficacy., Results: In 24 patients, the median (range) age was 65.5 (57-90) years, and 62.5% were female. TCZ exposures (C max and AUC τ ) were 11.2% and 20.0% lower at the 6- than 7-mg/kg dose. The mean interleukin 6 (IL-6) serum concentrations were elevated at baseline and remained elevated, with slightly higher concentrations in period 1 than in period 2. The mean serum soluble IL-6 receptor concentrations were elevated at baseline and comparable between the 2 doses at steady state. C-reactive protein levels and most erythrocyte sedimentation rates were within normal ranges throughout the study. Overall, 22 patients (91.7%) had ≥ 1 adverse event, and 4 (16.7%) had a serious adverse event. No patients experienced a GCA flare, and all remained in remission throughout the study., Conclusions: Both doses of TCZ IV Q4W were generally well tolerated in patients with GCA. The C max and C mean achieved with 6 mg/kg IV Q4W in patients with GCA were similar to those in patients with RA treated with 8 mg/kg IV Q4W, and C trough was within the range observed in patients with GCA treated with SC dosing every week or every 2 weeks., Trial Registration: ClinicalTrials.gov , NCT03923738., (© 2022. The Author(s).)

Rationale: Tocilizumab, an anti-IL-6 receptor antibody, had no statistically significant effect on skin sclerosis but preserved lung function over 48 weeks in patients with early systemic sclerosis (SSc)-associated interstitial lung disease (ILD) in a phase 3 randomized controlled trial. Objectives: Assess long-term safety and efficacy of tocilizumab. Methods: Adults with diffuse cutaneous SSc for ⩽60 months and elevated acute-phase reactants, including those with ILD, received weekly placebo or tocilizumab 162 mg subcutaneously in the 48-week, double-blind period and then open-label tocilizumab from Weeks 48 to 96 (placebo-tocilizumab; continuous-tocilizumab). Measurements and Main Results: Eighty-two of 107 patients in the placebo-tocilizumab group and 85 of 105 patients in the continuous-tocilizumab group completed 96 weeks. Mean age and disease duration were 48 years and 23 months; high-resolution computed tomography revealed ILD in 61%. Mean (95% confidence interval [CI]) change in modified Rodnan skin score from baseline to week 96 was -8.4 (-10.0 to -6.8) for placebo-tocilizumab and -9.6 (-10.9 to -8.4) for continuous-tocilizumab. Mean (95% CI) change in FVC (percent predicted) from baseline to week 96 was -3.3 (-5.1 to -1.5) for placebo-tocilizumab and -0.5 (-2.4 to 1.3) for continuous-tocilizumab among completers and, in a post hoc analysis, -4.1 (-6.7 to -1.6) and -0.6 (-3.1 to 2.0), respectively, among completers with ILD (mean [95% CI] change from Weeks 48 to 96: 0.9 [-0.8 to 2.7] and -0.4 [-2.3 to 1.5], respectively). Rates per 100 patient-years of serious adverse events from Weeks 48 to 96 were 14.8 for placebo-tocilizumab and 15.8 for continuous-tocilizumab. Conclusions: Tocilizumab preserved lung function, slowing decline in FVC, in patients with SSc, including those with ILD. Long-term safety was consistent with the known safety profile of tocilizumab. Clinical trial registered with www.clinicaltrials.gov (NCT02453256).

Emergency departments (EDs) are high-risk places for Workplace Violence (WPV). In Italy, this phenomenon is scarcely investigated. The aim of this study is to evaluate the incidence, experiencing and perception of WPV in the general ED (GED), paediatric ED (PED) and obstetric-gynaecological ED (OGED) of the teaching hospital Azienda Ospedaliera in Padua (AOP). We led a cross-sectional study among the GED, OGED and PED staffs, submitting an anonymous questionnaire, regarding personal information, verbal and physical aggression experiences, risk factors and proposals for corrective actions. Our sample consists of 73 people from GED, 45 from OGED and 53 from PED. Aggressions are common. Verbal aggressions are almost never recorded, even in the case of physical aggressions, 41% did not signal the event. Both in GED and in OGED, most of the staff (68.9% and 75.0%, respectively) underwent aggression by neither psychiatric nor substance abuser patients (PSAPs). Physical aggressions are more common in GED than in OGED and in PED; most of professionals were assaulted by PSAPs. In all EDs, verbal or physical assault has been lived through by anger, resignation or fear, rarely by indifference. Professionals think there are structural characteristics and risk factors that could be corrected. They do not know how to manage assaults and would deem it useful training meetings with experts. Our results regarding how staff perceive and experience violence in the ED concern a local situation, that nevertheless reflect current evidence about the topic of WPV which plagues EDs across the globe.

This double-blind, placebo-controlled, 3-period cross-over, 4-treatment option, incomplete block study (ClinicalTrials.gov number NCT01485185), with an adaptive design for sample size re-estimation, was designed to evaluate gabapentin plus donepezil in an established experimental model of electrical hyperalgesia. Thirty healthy male subjects aged 18-55 years were randomized to receive gabapentin 900 mg or gabapentin 900 mg+donepezil 5mg for 2 of the 3 treatment periods, with 50% of subjects randomized to receive placebo (negative control) and 50% to gabapentin 1800 mg (positive control) for the remaining period. Each treatment period was 14 days. Gabapentin or corresponding placebo was administered on Day 13 and the morning of Day 14. Donepezil or corresponding placebo was administered nocturnally from Day 1-13 and the morning of Day 14. Co-primary endpoints were the area of pinprick hyperalgesia (260 mN von Frey filament) and allodynia (stroking by cotton bud) evoked by electrical hyperalgesia on Day 14. Gabapentin 1800 mg (n=14) significantly reduced the area of allodynia vs placebo (n=14; -12.83 cm(2); 95% confidence interval [CI] -23.14 to -2.53; P=0.015) with supportive results for hyperalgesia (-14.04 cm(2); 95% CI -28.49-0.41; P=0.057), validating the electrical hyperalgesia model. Gabapentin+donepezil (n=30) significantly reduced the area of hyperalgesia vs gabapentin 900 mg (n=30; -11.73 cm(2); 95% CI -21.04 to -2.42; P=0.014), with supportive results for allodynia (-6.62 cm(2); 95% CI -13.29-0.04; P=0.052). The adverse event profile for gabapentin+donepezil was similar to the same dose of gabapentin. Data are supportive of further clinical investigation of a gabapentin-and-donepezil combination in patients with an inadequate response to gabapentin., (Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.)

Background: Considerable variations in the incidence of psychosis have been observed across countries, in terms of age, gender, immigration status, urbanicity and socioeconomic deprivation., Aims: To evaluate the incidence rate of first-episode psychosis in a large area of north-eastern Italy and the distribution of the above-mentioned risk factors in individuals with psychoses., Method: Epidemiologically based survey. Over a 3-year period individuals with psychosis on first contact with services were identified and diagnosed according to ICD-10 criteria., Results: In total, 558 individuals with first-episode psychosis were identified during 3,077,555 person-years at risk. The annual incidence rate per 100,000 was 18.1 for all psychoses, 14.3 for non-affective psychoses and 3.8 for affective psychoses. The rate for all psychoses was higher in young people aged 20-29 (incidence rate ratio (IRR) = 4.18, 95% CI 2.77-6.30), immigrants (IRR = 2.26, 95% CI 1.85-2.75) and those living in the most deprived areas (IRR = 2.09, 95% CI 1.54-2.85)., Conclusions: The incidence rate in our study area was lower than that found in other European and North American studies and provides new insights into the factors that may increase and/or decrease risk for developing psychosis., (Royal College of Psychiatrists.)

The mu-opioid system has a key role in hedonic and motivational processes critical to substance addiction. However, existing mu-opioid antagonists have had limited success as anti-addiction treatments. GSK1521498 is a selective and potent mu-opioid antagonist being developed for the treatment of overeating and substance addictions. In this study, 28 healthy participants were administered single doses of GSK1521498 20 mg, ethanol 0.5 g/kg body weight, or both in combination, in a double blind placebo controlled four-way crossover design. The primary objective was to determine the risk of significant adverse pharmacodynamic and pharmacokinetic (PK) interactions. The effects of GSK1521498 on hedonic and consummatory responses to alcohol and the attentional processing of alcohol-related stimuli, and their modulation by the OPRM1 A118G polymorphism were also explored. GSK1521498 20 mg was well tolerated alone and in combination with ethanol. There were mild transient effects of GSK1521498 on alertness and mood that were greater when it was combined with ethanol. These effects were not of clinical significance. There were no effects of GSK1521498 on reaction time, hedonic or consummatory responses. These findings provide encouraging safety and PK data to support continued development of GSK1521498 for the treatment of alcohol addiction., (© The Authors 2013. The Journal of Clinical Pharmacology. Published by Wiley Periodicals, Inc.)

Background: We sought to assess long-term changes in bone, muscle area, and muscle strength at different levels of the forearm and hand mobility according to arterial patency and nerve damage after surgically treated trauma related to involuntary local cutting/piercing injuries., Methods: Forty subjects were evaluated 11 years after surgery for traumatic lesions involving the major vascular axis of the distal forearm. Peripheral quantitative computed tomography was used to measure cortical bone mineral density (BMD) and muscle area at the proximal radius, trabecular BMD at the distal radius, and cortical BMD at the third finger. Hand grip strength was assessed using dynamometry. Muscle area and hand grip strength were corrected for the limb dominance effect., Results: All subjects had reduced trabecular BMD at the distal radius on the affected side (Δ, -5.8%; P < 0.001) and reduced cortical BMD in the third finger (Δ, -2.8%; P < 0.05). Hand grip strength was significantly lower on the affected side. According to vascular patency, only subjects with nonpreserved blood flow had significantly reduced distal radius BMD (Δ, -6.7%; P = 0.004), and those with nerve damage had a significant reduction in BMD at the third finger (Δ, -3.5%; P = 0.05). Moreover, nerve injury was associated with the presence of clinical symptoms and hand functional impairment., Conclusions: The absence of blood flow and nerve damage after forearm trauma caused by involuntary cutting/piercing injuries causes remarkable permanent impairment in musculoskeletal structures, hand grip strength, and hand functionality., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Synergistic effects of NK₁ receptor antagonism combined with serotonin reuptake inhibition have been reported in preclinical models. GSK424887 is a selective competitive antagonist of the human NK₁ receptor and inhibitor of the serotonin transporter. However, its actions in human models of depression have not been assessed., Methods: This study explored the effects of acute administration of GSK424887 compared to placebo in healthy male volunteers. The selective serotonin reuptake inhibitor (SSRI) citalopram was used as a positive control. A battery of emotional processing tasks was given at the peak time of drug effect., Results: GSK424887 enhanced attentional vigilance in the dot-probe task to both positive and negative stimuli. By contrast, citalopram enhanced perception of angry, sad and happy facial expressions and increased positive bias in the facial expression recognition task. Neither drug significantly affected emotion potentiated startle responses or emotional memory., Conclusions: These results suggest that acute administration of GSK424887 modulated some aspects of emotional processing but these effects were not similar to those seen previously with antidepressant agents. This was the first use of the battery of emotional processing tasks in a Phase 1 study. Repeated administration of the test and active control drugs may be needed to reliably characterise their effects.

Background: Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services., Methods/design: The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers' patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrollment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms' severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in 'real-world' clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction.

Aims: Hypertrophic cardiomyopathy (HCM) is an important cause of heart failure-related disability over a wide range of ages. Profiles of severe progressive heart failure symptoms and death, or heart transplantation deserve more complete definition within large patient cohorts., Methods and Results: Clinical and morphological features of heart failure were assessed in 293 consecutive HCM patients over a median follow-up of 6 (inter-quartile range 2-11) years. Gross and histopathological features were analysed in 12 patients for whom the heart was available for inspection. Of the 293 patients, 50 (17%) developed severe progressive heart failure, including 18 who died or were transplanted. Three profiles of heart failure were identified predominantly associated with: (i) end-stage systolic dysfunction (ejection fraction <50%) (15; 30%); (ii) left ventricular (LV) outflow obstruction at rest (11; 22%); and (iii) non-obstructive with preserved systolic function (24; 48%). Overall, atrial fibrillation (AF) contributed to heart failure in 32 patients (64%) among the three profiles. Compared with other patients, those non-obstructive with preserved systolic function had earlier onset of heart failure symptoms mainly due to diastolic dysfunction, and the most accelerated progression to advanced heart failure and adverse outcome (P = 0.04). Thrombi were identified in the left atrial appendage of five gross heart specimens all belonging to patients with AF, including three of which were unrecognized clinically and had previously embolized. Extensive myocardial scarring with LV remodelling was evident in all end-stage patients; no or only focal scars were present in other patients., Conclusion: Profiles of advanced heart failure in HCM are due to diverse pathophysiological mechanisms, including LV outflow obstruction and diastolic or global systolic ventricular dysfunction. Atrial fibrillation proved to be the most common disease variable associated with progressive heart failure. Recognition of the heterogeneous pathophysiology of heart failure in HCM is relevant, given the targeted management strategies necessary in this disease.

Whether the best option for the emergency treatment of major forearm artery lesions is anastomosis or ligation is still debated in the literature. The choice may be influenced by the resulting long-term musculoskeletal changes relating to vessel patency and the surgical procedure used. Fifty-three patients who had undergone emergency surgery involving arterial microanastomoses for lesions affecting one or more major forearm arteries (with a preserved distal circulation) were reassessed in terms of anastomosis patency at the end of a long-term follow-up, using arterial plethysmography, eco-color Doppler, and magnetic resonance angiography. In a subset of 40 patients, changes in bone mineral density (BMD) and lean mass of the affected limb were compared with the contralateral healthy limb and correlated with vessel patency and severity of trauma, using peripheral quantitative computed tomography and dual X-ray absorptiometry. Functional performance was also tested with a dynamometer by means of the hand-grip test. At long-term reassessment, 75% of the microanastomosed vessels were patent. BMD showed significant impairments at and around the site of the lesion (Delta: -6%, P < 0.001) and distally thereto (Delta: -3%, P < 0.05), which correlated with vessel occlusion and trauma severity. The fracture risk consequently also increased. There was evidence of a significant loss of lean mass ( P < 0.01) and muscle strength in the affected limb, especially in cases of occlusion of a major vessel. Given the satisfactory outcome of the anastomotic procedures as opposed to the greater loss of bone mass, muscular mass, and strength in patients who had undergone arterial ligation, we suggest that anastomosis is always preferable to ligation, even in emergencies. Anastomosis enables overall limb function to be better preserved (both in the vicinity of the lesion and distally)., ((c) Thieme Medical Publishers.)

Background: Staff burnout is a critical issue for mental healthcare delivery, as it can lead to decreased work performance and, ultimately, to poorer treatment outcomes., Aims: To explore the relative weight of job-related characteristics and perceived organisational factors in predicting burnout in staff working in community-based psychiatric services., Method: A representative sample of 2000 mental health staff working in the Veneto region, Italy, participated. Burnout and perceived organisational factors were assessed by using the Organizational Checkup Survey., Results: Overall, high levels of job distress affected nearly two-thirds of the psychiatric staff and one in five staff members suffered from burnout. Psychiatrists and social workers reported the highest levels of burnout, and support workers and psychologists, the lowest. Burnout was mostly predicted by a higher frequency of face-to-face interaction with users, longer tenure in mental healthcare, weak work group cohesion and perceived unfairness., Conclusions: Improving the workplace atmosphere within psychiatric services should be one of the most important targets in staff burnout prevention strategies. The potential benefits of such programmes may, in turn, have a favourable impact on patient outcomes.

A questionnaire to assess quality of life in the elderly was developed under the auspices of the European office of the World Health Organization. Stages in construction of the instrument, which was designed for international application, particularly at the primary level, are described. The latest version of the questionnaire is composed of 49 self-assessment item, 31 of which can be grouped into 7 subscales: Physical Function, Self-Care, Depression and Anxiety, Cognitive Functioning, Sexual Functioning, and Life Satisfaction. The remaining 18 items serve as moderators for assessing the influence of social desirability factors and personality characteristics on the individual scores for the 7 core instrument subscales. The questionnaire has been administered to 586 individuals aged 65 years and over recruited in communities in Italy (Padua and Brescia), the Netherlands (Leiden), and Finland (Helsinki). The main psychometric characteristics of the instrument, together with its concurrent validity with the Rotterdam Questionnaire, are illustrated.

Objectives: Primary biliary cirrhosis (PBC) patients frequently complain of fatigue and loss of memory. The aim of this study was to evaluate the mental performance and the neuropsychological assessment in patients with PBC., Methods: A case-control study was performed that included 36 PBC patients (34 female, two male, mean age 55 yrs, 11 with stage II, 16 with stage III, and nine with stage IV disease) and 36 sex and age-matched controls with rheumatoid arthritis. A preliminary routine neurological examination failed to show any abnormality in each patient, including signs of encephalopathy. A battery of neuropsychological tests was administered to each subject, including: the Global Deterioration Scale; the Mini Mental State Examination; Buschke test; Gatterer's test; the Wechsler Memory Scale; the Blessed-Roth memory test; and the Clifton Assessment Schedule., Results: The overall score for each test was not statistically different in PBC patients compared with rheumatoid arthritis patients, except for the Global Deterioration Scale and the Clifton Assessment Schedule; the performance was significantly poorer for these measures in PBC patients compared with rheumatoid arthritis patients. In both groups no correlation was found between the score of each test and age and/or duration of the disease. However, in the PBC group the score of BR was negatively correlated with the histological stage (p < 0.0025)., Conclusion: The global mental status is not altered in PBC, but early changes in orientation and in personal memory are present in cirrhotic stage.

The pathogenesis of branch retinal vein occlusion has not been completely clarified. The role of abnormal blood viscosity in the appearance and evolution of the disease has recently been advocated. We studied 54 patients with long-standing branch retinal vein occlusion from a hemorrheologic point of view. Depending on the extension of retinal ischemia, two subgroups were identified. Hematocrit, blood and plasma viscosity, whole blood filterability, cell deformability, and fibrinogen levels were investigated. Thirty-five subjects of similar age, sex, and risk factors of diabetes and hypertension served as controls. Our results showed that blood viscosity is higher in patients with occlusion and particularly in those with severe retinal ischemia. Statistical analysis showed a direct correlation between blood viscosity and hematocrit.

Tranexamic acid in a dose of 50 mg/kg b.w. was unable to alter the ellagic acid induced hypercoagulable state. No change in the hypercoagulability pattern was observed regardless of the time of administration of the compound (before or after the ellagic infusion). The silicone clotting times after the infusion of ellagic acid were markedly shortened and remained so for about 60 minutes. The results observed in two control groups treated with saline were similar. The euglobulin lysis times were clearly prolonged after the administration of tranexamic acid, whereas no changes were observed after the administration of saline. These results indicate that tranexamic acid has no anti-factor XII activity.

The effect of four viper venoms (Oxyuranus scutellatus, Notechis scutatus scutatus, Echis carinatus, Naja nigricollis) on prothrombin Padua has been studied. Using Oxyuranus scutellatus venom and Notechis scutatus scutatus venom, prothrombin activity resulted to be moderately decreased similarly to what observed with other one-stage and two-stage methods. On the contrary, using Echis carinatus venom a normal level was obtained. No clotting was observed using the Naja nigricollis venom, regardless of the concentration used. The normal level of factor II obtained with Echis carinatus venom as compared with the low levels obtained with the other venoms, suggests that it acts on a different site of the prothrombin molecule.

Glycated serum proteins (GSP), stable glycated hemoglobin (HbA1c) together with some metabolic parameters were evaluated in 120 subjects, 30 with normal glucose tolerance (NGT), 30 with impaired glucose tolerance (IGT), 30 with non-insulin-dependent diabetes mellitus (NIDD), and 30 with insulin-dependent diabetes mellitus (IDD). GSP levels were significantly higher in IGT, NIDD and IDD than in NGT. HbA1c levels were not significantly higher in IGT in comparison with NGT, but were significantly higher in NIDD and in IDD than in NGT and IGT. GSP correlated better than HbA1c with all metabolic parameters considered. Taking into account the distribution of the values, GSP showed a smaller overlap than HbA1c in all four groups studied. Moreover, only 9 subjects (30%) with IGT showed GSP levels above the normal range. Therefore, GSP assay is able to distinguish between normal and diabetic subjects but is unable by itself to discriminate subjects with normal from those with reduced glucose tolerance.