Orofacial Manifestation of Systemic Sclerosis: A Cross-Sectional Study and Future Prospects of Oral Capillaroscopy.

BACKGROUND AND OBJECTIVES: oral alterations in Systemic Sclerosis (SSc) patients are widespread and include microstomia, periodontitis, telangiectasias, mandibular resorption, bone lesions, and xerostomia. This cross-sectional study aims to evaluate the differences between SSc patients (cases) and healthy subjects (controls) regarding oral manifestations, quality of life (QoL), and microcirculation alterations. METHODS: plaque index (PCR), periodontal index (PSR), DMFT, salivary flow rate, and buccal opening were measured by expert clinicians. S-HAQ test, the Self-Rating Anxiety State (SAS), the Self-Rating Depression Scale (SDS), and the WHOQOL-BREF test were administered to patients to evaluate their QoL. Microvascular alterations were assessed by oral videocapillaroscopy, performed on gingival and labial mucosa. A statistical analysis was conducted to find significant differences between healthy people and SSc patients. RESULTS: 59 patients were enrolled in this study. Standard salivary flow is significantly more frequent in controls, while xerostomia, reduced flow, microstomia, lip retraction, and periodontitis are significantly more frequent in the cases. Gingival capillaroscopy showed differences concerning loop visibility, thickening of the gum, tortuosity of gingival loops, and reduced gingival density. Labial capillaroscopy demonstrates that visibility of the labial loops, the labial ectasias, and the tortuosity of the loops are significantly associated with the presence of scleroderma. Hand and facial deformities, hypomobility of the tongue, cheeks, lips, microstomia, and xerostomia significantly compromised the quality of life of SSc patients, which was significantly worse among them. Moreover, oral videocapillaroscopy could be a proper diagnostic method to detect oral microcirculation alterations. SSc patients often present ectasias, rarefaction of the reticulum, microhemorrhages, and megacapillaries, which negatively impact their oral health. CONCLUSIONS: periodontitis, reduced salivary flow, and microstomia could be considered SSc oral manifestations. Joint deformities, facial appearance, and comorbidities significantly reduce the QoL of SSc patients compared to healthy subjects. Oral videocapillaroscopy could be an innovative and reliable technique to detect oral microcirculation anomalies.

Long-acting glucagon-like peptide 1 receptor agonists boost erectile function in men with type 2 diabetes mellitus complaining of erectile dysfunction: A retrospective cohort study.

INTRODUCTION: The pharmacological management of erectile dysfunction (ED) in type 2 diabetes (T2D) is challenging as ED has a multifactorial etiology. The therapeutic potential of certain antihyperglycemic medications, such as glucagon-like peptide 1 receptor agonists (GLP-1RAs), has yet to be entirely studied in this setting. MATERIAL AND METHODS: A retrospective cohort study was conducted on 108 outpatients (median age 60 [56, 65] years) with T2D complaining of ED. Data were extracted from a database referring to patients with a 1-year follow-up on stable treatment with metformin alone (n = 45) and GLP-1RAs as an add-on to metformin (n = 63). Erectile function was assessed by the 5-item International Index of Erectile Function (IIEF5) at baseline and after 1 year of stable treatment . Values were compared between baseline (T0) and after 12 months of treatment (T12). RESULTS: ED was confirmed in all at baseline, with an IIEF5 score range between 13 and 19 points. After 12 months of treatment, glucose management was better in patients treated with GLP-1RAs plus metformin (HbA1c T0: 8.3 ± 0.2 vs. HbA1c T12: 7% ± 0.3%, p < 0.0001) than in those on metformin alone (HbA1c T0: 7 ± 0.5 vs. HbA1c T12: 7.3 ± 0.4, p = 0.0007). GLP-1RAs plus metformin over metformin alone resulted in a significant weight loss (-5.82 ± 0.69 kg, p < 0.0001), reduction in waist circumference (-4.99 ± 0.6 cm, p < 0.0001), improvement in HbA1c (-0.56% ± 0.13%, p < 0.0001), and fasting plasma glucose (-25.54 ± 3.09 mg/dL, p < 0.0001), increase in total (+41.41 ± 6.11 ng/dL, p < 0.0001) and free (0.44 ± 0.09 ng/dL, p < 0.0001) testosterone levels, and gain in self-reported erectile function (IIEF5 score: +2.26 ± 0.26, p < 0.0001). The gain in the IIEF5 score was more relevant in patients with higher baseline IIEF5 score (estimated coefficient: 0.16 ± 0.08, p = 0.045), those having carotid stenosis (0.50 ± 0.24, p = 0.045), and showing weight loss from baseline (-0.08 ± 0.03, p = 0.013). The leading determinant of the final IIEF5 score was a 1-year treatment with GLP-1RAs plus metformin over metformin alone (2.74 ± 0.53, p < 0.0001). DISCUSSION: GLP-1RAs plus metformin over metformin alone improved ED regardless of different background characteristics of patients and partially irrespective of therapeutic targets achieved after 12 months of treatment. GLP-1RAs may have induced positive vasculature effects, resulting in improved erectile function in T2D. CONCLUSION: Due to the retrospective nature of the study, a potential cause-effect relationship between the use of GLP-1RAs plus metformin over metformin alone in improving ED cannot be verified and confirmed. Randomized clinical trials are needed to provide evidence supporting the use of GLP-1RAs for treating ED in T2D.

A Retrospective Observational Study Using Administrative Databases to Assess the Risk of Spontaneous Abortions Related to Environmental and Socioeconomic Conditions.

Miscarriage is one of the most frequent adverse events that occurs during pregnancy. This retrospective study aimed to verify if the environmental and socioeconomic conditions related to geographical areas where women live, and the socio-demographic and clinical factors play a role in the risk of spontaneous abortion (SA). The analyses were conducted by hospital discharge records (HDRs) from public and private hospitals in Apulia from 1 January 2021 to 31 December 2021. Women with an age over 40 years old had a major risk of SA compared with women under 18 years (OR 2.30, IC95%1.16-4.54). A reduction in the risk of SA was found for women with an endocrinological or metabolic disease (OR 0.28, 95% CI 0.19-0.41), while genetic disease greatly increases the risk (OR 9.63, IC95% 1.98-46.86). The greatest risk of spontaneous abortion was found in the province of Taranto compared to the province of Foggia (OR 2.01, 95% CI 1.52-2.64). The provinces with a higher risk of SA in the multiple comparisons were Taranto, Brindisi, and BAT. Municipalities with socioeconomic disadvantages classified as very low, low, and medium had a higher risk of SA compared to the municipalities with a high disadvantage. In conclusion, our study indicates the possible association between SA rate and environmental conditions. Additionally, the socioeconomic, clinical, and demographic factors were related to the risk of SAs.

Prevalence and Risk Factors for Poor Sleep Quality in People Living with HIV: Preliminary Observations from an HIV Outpatient Clinic.

INTRODUCTION: Sleep disorders have been reported in individuals living with HIV (PLWH), with a prevalence rate of over 50%. The main risk factors contributing to the development of sleep disturbances are not yet fully understood. We investigate the prevalence and risk factors associated with poor sleep quality in a population of PLWH who are receiving antiretroviral therapy (ART). METHODS: The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate sleep quality in PLWH attending our HIV Outpatient Clinic between October 2022 and April 2023. All subjects with a PSQI score > 5 were considered bad sleepers. A logistic regression analysis was carried out to assess risk factors associated with a PSQI score > 5. RESULTS: A total of 132 PLWH (78% males) who received ART for at least one month were included in this observational study. The median age was 56 (IQR 47-61). Among all, 41 (31%) had a history of AIDS, and 95 (72%) were receiving an INSTI-based ART. The study population was divided into two groups: PSQI ≤ 5 (90; 68.2%) and PSQI > 5 (42; 31.8%). A lower BMI and the use of bictegravir in the current ART were associated with a PSQI score ≤ 5. In the multivariate analysis, the use of a bictegravir-based ART remained the only factor associated with better sleep quality (OR 0.17; p = 0.0222). No further associations between sleep disturbances and other epidemiological and clinical features were found. CONCLUSION: In this real-life scenario, poor sleep quality was observed in 31% of the cases, primarily among individuals with higher BMI. In addition, bictegravir users might seem to have a lower likelihood of experiencing poor sleep quality.

Subclinical cardiac dysfunction may impact on fluid and vasopressor administration during early resuscitation of septic shock.

BACKGROUND: According to the Surviving Sepsis Campaign (SSC) fluids and vasopressors are the mainstays of early resuscitation of septic shock while inotropes are indicated in case of tissue hypoperfusion refractory to fluids and vasopressors, suggesting severe cardiac dysfunction. However, septic cardiac disfunction encompasses a large spectrum of severities and may remain "subclinical" during early resuscitation. We hypothesized that "subclinical" cardiac dysfunction may nevertheless influence fluid and vasopressor administration during early resuscitation. We retrospectively reviewed prospectically collected data on fluids and vasoconstrictors administered outside the ICU in patients with septic shock resuscitated according to the SSC guidelines that had reached hemodynamic stability without the use of inotropes. All the patients were submitted to transpulmonary thermodilution (TPTD) hemodynamic monitoring at ICU entry. Subclinical cardiac dysfunction was defined as a TPTD-derived cardiac function index (CFI) ≤ 4.5 min-1. RESULTS: At ICU admission, subclinical cardiac dysfunction was present in 17/40 patients (42%; CFI 3.6 ± 0.7 min-1 vs 6.6 ± 1.9 min-1; p < 0.01). Compared with patients with normal CFI, these patients had been resuscitate with more fluids (crystalloids 57 ± 10 vs 47 ± 9 ml/kg PBW; p < 0.01) and vasopressors (norepinephrine 0.65 ± 0.25 vs 0.43 ± 0.29 mcg/kg/min; p < 0.05). At ICU admission these patients had lower cardiac index (2.2 ± 0.6 vs 3.6 ± 0.9 L/min/m2, p < 0.01) and higher systemic vascular resistances (2721 ± 860 vs 1532 ± 480 dyn*s*cm-5/m2, p < 0.01). CONCLUSIONS: In patients with septic shock resuscitated according to the SSC, we found that subclinical cardiac dysfunction may influence the approach to fluids and vasopressor administration during early resuscitation. Our data support the implementation of early, bedside assessment of cardiac function during early resuscitation of septic shock.

Effects of Elastodontic Appliance on the Pharyngeal Airway Space in Class II Malocclusion.

BACKGROUND: The present study analyzed the changes obtained on the upper airway and hyoid bone dimensions in a group of patients with skeletal Class II malocclusion treated with functional elastodontic devices compared to an untreated control group. METHODS: A group of 33 patients (19 females and 14 males) with Class II malocclusion treated with AMCOP® SC elastodontic device was compared with a control group of 35 subjects (17 females and 18 males) with untreated Class II malocclusion. Lateral cephalograms were available at the start (T0) and end of treatment/period of observation (T1). Cephalometric analysis was performed and linear measurements to evaluate airway space and hyoid bone position were also obtained. A multivariate analysis of variance for repeated measures (MANOVA) was performed to determine the effects of interactions for the groups for time. RESULTS: Statistically significant differences were found in the study group from T0 and T1 with an improvement of superior upper airway (SPAS p < 0.0001), while in the control group it did not change in a statistically significant way from T0 to T1. The MANOVA test showed statistically significant differences between the two groups for the changes of SPAS (p = 0.003), IAS (p = 0.049), and H-C3 vertical (p = 0.038) values. CONCLUSIONS: Functional elastodontic therapy produced significant favorable airway changes in skeletal class II subjects.

The Impact of the COVID-19 Pandemic and Socioeconomic Deprivation on Admissions to the Emergency Department for Psychiatric Illness: An Observational Study in a Province of Southern Italy.

The restriction measures adopted to limit population movement in order to contain the COVID-19 pandemic contributed to a global public health system crisis. This retrospective study aimed at identifying changes in psychiatric admissions to Accident and Emergency Departments (A&Es) in a province in southern Italy during the first two years of the pandemic and was characterized by two different restriction levels (phases 2 and 3) compared to the pre-pandemic period (phase 1). We also investigated the role of socioeconomic deprivation (DI) on psychiatric admissions. The total number of patients admitted to the A&Es was 291,310. The incidence of admission for a psychiatric disorder (IPd) was 4.9 per 1000 admissions, with a significant younger median age of 42 [IQR 33-56] compared to non-psychiatric patients (54 [35-73]). The type of admission and type of discharge were factors related to the psychiatric admission to A&E, and their relationship was modified by the pandemic. In the first year of the pandemic, patients with psychomotor agitation increased compared to the pre-pandemic period (72.5% vs. 62.3%). In the period preceding the spread of SARS-CoV-2, the IPd was equal to 3.33 ± 0.19; after the pandemic started, there was an increase in the IPd: 4.74 ± 0.32 for phase 2 and 3.68 ± 0.25 for phase 3. The IPd was higher for psychiatric admissions from areas with a very low DI compared to areas with a low DI; however, during phase 2, this difference was reduced. In conclusion, an increase in admissions for psychiatric disease was observed during the initial spread of SARS-CoV-2. Patients who lived in the most deprived municipalities generally came to the A&Es less than others, probably because the patients and their families had less awareness of their mental health. Therefore, public health policies to address these issues are needed to reduce the pandemic's impact on these conditions.

The role of male hypogonadism, aging, and chronic diseases in characterizing adult and elderly men with erectile dysfunction: a cross-sectional study.

BACKGROUND: Erectile function depends on a complex interaction between demographic, metabolic, vascular, hormonal, and psychological factors that trigger erectile dysfunction (ED). In the present study we carried out a cross-sectional study assessing the impact of non-communicable chronic diseases (NCDs), male hypogonadism, and demographic factors in characterizing men with ED. Four hundred thirty-three consecutive outpatients with ED were extracted from the electronic database from January 2017 to December 2019. The International Index of Erectile Function (IIEF) 5 score was used to diagnose ED and stratify its severity, standardized values of serum testosterone (10.5 nM/L) and luteinizing hormone (LH 9.4 IU/L) to diagnose and classify male hypogonadism and the Charlson Comorbidity Index (CCI) to weigh the role of each NCD on ED. RESULTS: Forty-six percent of participants were eugonadal (EuG), 13% had organic hypogonadism (OrH), and the remaining 41% had functional hypogonadism (FuH). Hypogonadal men had a significantly lower IIEF 5 score (p < .0001) than EuG. FuH had a higher CCI than OrH and EuG (all p < .0001). In a multivariable model, only free T (FT) and Sex Hormone Binding Globulin (SHBG) showed a direct correlation with the IIEF 5 score (all p < .0001). Age and CCI had an inverse correlation with IIEF 5 score (all p < .0001). CONCLUSION: Serum FT, SHBG, and CCI are the leading determinants of ED severity. Besides overt hypogonadism, a relevant burden of severe NTCDs in middle-aged or older adults features the patient's characteristics who will suffer from severe ED. Appropriate clinical approaches and, when necessary, treatments are required in these clusters of patients.

RéSUMé: CONTEXTE: La fonction érectile dépend d'une interaction complexe entre les facteurs démographiques, métaboliques, vasculaires, hormonaux et psychologiques qui déclenchent la dysfonction érectile (DE). Dans la présente étude, nous avons mené ici une étude transversale évaluant l'impact des maladies chroniques non transmissibles (MNT), de l'hypogonadisme masculin et des facteurs démographiques dans la caractérisation des hommes atteints de dysfonction érectile. Quatre cent trente-trois patients externes consécutifs présentant une dysfonction érectile ont été extraits de la base de données électronique de janvier 2017 à décembre 2019. Le score de l'indice international de la fonction érectile (IIEF) 5 a été utilisé pour diagnostiquer la dysfonction érectile et stratifier sa gravité, les valeurs normalisées de la testostérone sérique (10,5 nM/L) et de l'hormone lutéinisante (LH 9,4 UI/L) pour diagnostiquer et classer l'hypogonadisme masculin, et l'indice de comorbidité de Charlson (ICC) pour évaluer le rôle de chaque MNT sur la DE. RéSULTATS: Quarante-six pour cent des participants étaient eugonadiques (EuG), 13% avaient un hypogonadisme organique (OrH) et les 41% restants avaient un hypogonadisme fonctionnel (FuH). Les hommes hypogonadiques avaient un score IIEF 5 significativement plus faible (p < 0,0001) que EuG. Les hommes FuH avait un ICC plus élevé que les hommes OrH et EuG (tous p < .0001). Dans un modèle multivariable, seules la T libre (TL) et la globuline liant les hormones sexuelles (SHBG) ont montré une corrélation directe avec le score IIEF 5 (tous p <,0001). L'âge et l'ICC avaient une corrélation inverse avec le score IIEF 5 (tous p < 0,0001). CONCLUSION: La TL sérique, la SHBG et le CCI sont les principaux déterminants de la gravité de la DE. Outre l'hypogonadisme manifeste, une charge significative de MNT sévères chez les adultes d'âge moyen ou plus âgés dessine les caractéristiques du patient qui souffrira de DE sévère. Des approches cliniques appropriées et, si nécessaire, des traitements sont requis chez ces patients. MOTS-CLéS : Dysfonction érectile, Testostérone, Indice de Comorbidité de Charlson, Maladies chroniques non transmissibles, Hypogonadisme masculin.

No Excess of Mortality from Lung Cancer during the COVID-19 Pandemic in an Area at Environmental Risk: Results of an Explorative Analysis.

BACKGROUND: The COVID-19 pandemic and the restrictive measures associated with it placed enormous pressure on health facilities and may have caused delays in the treatment of other diseases, leading to increases in mortality compared to the expected rates. Areas with high levels of air pollution already have a high risk of death from cancer, so we aimed to evaluate the possible indirect effects of the pandemic on mortality from lung cancer compared to the pre-pandemic period in the province of Taranto, a polluted site of national interest for environmental risk in the south of Italy. METHODS: We carried out a retrospective observational study on lung cancer data (ICD-10: C34) from the Registry of Mortality (ReMo) for municipalities in Taranto Province over the period of 1 January 2011 to 31 December 2021. Seasonal exponential smoothing, Holt-Winters additive, Holt-Winters multiplicative, and auto-regressive integrated moving average (ARIMA) models were used to forecast the number of deaths during the pandemic period. Data were standardized by sex and age via an indirect method and shown as monthly mortality rates (MRs), standardized mortality ratios (SMRs), and adjusted mortality rates (AMRs). RESULTS: In Taranto Province, 3108 deaths from lung cancer were recorded between 2011 and 2021. In the province of Taranto, almost all of the adjusted monthly mortality rates during the pandemic were within the confidence interval of the predicted rates, with the exception of significant excesses in March (+1.82, 95% CI 0.11-3.08) and August 2020 (+2.09, 95% CI 0.20-3.44). In the municipality of Taranto, the only significant excess rate was in August 2020 (+3.51, 95% CI 0.33-6.69). However, in total, in 2020 and 2021, the excess deaths from lung cancer were not significant both for the province of Taranto (+30 (95% CI -77; +106) for 2020 and +28 (95% CI -130; +133) for 2021) and for the municipality of Taranto alone (+14 (95% CI -47; +74) for 2020 and -2 (95% CI -86; +76) for 2021). CONCLUSIONS: This study shows that there was no excess mortality from lung cancer as a result of the COVID-19 pandemic in the province of Taranto. The strategies applied by the local oncological services during the pandemic were probably effective in minimizing the possible interruption of cancer treatment. Strategies for accessing care in future health emergencies should take into account the results of continuous monitoring of disease trends.

Erectile Dysfunction in Patients with Multiple Chronic Conditions: A Cross- Sectional Study.

BACKGROUND: The prevalence of erectile dysfunction (ED) rises with the number and severity of chronic diseases. AIMS: This cross-sectional study assessed the frequency and severity of ED in patients with multiple chronic conditions. METHODS: The 5-item International Index of Erectile Function questionnaire (IIEF-5) was used to diagnose and classify ED. The Charlson Comorbidity Index (CCI) was used to assess the burden of chronic comorbidity. The primary outcome was to assess the ED frequency according to CCI severity. The secondary outcomes included the assessment of the correlation between 1) IIEF-5 and total testosterone (TT), 2) CCI and TT, and 3) IIEF-5 and CCI. Lastly, the CCI and modified CCI (mCCI) performances were compared with each other. RESULTS: The overall frequency of ED increased along with the CCI score severity: 45% for CCI=0; 95% for CCI=1; 91% for CCI=2; 99% for CCI≥3 (p<.0001). CCI correlated negatively with TT levels and IIEF-5 score (r=-0.34 and -0.44; p<.0001). Compared to the CCI, a novel proposed mCCI performs well. DISCUSSION: The frequency and severity of ED are relevant in outpatients with sexual complaints and those with chronic comorbidities. Despite limitations, mCCI may be considered a reliable tool to assess the overall burden of multiple chronic conditions in patients with comorbidities. CONCLUSION: ED is a reliable proxy of overall male health. Further studies are needed to confirm this potential application.

Efficacy and safety of oral antivirals in individuals aged 80 years or older with mild-to-moderate COVID-19: preliminary report from an Italian Prescriber Center.

Introduction: Molnupiravir and Nirmatrelvir/ritonavir( r), have demonstrated to prevent the progression to severe COVID-19 in high-risk individuals. Real life data are lacking in the elderly. Methods: All consecutive individuals aged ≥80 years with confirmed COVID-19 and mild-to-moderate illness who received an oral antiviral prescription between 11th January and 31st May 2022 were included in this retrospective single-centre study. The aim was to assess safety and effectiveness of oral antivirals in individuals ≥80 years with mild to moderate COVID-19. Results: A total of 168 subjects ≥80 years were included. Molnupiravir was prescribed in 147 (87.5%) subjects whereas Nirmatrelvir/r in 21 (12.5%); 16 (9.5%) experienced at least one adverse event. Overall, 21 (12.5%) hospitalizations and five deaths were reported at 28 days. At multivariate analysis male sex (OR=4.196, 95% CI=1.479-11.908; p=0.007), a moderate illness at time of prescription (OR=10.946, 95% CI=2.857-41.395; p=0.0005) and a greater number of days from the onset of symptoms to the therapy (OR=2.066, 95% CI=1.285-3.322; p=0.0027) were associated with hospitalization and/or death. Conclusion: In this real-life setting, including older individuals' hospitalizations and mortality at 28 days remained low thanks to the prompt initiation of oral antiviral therapy. The use of oral antivirals can play a significant role in reducing healthcare costs and ensuring benefits among the elderly population.

Early Access to Oral Antivirals in High-Risk Outpatients: Good Weapons to Fight COVID-19.

INTRODUCTION: Molnupiravir and Nirmatrelvir/r (NMV-r) have been proven to reduce severe Coronavirus Disease 2019 (COVID-19) in unvaccinated high-risk individuals. Data regarding their impact in fully vaccinated vulnerable subjects with mild-to-moderate COVID-19 are still limited, particularly in the era of Omicron and sub-variants. METHODS: Our retrospective study aimed to compare the safety profile and effectiveness of the two antivirals in all consecutive high-risk outpatients between 11 January and 10 July 2022. A logistic regression model was carried out to assess factors associated with the composite outcome defined as all-cause hospitalization and/or death at 30 days. RESULTS: A total of 719 individuals were included: 554 (77%) received Molnupiravir, whereas 165 (23%) were NMV-r users. Overall, 43 all-cause hospitalizations (5.9%) and 13 (1.8%) deaths were observed at 30 days. A composite outcome occurred in 47 (6.5%) individuals. At multivariate analysis, male sex [OR 3.785; p = 0.0021], age ≥ 75 [OR 2.647; p = 0.0124], moderate illness [OR 16.75; p < 0.001], and treatment discontinuation after medical decision [OR 8.148; p = 0.0123] remained independently associated with the composite outcome. CONCLUSIONS: No differences between the two antivirals were observed. In this real-life setting, the early use of both of the oral antivirals helped limit composite outcome at 30 days among subjects who were at high risk of disease progression.

Impact of Socioeconomic Deprivation on the Local Spread of COVID-19 Cases Mediated by the Effect of Seasons and Restrictive Public Health Measures: A Retrospective Observational Study in Apulia Region, Italy.

The aim of this study was to investigate the spatiotemporal association between socioeconomic deprivation and the incidence of COVID-19 and how this association changes through the seasons due to the existence of restrictive public health measures. A retrospective observational study was conducted among COVID-19 cases that occurred in the Apulia region from 29 February 2020 to 31 December 2021, dividing the period into four phases with different levels of restrictions. A generalized estimating equation (GEE) model was applied to test the independent effect of deprivation on the incidence of COVID-19, taking into account age, sex, and regional incidence as possible confounding effects and covariates, such as season and levels of restrictions, as possible modifying effects. The highest incidence was in areas with a very high deprivation index (DI) in winter. During total lockdown, no rate ratio between areas with different levels of DI was significant, while during soft lockdown, areas with very high DI were more at risk than all other areas. The effects of social inequalities on the incidence of COVID-19 changed in association with the seasons and restrictions on public health. Disadvantaged areas showed a higher incidence of COVID-19 in the cold seasons and in the phases of soft lockdown.

Body Composition in Adolescent PKU Patients: Beyond Fat Mass.

There is a lack of evidence on the impact on body composition of high protein intake and types of protein substitutes in PKU patients­particularly in adolescents, who are more inclined to dietary transgressions. In this observational, cross-sectional study, PKU patients were observed during prepubertal age (p) or after the pubertal spurt (P), assessing body composition and bone quality and correlating these parameters with dietary compliance and types of protein substitutes. Anthropometric and dietary data were evaluated together with bioelectrical impedance analysis (BIA), quantitative ultrasound (QUS) and branched-chain amino acids (BCAAs). A total of 36 patients (16 males, 17 prepubertal and 19 post-pubertal; mean ± SD age 11.4 ± 3.9 years) were included. A higher BMI was observed in adolescents (p-value: 0.018). The BIA revealed a significant increase in total body water (TBW) and muscle mass (MM) in P subjects either compliant (p-value: 0.001) or non-compliant with the diet (p-value: 0.001). MM content correlated with increased Phe intake (r = 0.63; p < 0.001). In the subgroup of five patients taking L-AAs and glycomacropeptides (GMPs), BCAA values tended to be lower than those taking only L-AA mixtures, with a significant trend for valine. Maintenance of body composition parameters within the normal range­for both fat and muscle mass­and levels of BCAAs can be helpful in reducing the risk of becoming overweight in adulthood. Further studies are needed to confirm these findings.

Basal and one-month differed neutrophil, lymphocyte and platelet values and their ratios strongly predict the efficacy of checkpoint inhibitors immunotherapy in patients with advanced BRAF wild-type melanoma.

BACKGROUND: To evaluate the capability of basal and one-month differed white blood cells (WBC), neutrophil, lymphocyte and platelet values and their ratios (neutrophils-to-lymphocytes ratio, NLR, and platelets-to-lymphocytes ratio, PLR) in predicting the response to immune checkpoint inhibitors (ICI) in metastatic melanoma (MM). METHODS: We performed a retrospective study of 272 BRAF wild-type MM patients treated with first line ICI. Bivariable analysis was used to correlate patient/tumor characteristics with clinical outcomes. Variations between time 1 and time 0 (Δ) of blood parameters were also calculated and dichotomized using cut-off values assessed by ROC curve. RESULTS: At baseline, higher neutrophils and NLR negatively correlated with PFS, OS and disease control rate (DCR). Higher PLR was also associated with worse OS. In multivariable analysis, neutrophils (p = 0.003), WBC (p = 0.069) and LDH (p = 0.07) maintained their impact on PFS, while OS was affected by LDH (p < 0.001), neutrophils (p < 0.001) and PLR (p = 0.022), while DCR by LDH (p = 0.03) and neutrophils (p = 0.004). In the longitudinal analysis, PFS negatively correlated with higher Δplatelets (p = 0.039), ΔWBC (p < 0.001), and Δneutrophils (p = 0.020), and with lower Δlymphocytes (p < 0.001). Moreover, higher ΔNLR and ΔPLR identified patients with worse PFS, OS and DCR. In the multivariable model, only ΔNLR influenced PFS (p = 0.004), while OS resulted affected by higher ΔWBC (p < 0.001) and lower Δlymphocytes (p = 0.038). Higher ΔWBC also affected the DCR (p = 0.003). When clustering patients in 4 categories using basal LDH and ΔNLR, normal LDH/lower ΔNLR showed a higher PFS than high LDH/higher ΔNLR (20 vs 5 months). Moreover, normal LDH/higher Δlymphocytes had a higher OS than high LDH/lower Δlymphocytes (50 vs. 10 months). CONCLUSIONS: Baseline and early variations of blood cells, together with basal LDH, strongly predict the efficacy of ICI in MM. Our findings propose simple, inexpensive biomarkers for a better selection of patient treatments. Prospective multicenter studies are warranted to confirm these data.

Overall Sexual Function in Dysmetabolic Obese Men with Low Testosterone Levels Treated with Clomiphene Citrate.

BACKGROUND: Sexual disorders are the most common clinical manifestations of hypogonadism. Functional hypogonadism is the most frequent form, and clomiphene citrate (CC) has been recently introduced as a possible off-label therapeutic option for these patients. OBJECTIVES: This study aimed to evaluate the effects of CC on the overall sexual function in dysmetabolic obese men with low testosterone (T) levels. METHODS: This was a sub-study of a randomized, double-blind, cross-over, placebo-controlled trial that included twenty-four obese or overweight subjects with impaired glucose tolerance or type 2 diabetes and confirmed low total T (≤10.4 nmol/l) levels. Subjects were treated with CC or placebo (Plac) for 12 weeks, with an interval wash-out period of 6 weeks between treatments. All subjects were on metformin 2gr/day and a low-calorie diet. The between-treatment difference in the overall sexual function was assessed by IIEF-15 and a qADAM questionnaire. RESULTS: IIEF-15 and qADAM questionnaire data were available for 18 individuals. In unadjusted analyses, CC was associated with lower IIEF-15 total, erectile function, and intercourse satisfaction domain scores than Plac. After adjustments for multiple variables, CC was associated with a higher IIEF-15 sexual desire domain score (+0.9 ± 0.8; p<.001) despite a lower qADAM score (-2.1 ± 0.9; p=.008) with respect to Plac. No differences were found for the other domains between groups. DISCUSSION: The clinical significance of the absolute changes in IIEF-15 and qADAM scores during CC versus Plac is limited. However, CC has a reliable effect on sexual desire and is also as safe as Plac. According to the sample size, duration of follow-up, and inclusion criteria defined for the main study, further studies are therefore needed to assess the long-term efficacy of CC. CONCLUSION: Compared to Plac, CC was found to be associated with a neutral effect on overall sexual function.

A Retrospective Observational Study to Assess the Effect of the COVID-19 Pandemic on Spontaneous and Voluntary Abortivity in the Apulia Region of Italy.

The spread of COVID-19 in Italy required urgent restrictive measures that led to delays in access to care and to hospital overloads and impacts on the quality of services provided by the national health service. It is likely that the area related to maternal and child health was also affected. The objective of the study was to evaluate the intensity of a possible variation in spontaneous abortion (SA) and voluntary termination of pregnancy (VTP) rates in relation to the different restrictive public health measures adopted during the pandemic period of 2020. The analysis concerned the data collected on the SAs and VTPs from public and private structures in Apulia that related to the years 2019 and 2020. The SRR (standardized rate ratio) between the standardized rates by age group in 2019 and those in 2020 were calculated using a multivariable Poisson model, and it was applied to evaluate the effect of public health restrictions on the number of SAs and VTPs, considering other possible confounding factors. The SSR was significantly lower in the first months of the pandemic compared to the same period of the previous year, both for SAs and for VTPs. The major decrease in SAs and VTPs occurred during the total lockdown phase. The results, therefore, highlight how the measures to reduce infection risk could also have modified the demand for assistance related to pregnancy interruption.

SARS-CoV-2 and Public Transport in Italy.

Although direct contact is considered the main mode of transmission of SARS-CoV-2, environmental factors play an important role. In this study, we evaluated the presence of SARS-CoV-2 on bus and train surfaces. From the buses, we took samples from the following areas: handrails used to enter or exit the bus, stop request buttons and handles next to the seats. From the trains, the sampled surfaces were handrails used to enter or exit the train, door open/close buttons, handles next to the seats, tables and toilet handles. SARS-CoV-2 was detected on 10.7% of the tested surfaces overall, 19.3% of bus surfaces and 2% of train surfaces (p < 0.0001). On the buses, the most contaminated surfaces were the handles near the seats (12.8%), followed by door open/close buttons (12.5%) and handrails (10.5%). Of the five analyzed transport companies, bus companies were the most contaminated, in particular, companies C (40%) and B (23.3%). A greater number of positive samples were found among those taken at 10:00 a.m. and 10:55 a.m. (45% and 40%, respectively). The presence of the virus on many bus surfaces highlights how the sanitation systems on public transport currently in use are not sufficient to limit the spread of SARS-CoV-2.

In-Hospital Mortality in Non-COVID-19-Related Diseases before and during the Pandemic: A Regional Retrospective Study.

Italy was one of the nations most affected by SARS-CoV-2. During the pandemic period, the national government approved some restrictions to reduce diffusion of the virus. We aimed to evaluate changes in in-hospital mortality and its possible relation with patient comorbidities and different restrictive public health measures adopted during the 2020 pandemic period. We analyzed the hospital discharge records of inpatients from public and private hospitals in Apulia (Southern Italy) from 1 January 2019 to 31 December 2020. The study period was divided into four phases according to administrative restriction. The possible association between in-hospital deaths, hospitalization period, and covariates such as age group, sex, Charlson comorbidity index (CCI) class, and length of hospitalization stay (LoS) class was evaluated using a multivariable logistic regression model. The risk of death was slightly higher in men than in women (OR 1.04, 95% CI: 1.01-1.07) and was lower for every age group below the >75 years age group. The risk of in-hospital death was lower for hospitalizations with a lower CCI score. In summary, our analysis shows a possible association between in-hospital mortality in non-COVID-19-related diseases and restrictive measures of public health. The risk of hospital death increased during the lockdown period.

Effectiveness of an Innovative Sensory Approach to Improve Children's Nutritional Choices.

A case-control study was conducted to investigate the effectiveness of the Edueat® Method, through experiential workshops focused on the use of all 5 senses. In two different primary schools in the same city, questionnaires were administered in two months with a follow-up one year later. Participants: 119 children (age 8.2-9.0) chosen randomly; control group 66 (55.5%). Seven lessons of 2 h each were held in the schools by experts of the Edueat® method and seven extra lessons by the teachers. The main outcome measures were the children's changes in their approach and attitude towards their eating habits. The answers were grouped with factor analysis and summarized through scores. Repeated-measures analysis of variance was conducted in order to identify the relationships between scores and treatment over time. At the end of treatment, the intervention group showed a significant appreciation towards healthy foods (+4.15 vs. -0.05, p = 0.02) and a greater capacity in identifying foods which are very good for the health (+15.6 vs. +14.4, p = 0.02). In conclusion, the Edueat® method was found to be particularly promising in transmitting knowledge of those foods which are healthy. Greater involvement of teachers and parents is crucial.