Background. Italy was the first western country to face an uncontrolled outbreak of SARS-CoV-2 infection. The epidemic began in March 2020 within a context characterised by a general lack of knowledge about the disease. The first scientific evidence emerged months later, leading to treatment changes. The aim of our study was to evaluate the effects of these changes. Methods. Data from a hospital in Genoa, Italy, were analysed. Patients deceased from SARS-CoV-2 infection were selected. Data were compared by dividing patients into two cohorts: “phase A” (March–May 2020) and “phase B” (October–December 2020). Results. A total of 5142 patients were admitted. There were 274 SARS-CoV-2-related deaths (162 phase A and 112 phase B). No differences were observed in terms of demographics, presentation, or comorbidities. A significant increase was recorded in corticosteroid use. Mortality was 33.36% during phase A, falling to 21.71% during phase B. When subdividing the trend during the two phases by age, we found a difference in people aged 65–74 years. Conclusions. There is scarce evidence regarding treatment for SARS-CoV-2 (especially for severe infection). However, treatment changes improved the prognosis for people under the age of 75. The prognosis for older people remains poor, despite the improvements achieved.
Background: Vitamin D’s role in COVID-19 management remains controversial. This meta-analysis aimed to evaluate the efficacy of vitamin D supplementation in patients with SARS-CoV-2 infection, focusing on mortality, intensive care unit (ICU) admissions, intubation rates, and hospital length of stay (LOS). Methods: A systematic review of PubMed/MEDLINE, Scopus, Cochrane, and Google Scholar databases was conducted. Randomized controlled trials (RCTs) and analytical studies investigating vitamin D supplementation in COVID-19 patients were included. The meta-analysis was performed using STATA MP 18.5, employing random-effect or fixed-effect models based on heterogeneity. Results: Twenty-nine studies (twenty-one RCTs, eight analytical) were analyzed. Vitamin D supplementation significantly reduced ICU admissions (OR = 0.55, 95% CI: 0.37 to 0.79) in RCTs and analytical studies (OR = 0.35, 95% CI: 0.18 to 0.66). Intubation rates were significantly reduced in RCTs (OR = 0.50, 95% CI: 0.27 to 0.92). Mortality reduction was significant in analytical studies (OR = 0.45, 95% CI: 0.24 to 0.86) but not in RCTs (OR = 0.80, 95% CI: 0.61 to 1.04). Subgroup analyses revealed more pronounced effects in older patients and severe COVID-19 cases. LOS showed a non-significant reduction (mean difference = −0.62 days, 95% CI: −1.41 to 0.18). Conclusions: This meta-analysis suggests potential benefits of vitamin D supplementation in COVID-19 patients, particularly in reducing ICU admissions. However, the evidence varies across outcomes and patient subgroups. Discrepancies between RCTs and analytical studies highlight the need for further large-scale, well-designed trials accounting for baseline vitamin D status, standardized supplementation protocols, and patient characteristics to inform clinical guidelines for vitamin D use in COVID-19 management.
Multiple studies have demonstrated the presence of microorganisms commonly associated with surgical site infections (SSIs), in the air within the operating theatre (OT). In some countries such Italy, the limit of microbial concentration in the air for OT with turbulent airflows is 35 CFU/m3 for an empty OT and 180 CFU/m3 during activity. This study aims to hypothesize new benchmarks for the airborne microbial load in turbulent airflow operating theatres in operational and at rest conditions using the percentile distribution of data through a 17-year environmental monitoring campaign in various Italian hospitals that implemented a continuous quality improvement policy. The quartile distribution analysis has shown how in operational and at rest conditions, 75% of the values were below 110 CFU/m3 and 18 CFU/m3, respectively, which can be considered a new benchmark for the monitored OTs. During the initial stages of the monitoring campaign, 28.14% of the concentration values in operational conditions and 29.29% of the values in at rest conditions did not conform to the Italian guidelines’ reference values. In contrast, during the last 5 years, all values in both conditions conformed to the reference values and 98.94% of these values were below the new benchmarks. Continuous improvement has allowed contamination to be reduced to levels well below the current reference values.
Purpose: Low-dose tamoxifen 5 mg/day (babytam) for 3 years can decrease the incidence of new breast cancer events in women with breast intraepithelial neoplasia by 42% with limited toxicity, which provides a new treatment option for these disorders. However, predictive biomarkers of babytam efficacy are lacking. We studied whether baseline levels of insulin-like growth factor-1 (IGF-I), IGF-binding protein-3 (IGFBP-3), estradiol, and sex hormone–binding globulin (SHBG) and their ratios predict babytam efficacy on breast cancer events in a preplanned secondary analysis. Patients and Methods: Within a 1:1 placebo-controlled, multicenter randomized trial of babytam or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ, 406 of 500 participants consented to blood sampling at baseline and at 1 and 3 years. Serum IGF-I, IGFBP-3, estradiol, and SHBG levels and their ratios were measured using chemiluminescent immunoassays. Biomarker changes were estimated using mixed-effects models, and incidence rate ratios were calculated after 10 years of follow-up with Poisson regression. Subgroup analyses were performed using an interaction test and subpopulation treatment effect pattern plot. Results: Baseline levels of IGFBP-3 in the three top quartiles (≥3.44 µg/mL), but not in the lower quartile, predicted greater babytam efficacy compared with placebo (Pinteraction = 0.006). Baseline IGF-I, estradiol, or SHBG levels were not predictive of babytam efficacy, whereas the IGF-I/IGFBP-3 ratio was borderline significant (Pinteraction = 0.067). Conclusions: High baseline levels of IGFBP-3 (≥3.44 µg/mL) predicted babytam efficacy and may help differentiate which women benefit most from this treatment.
29 August 2025 in JNCI: Journal of the National Cancer Institute
Despite the proven efficacy of tamoxifen in breast cancer prevention, its uptake remains limited due to concerns over side effects. A phase 3 trial showed that low-dose tamoxifen (5 mg/d for 3 years) substantially reduces recurrence with minimal toxicity. After 10 years of follow-up, we observed no clinically significant differences in benign gynecological or breast events between the tamoxifen and placebo arms. The uterus was the most frequently affected site (30 cases per arm), followed by the breast (18 cases) and ovary (5 cases vs 3 cases for tamoxifen and placebo, respectively). Endometrial polyps were similarly distributed. Endometrial thickness remained stable in premenopausal women and showed only a mild, non–clinically significant increase in postmenopausal women on tamoxifen (approximately 1.5 mm). Compared with data on standard-dose tamoxifen, rates of benign events were lower. These findings reinforce the favorable safety profile of low-dose tamoxifen.
Mean event rate (per 1000 person-years) stratified by treatment arm, menopausal status, and baseline IGF-I, IGFBP-3, IGF-I/IGFBP-3 at 10 years of follow-up.