ABSTRACT
The increasing need to improve the sustainability of industrial processes requires more flexible and intensified solutions. For this purpose, nowadays lots of efforts are made to switch from batch to continuous processes, the latter being able to ensure the same processing history to all fluid elements, with a consequent better control of the operating conditions and product quality. The present work aims at developing a continuous flow reactor for the production of several fine chemicals, including medical-surgical aids, but also other substances for specific industrial sectors. The plant is basically an inline reactor equipped with various static mixers and side inlets, and it is conceived to ensure on-site production. This is an important feature also in light of the recent COVID-19 pandemic, which asked for flexible and distributed production of chemicals. Numerical simulations based on computational fluid dynamics are employed to study the performance, in terms of pressure drops and degree of mixing, of different static mixers, that is, the Lightnin Inliner Series 50 and Ross low pressure drop (LPD), combining various elements of mixing and injections in different operating conditions in both laminar and turbulent regimes. The results highlighted how numerical simulations may represent a valid tool for supporting the detailed design of such flow reactors by allowing the evaluation of the optimal design solutions.
ABSTRACT
Influencing behavioral patterns through primary prevention, possibly addressing more risk factors at a time, is the most effective means to tackle cardiovascular diseases. Many interdisciplinary prevention activities have been coordinated by community nurses outside of specialist centers, resulting in a more effective control of risk factors. Our study aims at describing the impact of an 18-month prevention and promotion, interdisciplinary intervention on lifestyle habits and cardiovascular risk. From December 2018 to May 2020, patients were recruited by 4 General Practitioners (GPs) in the Roman neighborhood of Torresina and received nutritional, physical and psychological counselling to learn healthy lifestyles. Until May 2020 patients had to self-manage their new healthy habits, but during this phase the SARS-CoV-2 pandemic broke out. Patients were assessed at baseline, 6, 12 and 18 months by a nutritionist, a physiotherapist, a psychologist, the 4 GPs and community nurses, and the cardiovascular risk score (CRS) was estimated at every examination. 76 patients were included, with a mean age of 54,6 years. Mean CRS showed a significant reduction between baseline and 12 months (from 4.9 to 3.8, p < 0.001), but this trend was not maintained at 18 months. As for variables included in the calculation of the cardiovascular risk score, both total cholesterol and systolic blood pressure significantly decreased at 6 months of follow up (respectively, from 211.1 to 192 (p < 0.001) and from 133.1 to 123.1(p < 0.001)). Nontheless, the reduction was maintained in the remaining points in time only for systolic blood pressure. Our interdisciplinary educational intervention in a primary care setting resulted in a CRS improvement at 12 months, but this changes where not maintained at 18 months. Community nurses were facilitators in improving health outcomes and patient's satisfaction in the described primary care setting. Key messages Our interdisciplinary educational intervention in a primary care setting resulted in a CRS improvement at 12 months, but this changes where not maintained at 18 months. Community nurses are facilitators in improving health outcomes and patient’s satisfaction in the described primary care setting.
ABSTRACT
Introduction: Chronic rhinosinusitis with nasal polyposis (CRSwNP) is characterized by a type 2 pattern of inflammation resulting in the production of some cytokines such as interleukin (IL)-4, IL5, and IL13. Options for treatment-resistant CRSwNP include aspirin desensitization, recurrent topic and systemic corticosteroid use, and functional endoscopic sinus surgery (FESS). However, frequent relapses after medical and surgical treatment have been observed. Thus, dupilumab, a human recombinant monoclonal IgG4 antibody, changes radically the treatment of CRSwNP because of its binding effects on major drivers of human type 2 inflammatory processes [1- 3]. Considering its recent approval, it may be useful to evaluate its safety profile. Objective(s): The aim of this study was to describe better adverse drug reactions (ADRs) related to dupilumab in the treatment of CRSwNP analyzing all individual case safety reports (ICSRs) collected into the European Spontaneous Reporting System (SRS) database. Method(s): All ICSRs recorded starting from the drug approval up to 31 December 2021 with dupilumab reported as suspected and having the specific indication of CRSwNP were considered. A descriptive analysis was conducted to assess demographic characteristics and dupilumab-related variables. Result(s): Out of 10,400 ICSRs related to dupilumab, only 481 (4.6%) had CRSwNP indication, of which 68.2% were related to adults and 54.3% to females. The 68.4% were serious;however, ICSRs mainly led to a completely or partial recovering (25.4%) and 8 cases were fatal (1.7%). The time to onset (TTO) of ADRs was 25 (1-84.75) days while the time to resolution (TTR) was 5 (1.75-15.75) days. Analyzing ADRs by System Organ Classes (SOCs), the most reported were general and administration site conditions (36.4%) followed by injuries (21.6%), infections (21.2%), respiratory (19.1%), skin (16.6%), and nervous system disorders (16.4%). Looking at Preferred Terms (PTs), arthralgia (7.3%), eosinophilia (6.9%), COVID-19 (6.0%), pyrexia (5.8%), asthenia (5.6%), rash (5.4%), and dyspnoea (5.2%) were the most reported. The 7.5% of ICSRs described an aggravated condition with persistent nasal polyps: in 4 cases (0.8%) a nasal polypectomy was required. Considering fatal ICSRs, two cases were related to progression of COVID-19, one to road traffic accident, one to accidental death and the others were not fully specified. Conclusion(s): These results showed that dupilumab-related ICSRs are not commonly reported in CRSwNP. However, given the good treatment response and the minimal adverse effects observed, clinicians should consider treating CRSwNP with dupilumab. Moreover, additional analyses are necessary to better outline the safety profile of dupilumab in this particular setting.
ABSTRACT
Introduction: Chronic rhinosinusitis with nasal polyposis (CRSwNP) is characterized by a type 2 pattern of inflammation resulting in the production of some cytokines such as interleukin (IL)-4, IL5, and IL13. Options for treatment-resistant CRSwNP include aspirin desensitization, recurrent topic and systemic corticosteroid use, and functional endoscopic sinus surgery (FESS). However, frequent relapses after medical and surgical treatment have been observed. Thus, dupilumab, a human recombinant monoclonal IgG4 antibody, changes radically the treatment of CRSwNP because of its binding effects on major drivers of human type 2 inflammatory processes [1-3]. Considering its recent approval, it may be useful to evaluate its safety profile. Objective: The aim of this study was to describe better adverse drug reactions (ADRs) related to dupilumab in the treatment of CRSwNP analyzing all individual case safety reports (ICSRs) collected into the European Spontaneous Reporting System (SRS) database. Methods: All ICSRs recorded starting from the drug approval up to 31 December 2021 with dupilumab reported as suspected and having the specific indication of CRSwNP were considered. A descriptive analysis was conducted to assess demographic characteristics and dupilumab-related variables. Results: Out of 10,400 ICSRs related to dupilumab, only 481 (4.6%) had CRSwNP indication, of which 68.2% were related to adults and 54.3% to females. The 68.4% were serious;however, ICSRs mainly led to a completely or partial recovering (25.4%) and 8 cases were fatal (1.7%). The time to onset (TTO) of ADRs was 25 (1-84.75) days while the time to resolution (TTR) was 5 (1.75-15.75) days. Analyzing ADRs by System Organ Classes (SOCs), the most reported were general and administration site conditions (36.4%) followed by injuries (21.6%), infections (21.2%), respiratory (19.1%), skin (16.6%), and nervous system disorders (16.4%). Looking at Preferred Terms (PTs), arthralgia (7.3%), eosinophilia (6.9%), COVID-19 (6.0%), pyrexia (5.8%), asthenia (5.6%), rash (5.4%), and dyspnoea (5.2%) were the most reported. The 7.5% of ICSRs described an aggravated condition with persistent nasal polyps: in 4 cases (0.8%) a nasal polypectomy was required. Considering fatal ICSRs, two cases were related to progression of COVID-19, one to road traffic accident, one to accidental death and the others were not fully specified. Conclusion: These results showed that dupilumab-related ICSRs are not commonly reported in CRSwNP. However, given the good treatment response and the minimal adverse effects observed, clinicians should consider treating CRSwNP with dupilumab. Moreover, additional analyses are necessary to better outline the safety profile of dupilumab in this particular setting.