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1.
Int J Pharm ; 636: 122798, 2023 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-36889417

RESUMO

Chemical and enzymatic in vivo degradation of antimicrobial peptides represents a major challenge for their therapeutic use to treat bacterial infections. In this work, anionic polysaccharides were investigated for their ability to increase the chemical stability and achieve sustained release of such peptides. The investigated formulations comprised a combination of antimicrobial peptides (vancomycin (VAN) and daptomycin (DAP)) and anionic polysaccharides (xanthan gum (XA), hyaluronic acid (HA), propylene glycol alginate (PGA) and alginic acid (ALG)). VAN dissolved in buffer of pH 7.4 and incubated at 37 °C showed first order degradation kinetics with a reaction rate constant kobs of 5.5 × 10-2 day-1 corresponding with a half-life of 13.9 days. However, once VAN was present in a XA, HA or PGA-based hydrogel, kobs decreased to (2.1-2.3) × 10-2 day-1 while kobs was not affected in an alginate hydrogel and a dextran solution (5.4 × 10-2 and 4.4 × 10-2 day-1). Under the same conditions, XA and PGA also effectively decreased kobs for DAP (5.6 × 10-2 day-1), whereas ALG had no effect and HA even increased the degradation rate. These results demonstrate that the investigated polysaccharides (except ALG for both peptides and HA for DAP) slowed down the degradation of VAN and DAP. DSC analysis was used to investigate on polysaccharide ability to bind water molecules. Rheological analysis highlighted that the polysaccharides containing VAN displayed an increase in G' of their formulations, pointing that the peptides interaction act as crosslinker of the polymer chains. The obtained results suggest that the mechanism of stabilization of VAN and DAP against hydrolytic degradation is conferred by electrostatic interactions between the ionizable amine groups of the drugs and the anionic carboxylate groups of the polysaccharides. This, in turn, results in a close proximity of the drugs to the polysaccharide chain, where the water molecules have a lower mobility and, therefore, a lower thermodynamic activity.


Assuntos
Peptídeos Antimicrobianos , Daptomicina , Preparações de Ação Retardada , Vancomicina , Polissacarídeos , Hidrogéis/química
2.
Dalton Trans ; 51(37): 14165-14181, 2022 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-36053151

RESUMO

Hydrazones and their metal derivatives are very important compounds in medicinal chemistry due to their reported variety of biological activities, such as antibacterial, antifungal and anticancer action. Five hydrazone-pyrazolone ligands H2Ln (n = 1-5) were prepared and fully characterized and their tautomerism was investigated in the solid state and solution. Five zinc(II) complexes 1-5 of composition [Zn(HLn)2] (n = 1 and 2), [Zn(HLn)2(H2O)2] (n = 3 and 5) and [Zn(HL4)2]n were synthesized and characterized by elemental analysis, IR, 1H, 19F, 13C, and 15N NMR spectroscopy, and ESI mass spectrometry. In addition, the structures of two ligands and three complexes were determined by single-crystal X-ray diffraction. The ligands H2L2 and H2L4 exist both in the NH,NH tautomeric form. Complexes 1 and 2 are mononuclear compounds, while complex 4 is a one-dimensional coordination compound. Density functional theory (DFT) calculations were carried out on proligands, their anions and all zinc complexes, confirming the experimental results, supporting IR and NMR assignments and giving proofs of the mononuclear diaqua structure of complexes 3 and 5. The antibacterial activity of the free ligands and the Zn(II) complexes was established against Escherichia coli and Staphylococcus aureus, and a strong efficiency has been found for Zn(II) complexes, particularly for the polynuclear 4 and the mononuclear diaqua complex 5, the latter containing a ligand with aliphatic and fluorinated substituents able to compromise the permeability of and disrupt the bacterial cell membrane.


Assuntos
Complexos de Coordenação , Pirazolonas , Antibacterianos/química , Antibacterianos/farmacologia , Antifúngicos/química , Complexos de Coordenação/química , Complexos de Coordenação/farmacologia , Escherichia coli , Hidrazonas/química , Hidrazonas/farmacologia , Ligantes , Testes de Sensibilidade Microbiana , Estrutura Molecular , Pirazolonas/química , Pirazolonas/farmacologia , Zinco/química
3.
Artigo em Inglês | MEDLINE | ID: mdl-35682388

RESUMO

Background: The SARS-CoV-2 pandemic (Severe Acute Respiratory Syndrome Coronavirus 2) and the worldwide health crisis have significantly changed both people's habits and lifestyles. Most of the studies found in the literature were carried out on specific professional categories in the socio-health sector, taking into consideration psychological disorders in relation to work. The purpose of this study was to analyze the psychological impact on a portion of the normal population subjected to lockdown. Methods: A questionnaire was distributed in the period between 23 March 2020 and 18 May 2020 (during Italian lockdown) using an online platform. The scales GAD-7, IES-r, PHQ-9 and MANSA were used to investigate the level of anxiety, the presence of post-traumatic stress disorder, the severity of depression and the perceived quality of life, respectively. Results: Four hundred and eight Italian subjects responded. Females and younger people were more affected by anxiety and depression. Post-traumatic stress disorder affected about 40% of the population sample, significantly young people and women, thus attesting to an important psychopathological response. About one-fifth of the sample population recorded an unsatisfactory quality of life. Conclusions: The results highlight the need to set up preventive interventions (primary and secondary), trying to focus on the most fragile group of subjects from a psychosocial point of view, in order to obtain a significant reduction in psychophysical damage in terms of relapses and outcomes.


Assuntos
COVID-19 , Adolescente , Ansiedade/epidemiologia , Ansiedade/psicologia , COVID-19/epidemiologia , COVID-19/prevenção & controle , Controle de Doenças Transmissíveis , Depressão/epidemiologia , Depressão/psicologia , Feminino , Humanos , Distanciamento Físico , Qualidade de Vida , SARS-CoV-2
4.
Qual Life Res ; 31(3): 733-743, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34258697

RESUMO

PURPOSE: This study aims to evaluate the quality of life (QoL) of chronic myeloid leukemia (CML) patients prescribed with nilotinib as a second-line therapy and explores the influential factors. METHODS: A multicenter retrospective survey was conducted via face-to-face interviews based on the EORTC QLQ-C30 questionnaire. A total of 121 adult CML patients resistant to imatinib and used nilotinib for at least 3 months were enrolled. The influential features were assessed by multiple linear regression models. RESULTS: Patients had the mean age of 47.49 (SD = 13.67) years, dominated by middle-aged and male groups. The mean scores of functions ranged from 75 to 83, and those of symptoms were from 5 to 28, with the highest of fatigue (28.28), insomnia (22.87), and pain (21.07). The mean global health status/QoL score was 67.70 (SD = 16.80) with considerable financial difficulties (52.34 (SD = 32.15)). Male patients reported higher functional scores and fewer symptoms compared with female patients. All aspects of QoL became worse with increasing age. Besides age and gender, level of education, duration of nilotinib usage, and comorbidities were also significantly influential factors in many QoL domains. A predicted model for expected mean scores of QoL domains was built based on these factors. CONCLUSIONS: The CML patients treated with nilotinib had the above-moderate QoL scores, a light decrease of functional scores, great financial difficulties, and still experienced symptoms. Strategies and more therapeutic considerations to enhance QoL for CML patients targeted toward women, the old, low educational level, and long duration of nilotinib usage, and many comorbidities are needed in the setting.


Assuntos
Leucemia Mielogênica Crônica BCR-ABL Positiva , Qualidade de Vida , Adulto , Feminino , Humanos , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Pirimidinas/uso terapêutico , Qualidade de Vida/psicologia , Estudos Retrospectivos
5.
Vaccines (Basel) ; 9(4)2021 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-33916132

RESUMO

Human papillomavirus infection is a cause of the development of invasive cervical cancer. Three types of vaccine are currently available to prevent precancerous/cancerous lesions due to persistent infection, which is supported mainly by 7 different high-risk genotypes. The aim of this pilot study was to acquire preliminary data on type-specific prevalence 10 years after the implementation of the HPV vaccination program in Italy, in order to subsequently plan appropriate observational studies in the Italian population. First-voided urine samples were collected from 393 consenting subjects, both females and males, aged 18-40 years, and HPV DNA was detected by PCR amplification of a 450 bp L1 fragment. All amplified products were genotyped by means of the Restriction Fragment Length Polymorphism (RFLP) method. The female population was divided into three cohorts ("vaccine-eligible", "pre-screening" and "screening" cohorts) according to the preventive intervention scheduled by age; males were included in the same three cohorts according to their year of birth. The overall prevalence of HPV infection was 19%, being higher in females than in males (22.1% vs. 13.6%, p = 0.03729). In the female population, 10 years after the start of the national immunization program, we observed a reduction in the prevalence of vaccine types and the number of circulating genotypes, especially in the "vaccine-eligible" cohort. The frequency of HPV vaccine types increased with age, particularly in males in the "pre-screening" and "screening" cohorts. Our study highlights the importance of monitoring HPV infection in both genders, to validate the effect of the HPV vaccination program.

6.
Artigo em Inglês | MEDLINE | ID: mdl-33806848

RESUMO

The awareness of citizens concerning the health risks caused by environmental pollution is growing, but studies on determinants of pro-environmental behaviors have rarely examined health-related aspects. In this study, we investigated these determinants using data from a large survey among Italian university students (15 Universities: 4778 filled questionnaires). Besides the health-related aspects, represented by environmental health risk perception and functional health literacy, we considered social and demographic characteristics (gender, area of residence, sources of information, trust in institutional and non-institutional subjects, and students' capacity of positive actions, indicated as internal locus of control). The attitudes towards pro-environmental behaviors were positive for more than 70% of students and positively related with health risk perception, internal locus of control, and health literacy. The correspondence between the positive attitudes towards pro-environmental behaviors and the real adoption of such behaviors was approximately 20% for most behaviors, except for the separate collection of waste (60%). Such a discrepancy can be attributable to external obstacles (i.e., lack of time, costs, lack of support). The health-related aspects were linked to the pro-environmental attitudes, but to a lesser extent to pro-environmental behaviors, owing to the complexity of their determinants. However, they should be taken in account in planning education interventions.


Assuntos
Estudantes , Universidades , Atitude , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Itália , Inquéritos e Questionários
7.
Diabetes Res Clin Pract ; 169: 108481, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33002544

RESUMO

BACKGROUND: The recent COVID-19 pandemic has accelerated the treatment process through IT/technological supports, useful in the management of chronic patients such as those affected by type 1 Diabetes Mellitus (T1DM). Specific routes for fragile patients such as those with micro-infusers have been created thanks to the application of "Diabetes Technology," which allows patients to monitor blood glucose quickly and easily. The present pilot study aimed to assess the quality of care provided to patients with micro-infusers in a delicate phase such as a pandemic lockdown. MATERIALS AND METHODS: A mixed-methods approach was used. In the first part, with prior written consent, patients with insulin pumps enrolled voluntarily. In the second part, the focus group discussion (FGD) was carried out with the voluntarily enrolled participants. The FGD data were organized and analyzed by the thematic areas. RESULTS: The number of patients with afferent insulin pumps at the center was 50 individuals. Among them, 20 patients voluntarily joined the first part of the study by completing the PACIC questionnaire, which gave an average result of 3.34 (min. 2.2 and max. 4.2). In the second part, the application of the focus group technique demonstrated that technology is decisive in the management of diabetic pathology, not only in the emergency phase. CONCLUSIONS: At the time of public health crises, alternative strategies such as Tele-Nursing or Telemedicine could be crucial for the management of patients with micro-infuser not only in critical moments, such as lockdown, but also in ordinary health management.


Assuntos
COVID-19/complicações , Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina/estatística & dados numéricos , Insulina/administração & dosagem , SARS-CoV-2/isolamento & purificação , Telemedicina , Adulto , Glicemia/análise , COVID-19/transmissão , COVID-19/virologia , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/virologia , Gerenciamento Clínico , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Masculino , Monitorização Fisiológica , Projetos Piloto , Inquéritos e Questionários
8.
PLoS One ; 15(5): e0233172, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32396568

RESUMO

In 2005, a random sample of 200 people were assessed in Camerino, Italy, eight years after an earthquake. Psychological symptom levels were low and only one person had current Post-Traumatic Stress Disorder (PTSD). In 2016 a new earthquake occurred in Camerino. The study aims to assess the impact of the second exposure in the same cohort. A longitudinal study was conducted, 130 participants were re-interviewed between July and December 2017. Psychological symptoms were self-rated on the Brief Symptom Inventory (BSI) and the Global Severity Index (GSI) was analysed. Post-traumatic stress symptoms were self-rated on the Impact of Event Scale-Revised (IES-R). Subjective quality of life (SQOL) was assessed on the Manchester Short Assessment of Quality of Life (MANSA). Mean scores of GSI and IES-R were significantly higher than in 2005 (p<0.01 and p<0.001), whilst SQOL remained almost unchanged (p = 0.163). In 2017, 16.9% of the sample had reached the PTSD threshold whilst in 2005 only the 0.5% had reached it. Despite low symptom levels several years after an earthquake, people can show psychological distress after a new exposure, whilst average quality of life levels are not affected.


Assuntos
Terremotos , Qualidade de Vida , Transtornos de Estresse Pós-Traumáticos , Inquéritos e Questionários , Adulto , Feminino , Humanos , Itália/epidemiologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/fisiopatologia , Transtornos de Estresse Pós-Traumáticos/psicologia
9.
Acta Biomed ; 91(3-S): 160-164, 2020 04 10.
Artigo em Italiano | MEDLINE | ID: mdl-32275283

RESUMO

Il diabete rappresenta una patologia in costante aumento: familiarità, età e stili di vita rappresentano i principali fattori di rischio per questa malattia e per le complicanze ad essa correlate. Considerando l'importanza del regime alimentare per la prevenzione e il trattamento di questa patologia, scopo del presente studio è stato quello di valutare le conoscenze alimentari di pazienti al primo accesso presso un centro di Diabetologia e di indagare sulla loro eventuale influenza su alcuni parametri ematici. È stato somministrato il questionario di Moynihan. La relazione tra i punteggi ottenuti e le variabili emoglobina glicata, BMI, glicemia a digiuno, è stata analizzata attraverso regressione multipla basata sul metodo dei minimi quadrati ordinari (modello OLS). Il response rate è stato del 73,3%. Il punteggio medio totale ottenuto dal questionario è stato di 23,61 ed è stata osservata una correlazione statisticamente significativa (p<0,0473) tra i migliori punteggi del questionario e i valori di Hb1Ac. Questo studio è il primo passo di un'indagine più ampia che verrà condotta nell'ottica di promuovere una formazione del paziente volta a verificare nel tempo le ricadute positive sulle scelte alimentari e sui parametri clinici.


Assuntos
Diabetes Mellitus , Alimentos , Conhecimentos, Atitudes e Prática em Saúde , Idoso , Feminino , Hospitais Especializados , Humanos , Masculino , Pessoa de Meia-Idade
10.
Materials (Basel) ; 13(3)2020 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-31978989

RESUMO

The acylpyrazolone proligands HQR (HQR in general, in detail: HQCy = 1-phenyl-3-methyl-4-carbonylcyclohexyl-5-pyrazolone, 4-C(O)-phenyl, HQPh = 1-phenyl-3-methyl-4-benzoyl-5-pyrazolone, HQC17 = 1-phenyl-3-methyl-4-stearoyl-5-pyrazolone, HQC17,Ph = 1-phenyl-3-stearyl-4-benzoyl-5-pyrazolone) were synthesized and reacted with (arene)Ru(II) acceptors affording complexes [(arene)Ru(QR)Cl] (arene = cymene (cym) or hexamethylbenzene (hmb)). The complexes were characterized by elemental analyses, thermogravimetric analysis-Differntial Thermal Analysis (TGA-DTA), IR spectroscopy, ESI-MS and 1H, and 13C NMR spectroscopy. Complexes [(arene)Ru(QR)Cl] where QR = QC17 and QC17,Ph, due to the long aliphatic chain in the ligand, afford nanometric dispersions in methanol via self-assembly into micellar aggregates of dimensions 50-200 nm. The antibacterial activity of the complexes was established against Escherichia coli and Staphylococcus aureus, those containing the ligands with a long aliphatic chain being the most effective. The complexes were immobilized on polystyrene by a simple procedure, and the resulting composite materials showed to be very effective against E. coli and S. aureus.

11.
Acta Biomed ; 90(3): 370-377, 2019 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-31580329

RESUMO

BACKGROUND: Public health systems today face the dual challenges of controlling infections and curbing the increase in antimicrobial resistance manifested in drug-resistant microorganisms in hospitals and elsewhere. In the last ten years, research has been conducted to develop new materials with antimicrobial properties to be used in medical devices, increasingly found to harbour critical nosocomial infections. METHODS: Two next-generation composites using the antimicrobial qualities of silver were tested against Escherichia coli, Staphylococcus aureus and Candida albicans with the purpose of evaluating their antimicrobial and antifungal activity. These tests applied the standardized method according to ISO-2216: Plastics-Measurement of Antibacterial Activity on Plastics Surfaces. Testing was carried out using polyethylene (PE) enriched with AgNO3 as a positive control and PE as a negative control. RESULTS: The antimicrobial activity of the composites proved to be between medium (bacteriostatic) and very good (bactericidal). In particular, PE2 showed the highest scores against all microorganisms, with values ranging from good to very good. Instead, PE1 had lower scores, with a value of medium for Escherichia coli and slight for Candida albicans. Statistical analysis carried out with the t-test for unpaired data showed a statistically significant difference between the positive control and the other polymers (p< .0001). CONCLUSIONS: Based on our findings, we conclude that the test, conducted to ISO-2216 standards, could be extended to include fungal strains and that the new composites could be used to produce antimicrobial surfaces for medical devices, for example, intubation tubes, urinary catheters, vascular prostheses, and mechanical heart valves. This would reduce the risk of microbial contamination and biofilm formation, ensuring better health outcomes for patients treated with these devices. Further testing should be done to evaluate potential future applications of these composites and the possibility of adding fungal strains to the IS0-2216 standard.


Assuntos
Anti-Infecciosos/farmacologia , Plásticos/farmacologia , Pirazolonas/farmacologia , Prata/farmacologia , Testes de Sensibilidade Microbiana , Polietileno/farmacologia
12.
Acta Biomed ; 90(3): 378-384, 2019 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-31580330

RESUMO

Malaria is a potentially deadly parasitosis. Due to its geographical distribution, seafarers are particularly exposed to it. This study is an epidemiological analysis on the morbidity of malaria onboard commercial ships without a physician, with the purpose of proposing solutions aimed at limiting further infections in this delicate and difficult working environment. METHODS: We examined 17,212 health records of patients embarked on ships assisted by the CIRM from 2011 to 2015. All the diagnosed diseases have been categorized based on the ICD-10 classification system by the WHO. This study analyzed the cases of suspected malaria and the cases of malaria confirmed by clinical tests. The geographical distribution of infections and the drugs chosen by physicians are also assessed. RESULTS: Although a reduction in malaria cases was appreciated during the 5-year period taken into consideration, this disease still covers an important percentage of all infectious diseases that occurred onboard. This proves that it is a major health problem for seafarers. CONCLUSIONS: In order to protect seafarers' population, strengthen malaria prevention and control programs, as well to improve the availability of antimalarial drugs onboard ships is necessary. This may ensure rapid and efficient health interventions in case of need.


Assuntos
Malária/epidemiologia , Humanos , Incidência , Malária/etiologia , Malária/prevenção & controle , Navios
13.
Sci Total Environ ; 691: 1162-1172, 2019 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-31466198

RESUMO

Among the determinants of environmental health risk perception, health literacy and social media messages have been generally neglected. This study details the environmental health risk perception and its determinants in Italian university students, including a measure of functional health literacy and an analysis of newspapers and social media. A cross sectional survey was carried out among students from 15 Italian universities and different disciplines (grouped into Scientific-Health and Humanistic-Legal-Social sectors) using a self-administered anonymous questionnaire, divided into six sections: socio-demographic characteristics, information on health and environment, environmental health risk perception, trust, attitudes and behaviors and functional health literacy. Local newspapers and tweets in the same areas and period were analyzed in relation to quantity and topics. The study population included 4778 students (65.1% female) aged 21 ±â€¯4.3 years, and functional health literacy was low (below the cutoff value) for 44.4% of students. A new outcome of the survey is that the detected association between high functional health literacy a higher global health risk perception and trust in institutions both as sources of information and as actors for protection against environmental risks. The internet and social networks were the most frequently consulted sources of information (77.7%), which was predictive of a higher risk perception. The possible relation between environmental health risk perception and tweet communication was highlighted by a comparison between the risk perception in the city with the highest number of tweets (Modena) and another one similar for socio-demographic characteristics (Pisa). In conclusion, the results of our study may be of help to strengthen information and education programs: functional health literacy should be taken into account in school programs, to produce a basic knowledge for a better understanding of health and environment. Moreover, mass and social media should be included in planning communication intervention and in verifying their results.


Assuntos
Meio Ambiente , Conhecimentos, Atitudes e Prática em Saúde , Adolescente , Adulto , Estudos Transversais , Feminino , Humanos , Itália , Masculino , Risco , Instituições Acadêmicas , Estudantes , Inquéritos e Questionários , Universidades , Adulto Jovem
14.
Eur J Pharm Biopharm ; 142: 322-333, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31295503

RESUMO

The purpose of this work was the development of antibacterial delivery systems for vancomycin, with potential application in the prevention or treatment of orthopedic implant infections. Previous studies have shown tandem thermal gelling and Michael addition cross-linking of hydrogels based on methacrylate, acrylate or vinylsulfone triblock copolymers of PEG-p(HPMAm-lac1-2) and thiolated hyaluronic acid. In this work we exploited these α-ß unsaturated derivatives of PEG-p(HPMAm-lac1-2) triblock copolymers and used them in combination with thiolated hyaluronic acid as controlled delivery systems for vancomycin. It was found that the antibiotic was sustainably released from the hydrogel networks for at least 5 days with release kinetics depending on diffusion and dissociation of the positively charged vancomycin from the negatively charged hyaluronic acid. The release of vancomycin could be tailored mainly by HA-SH solid content and degree of thiolation. The developed hydrogels were demonstrate efficacious in preserving the structural and functional integrity of the encapsulated drug by physical immobilization within the gel network and ionic interaction with hyaluronic acid, thereby preventing vancomycin deamidation processes. Furthermore, the antimicrobial activity of vancomycin loaded hydrogels was assessed, demonstrating retention of inhibitory activity towards Staphylococcus aureus during formulation and release, with slightly increased activity of vancomycin encapsulated in hydrogels of higher HA-SH content as compared to controls.


Assuntos
Preparações de Ação Retardada/química , Preparações de Ação Retardada/farmacologia , Hidrogéis/química , Infecções Relacionadas à Prótese/tratamento farmacológico , Vancomicina/química , Vancomicina/farmacologia , Acrilatos/química , Antibacterianos/química , Antibacterianos/farmacologia , Ácido Hialurônico/química , Metacrilatos/química , Ortopedia/métodos , Polietilenoglicóis/química , Polímeros/química , Próteses e Implantes/microbiologia , Infecções Relacionadas à Prótese/microbiologia , Infecções Estafilocócicas/tratamento farmacológico , Infecções Estafilocócicas/microbiologia , Staphylococcus aureus/efeitos dos fármacos
15.
Acta Biomed ; 90(2): 288-299, 2019 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-31125009

RESUMO

BACKGROUND: To date there exist no internationally recognised Good Manufacturing Practices (GMP) that clearly outline universally accepted standards for manufacturing highly active or sensitising ingredients. The pharmaceutical industry is faced with a twofold problem: determining which drugs need dedicated production areas and identifying the different regulations required in different countries. The aim of this paper is to find, by comparing the current regulations of the various Regulatory Agencies, the differences between containment requirements for the production of highly active or sensitising ingredients. METHODS: An analysis of the following Regulatory Agencies' GMPs was performed: Europe (EMA), China (CFDA), Mexico (COFEPRIS), United States (FDA), Canada (Health Canada) Brazil (ANVISA), India (CDSCO), PIC/S and WHO in order to examine the differences in terms of  containment requirements set by the different Regulatory Authorities for the manufacture of highly active or sensitising ingredients. RESULTS: Our analysis found that the majority of Regulatory Agencies require that beta-lactams (sensitising materials) be produced in dedicated and segregated facilities. For "certain" highly active pharmaceutical ingredients (APIs), COFEPRIS, FDA, HC, EMA, PIC/S and WHO require that they be produced in facilities similar to those required for beta-lactams, while CDSCO, CFDA and ANVISA require that production takes place in segregated areas. Further differences between the Agencies  have emerged regarding classes of highly APIs that require dedicated production. CONCLUSION: A study of GMP adopted by Regulatory Agencies has uncovered significant differences, in particular concerning containment requirements for the production of APIs. For this reason, the harmonisation of GMP following  up-to-date quality standards based on cutting-edge science which are globally applicable is fundamental and will benefit companies and patients alike. Pharmaceutical companies would not be obliged to follow requirements enforced by the State in which they intend to manufacture a product, and patients would benefit from high-quality drugs regardless of their place of production.


Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Medicamentos Genéricos/farmacologia , Órgãos Governamentais/normas , Preparações Farmacêuticas/normas , Controle de Qualidade , Gestão da Segurança , Aprovação de Drogas , Medicamentos Genéricos/efeitos adversos , Europa (Continente) , Órgãos Governamentais/legislação & jurisprudência , Humanos , Internacionalidade , Preparações Farmacêuticas/administração & dosagem , Estados Unidos , Organização Mundial da Saúde
16.
Int Marit Health ; 70(1): 68-75, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30931521

RESUMO

BACKGROUND: Microbiological monitoring of surfaces used for food preparation, as required by the Hazard Analysis and Critical Control Points (HACCP) plan, is important in risky conditions as those observed in the kitchens of ships. Limits to introduce a classification of risk levels and methods to adopt in conditions as those occurring in tankers have not been investigated. This paper presents the results of the "Healthy Ship" project on HACCP monitoring of surfaces used in food preparation on Italian flag tankers. MATERIALS AND METHODS: Microbiological monitoring was carried out on 19 tankers between 2013 and 2017. Food handlers were also trained on board ship according to HACCP standards. Contact plates (ISO 18593:2004 compliant) were used to determine the colonies and bacterial charge according to the Wirtanen and Salo's method. RESULTS: A total of 1074 samples, 108 before the first course, 168 after the first course, 390 during the period of refresher (2015-2016), and 408 after the refresher training, were obtained from the three main kitchen surfaces: the worktop, cutting board, and kitchen sink. A good level of hygiene was observed in 56.9% of all samples, 0.1% were classified as adequate, and the remaining 43% as poor. The highest contamination was observed on the cutting board and kitchen sink and involved the total aerobic count. The only surface with inadequate levels of hygiene was the worktop. A reduction of contaminated samples was noted after training. CONCLUSIONS: Our results suggest that continuous training should be provided for personnel responsible for handling foodstuffs on board ships.


Assuntos
Manipulação de Alimentos/métodos , Microbiologia de Alimentos/estatística & dados numéricos , Inocuidade dos Alimentos , Navios , Carga Bacteriana/estatística & dados numéricos , Humanos , Higiene/educação , Itália , Medicina Naval/métodos
17.
Altern Ther Health Med ; 25(2): 22-38, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30990791

RESUMO

Insulin resistance (IR) is defined as the inability of a known quantity of exogenous or endogenous insulin to increase glucose uptake and utilization. Several mechanisms have been proposed as possible causes underlying the development of IR and the IR syndrome. IR occurs as part of a cluster of cardiovascular-metabolic abnormalities commonly referred to as "The Metabolic Syndrome." This may lead to the development of type 2 diabetes, accelerated atherosclerosis, hypertension, dysmenorrhea, hirsutism, and polycystic ovarian syndrome, depending on the genetic background of the individual developing IR. The aim of this study was to assess, in 123 female and 35 male (mean age, 42 y ± 10.3; range 19-75 y) volunteers) whether IR could be partly related to a dietary sugar intolerance and whether there could be a correlation between the ALCAT intolerance test and a mutation of the TCFTL2 gene (it promotes the trascription of the proglucagone and plays a key role in the development of the Langherans islands). Results evidenced that subjects with an intolerance to sugar, also showed a statistically significant complete or incomplete alteration of the TCFTL2 genetic test. Based upon these findings, our study demonstrated that there is a clinical correlation between the ALCAT food intolerance test and the IR. The positivity to the ALCAT test of one of the sugars tested (fructose, sugar cane, and sugar beet) indicates, in the majority of the subjects, the presence of a mutation of the gene TCF7L2 and could contribute to the prevention and treatment of the IR.


Assuntos
Diabetes Mellitus Tipo 2 , Açúcares da Dieta , Intolerância Alimentar , Resistência à Insulina , Adulto , Idoso , Feminino , Teste de Tolerância a Glucose , Humanos , Insulina/sangue , Masculino , Síndrome Metabólica , Pessoa de Meia-Idade
18.
Eur J Health Econ ; 20(5): 763-777, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30840166

RESUMO

OBJECTIVE: To review and assess the quality of the available evidence on the cost-effectiveness of erlotinib in the first-line treatment of advanced non-small cell lung cancer (NSCLC). METHODS: A systematic review was conducted to identify full-text original economic evaluations of erlotinib in the first-line treatment of advanced NSCLC written in English and published from the year 2000 onwards. Study characteristics and results were recorded and compared. The quality of the studies was assessed by the Quality of Health Economic Studies (QHES) questionnaire. RESULTS: Eleven out of 130 papers were chosen for this review. Comparative regimens consisted of a best supportive care, reverse strategy, bevacizumab, cisplatin plus pemetrexed, carboplatin plus gemcitabine or gefitinib. The methods most used in these studies were modeling and sensitivity analysis and cost-effectiveness analysis. All of the studies evaluated direct costs and used quality-adjusted life-year (QALY) and life-years gained (LYG) as outcome, with 3% and 3.5% discount rate. The studies assigned ICER that ranged from dominant to I$305,510.31/QALY and from I$31,209.55/LYG to I$66,540.20/LYG. Based on the willingness to pay threshold, seven studies concluded that erlotinib was cost-effective, two studies showed that erlotinib was cost-effective on specific patients with certain conditions, and two studies comparing erlotinib with reverse strategy did not find a difference in cost-effectiveness. The high quality of these studies was confirmed using the QHES tool: the mean score was 75.77 out of 100 (SD 9.38). CONCLUSION: Most of these high-quality studies suggested that erlotinib was cost-effective in the first-line treatment of advanced NSCLC.


Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Farmacoeconomia , Cloridrato de Erlotinib/economia , Cloridrato de Erlotinib/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Humanos
19.
Acta Biomed ; 90(1): 83-91, 2019 01 23.
Artigo em Inglês | MEDLINE | ID: mdl-30889159

RESUMO

BACKGROUND AND AIM: In recent years, self-medication is an increasing public health issue, also among the European young people. Only 48% of people throughout the world use prescribed medications, while the remainder admits that they self-medicate with over the counter drugs or leftover prescribed drugs. Also, the risk of antibiotic resistance, throughout the world, has doubled, due to the recourse to these drugs when they are not called for, or to failure to follow their instructions for use. METHODS: A five-part questionnaire, translated into the national languages and validated, was given to Pharmacy students in Italy, Spain, the Czech Republic and Romania obtain anonymous information about their pharmaceutical drugs use. RESULTS: Regarding the use of pharmaceutical drugs, students in Spain and Romania indicated the highest percentages of use. In Italy and Romania, the pharmacist is rarely consulted, while the advice of family members or friends is more frequently requested. In all four countries the problem of taking antibiotics without a medical prescription is significant, and 50% of Romanian students use antibiotics to treat the flu. Another important result is that, in Spain, 38.4% of the respondents admitted to using medicines with alcohol. CONCLUSIONS: Considering that the drug information leaflet is not read by 50% of young people interviewed, it would be important for public health entities to instruct the population, especially younger age groups such as secondary school students, about the importance of reading this information carefully. The use of mass media in such a preventive medicine campaign could be effective.


Assuntos
Automedicação , Estudantes de Farmácia , Adulto , Europa (Continente) , Feminino , Humanos , Masculino , Saúde Pública , Inquéritos e Questionários , Universidades
20.
Front Public Health ; 7: 378, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31921743

RESUMO

This paper outlines the characteristics of scientific leadership and the role of Scientific Associations with their specific activities. The recent activities of the Lombard Academy of Public Health are subsequently described, including the creation, in 2019, of the Academy of young leaders in public health. Comparing to other sectors, scientific leadership dynamics take into consideration different aspects. Besides awards (Nobel Prize or several other) and prestigious affiliations, eventual indicators might be academic roles, fundraising abilities, relevant positions among scientific associations, editors of prestigious journals or editorial series and, more recently, high bibliometric indicators. The peculiar topics of public health encompass interactions with institutions, authorities, politicians, involved in different levels in health policies. Recently, in Italy, the Ministry of Health has identified parameters to be accreditated as a scientific and technical association. The role of SItI (Italian Society of Hygiene), EUPHA, ASPHER, and WFPHA appears relevant in PH, in national and international contexts, with Italian praiseworthy members constantly achieving leading roles. Considering that few training opportunities aimed to improve research and leadership skills are available, Accademia Lombarda di Sanità Pubblica (ALSP) designed the AYLPH (Academy of Young Leaders in Public Health) program. AYLPH program is a 1-year training to shape leadership skills among young professionals. A set of didactic, theoretical and practical methods was offered and evaluated.

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