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OBJECTIVES: In comparison to conventional combustible cigarettes, Electronic Nicotine Delivery Systems (ENDS) including both e-cigarettes (ECs) and heated tobacco products (HTPs) significantly reduce exposure to toxic chemical emissions. However, their impact on dental plaque remains unclear. This study measures dental plaque in ENDS (ECs and HTPs) users using quantitative light-induced fluorescence (QLF) technology, comparing them with current, former, and never smokers. METHODS: This cross-sectional study compared dental plaque measurements using QLF technology (Q-ray cam™ Pro) among current smokers (≥10 cigarettes/day), former smokers (quit ≥6 months), never smokers, and exclusive ENDS users (quit ≥6 months). Dental plaque measurements were expressed as ΔR30 (total area of mature dental plaque) and ΔR120 (greater plaque thickness/maturation-calculus). The Simple Oral Hygiene (SOH) score was calculated by the QLF proprietary software. Statistical analyses including ANCOVA was performed by R version (4.2.3) with p < 0.05. RESULTS: A total 30 smokers, 24 former smokers, 29 never smokers, and 53 ENDS users were included. Current smokers had significantly higher ΔR30 and ΔR120 values compared to other groups (p < 0.001). ENDS users showed plaque levels similar to never and former smokers (p > 0.05) but significantly lower than current smokers (p < 0.01). Although ENDS users showed a lower SOH score than smokers, this difference was not statistically significant. Daily toothbrushing and mouthwash usage were significant covariates. CONCLUSION: ENDS users exhibited reduced accumulation of dental plaque and calculus compared with current smokers. CLINICAL SIGNIFICANCE: Exclusive ENDS use could less impact dental plaque accumulation compared to cigarette smoking. Further research is needed to confirm these findings and fully understand ENDS impact on dental plaque formation.
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Placa Dentária , Sistemas Eletrônicos de Liberação de Nicotina , Humanos , Estudos Transversais , Feminino , Adulto , Masculino , Fluorescência , Pessoa de Meia-Idade , Fumantes , Luz , Higiene Bucal , Nicotina/administração & dosagem , Fumar , Índice de Placa Dentária , Adulto Jovem , Produtos do Tabaco/efeitos adversosRESUMO
Objectives: Abstaining from tobacco smoking may not only improve general health, but also reduce teeth staining and restore teeth whiteness. Compared with conventional cigarettes, E-cigarettes (ECs) and heated tobacco products (HTPs) may offer substantial reduction in exposure to pigmented tar-like compounds of cigarette smoke. It is possible that improvements in dental color indices may be observed in those who have stopped smoking combustible cigarettes by switching to tar-free nicotine delivery products. Methods: This cross-sectional study evaluated and compared dental color parameters by digital spectrophotometry among five different groups: individuals who currently smoke ; individuals who used to smoke but have quit ; individuals who have never smoked ; exclusive users of electronic cigarettes (former smokers) ; and exclusive users of heated tobacco products (former smokers) . Results: Dental whiteness in current cigarette smokers was notably worse compared with never and former smokers, (13.38 Whiteness Index for Dentistry (WID) units vs. 19.96 and 16.79 WID units). Remarkably high WID values (i.e., whiter teeth) were also observed in ECs (16.72 WID units) and HTPs users (17.82 WID units). Compared to current smokers, difference in dental whiteness for ECs and HTPs users was visually noticeable (ΔWID difference being on average > 2.90 units). The colour differences measured as delta E*(ΔE*) were all visually detectable except for the comparison between ex-smokers and ECs users for which no perceptible color difference was observed (0.415). Conclusion: Exclusive use of ECs and HTPs is associated with better dental color measurements than current smoking, suggesting that tar-free nicotine delivery technologies are unlikely to have negative effects on dental appearance. Clinical significance: Use of alternative nicotine delivery systems may be associated with cosmetic benefits with important implications for those smokers perceiving dental aesthetics as a significant problem. For these an oral-based narrative may be a much more significant reason to refrain from smoking than the fear of developing smoking-related diseases in future.
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We provide an extensive review of 17 independent and industry-funded studies targeting carbonyls in aerosol emissions of Heated Tobacco Products (HTPs), focusing on quality criteria based on the reproducibility of experiments, appropriate analytic methods, and puffing regimes. Most revised studies complied with these requirements, but some were unreproducible, while others failed to consider analytical variables that may have affected the results and/or produced unrealistic comparisons. We also provide a review of the literature on the physicochemical properties of heated tobacco and HTP aerosols, as well as the evaluation of HTPs by regulatory agencies, addressing various critiques of their relative safety profile. The outcomes from the revised studies and regulatory evaluations tend to agree with and converge to a general consensus that HTP aerosols expose users to significantly lower levels of toxicity than tobacco smoke.
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Concerns have recently increased that the integrity of some scientific research is questionable due to the inability to reproduce the claimed results of some experiments and thereby confirm that the original researcher's conclusions were justified. This phenomenon has been described as 'reproducibility crisis' and affects various fields from medicine to basic applied sciences. In this context, the REPLICA project aims to replicate previously conducted in vitro studies on the toxicity of cigarette smoke and e-cigarette aerosol, sometimes adding experiments or conditions where necessary, in order to verify the robustness and replicability of the data. In this work the REPLICA Team replicated biological and toxicological assessment published by Rudd and colleagues in 2020. As in the original paper, we performed Neutral Red Uptake (NRU) assay for the evaluation of cytotoxicity, Ames test for the evaluation of mutagenesis and In Vitro Micronuclei (IVMN) assay for the evaluation of genotoxicity on cells treated with cigarette smoke or e-cigarette aerosol. The results showed high cytotoxicity, mutagenicity and genotoxicity induced by cigarette smoke, but slight or no cytotoxic, mutagenic and genotoxic effects induced by the e-cigarette aerosol. Although the two studies presented some methodological differences, the findings supported those previously presented by Rudd and colleagues.
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Fumar Cigarros , Sistemas Eletrônicos de Liberação de Nicotina , Mutagênicos/toxicidade , Reprodutibilidade dos Testes , Nicotiana , Mutagênese , Dano ao DNA , Aerossóis , Testes de Mutagenicidade/métodosRESUMO
BACKGROUND: The effects of smoking on the accumulation of dental plaque have not been studied in depth. We compared dental plaque quantitation obtained with a novel light induced fluorescence technology among current, former, and never smokers and verified measurements' repeatability. METHODS: Dental plaque quantitation was objectively assessed by quantitative light induced fluorescence (QLF) technology on three separate study visits in current, former, and never smokers: baseline (day 0), day 7, day 30. Increase in the fluorescence intensity of at least 30% (ΔR30) and 120% (ΔR120) together with the simple oral hygiene (SOH) scoring were considered for analysis. RESULTS: The QLF parameters were highly repeatable in each study group (p < 0.0001, by regression analyses). All QLF parameters showed a significant difference between never smokers and current smokers (p = 0.041 for ΔR30; p = 0.027 for ΔR120; p = 0.04 for SOH). No significant differences were observed between never and former smokers and between current and former smokers except for ΔR120 (p = 0.033). CONCLUSION: Dental plaque measurements by QLF technology were highly reproducible and showed greater plaque formation among current smokers compared to non-smokers. Objective and reproducible quantitation of dental plaque can be a valuable clinical and regulatory science endpoint to investigate the effect of smoking cessation medications, combustion-free tobacco products, and consumer care products on oral health. CLINICAL RELEVANCE: There is a need to objectively evaluate the relationship between smoking and plaque build-up as well as maturation. Current smokers demonstrated greater and more mature plaque buildup when compared to never and former smokers. Differences in plaque build-up and maturation between current, former and non-smokers may be utilized as an effective tool for patient motivation, identifying therapeutic end-points, translational research as well as prognostication. TRIAL REGISTRATION: The study is a pilot study parts of a larger project with registration ID: NCT04649645. As preliminary study, the pilot study referred into this paper started before the larger study registered in ClinicalTrials.gov.
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Placa Dentária , Abandono do Hábito de Fumar , Humanos , Higiene Bucal , Projetos Piloto , Fumar/efeitos adversosRESUMO
BACKGROUND: People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness. OBJECTIVE: We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit. METHODS: We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide-confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence. RESULTS: A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (P=.20). The CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively, and the between-group difference was not significant (P=.24). At week 12, the 7-day point prevalence of smoking abstinence values for IQOS-HTP and JustFog-EC were 54.5% (60/110) and 41.1% (44/107), respectively. The most frequent adverse events were cough and reduced physical fitness. Both study products elicited a moderately pleasant user experience, and the between-group difference was not significant. A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation. Risk perception for conventional cigarettes was consistently higher than that for the combustion-free study products under investigation. CONCLUSIONS: Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support. TRIAL REGISTRATION: ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748.
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Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar , Produtos do Tabaco , Humanos , Nicotina , Abandono do Hábito de Fumar/métodos , Abandono do Hábito de Fumar/psicologia , Comportamentos Relacionados com a SaúdeRESUMO
Cigarette smoke is associated to severe chronic diseases. The most harmful components of cigarette smoke derive from the combustion process, which are significantly reduced in the electronic cigarette aerosol, thus providing a valid option in harm reduction strategies. To develop safer products, it is therefore necessary to screen electronic cigarette liquids (e-liquids) to meet high safety standards defined by government regulations. The aim of the present study was to evaluate the presence of metal- and plastic-derived contaminants in four different commercial e-liquids with high concentration of nicotine and their cytotoxic effect in normal human bronchial epithelial cells by a number of in vitro assays, in comparison with the 1R6F reference cigarette, using an air-liquid interface (ALI) exposure system. Moreover, we evaluated the effect of aerosol exposure on oxidative stress by measuring the production of reactive oxygen species and mitochondrial potential. Our results showed no contaminants in all e-liquids and a significantly reduced cytotoxic effect of e-liquid aerosol compared to cigarette smoke as well as a maintained mitochondria integrity. Moreover, no production of reactive oxygen species was detected with e-cigarette aerosol. In conclusion, these results support the reduced toxicity potential of e-cigs compared to tobacco cigarettes in an in vitro model resembling real life smoke exposure.
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Sistemas Eletrônicos de Liberação de Nicotina , Produtos do Tabaco , Humanos , Espécies Reativas de Oxigênio , Nicotiana , Aerossóis/toxicidade , Células EpiteliaisRESUMO
Cigarette smoking is associated with impairment of repair mechanisms necessary for vascular endothelium homeostasis. Reducing the exposure to smoke toxicants may result in the mitigation of the harmful effect on the endothelium and cardiovascular disease development. Previous investigations evaluated in vitro the effect of electronic cigarette (EC) compared with cigarette smoke demonstrating a significant reduction in human umbilical vein endothelial cells (HUVECs) migration inhibition following EC aerosol exposure. In the present study, we replicated one of these studies, evaluating the effects of cigarette smoke on endothelial cell migration compared with aerosol from EC and heated tobacco products (HTPs). We performed an in vitro scratch wound assay on endothelial cells with a multi-center approach (ring-study) to verify the robustness and reliability of the results obtained in the replicated study, also testing the effect of aerosol from two HTPs on endothelial cells. Consistently with the original study, we observed a substantial reduction of the effects of aerosol from EC and HTPs on endothelial cell migration compared with cigarette smoke. While cigarette smoke reduced endothelial wound healing ability already at low concentrations (12.5%) and in a concentration-dependent manner, EC and HTPs aerosol showed no effect on endothelial cells until 80%-100% concentrations. In conclusion, our study further confirms the importance of EC and tobacco heated products as a possible harm reduction strategy for cardiovascular diseases development in smokers.
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Fumar Cigarros , Sistemas Eletrônicos de Liberação de Nicotina , Humanos , Nicotiana , Nicotina , Reprodutibilidade dos Testes , Aerossóis/farmacologia , Células Endoteliais da Veia Umbilical HumanaRESUMO
Cells constantly produce oxidizing species because of their metabolic activity, which is counteracted by the continuous production of antioxidant species to maintain the homeostasis of the redox balance. A deviation from the metabolic steady state leads to a condition of oxidative stress. The source of oxidative species can be endogenous or exogenous. A major exogenous source of these species is tobacco smoking. Oxidative damage can be induced in cells by chemical species contained in smoke through the generation of pro-inflammatory compounds and the modulation of intracellular pro-inflammatory pathways, resulting in a pathological condition. Cessation of smoking reduces the morbidity and mortality associated with cigarette use. Next-generation products (NGPs), as alternatives to combustible cigarettes, such as electronic cigarettes (e-cig) and tobacco heating products (THPs), have been proposed as a harm reduction strategy to reduce the deleterious impacts of cigarette smoking. In this review, we examine the impact of tobacco smoke and MRPs on oxidative stress in different pathologies, including respiratory and cardiovascular diseases and tumors. The impact of tobacco cigarette smoke on oxidative stress signaling in human health is well established, whereas the safety profile of MRPs seems to be higher than tobacco cigarettes, but further, well-conceived, studies are needed to better understand the oxidative effects of these products with long-term exposure.
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Cigarette smoking contributes to poor oral health and dental discoloration. Therefore, stopping smoking may translate into measurable amelioration of dental shade indices. We compared dental shade parameters by digital spectrophotometry among current, former, and never smokers and verified their repeatability at 7 and 30 days. Dental shade parameters (CIE L*a*b* and corresponding whiteness index for dentistry-WID) were measured in current, former, and never smokers with a digital spectrophotometer (Vita Easyshade V) on three separate study visits: at baseline (day 0), at day 7, and day 30. Dental shade parameters were analyzed in 18 current, 18 former, and 20 never smokers. The repeatability of shade parameters was consistent in current, former, and never smokers. L*, a*, b*, and WID show significant short and long-term repeatability (p < 0.0001, by regression analyses). The mean (± SD) WID score of 13.42 (± 4.9) in current smokers was significantly lower compared to the WID score of 20.38 (± 5.3) in never smokers (p = 0.001). No significant differences were observed between current and former smokers and between former smokers and former smokers. Dental shade measurements by digital spectrophotometry were highly reproducible and showed that teeth whiteness of current smokers is substantially inferior compared to never smokers. Objective discrimination of dental shade can be a valuable regulatory science endpoint for investigating oral hygiene and dental aesthetics of consumer care products, smoking cessation medications, and tar-free tobacco products (e-cigarettes, heated tobacco products, oral nicotine products) for cigarette substitution.Clinical trial registration: the study was not registered in ClinicalTrials.gov considering that it is a pilot study, parts of a larger project with ID: NCT04649645.
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Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar , Humanos , Projetos Piloto , Fumantes , EspectrofotometriaRESUMO
Electronic nicotine delivery systems (ENDS) may reduce health risks associated with chronic exposure to smoke and their potential benefits have been the matter of intense scientific debate. We aimed to replicate three published studies on cytotoxic and inflammatory effects of cigarette smoke and ENDS aerosol in an independent multi-center ring study. We aimed to establish the reliability of results and the robustness of conclusions by replicating the authors' experimental protocols and further validating them with different techniques. Human bronchial epithelial cells (NCI-H292) were exposed to cigarette whole smoke and vapor phase and to aerosol from ENDS. We also assessed the inflammatory cytokines interleukin-6 and interleukin-8 and the remodeling mediator matrix metalloproteinase-1. We replicated cell viability results and confirmed that almost 80% of cytotoxic effects are due to volatile compounds in the vapor phase of smoke. Our findings substantiated the reduced cytotoxic effects of ENDS aerosol. However, our data on inflammatory and remodeling activity triggered by smoke differed significantly from those in the original reports. Taken together, independent data from multiple laboratories clearly demonstrated the reduced toxicity of ENDS products compared to cigarettes.
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Nicotiana/efeitos adversos , Nicotina/efeitos adversos , Fumaça/efeitos adversos , Produtos do Tabaco/efeitos adversos , Aerossóis/efeitos adversos , Aerossóis/química , Brônquios/citologia , Sobrevivência Celular/efeitos dos fármacos , Citocinas/metabolismo , Sistemas Eletrônicos de Liberação de Nicotina , Células Epiteliais , Humanos , Concentração Inibidora 50 , Compostos Orgânicos Voláteis/efeitos adversosRESUMO
Electronic Nicotine Delivery Systems (ENDS), i.e., electronic-cigarettes (e-cigs) and Tobacco Heating Products (THPs), are rapidly growing in popularity. Nonetheless, comprehensive quality and safety requirements for regulatory purposes are still under development. Cytotoxicity studies are important initial steps in appraising the potential ENDS toxicity. The aim of the present study was to screen different in vitro cytotoxicity methods for the assessment of ENDS toxicity. We evaluated NRU, MTT, Annexin V apoptosis (AN-V), High-Content Screening (HCS) assays and Real-Time Cell Analysis (RTCA), to compare two e-cigs and two THPs with the 1R6F reference tobacco cigarette. Human adenocarcinoma lung epithelial cells (H292) were exposed to tobacco smoke and ENDS vapor at air-liquid interface. All tests showed reduced cell viability following 1R6F smoke exposure and slight or no reduction with ENDS at 24 h. AN-V and RTCA exhibited a further significant reduction in cell viability following 1R6F exposure. AN-V allowed to discriminate viable cells from those in early/late apoptosis. RTCA and HCS being time-resolved analyses elucidate the kinetic dependency parameter for toxicity of smoke/vapor chemicals on cell viability. In conclusion, NRU assay may be considered a suitable test, especially when combined with a time-resolved analysis, for assessing the kinetic of cytotoxicity induced by these products.
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Sobrevivência Celular/efeitos dos fármacos , Sistemas Eletrônicos de Liberação de Nicotina , Produtos do Tabaco/análise , Produtos do Tabaco/toxicidade , Linhagem Celular , Células Epiteliais/efeitos dos fármacos , HumanosRESUMO
Prevalence studies of current smoking, among hospitalized COVID-19 patients, demonstrated an unexpectedly low prevalence among patients with COVID-19. The aim of the present study was to evaluate the effect of smoke from cigarettes on ACE-2 in bronchial epithelial cells. Normal bronchial epithelial cells (H292) were exposed to smoke by an air-liquid-interface (ALI) system and ACE-2 membrane protein expression was evaluated after 24 h from exposure. Our transcriptomics data analysis showed a significant selective reduction of membrane ACE-2 expression (about 25%) following smoking exposure. Interestingly, we observed a positive direct correlation between ACE-2 reduction and nicotine delivery. Furthermore, by stratifying GSE52237 as a function of ACE-2 gene expression levels, we highlighted 1,012 genes related to ACE-2 in smokers and 855 in non-smokers. Furthermore, we showed that 161 genes involved in the endocytosis process were highlighted using the online pathway tool KEGG. Finally, 11 genes were in common between the ACE-2 pathway in smokers and the genes regulated during endocytosis, while 12 genes with non-smokers. Interestingly, six in non-smokers and four genes in smokers were closely involved during the viral internalization process. Our data may offer a pharmaceutical role of nicotine as potential treatment option in COVID-19.
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Despite the growing numbers of studies on cigarettes and electronic nicotine delivery products (ENDs), no standard assessment of nicotine stability in various matrix post exposure is currently available. The aim of the present study was to evaluate the optimal standard condition to store Cambridge Filter Pads (CFPs) before chemical analysis in order to guarantee the titer of nicotine.We further performed data normalization according to different smoking or vaping runs. Smoke and vapor generated respectively by a reference tobacco cigarette (1R6F) and ENDs under different exposure regimes (ISO, HCI and CRM81) were collected on CFPs as total particulate matter (TPM) and subsequently analyzed for nicotine content. For each exposure, some CFPs were analyzed at time zero, whereas the others were stored under different conditions for nicotine assessment after 30 days. Principal Component Analysis (PCA) showed the best correlation between nicotine on CFPs and TPM for normalization. This study suggests that different exposure regimes and products can affect the preservation of nicotine titer on CFPs while samples storage at -80 °C may prevent the loss of nicotine. Finally, normalization of nicotine with TPM is strongly recommended for regulatory purpose.
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Estabilidade de Medicamentos , Sistemas Eletrônicos de Liberação de Nicotina/normas , Nicotina/análise , Temperatura , Material Particulado/análise , Análise de Componente Principal , Padrões de ReferênciaRESUMO
Citrus fruits are rich sources of bioactive compounds and their consumption is associated to health-promoting effects. Citrus processing wastes contain bioflavonoids and other high added value compounds. The aim of this study was to evaluate the antiallergic properties of a new phytoextract obtained by citrus wastes and peels. Blood orange and lemon processing wastes were used to produce a Red orange and Lemon Extract (RLE). Blood samples from 30 allergic donors were collected and used to evaluate the basophil activation (CD203c) and degranulation (CD63) by stimulation trough allergen with and without the RLE. Reduced basophil expression of CD203c and CD63 were observed in RLE + Allergen treated samples, with -20.21% of CD203c expression (p < 0.0001) and -54.11% of CD63 expression (p < 0.0001), compared to Allergen treated samples. The RLE evidenced a good antiallergic activity, mainly acting on basophils degranulation, and therefore reducing the key event of pro-inflammatory mediators release after allergic stimuli.
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Basófilos , Citrus , Teste de Degranulação de Basófilos , Citometria de Fluxo , Extratos Vegetais/farmacologia , Tetraspanina 30RESUMO
BACKGROUND: The key ingredients of e-cigarettes liquid are commonly propane-1,2-diol (also called propylene glycol) and propane-1,2,3-triol (vegetal glycerol) and their antimicrobial effects are already established. The nicotine and flavors which are often present in e-liquids can interfere with the growth of some microorganisms. OBJECTIVE: The effect of combining these elements in e-liquids is unknown. The aim of the study was to investigate the possible effects of these liquids on bacterial growth in the presence or absence of nicotine and flavors. METHODS: Susceptibilities of pathogenic strains (Klebsiella pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter baumannii, Escherichia coli, Enterococcus faecalis and Sarcina lutea) were studied by means of a multidisciplinary approach. Cell viability and antioxidant assays were also evaluated. RESULTS: All e-liquids investigated showed antibacterial activity against at least one pathogenic strain. Higher activity was correlated to the presence of flavors and nicotine. DISCUSSION: In most cases, the value of minimal bactericidal concentration is equal to the value of minimal inhibitory concentration showing that these substances have a bactericidal effect. This effect was observed in concentrations up to 6.25% v/v. Antioxidant activity was also correlated to the presence of flavors. Over time, the viability assay in human epithelial lung A549 cells showed a dose-dependent inhibition of cell growth. CONCLUSION: Our results have shown that flavors considerably enhance the antibacterial activity of propane-1,2-diol and propane-1,2,3-triol. This study provides important evidence that should be taken into consideration in further investigative approaches, to clarify the different sensitivity of the various bacterial species to e-liquids, including the respiratory microbiota, to highlight the possible role of flavors and nicotine.
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Antibacterianos/farmacologia , Sistemas Eletrônicos de Liberação de Nicotina , Aromatizantes/farmacologia , Glicerol/farmacologia , Estudo de Prova de Conceito , Propilenoglicol/farmacologia , Células A549 , Sobrevivência Celular/efeitos dos fármacos , Sobrevivência Celular/fisiologia , Escherichia coli/efeitos dos fármacos , Escherichia coli/fisiologia , Humanos , Klebsiella pneumoniae/efeitos dos fármacos , Klebsiella pneumoniae/fisiologia , Testes de Sensibilidade Microbiana/métodos , Nicotina/farmacologia , Pseudomonas aeruginosa/efeitos dos fármacos , Pseudomonas aeruginosa/fisiologia , Staphylococcus aureus/efeitos dos fármacos , Staphylococcus aureus/fisiologiaRESUMO
Smoking progressively damages the efficiency of mucociliary clearance (MCC) defense mechanisms, thus contributing to increased susceptibility to respiratory infections. Prolonged mucociliary clearance transit time (MCCTT) caused by chronic smoking has been investigated by saccharin test, but little data is available about its short- and long-term reproducibility. Moreover, it is not known if MCC impairment can be reversed when stopping smoking. Objective of the study is to investigate and compare short (3 days) and long term (30 days) repeatability of baseline saccharin transit time (STT) among current, former, and never smokers. STT results were analyzed in 39 current, 40 former, and 40 never smokers. Significant (p < 0.0001) short-term and long-term repeatability of STT were observed in current (R squared = 0.398 and 0.672, for short- and long-term, respectively) and former smokers (R squared = 0.714 and 0.595, for short- and long-term, respectively). Significant differences in MCCTT were observed among the three study groups (p < 0.0001); the median (IQR) MCCTT being 13.15 (10.24-17.25), 7.26 (6.18-9.17), and 7.24 (5.73-8.73) minutes for current, former and never smokers, respectively. Comparison between current smokers and former smokers was significantly different (p < 0.0001). There was no significant difference between former and never smokers. The Saccharin test was well tolerated by all participants. We have shown for the first time high level repeatability in both current and former smokers. Moreover, MCC impairment can be completely reversed, former smokers exhibiting similar STT as never smokers. Measurement of STT is a sensitive biomarker of physiological effect for the detection of early respiratory health changes and may be useful for clinical research.
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BACKGROUND: Despite the introduction of tobacco control measures, smoking remains highly prevalent in most EU countries. In Italy, one in four adults were still regular smokers in 2017. Increasing use of combustion-free delivering nicotine technologies for cigarette substitution may accelerate the current downward trends in smoking prevalence. Whether Heated Tobacco Products (HTPs) are more effective tobacco smoking substitutes that may potentially facilitate adoption and full conversion compared to e-cigarettes (ECs) is not known.We have designed a prospective study to compare changes in cigarette consumption and adoption rates among smokers randomized to either HTPs or ECs. Product acceptability, tolerability, and their tobacco harm reduction potential will be also compared. METHODS: 220 healthy smokers, not motivated to quit, will be randomized into a 12-weeks single-center, open label, non-inferiority trial comparing study outcomes from HTPs vs. ECs use. The primary outcome will be biochemically verified self-reported continuous abstinence at 12-weeks from the previous visit. Secondary outcomes will include: smoking reduction from baseline, adoption rates and product acceptability, tolerability, changes in step test values and in the level of selected biomarkers of exposure in exhaled breath (i.e. eCO) and in spot urine samples. A follow-up visit will be also included at 24-weeks to review product usage and smoking behavior under naturalistic condition of use.Recruitment of participants started in May 2019 and enrolment is expected to be completed in November 2019. DISCUSSION: This will be the first study directly comparing Heated Tobacco Products with Electronic Cigarettes in term of reduction in cigarette consumption, adoption rates, product acceptability, tolerability, and tobacco harm reduction potential. This knowledge can contribute to a better understanding of the potential role of this new technology in the evolving nicotine consumer market. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03569748.Registered June 25, 2018.https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4.