electronic cigarette

电子烟
  • 文章类型: Journal Article
    目标:一次性电子烟(电子烟)的使用在美国年轻人中越来越受欢迎,考虑到产品营销的变化,可用性和监管。这项研究旨在评估目前使用电子烟的9-18岁美国年轻人中最常用的电子烟产品(一次性与其他)的患病率和测试因素。
    方法:这是一项观察性研究,使用来自美国2021年和2022年全国青年烟草调查的横截面数据(n=48704)。我们将我们的分析样本限制在目前使用电子烟的年轻人(n=4137)。样本范围为9至18岁,女性占53.0%。
    方法:我们将电子烟设备类型分为一次性和所有其他类型(例如可再填充的豆荚/烟弹)。我们进行了逻辑回归来估计年龄,性别,种族/民族,性取向,电子烟的使用频率,尼古丁汽化,调味电子烟的使用和当前可燃/不可燃烟草的使用与一次性电子烟的使用有关,与其他电子烟相比。
    结果:在目前使用电子烟的年轻人中,54.5%使用一次性电子烟。年龄较大(17-18岁),相对于较年轻的年龄(9-14岁)[优势比(OR)=1.43,95%置信区间(CI)=1.07-1.91],非西班牙裔黑人(与非西班牙裔白人)种族/种族(OR=1.47,95%CI=1.01-2.15),任何尼古丁(与非尼古丁)蒸发(OR=2.51,95%CI=1.96-3.23)和调味(与非调味)电子烟使用(OR=1.93,95%CI=1.46-2.56)与主要使用一次性电子烟的几率增加有关,与使用其他电子烟产品相比,而当前的可燃烟草使用(相对于非当前)(OR=0.65,95%CI=0.53-0.80)和当前的不可燃烟草使用(相对于非当前)(OR=0.58,95%CI=0.43-0.78)与较低的几率相关.
    结论:一次性电子烟似乎是美国年轻人中使用最多的电子烟产品。年纪大了,非西班牙裔黑人种族/种族,尼古丁电子烟和调味电子烟的使用与主要使用一次性电子烟有关,相对于其他电子烟产品。
    OBJECTIVE: Disposable electronic cigarette (e-cigarette) use is becoming more popular among US youth, given the shifting landscape in product marketing, availability and regulation. This study aimed to estimate the prevalence of and test factors associated with the most used e-cigarette product (disposable versus other) among US youth aged 9-18 years who currently use e-cigarettes.
    METHODS: This was an observational study using cross-sectional data from the US-based 2021 and 2022 National Youth Tobacco Surveys (n = 48 704). We restricted our analytical sample to youth who currently use e-cigarettes (n = 4137). The sample ranged from 9 to 18 years old and was 53.0% female.
    METHODS: We dichotomized e-cigarette device type to disposable versus all other types (e.g. refillable pods/cartridges). We conducted logistic regression to estimate whether age, sex, race/ethnicity, sexual orientation, frequency of e-cigarette use, nicotine vaping, flavored e-cigarette use and current combustible/non-combustible tobacco use were associated with disposable e-cigarette use, compared with other e-cigarette use.
    RESULTS: Among youth who currently use e-cigarettes, 54.5% used disposable e-cigarettes. Older age (17-18 years), relative to younger age (9-14 years) [odds ratio (OR) = 1.43, 95% confidence interval (CI) = 1.07-1.91], non-Hispanic Black (versus non-Hispanic White) race/ethnicity (OR = 1.47, 95% CI = 1.01-2.15), any nicotine (versus non-nicotine) vaping (OR = 2.51, 95% CI = 1.96-3.23) and flavored (versus non-flavored) e-cigarette use (OR = 1.93, 95% CI = 1.46-2.56) were associated with increased odds of mainly using disposable e-cigarettes, compared with using other e-cigarette products, whereas current combustible tobacco use (versus non-current) (OR = 0.65, 95% CI = 0.53-0.80) and current non-combustible tobacco use (versus non-current) (OR = 0.58, 95% CI = 0.43-0.78) were associated with lower odds.
    CONCLUSIONS: Disposable e-cigarettes appear to be the most used type of e-cigarette product among US youth. Older age, non-Hispanic Black race/ethnicity, nicotine vaping and flavored e-cigarette use are associated with mainly using disposable e-cigarettes, relative to other e-cigarette products.
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  • 文章类型: Journal Article
    对电子烟中化学物质的新关注,即使是那些没有尼古丁的人,要求为其暴露和风险评估制定先进的标准。这项研究旨在强调肺核受体(NRs)对电子烟电子液体的敏感性,独立于尼古丁的存在,以及性别变量对这些影响的影响。成年雄性和雌性C57BL/6J小鼠暴露于0%的电子烟,3%,和每天6%的尼古丁(70毫升,3.3s,1次/分钟/30分钟)持续14天,使用inExpose全身腔室(SCIREQ)。曝光后,收集肺组织,提取RNA。使用RT2分析器mRNA阵列(Qiagen)测定84个NRs的表达。结果显示,无论是否存在尼古丁,对电子液体暴露都具有很高的敏感性,随着NRs的差异表达,与未暴露的对照小鼠相比,包括0%尼古丁组中的1只(雌性)和24只(雄性)。然而,尼古丁依赖的结果也显著,有7个NRs(女性),3%的53个NR(男性)和6%的尼古丁组中的23个NR(女性)的29个NR(男性),与0%尼古丁小鼠相比。性别特异性变化显著,但未观察到与性别相关的差异.该研究为进一步调查提供了强有力的理由。
    The emerging concern about chemicals in electronic cigarettes, even those without nicotine, demands the development of advanced criteria for their exposure and risk assessment. This study aims to highlight the sensitivity of lung nuclear receptors (NRs) to electronic cigarette e-liquids, independent of nicotine presence, and the influence of the sex variable on these effects. Adult male and female C57BL/6J mice were exposed to electronic cigarettes with 0%, 3%, and 6% nicotine daily (70 mL, 3.3 s, 1 puff per min/30 min) for 14 days, using the inExpose full body chamber (SCIREQ). Following exposure, lung tissues were harvested, and RNA extracted. The expression of 84 NRs was determined using the RT2 profiler mRNA array (Qiagen). Results exhibit a high sensitivity to e-liquid exposure irrespective of the presence of nicotine, with differential expression of NRs, including one (females) and twenty-four (males) in 0% nicotine groups compared to non-exposed control mice. However, nicotine-dependent results were also significant with seven NRs (females), fifty-three NRs (males) in 3% and twenty-three NRs (female) twenty-nine NRs (male) in 6% nicotine groups, compared to 0% nicotine mice. Sex-specific changes were significant, but sex-related differences were not observed. The study provides a strong rationale for further investigation.
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  • 文章类型: Journal Article
    背景:关于常规电子烟对健康的影响的信息有限。对曾经吸烟的人的健康状况进行研究面临的挑战是,以前的吸烟可能会对健康造成未知的影响。只有对vape但从未吸过可燃香烟的人的研究才能检测到vaping造成的危害。有必要对有和没有可燃吸烟史的特征良好的电子烟使用者进行大规模的前瞻性研究,以确定定期雾化对呼吸道健康的长期影响。
    目的:我们将对来自世界6个地区的个人进行全球横断面调查。将使用经过验证的问卷-呼吸症状体验量表(RSES)评估呼吸症状。当前非其他烟草或尼古丁产品使用者的vapers将与非vapes和其他烟草或尼古丁产品使用者的匹配对照进行比较。
    方法:这将是一个多国家,对750名年龄≥18岁的成年人进行横断面调查,这些成年人符合纳入仅使用vape且非使用其他烟草或尼古丁产品的人群(“vapers队列”;目标N=500)或非使用其他烟草或尼古丁产品的非vapers人群(“对照队列”;目标N=250)的标准.研究的主要终点是RSES评分。将“vapers队列”中的人的RSES得分与“控制组”中的人的得分进行比较。\"此外,这项研究将收集数据,以表征vapers队列中vaping产品使用的模式。数据收集将包括有关使用vape产品的年龄开始的信息,开始和继续使用vape产品的原因,使用的特定类型的产品,最近使用的产品的风味和尼古丁强度,以及过去30天内产品使用的频率和强度。
    结果:参与者招募于2023年4月开始,到2023年11月完成注册,有748名参与者。结果将在2024年报告。
    结论:这将是第一项研究,为在没有确定使用可燃香烟或其他烟草或尼古丁产品的情况下使用电子烟的人的呼吸健康影响提供关键见解。
    DERR1-10.2196/54236。
    BACKGROUND: There is only limited information about the health effects of regular vaping. Research on the health status of people who used to smoke faces the challenge that previous smoking may have caused unknown health effects. Only studies of people who vape but have never smoked combustible cigarettes can enable the detection of harms attributable to vaping. Large prospective studies of well-characterized electronic cigarette users with and without a history of combustible cigarette smoking are warranted to establish the long-term effects of regular vaping on respiratory health.
    OBJECTIVE: We will conduct a global cross-sectional survey of individuals from 6 world regions. Respiratory symptoms will be assessed using a validated questionnaire-the Respiratory Symptom Experience Scale (RSES). Current vapers who are nonusers of other tobacco or nicotine products will be compared with matched controls who are nonusers of vapes and other tobacco or nicotine products.
    METHODS: This will be a multicountry, cross-sectional internet-based survey of 750 adults aged ≥18 years who satisfy the criteria for inclusion in either a cohort of people who exclusively vape and who are nonusers of other tobacco or nicotine products (\"vapers cohort\"; target N=500) or a cohort of nonvapers who are also nonusers of other tobacco or nicotine products (\"controls cohort\"; target N=250). The primary end point of the study is the RSES score. RSES scores of people in the \"vapers cohort\" will be compared with those of people in the \"controls cohort.\" Additionally, the study will collect data to characterize patterns of vaping product use among the vapers cohort. Data collection will include information about the age initiation of using vape products, reasons for starting and continuing the use of vape products, specific types of products used, flavors and nicotine strengths of recently used products, as well as the frequency and intensity of product use in the past 30 days.
    RESULTS: Participant recruitment started in April 2023, and enrollment was completed by November 2023 with 748 participants. Results will be reported in 2024.
    CONCLUSIONS: This will be the first study providing key insights into respiratory health effects associated with using electronic cigarettes in people who vape with no established use of combustible cigarettes or other tobacco or nicotine products.
    UNASSIGNED: DERR1-10.2196/54236.
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  • 文章类型: Journal Article
    背景:这项研究的目的是检查杭州大学生中电子烟(电子烟)的使用情况,并分析其使用电子烟意向的影响因素。
    方法:使用分层整群抽样方法,选择杭州两所大学的775名学生于2022年3月至4月进行现场问卷调查。对使用意愿的影响因素进行调整logistic回归分析,基于创新扩散理论。
    结果:在我们的大学生样本中,16.5%的学生尝试过电子烟;6.32%的学生在过去一个月中使用过电子烟,8.0%有使用电子烟的意向。不同性别之间使用电子烟的意愿存在显著差异,经济地位,身边亲密朋友的吸烟状况,以及他们自己使用烟草和酒精(p<0.05)。Logistic回归模型显示,电子烟的可观测性(AOR=1.28;p<0.05),个人因素(AOR=1.39;p<0.05),和社会系统(AOR=1.63;p<0.05),均为电子烟使用意向的影响因素。
    结论:杭州大学生使用电子烟的意愿很高,以及产品本身的影响,个体特征和生活环境至关重要。有必要在社会和家庭层面加强烟草知识的推广,以减少电子烟的发生。
    BACKGROUND: The purpose of this study is to examine the use of electronic cigarettes (e-cigarettes) among college students in Hangzhou, and to analyze the influencing factors of their intention to use e-cigarettes.
    METHODS: Using a stratified cluster sampling method, 775 students from two universities in Hangzhou were selected for an on-site questionnaire survey from March to April 2022. Adjusted logistic regression analysis was conducted on the influencing factors of use intention, based on innovation diffusion theory.
    RESULTS: Within our sample of college students, 16.5% of students had tried e-cigarettes; 6.32% had used e-cigarettes in the past month, and 8.0% had the intention to use e-cigarettes. There were significant differences in willingness to use e-cigarettes among different genders, economic status, smoking status of close friends around them, and their own use of tobacco and alcohol (p<0.05). The logistic regression model showed that the observability of e-cigarettes (AOR=1.28; p<0.05), personal factors (AOR=1.39; p<0.05), and social systems (AOR=1.63; p<0.05), were all influencing factors of intention to use e-cigarettes.
    CONCLUSIONS: College students in Hangzhou have a high intention to use e-cigarettes, and the impacts of the product itself, individual characteristics and the living environment are crucial. It is necessary to strengthen the promotion of tobacco knowledge at the social and family levels to reduce the occurrence of vaping.
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  • 文章类型: Journal Article
    背景:先前的研究表明,电子烟市场包含大量品牌。识别这些现有的电子烟品牌是市场监管的关键要素,这将进一步协助政策制定和合规检查。
    目标:为了促进对电子烟市场多样化产品格局的监控,我们构建了截至2020-2022年在美国市场出现的电子烟品牌的语义数据库。
    方法:为了建立品牌数据库,我们从零售渠道和来源的综合列表中搜索和汇编了电子烟品牌,包括(1)在网络商店销售的电子液体和一次性品牌,(2)在实体店销售并由尼尔森零售扫描仪数据收集的电子烟品牌,(3)维基百科汇编的电子烟品牌,(4)来自2020年国际烟草控制四国吸烟和吸烟(ITC4CV)美国调查的自我报告的电子烟品牌,和(5)Twitter上的电子烟品牌。我们还估计了实体店销量排名前五位的电子烟品牌,根据基于网络的商店中产品的频率和种类,以及2020年ITC4CV美国调查中自我报告品牌的频率。
    结果:截至2020-2022年,各种零售渠道共销售了912个电子烟品牌。在2020-2022年期间,前5个品牌是JUUL,vuse,njoy,blu,实体店的逻辑和逻辑;blu,国王,怪物,twist,和基于网络的商店中的电子液体空气工厂;海德,吊舱网格,suorin,Vaporlax,和xtra,用于在基于网络的商店出售的一次性用品;和烟雾,aspire,vaporesso,innokin,和基于自我报告的调查数据。
    结论:随着美国食品和药物管理局执行售前烟草市场授权,许多电子烟品牌可能在美国市场成为非法。在这种情况下,电子烟品牌如何在不同的零售渠道中发展和整合,对于了解监管对产品可用性的影响至关重要。我们的电子烟品牌的语义数据库可以作为一个有用的工具来监测产品和市场的发展,进行合规性检查,评估制造商的营销行为,并确定监管影响。
    BACKGROUND: Prior studies have demonstrated that the e-cigarette market contains a large number of brands. Identifying these existing e-cigarette brands is a key element of market surveillance, which will further assist in policy making and compliance checks.
    OBJECTIVE: To facilitate the surveillance of the diverse product landscape in the e-cigarette market, we constructed a semantic database of e-cigarette brands that have appeared in the US market as of 2020-2022.
    METHODS: In order to build the brand database, we searched and compiled e-cigarette brands from a comprehensive list of retail channels and sources, including (1) e-liquid and disposable brands sold in web-based stores, (2) e-cigarette brands sold in brick-and-mortar stores and collected by the Nielsen Retail Scanner Data, (3) e-cigarette brands compiled by Wikipedia, (4) self-reported e-cigarette brands from the 2020 International Tobacco Control Four-Country Smoking and Vaping (ITC 4CV) US survey, and (5) e-cigarette brands on Twitter. We also estimated the top 5 e-cigarette brands by sales volume in brick-and-mortar stores, by the frequency and variety of offerings in web-based shops, and by the frequency of self-reported brands from the 2020 ITC 4CV US survey.
    RESULTS: As of 2020-2022, a total of 912 e-cigarette brands have been sold by various retail channels. During 2020-2022, the top 5 brands are JUUL, vuse, njoy, blu, and logic in brick-and-mortar stores; blu, king, monster, twist, and air factory for e-liquids in web-based stores; hyde, pod mesh, suorin, vaporlax, and xtra for disposables sold in web-based stores; and smok, aspire, vaporesso, innokin, and eleaf based on self-reported survey data.
    CONCLUSIONS: As the US Food and Drug Administration enforces the premarket tobacco market authorization, many e-cigarette brands may become illegal in the US market. In this context, how e-cigarette brands evolve and consolidate in different retail channels will be critical for understanding the regulatory impacts on product availability. Our semantic database of e-cigarette brands can serve as a useful tool to monitor product and marketplace development, conduct compliance checks, assess manufacturers\' marketing behaviors, and identify regulatory impacts.
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  • 文章类型: Published Erratum
    [这修正了文章DOI:10.3389/fchem.2023.1212744。].
    [This corrects the article DOI: 10.3389/fchem.2023.1212744.].
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  • 文章类型: Journal Article
    背景:在过去的十年中,电子尼古丁输送系统(ENDS)的使用有所增加,而描述消费者如何使用这些产品的研究却受到限制。大多数与ENDS使用相关的研究都涉及专注于在中央位置环境中使用或试图通过主观自我报告终点来衡量使用结果的研究设计。为了捕捉ENDS使用的复杂性,必须开发准确可靠的工具来在自然的现实环境中收集数据。在现实世界中使用连接的设备提供了一种方便和客观的方法来收集具有ENDS的行为结果。
    目的:开发了产品使用和行为工具,用于捕获VuseSoloENDS在非卧床环境中的使用情况,以最佳地复制现实世界的使用行为。本研究旨在确定地形结果的总体平均值,同时还为ENDS使用会话提供定义。
    方法:使用产品使用和行为工具进行前瞻性门诊临床研究。参与者(n=75)年龄在21至60岁之间,认为身体健康,并要求建立ENDS的常规用户。为了更好地了解人群中的使用行为,根据每日抽吸计数将样本按百分位数进行分类。要在相关上下文中构建这些数据,他们陷入了低谷,moderate-,和高用途类别(第10至第40,40至70,和第70到第100百分位数,分别),低使用率组代表非密集类别,代表激烈类别的高使用率群体,适度使用群体反映了普通消费者。
    结果:与低使用组的参与者相比,每日使用量较高的参与者每次使用的抽吸次数明显更多(6.71vs4.40),并且抽吸的频率更高(抽吸间隔:32.78svs61.66s)。抽吸持续时间在整个低点保持一致,中度-,和高使用率组(2.10s,2.18s,和2.19s,分别)。中度使用组的疗程长度明显短于高和低使用组(P<.001),彼此之间没有显着差异(P=0.16)。
    结论:使用连接的设备可以方便且可靠地收集与门诊使用产品相关的行为结果。通过使用这些工具捕获的变量,可以从预定义的使用周期移开,以更好地理解地形结果并定义使用会话。这里提供的数据提供了一种可能的方法来定义这些会话。这些数据也开始在正确的背景下构建用于ENDS分析评估的国际标准,并开始阐明标准化测试方案与实际使用行为之间的差异。
    背景:Clinicaltrials.govNCT04226404;https://clinicaltrials.gov/study/NCT04226404。
    BACKGROUND: Over the last decade, the use of electronic nicotine delivery systems (ENDSs) has risen, whereas studies that describe how consumers use these products have been limited. Most studies related to ENDS use have involved study designs focused on use in a central location environment or attempted to measure use outcomes through subjective self-reported end points. The development of accurate and reliable tools to collect data in a naturalistic real-world environment is necessary to capture the complexities of ENDS use. Using connected devices in a real-world setting provides a convenient and objective approach to collecting behavioral outcomes with ENDS.
    OBJECTIVE: The Product Use and Behavior instrument was developed and used to capture the use of the Vuse Solo ENDS in an ambulatory setting to best replicate real-world use behavior. This study aims to determine overall mean values for topography outcomes while also providing a definition for an ENDS use session.
    METHODS: A prospective ambulatory clinical study was performed with the Product Use and Behavior instrument. Participants (n=75) were aged between 21 and 60 years, considered in good health, and were required to be established regular users of ENDSs. To better understand use behavior within the population, the sample was sorted into percentiles with bins based on daily puff counts. To frame these data in the relevant context, they were binned into low-, moderate-, and high-use categories (10th to 40th, 40th to 70th, and 70th to 100th percentiles, respectively), with the low-use group representing the nonintense category, the high-use group representing the intense category, and the moderate-use group being reflective of the average consumer.
    RESULTS: Participants with higher daily use took substantially more puffs per use session (6.71 vs 4.40) and puffed more frequently (interpuff interval: 32.78 s vs 61.66 s) than participants in the low-use group. Puff duration remained consistent across the low-, moderate‑, and high-use groups (2.10 s, 2.18 s, and 2.19 s, respectively). The moderate-use group had significantly shorter session lengths (P<.001) than the high- and low-use groups, which did not differ significantly from each other (P=.16).
    CONCLUSIONS: Using connected devices allows for a convenient and robust approach to the collection of behavioral outcomes related to product use in an ambulatory setting. By using the variables captured with these tools, it becomes possible to move away from predefined periods of use to better understand topography outcomes and define use sessions. The data presented here offer a possible method to define these sessions. These data also begin to frame international standards used for the analytical assessments of ENDSs in the correct context and begin to shed light on the differences between standardized testing regimens and actual use behavior.
    BACKGROUND: Clinicaltrials.gov NCT04226404; https://clinicaltrials.gov/study/NCT04226404.
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  • 文章类型: Journal Article
    目的:电子烟已经上市超过15年,但对长期用户的了解相对较少。我们的目的是描述行为随时间的变化,长期用户的态度和依赖。
    方法:对2012-2016年在互联网上注册的375名电子烟用户进行了纵向研究,并在2021年(平均8年后)再次进行了调查,在间隔内连续使用电子烟。
    结果:在过去31天内,2021年(11%)的吸烟人数少于基线(33%)。参与者从基线时的第二代模型(例如Ego)切换到2021年的boxmods(例如iStick),他们用了更大的笔芯瓶,他们使用自制电子液体的频率是原来的两倍,他们使用烟草香料的频率较低,电子液体中的尼古丁浓度从12毫克/毫升降至6毫克/毫升。随着时间的推移,到当天的第一次电子烟,没有任何变化,但是0-100的电子烟依赖评分从75下降到60,vape冲动的频率和强度下降(从31%到18%的“强”冲动),并且表示如果他们试图停止vaping可能会成功的人的比例增加。与基线相比,2021年报告使用电子烟应对渴望或其他戒烟症状的人数减少,更少的人报告说戒烟,为了避免再次吸烟,或减少他们的烟草消费(所有差异p<0.001)。
    结论:从长期来看,连续用户,在8年的时间里,在使用的电子烟模型中观察到了实质性的变化,在电子液体的味道和强度中,以及电子烟的原因。随着时间的推移,他们的尼古丁依赖水平趋于下降。这些用户对电子烟感到满意,主要是因为他们认为电子烟的危险性低于吸烟,和享受。
    E-cigarettes have been available for over 15 years, but relatively little is known about long-term users. Our aim was to describe change over time in behaviours, attitudes and dependence in long-term users.
    A longitudinal study of 375 e-cigarette users enrolled on the Internet in 2012-2016 and surveyed again in 2021 (8 years later on average), who continuously used e-cigarettes in the interval.
    Fewer people in 2021 (11 %) than at baseline (33 %) had smoked tobacco in the past 31 days. Participants switched from second-generation models at baseline (e.g. Ego) to box mods in 2021 (e.g. iStick), they used larger refill bottles, they used home-made e-liquids twice as often, they used tobacco flavours less often and the nicotine concentration in e-liquids decreased from 12 to 6 mg/mL. There was no change over time in the time to the first e-cigarette puff of the day, but an e-cigarette dependence score of 0-100 decreased from 75 to 60, the frequency and strength of urges to vape decreased (from 31 % to 18 % of \"strong\" urges) and the proportion of people who said they would be likely to succeed if they tried to stop vaping increased. Compared to baseline, fewer people in 2021 reported vaping to cope with cravings or other smoking cessation symptoms, and fewer people reported vaping to quit smoking, to avoid relapse into smoking, or to reduce their tobacco consumption (p < 0.001 for all differences).
    In long-term, continuous users, over a period of 8 years, substantial changes were observed in the models of e-cigarettes used, in the flavours and strength of e-liquids, and in the reasons for vaping. Their level of nicotine dependence tended to decrease over time. These users were satisfied with e-cigarettes and vaped mostly because they felt that vaping was less dangerous than smoking, and for enjoyment.
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  • 文章类型: Multicenter Study
    结论:与单独使用者相比,双重EC/CC使用者患CRS或FESS的风险明显更大。与单独用户相比,双重EC/CC用户没有明显更大的息肉风险。这种效应可能与细菌有关,免疫细胞,遗传,和粘膜纤毛改变。
    CONCLUSIONS: Dual EC/CC users had a significantly greater risk of CRS or FESS when compared to solo users. Dual EC/CC users did not have a significantly greater risk of polyposis when compared to solo users. This effect likely relates to bacterial, immune cell, genetic, and mucociliary alterations.
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  • 文章类型: Journal Article
    可浸出调查通常在一系列部门进行(例如,制药,医疗器械,等。)以确定在正常使用条件下,来自容器封闭系统的化学物质是否转移到产品中。对于电子尼古丁输送系统(ENDS),容器封闭系统包括与被雾化并随后被使用者吸入的电子液体接触的所有材料。目前,没有对ENDS产品进行可浸出研究的指导,然而,有口服吸入药物产品的相关指导文件,可以应用于ENDS容器封闭系统。我们提供了一个案例研究,该案例研究了在模拟可浸出研究中使用装有无味电子液体(PG/VG/尼古丁/苯甲酸)的老化JUULpods进行的两种可浸出化合物的分析研究。两种化合物的毒理学信息有限,被认为缺乏数据。从老化的商业JUULpods(弗吉尼亚烟草和薄荷醇)收集的气溶胶的定性分析,使用模拟可浸出研究中使用的类似分析方法(LC-MS/MS),未显示任何可浸出化合物的痕量或可检测水平。因此,此定性分析未提供支持毒理学风险评估所需的数据缺乏的可浸出化合物的半定量值.Further,由于化合物的分子大小和结构复杂性,没有商业上可靠的标准或合理的合成路线。相反,方法限值是使用标准ICH指南的替代方法建立的。实验确定的定量方法极限,使用模拟可浸出电子液体的加标样品,提供了气溶胶中每个数据缺乏的可浸出化合物的保守半定量值,从而能够估计从电子液体到气溶胶的转移效率。根据定量极限,实验确定每种可浸出化合物的转移效率小于2%,然后可用于定义毒理学风险评估的相关暴露限值。这项工作详细介绍了一种新颖的分析方法,用于确定从ENDS容器封闭系统到ENDS气溶胶中的数据缺乏的可浸出化合物的传输效率,以支持毒理学健康风险评估。
    Leachable investigations are routinely undertaken across a range of sectors (e.g., pharmaceuticals, medical devices, etc.) to determine whether chemicals from a container closure system transfer into a product under normal conditions of use. For Electronic Nicotine Delivery Systems (ENDS) the container closure system includes all materials in contact with the e-liquid that is aerosolized and subsequently inhaled by the user. Currently, there is no guidance for conducting leachable studies for ENDS products, however, there are relevant guidance documents for orally inhaled drug products that can be applied to an ENDS container closure system. We present a case study of the analytical investigation of two leachable compounds identified in simulated leachable studies using aged JUULpods filled with unflavored e-liquid (PG/VG/nicotine/benzoic acid). Both compounds had limited toxicological information and were considered data deficient. A qualitative analysis of the aerosol collected from aged commercial JUULpods (Virginia Tobacco and Menthol), using a similar analytical method (LC-MS/MS) used in the simulated leachable studies, showed no trace or detectable levels of either leachable compound. Therefore, this qualitative analysis did not provide semi-quantitative values for the data-deficient leachable compounds necessary to support toxicological risk assessment. Further, no commercial authentic standards or reasonable synthetic route were available due to the molecular size and structural complexity of the compounds. Instead, method limits were established using an alternative approach to standard ICH guidelines. The experimentally determined method limit of quantitation, using spiked samples of simulated leachable e-liquid, provided conservative semi-quantitative values for each data deficient leachable compound in the aerosol that enabled a transfer efficiency from e-liquid to aerosol to be estimated. The transfer efficiency of each leachable compound was experimentally determined to be less than 2% based on the limit of quantitation, which then could be used to define a relevant exposure limit for the toxicological risk assessment. This work details a novel analytical approach for determining the transfer efficiency of data deficient leachable compounds from ENDS container closure systems into the ENDS aerosol to support toxicological health risk assessments.
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