EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study.
EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study.
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DOI：
10.1371/journal.pone.0066317
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Polosa R
中科院分区：
文献类型：
--
作者：
Caponnetto P;Campagna D;Cibella F;Morjaria JB;Caruso M;Russo C;Polosa R
电子烟（e-香烟）越来越受到全球吸烟者的欢迎。用户报告说，购买它们是为了帮助戒烟、减少香烟消费、缓解烟草戒断症状以及继续拥有“吸烟”体验，同时降低健康风险。迫切需要对电子烟进行研究，以确保监管机构、医疗保健提供者和消费者的决策基于科学。 方法 ECLAT 是一项为期 12 个月的前瞻性随机对照试验，评估了 300 名不打算戒烟的吸烟者尝试流行电子烟模型（“Categoria”；Arbi Group Srl，意大利）的两种不同尼古丁强度与非尼古丁选择相比的吸烟减少/戒烟情况。 A 组（n = 100）接受 7.2 mg 尼古丁烟弹治疗 12 周； B 组 (n = 100)，使用 6 周 7.2 mg 尼古丁烟弹，然后再使用 6 周 5.4 mg 尼古丁烟弹； C 组（n = 100）接受无尼古丁烟弹治疗 12 周。该研究包括九次访问，期间测量了每天的香烟使用量和呼出的一氧化碳 (eCO) 水平。计算吸烟减少率和戒烟率。还审查了不良事件和产品偏好。所有三个研究组的每次研究访视均观察到每日香烟使用量和 eCO 水平下降（与基线相比，p<0.001），但研究组之间没有一致的差异。第 12 周和第 52 周吸烟率分别减少了 22.3% 和 10.3%。第 12 周和第 52 周完全戒烟的比例分别为 10.7% 和 8.7%。研究期间观察到不良事件较基线大幅减少，并且很少报告戒断症状。参与者对所调查产品的看法和接受程度令人满意。对于不打算戒烟的吸烟者来说，使用含有或不含尼古丁的电子烟，可以减少香烟的消费，并引起持久的戒烟，而不会造成明显的副作用。 ClinicalTrials.gov NCT01164072 NCT01164072
Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a ‘smoking’ experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model (‘Categoria’; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n = 100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants’ perception and acceptance of the product under investigation was satisfactory. In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects. ClinicalTrials.gov NCT01164072 NCT01164072
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影响因子：
5.2
作者：
Bullen, C.;McRobbie, H.;Laugesen, M.
通讯作者：
Laugesen, M.
影响因子：
24.3
作者：
Caponnetto, P.;Cibella, F.;Polosa, R.
通讯作者：
Polosa, R.
影响因子：
1
作者：
Caponnetto, Pasquale;Polosa, Riccardo;Campagna, Davide
通讯作者：
Campagna, Davide
影响因子：
4.4
作者：
Dawkins, Lynne;Turner, John;Soar, Kirstie
通讯作者：
Soar, Kirstie
影响因子：
5.2
作者：
Etter JF;Bullen C;Flouris AD;Laugesen M;Eissenberg T
通讯作者：
Eissenberg T