Manzoli Lamberto, La Vecchia Carlo, Flacco Maria Elena, Capasso Lorenzo, Simonetti Valentina, Boccia Stefania, Di Baldassarre Angela, Villari Paolo, Mezzetti Andrea, Cicolini Giancarlo
Department of Medicine and Aging Sciences, University of Chieti, via dei Vestini 5, 66013 Chieti, Italy.
BMC Public Health. 2013 Sep 24;13:883. doi: 10.1186/1471-2458-13-883.
While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety.We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking.
METHODS/DESIGN: From June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ≥ 50 puffs per week since ≥ 6 months); (TC) traditional cigarettes (≥ 1 per day since ≥ 6 m); (Mixed) both electronic and traditional cigarettes (≥ 1 per day since ≥ 6 m). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable.
Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes.
The protocol has been registered (NCT01785537) and approved by the Ethics Committee of the University of Chieti (Record n. 6; 25-03-2013).
虽然电子烟在一些国家被禁止，但在其他许多国家其销量却在激增。尽管电子烟已被提议作为传统吸烟的长期替代品或戒烟工具，但关于其功效和安全性的数据却非常稀少。我们描述了一项为期5年的多中心前瞻性研究方案，旨在评估对电子烟吸食的短期和长期依从性以及电子烟在减少和/或戒断传统吸烟方面的功效。该研究还将比较电子烟、传统香烟和混合烟吸食对健康的影响。
方法/设计：2013年6月至12月，我们将招募以下成年吸烟者：（EC）电子烟使用者（自报每周吸食≥50口且持续≥6个月）；（TC）传统香烟使用者（自报每天吸食≥1支且持续≥6个月）；（混合）同时使用电子烟和传统香烟者（自报每天吸食≥1支且持续≥6个月）。符合条件的受试者将通过报纸广告和在商店直接联系的方式被邀请参与。每位受试者在入组时以及6、12、24、36和60个月后都必须填写一份结构化问卷。对于在任何随访阶段都宣称不吸食传统香烟的所有受试者，将使用便携式一氧化碳分析仪评估呼出气中的一氧化碳水平。主要结局是传统吸烟戒断率和吸烟支数。次要结局包括对电子烟的依从性、自报的不良事件、生活质量以及因心血管疾病、慢性阻塞性肺疾病、肺癌、食管癌、喉癌、口腔癌、膀胱癌、胰腺癌、肾癌、胃癌、宫颈癌和髓系白血病之一住院的时间。将使用阿布鲁佐地区的官方出院数据检查住院情况。每组至少招募500名受试者，总共1500名参与者。将使用Cox比例风险分析来计算每个变量对戒烟的调整后相对风险。
关于电子烟长期功效和安全性的数据对于形成电子烟指南和监管决策的基础至关重要。
该方案已注册（NCT01785537）并获得基耶蒂大学伦理委员会批准（记录编号6；2013年3月25日）。
