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一项随机试验,研究一种新型尼古丁输送装置(日蚀)和尼古丁口腔吸入器对吸烟行为、尼古丁和一氧化碳暴露以及戒烟动机的影响。

Randomised trial investigating effect of a novel nicotine delivery device (Eclipse) and a nicotine oral inhaler on smoking behaviour, nicotine and carbon monoxide exposure, and motivation to quit.

作者信息

Fagerström K O, Hughes J R, Rasmussen T, Callas P W

机构信息

Smokers Information Center and Fagerstrom Consulting, Helsingborg, Sweden.

出版信息

Tob Control. 2000 Sep;9(3):327-33. doi: 10.1136/tc.9.3.327.

Abstract

OBJECTIVE

To monitor the effect of a novel nicotine delivery device that may produce fewer carcinogens (Eclipse) on cigarette smoking, carbon monoxide and nicotine concentrations, and motivation to give up smoking. The smoker's own brand of cigarette and a nicotine replacement product (Nicotrol inhaler) were used as comparisons.

DESIGN

After baseline data were recorded, smokers were randomised to either Eclipse or inhaler for two weeks and then switched to the other product for another two weeks. Thereafter a second baseline was obtained.

SETTING AND PARTICIPANTS

Fifty smokers were included and data are reported for the 40 with complete data sets. The smokers were not trying to quit but were interested in trying a new product to reduce their risk. They visited a smoking clinic 10 times during the six week period of the trial.

INTERVENTION

No counselling to aid reduction by Eclipse or inhaler was given.

MAIN OUTCOME MEASURES

At each visit smoking status and carbon monoxide concentrations were recorded. In half of the visits withdrawal symptoms, attitudes towards smoking, heart rate, and blood nicotine concentrations were also recorded.

RESULTS

Eclipse use decreased the number of cigarettes smoked per day (cpd) from 19.1 cpd at baseline to 2.1 cpd (p < 0.001), but increased carbon monoxide concentrations in parts per million (ppm) from 21.0 ppm to 33.0 ppm (p < 0.001). A similar decrease in cigarettes smoked per day was seen with the Nicotrol inhaler, from 19.1 cpd to 4.8 cpd (p < 0.001), but carbon monoxide decreased from 21.0 ppm to 12.7 ppm (p < 0.001). The blood nicotine concentration remained fairly stable with Eclipse, increasing slightly from 16.8 ng/ml to 18.0 ng/ml, while for the inhaler a significant drop was noted, from 16.8 ng/ml to 12. 2 ng/ml (p < 0.002). Craving and withdrawal did not increase with Eclipse. Few significant adverse events occurred with Eclipse.

CONCLUSIONS

Eclipse can dramatically decrease cigarette consumption without causing withdrawal symptoms or decreases in nicotine concentrations or motivation to quit altogether. Unlike the inhaler, Eclipse produces an increase in carbon monoxide concentration. Thus Eclipse may not be a safer cigarette.

摘要

目的

监测一种可能产生较少致癌物的新型尼古丁递送装置(日蚀牌香烟)对吸烟量、一氧化碳和尼古丁浓度以及戒烟动机的影响。将吸烟者自己品牌的香烟和一种尼古丁替代产品(尼古丁吸入器)用作对照。

设计

记录基线数据后,吸烟者被随机分为使用日蚀牌香烟或吸入器两组,为期两周,然后换用另一种产品再持续两周。此后获取第二次基线数据。

地点和参与者

纳入了50名吸烟者,报告了其中40名具有完整数据集者的数据。这些吸烟者并非试图戒烟,而是有兴趣尝试一种新产品以降低风险。在试验的六周期间,他们到吸烟诊所就诊10次。

干预措施

未提供通过日蚀牌香烟或吸入器辅助减少吸烟的咨询服务。

主要观察指标

每次就诊时记录吸烟状况和一氧化碳浓度。在一半的就诊中,还记录戒断症状、对吸烟的态度、心率和血液尼古丁浓度。

结果

使用日蚀牌香烟后,每日吸烟量从基线时的19.1支/天降至2.1支/天(p<0.001),但百万分率(ppm)的一氧化碳浓度从21.0 ppm增至33.0 ppm(p<0.001)。使用尼古丁吸入器时,每日吸烟量也有类似下降,从19.1支/天降至4.8支/天(p<0.001),但一氧化碳浓度从21.0 ppm降至12.7 ppm(p<0.001)。使用日蚀牌香烟时,血液尼古丁浓度保持相当稳定,从16.8纳克/毫升略有增至18.0纳克/毫升,而使用吸入器时则显著下降,从16.8纳克/毫升降至12.2纳克/毫升(p<0.002)。使用日蚀牌香烟时,渴求感和戒断反应并未增加。日蚀牌香烟几乎未出现显著不良事件。

结论

日蚀牌香烟可大幅减少香烟消费量,且不会引起戒断症状,也不会降低尼古丁浓度或完全丧失戒烟动机。与吸入器不同,日蚀牌香烟会使一氧化碳浓度升高。因此,日蚀牌香烟可能并非更安全的香烟。

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