Silagy C, Lancaster T, Stead L, Mant D, Fowler G
Cochrane Database Syst Rev. 2004(3):CD000146. doi: 10.1002/14651858.CD000146.pub2.
The aim of nicotine replacement therapy (NRT) is to replace nicotine from cigarettes. This reduces withdrawal symptoms associated with smoking cessation thus helping resist the urge to smoke cigarettes.
The aims of this review were:to determine the effectiveness of the different forms of NRT (chewing gum, transdermal patches, nasal spray, inhalers and tablets) in achieving abstinence from cigarettes, or a sustained reduction in amount smoked; to determine whether the effect is influenced by the clinical setting in which the smoker is recruited and treated, the dosage and form of the NRT used, or the intensity of additional advice and support offered to the smoker; to determine whether combinations of NRT are more effective than one type alone; to determine its effectiveness compared to other pharmacotherapies.
We searched the Cochrane Tobacco Addiction Group trials register in March 2004.
Randomized trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow up of less than six months.
We extracted data in duplicate on the type of participants, the dose, duration and form of nicotine therapy, the outcome measures, method of randomization, and completeness of follow up. The main outcome measure was abstinence from smoking after at least six months of follow up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. For each study we calculated summary odds ratios. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed effect model.
We identified 123 trials; 103 contributing to the primary comparison between NRT and a placebo or non-NRT control group. The odds ratio (OR) for abstinence with NRT compared to control was 1.77 (95% confidence intervals (CI): 1.66 to 1.88). The ORs for the different forms of NRT were 1.66 (95% CI: 1.52 to 1.81) for gum, 1.81 (95% CI: 1.63 to 2.02) for patches, 2.35 (95% CI: 1.63 to 3.38) for nasal spray, 2.14 (95% CI: 1.44 to 3.18) for inhaled nicotine and 2.05 (95% CI: 1.62 to 2.59) for nicotine sublingual tablet/lozenge. These odds were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. In highly dependent smokers there was a significant benefit of 4 mg gum compared with 2 mg gum (OR 2.20, 95% CI: 1.85 to 3.25). There was weak evidence that combinations of forms of NRT are more effective. Higher doses of nicotine patch may produce small increases in quit rates. Only one study directly compared NRT to another pharmacotherapy. In this study quit rates with bupropion were higher than with nicotine patch or placebo.
REVIEWERS' CONCLUSIONS: All of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) are effective as part of a strategy to promote smoking cessation. They increase the odds of quitting approximately 1.5 to 2 fold regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the smoker. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT.
尼古丁替代疗法(NRT)的目的是替代香烟中的尼古丁。这可减轻与戒烟相关的戒断症状,从而有助于抵制吸烟的冲动。
本综述的目的是:确定不同形式的NRT(口香糖、透皮贴剂、鼻喷雾剂、吸入器和片剂)在实现戒烟或持续减少吸烟量方面的有效性;确定效果是否受吸烟者招募和治疗的临床环境、所用NRT的剂量和形式,或提供给吸烟者的额外建议和支持强度的影响;确定NRT联合使用是否比单一类型更有效;确定与其他药物疗法相比其有效性。
我们于2004年3月检索了Cochrane烟草成瘾组试验注册库。
将NRT与安慰剂或不治疗进行比较,或比较不同剂量NRT的随机试验。我们排除了未报告戒烟率以及随访时间少于6个月的试验。
我们对参与者类型、尼古丁治疗的剂量、持续时间和形式、结局指标、随机化方法以及随访完整性进行了重复数据提取。主要结局指标是至少随访6个月后的戒烟情况。我们对每个试验采用最严格的戒烟定义,如有可用数据则采用生化验证率。对于每项研究,我们计算汇总比值比。在适当情况下,我们使用Mantel-Haenszel固定效应模型进行荟萃分析。
我们识别出123项试验;103项有助于NRT与安慰剂或非NRT对照组之间的主要比较。与对照组相比,NRT戒烟的比值比(OR)为1.77(95%置信区间(CI):1.66至1.88)。不同形式NRT的OR分别为:口香糖1.66(95%CI:1.52至1.81)、贴剂1.81(95%CI:1.63至2.02)、鼻喷雾剂2.35(95%CI:1.63至3.38)、吸入性尼古丁2.14(95%CI:1.44至3.18)、尼古丁舌下片/含片2.05(95%CI:1.62至2.59)。这些比值在很大程度上与治疗持续时间、提供的额外支持强度或提供NRT的环境无关。在高度依赖吸烟的人群中,4毫克口香糖与2毫克口香糖相比有显著益处(OR 2.20,95%CI:1.85至3.25)。有微弱证据表明NRT联合使用形式更有效。较高剂量的尼古丁贴剂可能会使戒烟率略有提高。只有一项研究直接将NRT与另一种药物疗法进行了比较。在这项研究中,安非他酮的戒烟率高于尼古丁贴剂或安慰剂。
所有市售形式的NRT(口香糖、透皮贴剂、鼻喷雾剂、吸入器和舌下片/含片)作为促进戒烟策略的一部分都是有效的。无论环境如何,它们都能使戒烟几率提高约1.5至2倍。NRT的有效性似乎在很大程度上与提供给吸烟者的额外支持强度无关。提供更高强度的支持虽然有利于提高戒烟可能性,但对NRT的成功并非必不可少。