尼古丁替代疗法辅助戒烟的有效性和安全性：系统回顾和荟萃分析
2009/05/18
目的：确定尼古丁替代疗法辅助戒烟的有效性和安全性。
研究设计：对随机对照研究进行系统回顾。
数据来源：Cochrane数据库、Medline、Embase、CINAHL, PsychINFO, 科学引文检索、登记的正在进行的研究、参考文献列表、制药公司赞助的多数研究和临床专家观点。方法合格的研究为发表和未发表的随机对照试验，研究中需纳入吸烟人群（短期内不打算戒烟），有尼古丁替代治疗与安慰剂、不治疗、其他药物治疗或行为支持的对照，并且报告了戒烟率。分两个独立的专家评审小组，根据合格的评审条件，一组专家评估研究的质量和应用数据，另一组专家对这一过程进行检验。首要终点为通过单个患者数据分析评定的治疗开始连续6个月持续戒烟。其他终点包括随访结束时戒烟和吸烟量减少，以及不良反应。
数据组成：入选7个随机、安慰剂对照研究（4项使用尼古丁口香糖替代治疗，2项使用吸入尼古丁替代治疗，1项自由选择治疗方法）。这些研究以戒烟作为次要终点。研究共包括2767例吸烟人群，给予尼古丁替代治疗6～18个月，持续观察12～26个月。6.75%吸烟者使用尼古丁替代治疗后达到持续戒烟6个月，有效率是安慰剂的2倍，5个研究的相对风险（HR）固定效应为2.06（95% CI，1.34-3.15）；HR随机效应为1.99（95% CI，1.01-3.91）。需要治疗的人数为29。使用尼古丁替代治疗的吸烟者所有其他戒烟和吸烟量减少终点显著好于安慰剂组。除恶心外[在尼古丁组更常见（8.7% v 5.3%;OR为1.69, （95%CI，1.21-2.36））]，两组其他不良反应发生率相似：死亡的OR为1.00（95% CI，0.25-4.02）；严重不良反应的OR为1.16（95% CI，0.79-1.50）；由于不良反应引起的终止戒烟的OR为1.25（95% CI，0.64-2.51）。
结论：现有的研究显示，对于无意或不能马上戒烟的吸烟者，尼古丁替代治疗是获得持续戒烟的一种有效的方法，但是大部分研究都同时给予戒烟者常规行为支持和监测，因此不能确定在未接受常规咨询的戒烟者中，尼古丁替代治疗是否同样有效。
（刘国梁 卫生部中日友好医院呼吸内科 100029 摘译）
Moore D,et al.BMJ. 2009 Apr 2;338:b1024.
Moore D,et al.BMJ. 2009 Apr 2;338:b1024.
Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis
OBJECTIVE: To determine the effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking.
DESIGN: Systematic review of randomised controlled trials.
DATA SOURCES: Cochrane Library, Medline, Embase, CINAHL, PsychINFO, Science Citation Index, registries of ongoing trials, reference lists, the drug company that sponsored most of the trials, and clinical experts. Review methods Eligible studies were published or unpublished randomised controlled trials that enrolled smokers who declared no intention to quit smoking in the short term, and compared nicotine replacement therapy (with or without motivational support) with placebo, no treatment, other pharmacological therapy, or motivational support, and reported quit rates. Two reviewers independently applied eligibility criteria. One reviewer assessed study quality and extracted data and these processes were checked by a second reviewer. The primary outcome, six months sustained abstinence from smoking beginning during treatment, was assessed by individual patient data analysis. Other outcomes were cessation and reduction at end of follow-up, and adverse events.
DATA SYNTHESIS: Seven placebo controlled randomised controlled trials were included (four used nicotine replacement therapy gum, two nicotine replacement therapy inhaler, and one free choice of therapy). They were reduction studies that reported smoking cessation as a secondary outcome. The trials enrolled a total of 2767 smokers, gave nicotine replacement therapy for 6-18 months, and lasted 12-26 months. 6.75% of smokers receiving nicotine replacement therapy attained sustained abstinence for six months, twice the rate of those receiving placebo (relative risk (fixed effects) 2.06, 95% confidence interval 1.34 to 3.15; (random effects) 1.99, 1.01 to 3.91; five trials). The number needed to treat was 29. All other cessation and reduction outcomes were significantly more likely in smokers given nicotine replacement therapy than those given placebo. There were no statistically significant differences in adverse events (death, odds ratio 1.00, 95% confidence interval 0.25 to 4.02; serious adverse events, 1.16, 0.79 to 1.50; and discontinuation because of adverse events, 1.25, 0.64 to 2.51) except nausea, which was more common with nicotine replacement therapy (8.7% v 5.3%; odds ratio 1.69, 95% confidence interval 1.21 to 2.36).
CONCLUSIONS: Available trials indicate that nicotine replacement therapy is an effective intervention in achieving sustained smoking abstinence for smokers who have no intention or are unable to attempt an abrupt quit. Most of the evidence, however, comes from trials with regular behavioural support and monitoring and it is unclear whether using nicotine replacement therapy without regular contact would be as effective
研究设计：对随机对照研究进行系统回顾。
数据来源：Cochrane数据库、Medline、Embase、CINAHL, PsychINFO, 科学引文检索、登记的正在进行的研究、参考文献列表、制药公司赞助的多数研究和临床专家观点。方法合格的研究为发表和未发表的随机对照试验，研究中需纳入吸烟人群（短期内不打算戒烟），有尼古丁替代治疗与安慰剂、不治疗、其他药物治疗或行为支持的对照，并且报告了戒烟率。分两个独立的专家评审小组，根据合格的评审条件，一组专家评估研究的质量和应用数据，另一组专家对这一过程进行检验。首要终点为通过单个患者数据分析评定的治疗开始连续6个月持续戒烟。其他终点包括随访结束时戒烟和吸烟量减少，以及不良反应。
数据组成：入选7个随机、安慰剂对照研究（4项使用尼古丁口香糖替代治疗，2项使用吸入尼古丁替代治疗，1项自由选择治疗方法）。这些研究以戒烟作为次要终点。研究共包括2767例吸烟人群，给予尼古丁替代治疗6～18个月，持续观察12～26个月。6.75%吸烟者使用尼古丁替代治疗后达到持续戒烟6个月，有效率是安慰剂的2倍，5个研究的相对风险（HR）固定效应为2.06（95% CI，1.34-3.15）；HR随机效应为1.99（95% CI，1.01-3.91）。需要治疗的人数为29。使用尼古丁替代治疗的吸烟者所有其他戒烟和吸烟量减少终点显著好于安慰剂组。除恶心外[在尼古丁组更常见（8.7% v 5.3%;OR为1.69, （95%CI，1.21-2.36））]，两组其他不良反应发生率相似：死亡的OR为1.00（95% CI，0.25-4.02）；严重不良反应的OR为1.16（95% CI，0.79-1.50）；由于不良反应引起的终止戒烟的OR为1.25（95% CI，0.64-2.51）。
结论：现有的研究显示，对于无意或不能马上戒烟的吸烟者，尼古丁替代治疗是获得持续戒烟的一种有效的方法，但是大部分研究都同时给予戒烟者常规行为支持和监测，因此不能确定在未接受常规咨询的戒烟者中，尼古丁替代治疗是否同样有效。
（刘国梁 卫生部中日友好医院呼吸内科 100029 摘译）
Moore D,et al.BMJ. 2009 Apr 2;338:b1024.
Moore D,et al.BMJ. 2009 Apr 2;338:b1024.
Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis
OBJECTIVE: To determine the effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking.
DESIGN: Systematic review of randomised controlled trials.
DATA SOURCES: Cochrane Library, Medline, Embase, CINAHL, PsychINFO, Science Citation Index, registries of ongoing trials, reference lists, the drug company that sponsored most of the trials, and clinical experts. Review methods Eligible studies were published or unpublished randomised controlled trials that enrolled smokers who declared no intention to quit smoking in the short term, and compared nicotine replacement therapy (with or without motivational support) with placebo, no treatment, other pharmacological therapy, or motivational support, and reported quit rates. Two reviewers independently applied eligibility criteria. One reviewer assessed study quality and extracted data and these processes were checked by a second reviewer. The primary outcome, six months sustained abstinence from smoking beginning during treatment, was assessed by individual patient data analysis. Other outcomes were cessation and reduction at end of follow-up, and adverse events.
DATA SYNTHESIS: Seven placebo controlled randomised controlled trials were included (four used nicotine replacement therapy gum, two nicotine replacement therapy inhaler, and one free choice of therapy). They were reduction studies that reported smoking cessation as a secondary outcome. The trials enrolled a total of 2767 smokers, gave nicotine replacement therapy for 6-18 months, and lasted 12-26 months. 6.75% of smokers receiving nicotine replacement therapy attained sustained abstinence for six months, twice the rate of those receiving placebo (relative risk (fixed effects) 2.06, 95% confidence interval 1.34 to 3.15; (random effects) 1.99, 1.01 to 3.91; five trials). The number needed to treat was 29. All other cessation and reduction outcomes were significantly more likely in smokers given nicotine replacement therapy than those given placebo. There were no statistically significant differences in adverse events (death, odds ratio 1.00, 95% confidence interval 0.25 to 4.02; serious adverse events, 1.16, 0.79 to 1.50; and discontinuation because of adverse events, 1.25, 0.64 to 2.51) except nausea, which was more common with nicotine replacement therapy (8.7% v 5.3%; odds ratio 1.69, 95% confidence interval 1.21 to 2.36).
CONCLUSIONS: Available trials indicate that nicotine replacement therapy is an effective intervention in achieving sustained smoking abstinence for smokers who have no intention or are unable to attempt an abrupt quit. Most of the evidence, however, comes from trials with regular behavioural support and monitoring and it is unclear whether using nicotine replacement therapy without regular contact would be as effective
