轻度吸烟的非洲裔美国人中采用安非他酮戒烟：随机对照试验
2012/02/29
背景：前期的研究显示，安非他酮缓释剂能有效帮助白人和中度至重度吸烟（每天[CPD]≥10支）的非洲裔美国人戒烟。本试验评价安非他酮缓释剂是否能帮助轻度吸烟（≤10 CPD）的非洲裔美国人戒烟。
方法：本研究为在2007年12月27日～2010年5月13日间实施的随机、双盲、安慰剂对照试验。所有参与者为年龄≥18岁、轻度吸烟（≤10 CPD）的非洲裔美国人。参与者随机分为2组，一组采用300 mg安非他酮缓释剂（150 mg，每日一次，连续3天，然后150 mg，每日两次）（n = 270），另一组采用安慰剂（n = 270）。治疗持续7周，同时最多给予6次的健康教育咨询。基础水平下检测血清可替宁含量（0周）。主要转归为26周时唾液可替宁含量证实的7天点戒断率，鉴别吸烟者和非吸烟者的截止值为15 ng/mL。同时检测治疗7周后结束后唾液可替宁含量证实的戒断率。采用logistic回归模型计算戒断的优势比和95%可信区间（CI）。所有统计学检验采用双尾。
结果：基础水平就诊时，参与者的吸烟程度平均为8.0 CPD，血清平均可替宁水平为275.8 ng/mL（SD = 155.8 ng/mL），最为常用的为薄荷醇烟（83.7%），睡觉醒来后30 min即开始吸烟（72.2%）。将那些失访的受试者假定为吸烟者，26周时检测的长期戒断率，安非他酮缓释剂组和安慰剂组无显著差异（13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82～2.35, P =0.23)。治疗7周结束时，可替宁含量证实的戒断率，安非他酮缓释剂组显著高于安慰剂组（23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78～4.77, P <0.001）。
结论：安非他酮缓释剂能有效促进轻度吸烟的非洲裔美国人药物治疗期间戒烟，但对于长期戒断无影响。有必要进行更多的研究，寻找在轻度吸烟的非洲裔美国人中维持戒断的方法。
方法：本研究为在2007年12月27日～2010年5月13日间实施的随机、双盲、安慰剂对照试验。所有参与者为年龄≥18岁、轻度吸烟（≤10 CPD）的非洲裔美国人。参与者随机分为2组，一组采用300 mg安非他酮缓释剂（150 mg，每日一次，连续3天，然后150 mg，每日两次）（n = 270），另一组采用安慰剂（n = 270）。治疗持续7周，同时最多给予6次的健康教育咨询。基础水平下检测血清可替宁含量（0周）。主要转归为26周时唾液可替宁含量证实的7天点戒断率，鉴别吸烟者和非吸烟者的截止值为15 ng/mL。同时检测治疗7周后结束后唾液可替宁含量证实的戒断率。采用logistic回归模型计算戒断的优势比和95%可信区间（CI）。所有统计学检验采用双尾。
结果：基础水平就诊时，参与者的吸烟程度平均为8.0 CPD，血清平均可替宁水平为275.8 ng/mL（SD = 155.8 ng/mL），最为常用的为薄荷醇烟（83.7%），睡觉醒来后30 min即开始吸烟（72.2%）。将那些失访的受试者假定为吸烟者，26周时检测的长期戒断率，安非他酮缓释剂组和安慰剂组无显著差异（13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82～2.35, P =0.23)。治疗7周结束时，可替宁含量证实的戒断率，安非他酮缓释剂组显著高于安慰剂组（23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78～4.77, P <0.001）。
结论：安非他酮缓释剂能有效促进轻度吸烟的非洲裔美国人药物治疗期间戒烟，但对于长期戒断无影响。有必要进行更多的研究，寻找在轻度吸烟的非洲裔美国人中维持戒断的方法。
（陈欣 审校）
J Natl Cancer Inst. 2012 Jan 25. [Epub ahead of print]
J Natl Cancer Inst. 2012 Jan 25. [Epub ahead of print]
Source
Affiliations of authors: Department of Preventive Medicine and Public Health (LSC, NLN, WSC, BF) and Department of Biostatistics (MSM), University of Kansas Medical Center, Kansas City, KS; University of Kansas Cancer Center, Kansas City, KS (LSC, NLN, MSM, WSC, BF); Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine and Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, CA (NLB); Center for Addiction and Mental Health, Department of Psychiatry, and Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON (RFT); Department of Family Medicine and Community Health (KSO) and Department of Medicine (JSA), University of Minnesota Medical School, Minneapolis, MN (KSO); Center for Health Equity, University of Minnesota Medical School, Minneapolis, MN (KSO, JSA).
Affiliations of authors: Department of Preventive Medicine and Public Health (LSC, NLN, WSC, BF) and Department of Biostatistics (MSM), University of Kansas Medical Center, Kansas City, KS; University of Kansas Cancer Center, Kansas City, KS (LSC, NLN, MSM, WSC, BF); Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine and Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, CA (NLB); Center for Addiction and Mental Health, Department of Psychiatry, and Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON (RFT); Department of Family Medicine and Community Health (KSO) and Department of Medicine (JSA), University of Minnesota Medical School, Minneapolis, MN (KSO); Center for Health Equity, University of Minnesota Medical School, Minneapolis, MN (KSO, JSA).
Abstract
BACKGROUND： Previous research demonstrated the efficacy of sustained release bupropion (bupropion SR) for smoking cessation in whites as well as moderate to heavy (≥10 cigarettes per day [CPD]) African American smokers. We evaluated whether bupropion SR was effective for smoking cessation among African American light smokers (≤10 CPD).
METHODS：A randomized, double-blind placebo-controlled trial was conducted from December 27, 2007, to May 13, 2010. All participants were African American light smokers (≤10 CPD), aged 18 years or older. Participants were randomly assigned to receive 300 mg bupropion SR (150 mg once daily for 3 days and then 150 mg twice daily) (n = 270 participants) or placebo (n = 270 participants) for 7 weeks, and up to six sessions of health education counseling. Serum cotinine was measured at baseline (week 0). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26; a cut point of 15 ng/mL differentiated smokers from nonsmokers. Salivary cotinine-verified smoking abstinence at end of medication treatment at week 7 was also examined. Odds ratios (OR) for smoking abstinence and 95% confidence intervals (CIs) were calculated using logistic regression models. All statistical tests were two-sided.
RESULTS：Participants at baseline visit (week 0) smoked an average of 8.0 CPD and had a mean serum cotinine level of 275.8 ng/mL (SD = 155.8 ng/mL); most used menthol cigarettes (83.7%) and smoked within 30 minutes of waking (72.2%). After imputing those lost to follow-up as smokers, no statistically significant difference in long-term smoking abstinence rates at week 26 was observed between bupropion SR and placebo groups (13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82 to 2.35, P = .23). Cotinine-verified smoking abstinence rate at end of medication week 7 was higher in the bupropion SR vs placebo group (23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78 to 4.77, P < .001).
CONCLUSIONS：Bupropion SR was effective in promoting smoking cessation during the medication phase of treatment but showed no effect on long-term smoking cessation among African American light smokers. More research is needed to identify strategies for sustaining abstinence among African American light smokers.
BACKGROUND： Previous research demonstrated the efficacy of sustained release bupropion (bupropion SR) for smoking cessation in whites as well as moderate to heavy (≥10 cigarettes per day [CPD]) African American smokers. We evaluated whether bupropion SR was effective for smoking cessation among African American light smokers (≤10 CPD).
METHODS：A randomized, double-blind placebo-controlled trial was conducted from December 27, 2007, to May 13, 2010. All participants were African American light smokers (≤10 CPD), aged 18 years or older. Participants were randomly assigned to receive 300 mg bupropion SR (150 mg once daily for 3 days and then 150 mg twice daily) (n = 270 participants) or placebo (n = 270 participants) for 7 weeks, and up to six sessions of health education counseling. Serum cotinine was measured at baseline (week 0). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26; a cut point of 15 ng/mL differentiated smokers from nonsmokers. Salivary cotinine-verified smoking abstinence at end of medication treatment at week 7 was also examined. Odds ratios (OR) for smoking abstinence and 95% confidence intervals (CIs) were calculated using logistic regression models. All statistical tests were two-sided.
RESULTS：Participants at baseline visit (week 0) smoked an average of 8.0 CPD and had a mean serum cotinine level of 275.8 ng/mL (SD = 155.8 ng/mL); most used menthol cigarettes (83.7%) and smoked within 30 minutes of waking (72.2%). After imputing those lost to follow-up as smokers, no statistically significant difference in long-term smoking abstinence rates at week 26 was observed between bupropion SR and placebo groups (13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82 to 2.35, P = .23). Cotinine-verified smoking abstinence rate at end of medication week 7 was higher in the bupropion SR vs placebo group (23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78 to 4.77, P < .001).
CONCLUSIONS：Bupropion SR was effective in promoting smoking cessation during the medication phase of treatment but showed no effect on long-term smoking cessation among African American light smokers. More research is needed to identify strategies for sustaining abstinence among African American light smokers.
J Natl Cancer Inst. 2012 Jan 25. [Epub ahead of print]
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