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尼古丁托布研究中心。作者手稿；于 PMC 2011 年 1 月 28 日发布。
以最终编辑形式发布为：
号码：10.1080/14622200701540820
Efficacy of bupropion alone and in combination with nicotine gum
安非他酮单独使用以及与尼古丁口香糖联合使用的功效
出版商对本文的最终编辑版本可在 Nicotine Tob Res 获取
Abstract 抽象的
In this double-blind placebo-controlled smoking cessation treatment study, 608 participants were randomly assigned to receive active bupropion and active 4-mg gum (AA, n = 228), active bupropion and placebo gum (AP, n = 224), or placebo bupropion and placebo gum (PP, n = 156). Relative to the PP group, the AA and AP groups were each significantly more likely to be abstinent at one week, end of treatment and six months, but not twelve months post-quit. After the first week post-quit there were no differences in abstinence rates between the AA and AP groups. There were no significant individual difference variables that moderated outcome beyond one week post-quit.
在这项双盲安慰剂对照戒烟治疗研究中，608 名参与者被随机分配接受活性安非他酮和活性 4 毫克口香糖（AA，n = 228）、活性安非他酮和安慰剂口香糖（AP，n = 224），或安慰剂安非他酮和安慰剂口香糖（PP，n = 156）。相对于 PP 组，AA 组和 AP 组在治疗结束后一周、戒烟后六个月（但不是十二个月）戒烟的可能性明显更高。戒烟后第一周后，AA 组和 AP 组之间的戒烟率没有差异。戒烟后一周后，没有显着的个体差异变量可以调节结果。
关键词：安非他酮，尼古丁口香糖，戒烟
Introduction 介绍
Tobacco dependence is a chronic and pandemic disease (Fiore et al., 2000) that most commonly takes the form of cigarette smoking. In the United States, more than one-fifth of all adults smoke cigarettes (Centers for Disease Control, 2004, 2005) and approximately 15 million smokers make a quit attempt every year (Centers for Disease Control, 2002, 2004). Of these, fewer than 5% are able to maintain long-lasting abstinence (Centers for Disease Control, 2002). Smokers can increase the odds of quitting successfully by using cessation aids in their quit attempts (e.g., pharmacotherapy; counseling; Fiore et al., 2000), and over time, an increasing percentage of smokers have used such aids (e.g., Pierce & Gilpin, 2002; Solberg et al., 2001; Zhu, Melcer, Sun, Rosbrook & Pierce, 2000).
烟草依赖是一种慢性流行性疾病（Fiore 等，2000），最常见的形式是吸烟。在美国，超过五分之一的成年人吸烟（疾病控制中心，2004，2005），每年约有 1500 万吸烟者尝试戒烟（疾病控制中心，2002，2004）。其中，只有不到 5% 的人能够保持长期禁欲（疾病控制中心，2002 年）。吸烟者可以通过在戒烟尝试中使用戒烟辅助工具来增加成功戒烟的几率（例如，药物治疗；咨询；Fiore 等，2000），并且随着时间的推移，使用此类辅助工具的吸烟者比例不断增加（例如，Pierce & Gilpin） ，2002 年；Solberg 等人，2001 年；Zhu、Melcer、Sun、Rosbrook & Pierce，2000 年）。
Even with effective smoking cessation aids, only about 15-30% of smokers achieve long-term abstinence in a given quit attempt (Fiore et al., 2000). Therefore, it is vital to develop more effective cessation aids and more effective strategies for using such aids. One promising option for improving tobacco dependence treatment is combination pharmacotherapy. The 2000 Public Health Service Guideline (Fiore et al., 2000) recommended combination pharmacotherapies on the basis of a meta-analysis that showed that combinations were more efficacious than monotherapies (a single drug by itself; see also Richmond & Zwar, 2003). However, the Public Health Service Guideline research addressed only combinations of different nicotine replacement therapies (NRTs). Very little research has been done on combination therapies comprising bupropion – which has been shown to be an effective treatment when used by itself. The current study is a randomized clinical trail evaluating the efficacy of a combination of two first-line pharmacotherapies, bupropion SR and 4-mg nicotine gum, compared to bupropion SR alone and a double placebo control condition.
即使使用有效的戒烟辅助工具，也只有约 15-30% 的吸烟者在一次特定的戒烟尝试中实现了长期戒烟（Fiore 等，2000）。因此，开发更有效的戒烟辅助工具和更有效的使用此类辅助工具的策略至关重要。改善烟草依赖治疗的一种有前景的选择是联合药物治疗。 2000 年公共卫生服务指南（Fiore 等人，2000 年）根据一项荟萃分析推荐了联合药物疗法，该分析表明联合疗法比单一疗法（单一药物本身；另见 Richmond 和 Zwar，2003 年）更有效。然而，公共卫生服务指南研究仅涉及不同尼古丁替代疗法（NRT）的组合。关于包含安非他酮的联合疗法的研究很少——事实证明，单独使用安非他酮是一种有效的治疗方法。目前的研究是一项随机临床试验，评估两种一线药物疗法（安非他酮 SR 和 4 毫克尼古丁口香糖）组合的疗效，与单独使用安非他酮 SR 和双安慰剂对照条件进行比较。
While research strongly supports the efficacy of both bupropion and nicotine gum as monotherapies (Fiore et al., 2000) this is the first study to examine the efficacy of combining the two. Previous combination pharmacotherapy research has shown that adding the nicotine patch (a steady-state NRT) to bupropion did not improve cessation rates beyond those found with bupropion alone (Jorenby et al., 1999). In this study, we hypothesized that combining a non-nicotine pharmacotherapy (i.e., bupropion) with an ad lib nicotine replacement therapy (i.e., nicotine gum) would improve abstinence rates. As an ad lib pharmacotherapy, the nicotine gum allows smokers to respond acutely to stressors or strong temptations by using gum. Moreover, we hypothesized that the two drugs might have additive or synergistic effects because they appear to act via different neuropharmacologic mechanisms (Ascher et al., 1995; Ferry & Johnston, 2003; Shiffman et al., 2003). We also wanted to examine the effect of this combination pharmacotherapy on weight gain during smoking cessation.
虽然研究强烈支持安非他酮和尼古丁口香糖作为单一疗法的功效（Fiore 等，2000），但这是第一项检验两者结合的功效的研究。先前的联合药物治疗研究表明，与单独使用安非他酮相比，在安非他酮中添加尼古丁贴片（一种稳态 NRT）并没有改善戒烟率（Jorenby 等，1999）。在这项研究中，我们假设将非尼古丁药物疗法（即安非他酮）与随意尼古丁替代疗法（即尼古丁口香糖）相结合将提高戒烟率。作为一种随意的药物疗法，尼古丁口香糖允许吸烟者通过使用口香糖对压力源或强烈的诱惑做出敏锐的反应。此外，我们假设这两种药物可能具有相加或协同作用，因为它们似乎通过不同的神经药理学机制发挥作用（Ascher 等，1995；Ferry & Johnston，2003；Shiffman 等，2003）。我们还想检查这种联合药物疗法对戒烟期间体重增加的影响。
Tobacco dependence treatment could be improved if treatments could be assigned to the individuals for whom they would be most effective. Therefore, a second aim of this research was to explore potential moderators of treatment effects, in particular gender and tobacco dependence. Some data suggest that NRT produces differential abstinence rates in men and women, such that women attain lower cessation rates than do men (e.g., Bohadana, Nilsson, Rasmussen, & Martinet, 2003; Wetter et al., 1999). However, there is evidence that bupropion may eliminate this gender discrepancy (Collins et al., 2004; Smith et al., 2003; Scharf & Shiffman, 2004). This research will examine whether bupropion alone, or the bupropion + gum combination, produces differential benefit in the two sexes. Tobacco dependence is another important, potential moderator. Measures of tobacco dependence (e.g., Fagerström Tolerance Questionnaire; Fagerström, 1978) have been shown to predict differential response to treatment (Fagerstrom & Schneider, 1989). The current study comprised several different measures of dependence that were examined for relations with treatment effects. We also explored other potential moderators, such as age, history of depression, race, and length of previous quit attempts.
如果可以将治疗分配给最有效的个体，则可以改善烟草依赖治疗。因此，这项研究的第二个目的是探索治疗效果的潜在调节因素，特别是性别和烟草依赖。一些数据表明，NRT 在男性和女性中产生不同的戒烟率，因此女性的戒烟率低于男性（例如，Bohadana、Nilsson、Rasmussen 和 Martinet，2003 年；Wetter 等人，1999 年）。然而，有证据表明安非他酮可以消除这种性别差异（Collins 等人，2004 年；Smith 等人，2003 年；Scharf 和 Shiffman，2004 年）。这项研究将检验单独使用安非他酮或安非他酮+口香糖组合是否对两种性别产生不同的益处。烟草依赖是另一个重要的、潜在的调节因素。烟草依赖的测量（例如，Fagerström 耐受性问卷；Fagerström，1978）已被证明可以预测对治疗的不同反应（Fagerstrom 和 Schneider，1989）。当前的研究包括几种不同的依赖性测量方法，检查这些测量方法与治疗效果的关系。我们还探讨了其他潜在的调节因素，例如年龄、抑郁史、种族以及之前尝试戒烟的时间长度。
In sum, there are two main study goals: 1) determine the efficacy of the combination of bupropion and nicotine gum, bupropion alone, and a placebo condition in promoting abstinence from smoking; and 2) identify moderators of treatment effects, such as gender or tobacco dependence, that might be used to develop treatment algorithms.
总之，有两个主要研究目标：1）确定安非他酮和尼古丁口香糖的组合、单独使用安非他酮以及安慰剂条件在促进戒烟方面的功效； 2）确定治疗效果的调节因素，例如性别或烟草依赖，可用于开发治疗算法。
Methods 方法
Participants 参加者
Participants were recruited through TV, radio and newspaper advertisements and community flyers. Eligible participants reported smoking 10 or more cigarettes per day and being motivated to quit smoking. Participants denied any physical or mental health issues that would prevent them from participating in or completing the study. Female participants were not pregnant or breast-feeding and agreed to take steps to prevent pregnancy during treatment.
参与者是通过电视、广播和报纸广告以及社区传单招募的。符合条件的参与者报告每天吸 10 支或更多香烟，并有戒烟的动力。参与者否认存在任何妨碍他们参与或完成研究的身体或心理健康问题。女性参与者没有怀孕或哺乳，并同意在治疗期间采取措施预防怀孕。
Procedure 程序
Participants who passed a phone screen were invited to an Orientation Session where they provided written informed consent, as well as demographic and smoking history information. Participants then attended a Baseline Session during which they underwent multiple screenings, including a physical examination and a carbon monoxide (CO) breath test (excluded if CO < 10 parts per million). Participants also completed health-screening questionnaires (i.e., Primary Care Evaluation of Mental Disorders, Spitzer et al., 1994; Center for Epidemiologic Studies Depression Scale, Radloff, 1977) to assess for medical or psychological exclusion criteria including: Center for Epidemiologic Studies Depression Scale scores greater than 16, heavy alcohol use, history of eating disorders, and suicidality. Finally, participants completed the Fagerström Test of Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerström, 1991), the Nicotine Dependence Syndrome Scale (Shiffman, Waters, & Hickcox, 2004), the Tobacco Dependence Screener (Kawakami, Takatsuka, Inaba, & Shimizu, 1999), and the Wisconsin Inventory of Smoking Dependence Motives (Piper et al., 2004).
通过电话筛选的参与者被邀请参加迎新会，他们在会上提供了书面知情同意书以及人口统计和吸烟史信息。然后，参与者参加了基线会议，在此期间他们接受了多次筛查，包括体检和一氧化碳 (CO) 呼气测试（如果 CO < 百万分之十则除外）。参与者还完成了健康筛查问卷（即《精神疾病初级保健评估》，Spitzer 等人，1994 年；流行病学研究中心抑郁量表，Radloff，1977 年），以评估医学或心理排除标准，包括： 流行病学研究中心抑郁症量表得分大于 16、酗酒、饮食失调史和自杀倾向。最后，参与者完成了 Fagerström 尼古丁依赖测试（Heatherton、Kozlowski、Frecker 和 Fagerström，1991 年）、尼古丁依赖综合症量表（Shiffman、Waters 和 Hickcox，2004 年）、烟草依赖筛查仪（Kawakami、Takatsuka、Inaba、 & Shimizu，1999），以及威斯康星州吸烟依赖动机清单（Piper 等，2004）。
At the Baseline Session, eligible participants were randomized to one of the three treatment conditions: Active bupropion SR (150 mg, b.i.d.) + Active 4-mg nicotine gum (AA, n = 228); Active bupropion SR + Placebo nicotine gum (AP, n = 224); or Placebo bupropion SR + Placebo gum (PP, n = 156). The PP group is considerably smaller than the two active treatments so that there is more power to detect a difference between the active groups, which was hypothesized to be a smaller effect than an active versus placebo comparison. Randomization was conducted in double-blind fashion using blocked randomization within each of the 10 cohorts. Participants received brief (10-minute) smoking cessation counseling during which they set a quit date for the following week and their study medications, which they were instructed to use in a manner consistent with the package inserts. Specifically, participants were instructed to begin taking their study pills a week before their target quit date and continue taking the pills for nine weeks (eight weeks post-quit) and to begin chewing their study gum on their quit day and continue using the gum for eight weeks. Staff encouraged participants to chew up to 12 pieces of gum per day to cope with withdrawal symptoms and aid their quit attempt. Finally, participants provided a blood sample for cotinine analysis.
在基线会议上，符合条件的参与者被随机分配到三种治疗条件之一：活性安非他酮 SR（150 毫克，每日两次）+ 活性 4 毫克尼古丁口香糖（AA，n = 228）；活性安非他酮 SR + 安慰剂尼古丁口香糖（AP，n = 224）；或安慰剂安非他酮 SR + 安慰剂口香糖（PP，n = 156）。 PP 组比两种活性治疗组要小得多，因此更有能力检测活性组之间的差异，据推测，这比活性治疗组与安慰剂比较的效果更小。随机化是在 10 个队列中的每一个队列中使用分组随机化以双盲方式进行的。参与者接受了简短（10 分钟）的戒烟咨询，在此期间他们设定了下周的戒烟日期和研究药物，并指示他们按照包装说明书的方式使用这些药物。具体来说，参与者被要求在目标戒烟日期前一周开始服用研究药物，并继续服用药物九周（戒烟后八周），并在戒烟日开始咀嚼研究口香糖，并继续使用口香糖八周。工作人员鼓励参与者每天咀嚼最多 12 块口香糖，以应对戒断症状并帮助他们尝试戒烟。最后，参与者提供了血液样本用于可替宁分析。
After the Baseline Session, participants attended one session per week for four weeks and then two more sessions every other week. They received brief counseling at both the Quit Day Session and the first post-quit session (in addition to the Baseline Session) for a total of three 10-minute counseling sessions over three weeks. The counseling, provided by bachelor-degree-level staff, was designed to provide the most effective elements recommended by the Public Health Service Guideline: intra-treatment social support, information and problem-solving, and aid in seeking extra-treatment social support (Fiore et al., 2000). Counseling sessions were periodically audiotaped so that a licensed clinical psychologist could assess adherence to the counseling protocol. At the remaining sessions participants completed questionnaires, had their vital signs assessed and received study medications.
基线课程结束后，参与者每周参加一次课程，持续四个星期，然后每隔一周再参加两次课程。他们在戒烟日会议和第一次戒烟后会议（除了基线会议）上接受了简短的咨询，在三周内总共接受了 3 次 10 分钟的咨询会议。咨询由学士学位级别的工作人员提供，旨在提供《公共卫生服务指南》推荐的最有效的要素：治疗中的社会支持、信息和问题解决以及寻求治疗外社会支持的帮助（ Fiore 等人，2000）。咨询课程会定期录音，以便有执照的临床心理学家可以评估对咨询方案的遵守情况。在剩下的课程中，参与者完成了问卷调查，评估了他们的生命体征并接受了研究药物。
Data collection 数据采集
Data regarding smoking, vital signs (e.g., weight, blood pressure), medication use, affect (Positive and Negative Affect Schedule; Watson, Clark, & Tellegen, 1988) and withdrawal symptoms (Wisconsin Smoking Withdrawal Scale, Welsch et al., 1999) were collected at each study visit. In addition, participants completed a diary each day for the nine weeks of treatment which assessed number of cigarettes smoked, number of pieces of gum chewed, and the severity of withdrawal symptoms: depressed mood, difficulty sleeping, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness, and increased appetite. Participants also carried cellular phones for two weeks, centered around the quit date, to collect real-time data on symptoms and events.
有关吸烟、生命体征（例如体重、血压）、药物使用、情绪（积极和消极情绪表；Watson、Clark 和 Tellegen，1988 年）和戒断症状（威斯康星州吸烟戒断量表，Welsch 等人，1999 年）的数据）在每次研究访问时收集。此外，参与者在九周的治疗中每天完成一份日记，评估吸烟的数量、咀嚼的口香糖的数量以及戒断症状的严重程度：情绪低落、睡眠困难、烦躁、沮丧或愤怒、焦虑、注意力不集中、烦躁不安、食欲增加。参与者还以戒烟日期为中心携带手机两周，以收集有关症状和事件的实时数据。
Follow-up 跟进
Participants were followed-up monthly after treatment via telephone until relapse. Relapse was defined as smoking for three days in a row. We used a three-day criterion for relapse based on our previous research (e.g., Zelman, Brandon, Jorenby & Baker, 1992). Subsequently, an workgroup proposed that seven consecutive days should be the definition of treatment failure (Hughes et al., 2003). During follow-up calls participants completed a smoking calendar, similar to the Timeline Followback method for alcohol use (Sobell & Sobell, 1992), in which they reported all smoking during the previous month (or since previous contact) as well as use of other smoking cessation aids. Follow-up calls also solicited ratings of withdrawal symptoms, feeling fatigued/tired of trying to quit, confidence in ability to smoke and not return to smoking, motivation to stay quit based on the individual’s experiences during the previous seven days and suicidal ideation.
治疗后每月对参与者进行电话随访，直至复发。复发被定义为连续三天吸烟。根据我们之前的研究，我们使用三天复发标准（例如，Zelman、Brandon、Jorenby 和 Baker，1992）。随后，一个工作组提出连续 7 天应作为治疗失败的定义（Hughes 等，2003）。在后续电话中，参与者填写了一份吸烟日历，类似于饮酒的时间线追踪方法（Sobell & Sobell，1992），其中他们报告了上个月（或自上次接触以来）的所有吸烟情况以及使用其他药物的情况。戒烟辅助工具。后续电话还询问了戒断症状的评级、对尝试戒烟感到疲劳/厌倦、对吸烟能力和不再吸烟的信心、根据个人过去 7 天的经历保持戒烟的动机以及自杀意念。
Follow-up via telephone was attempted at six and 12 months post quit-day, with all participants. During the six- and 12-month follow-up calls all participants answered questions about smoking, suicidality, withdrawal, and affect. Participants who reported 7-day point prevalent abstinence (no smoking, not even a puff, during the seven days prior to the follow-up call) at their 6- or 12-month follow-up calls were scheduled to return to the clinic and provide either a breath sample for carbon monoxide analysis (six and twelve months) or a blood sample for cotinine analysis (12-months). Participants who could not be reached at follow-up were considered to be smoking for the purposes of follow-up analyses. Both 7-day point-prevalence abstinence and continuous abstinence were used as outcome measures.
戒烟日后 6 个月和 12 个月尝试通过电话对所有参与者进行随访。在 6 个月和 12 个月的随访电话中，所有参与者都回答了有关吸烟、自杀、戒断和情感的问题。在 6 或 12 个月的随访中报告 7 天点普遍戒烟（在随访前的 7 天内不吸烟，甚至不吸一口烟）的参与者计划返回诊所并提供呼吸样本用于一氧化碳分析（六个月和十二个月）或血液样本用于可替宁分析（12 个月）。出于后续分析的目的，在随访时无法联系到的参与者被视为吸烟。 7 天点流行戒断和持续戒断都被用作结果衡量标准。
Power 力量
Using a two-tailed power analyses with α=.05, this study is adequately powered to detect approximately a 12% difference in abstinence rates among the three treatment conditions (AA, AP, PP). Power calculations were based on the assumption that approximately 30% of participants receiving active bupropion alone will be abstinent at 12 months and that only 15% of the participants in the double placebo condition will be abstinent at 12 months (see Hurt et al., 1997; Jorenby et al., 1999). We assumed that using 4-mg nicotine gum would result in abstinence rates of approximately 40% at 12 months (Herrera et al., 1995; Kornitzer, Kittle, Dramaix, & Bourdous, 1997; Tonnesen et al., 1988).
使用 α=0.05 的双尾功效分析，本研究有足够的功效来检测三种治疗条件（AA、AP、PP）之间大约 12% 的戒断率差异。功效计算基于这样的假设：仅接受活性安非他酮的参与者中约 30% 将在 12 个月时戒酒，而双安慰剂条件下只有 15% 的参与者将在 12 个月时戒酒（参见 Hurt 等，1997） ；乔伦比等人，1999）。我们假设使用 4 毫克尼古丁口香糖将导致 12 个月时戒烟率约为 40%（Herrera 等人，1995 年；Kornitzer、Kittle、Dramix 和 Bourdous，1997 年；Tonnesen 等人，1988 年）。
Results 结果
Study enrollment began in 2001 and was completed in October 2002 (see Figure 1). Data collection was completed in January 2004. All analyses were conducted using SPSS 14.0 software. All analyses are intent-to-treat unless otherwise noted.
研究招募于 2001 年开始，并于 2002 年 10 月完成（见图 1）。数据收集于2004年1月完成。所有分析均使用SPSS 14.0软件进行。除非另有说明，所有分析均为意向治疗。
CONSORT figure of participant flow through the study.
研究中参与者流程的 CONSORT 图。
Participant Characteristics
参与者特征
Six hundred and eight smokers (57.9% women) participated in this study (see Table 1 for demographic information). Treatment conditions did not differ significantly (p > .05) on any demographic variables or tobacco dependence indicators (e.g., Fagerström Test of Nicotine Dependence, cigarettes smoked per day) or depression symptoms (e.g., Center for Epidemiologic Studies Depression Scale score; data not shown). In addition, during treatment there was no differential attrition across treatment conditions (χ2 = 2.86, p = .24). At 73.1% of study visits it was judged that participants were taking their pills as directed by study staff (i.e., they returned the correct number of pills plus or minus two) and compliance did not differ amongst treatment conditions (χ2 = 3.69, p = .16). Participants across the three treatment conditions did not differ in gum use (M = 4.17 pieces per day [SD = 3.4], F (2, 412) = .26, p = .77). A total of 781 adverse events were reported in this study. The most common adverse events were insomnia (4.73% of all adverse events), headache (2.59% of all adverse events) and cold symptoms (2.57% of all adverse events).
608 名吸烟者（57.9% 为女性）参与了这项研究（人口统计信息见表 1）。治疗条件在任何人口统计学变量或烟草依赖指标（例如，Fagerström 尼古丁依赖测试、每天吸的香烟）或抑郁症状（例如，流行病学研究中心抑郁量表评分）上没有显着差异 (p > .05)；数据未所示）。此外，在治疗期间，不同治疗条件之间的磨损没有差异（χ 2 = 2.86，p = .24）。在 73.1% 的研究访问中，判断参与者按照研究人员的指示服用药物（即，他们归还了正确数量的药片加或减两），并且依从性在治疗条件之间没有差异（χ 2
Table 1 表格1
Participant demographics.
参与者人口统计。
| Total (N=608) 总计 (N=608) | Active Bupropion, Active Gum (n = 228) 活性安非他酮、活性口香糖 (n = 228) | Active Bupropion, Placebo Gum (n = 224) 活性安非他酮、安慰剂口香糖 (n = 224) | Placebo Bupropion, Placebo Gum (n = 156) 安慰剂安非他酮、安慰剂口香糖 (n = 156) | |||||
|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | N | % | |
| Women 女性 | 352 | 57.9 | 127 | 55.7 | 135 | 60.3 | 90 | 57.7 |
| Hispanic 西班牙裔 | 10 | 1.6 | 4 | 1.8 | 3 | 1.3 | 3 | 1.9 |
| White 白色的 | 449 | 76.0 | 170 | 77.6 | 165 | 76.0 | 114 | 73.5 |
| African-American 非裔美国人 | 130 | 22.0 | 43 | 19.6 | 50 | 23.0 | 37 | 23.9 |
| Other race 其他种族 | 12 | 2.0 | 6 | 2.8 | 2 | 0.9 | 4 | 2.5 |
| Married 已婚 | 283 | 46.5 | 103 | 45.2 | 108 | 48.2 | 72 | 46.2 |
| High school education 高中阶段教育 | 186 | 30.7 | 79 | 34.8 | 66 | 29.5 | 41 | 26.6 |
| College degree 大专学历 | 98 | 16.2 | 35 | 15.4 | 32 | 14.3 | 31 | 20.1 |
| Employed for wages 受雇领取工资 | 414 | 69.2 | 154 | 69.1 | 147 | 66.5 | 113 | 73.4 |
| Household income < $25,000 家庭收入 < 25,000 美元 | 174 | 29.2 | 65 | 29.1 | 69 | 31.2 | 40 | 26.5 |
| Household income $50,000 or greater 家庭收入 50,000 美元或以上 | 208 | 34.9 | 71 | 31.9 | 80 | 36.2 | 57 | 37.7 |
| Mean 意思是 | SD | Mean 意思是 | SD | Mean 意思是 | SD | Mean 意思是 | SD | |
| Age | 41.78 | 11.34 | 41.14 | 11.30 | 42.26 | 11.41 | 42.03 | 11.31 |
| Age at first cigarette 第一次吸烟年龄 | 13.83 | 3.95 | 13.71 | 4.10 | 13.69 | 3.83 | 14.21 | 3.88 |
| Cigarettes smoked per day 每天吸的香烟数量 | 22.44 | 9.87 | 22.09 | 8.89 | 23.39 | 10.81 | 21.57 | 9.75 |
| Previous quit attempts 之前的戒烟尝试 | 6.06 | 13.28 | 6.03 | 13.55 | 5.61 | 10.56 | 6.70 | 15.98 |
| FTND Score FTND 分数 | 5.64 | 2.13 | 5.69 | 2.20 | 5.70 | 2.04 | 5.48 | 2.16 |
| Baseline CO level 基线二氧化碳水平 | 27.11 | 11.68 | 26.26 | 11.62 | 27.25 | 11.16 | 28.15 | 12.48 |
Efficacy 功效
The first hypothesis was that active pharmacotherapy (AA and AP groups) would improve cessation rates over placebo. A Cox Regression analysis of latency to relapse (defined as number of days to three consecutive days of smoking) conducted using 12-month follow-up data indicated that individuals who received active pharmacotherapy were statistically more likely to be abstinent than were individuals who received only placebo pharmacotherapy (AA: Wald = 11.64, OR = .64, p < .01; AP: Wald = 7.44, OR = .70, p < .01; see Figure 2 for survival curves). Logistic regression was used to predict CO-confirmed 7-day point-prevalence abstinence for the four different time-points with the double placebo condition (PP) coded as the baseline condition. See Table 2 for abstinence rates. Analyses revealed that at 1 week post-quit, both the AA (Wald = 23.41, OR = 3.12, p < .01) and AP (Wald = 10.38, OR = 2.15, p < .01) groups were significantly more likely to be abstinent than the PP group. These results also were true at the end of treatment (AA: Wald = 18.44, OR = 2.95, p < .01; AP: Wald = 9.17, OR = 2.17, p < .01) and at 6 months post-quit (AA: Wald = 3.78, OR = 1.71, p = .05; AP: Wald = 5.92, OR = 1.88, p = .02). At 12 months post-quit the active treatment conditions no longer differed statistically from the double placebo condition (AA: Wald = 3.21, OR = 1.67, p = .07; AP: Wald = 1.85, OR = 1.48, p = .17).
第一个假设是，与安慰剂相比，积极的药物治疗（AA 和 AP 组）会提高戒烟率。使用 12 个月的随访数据进行的复发潜伏期（定义为连续三天吸烟的天数）的考克斯回归分析表明，接受积极药物治疗的个体比仅接受药物治疗的个体更有可能戒烟。安慰剂药物治疗（AA：Wald = 11.64，OR = .64，p < .01；AP：Wald = 7.44，OR = .70，p < .01；生存曲线见图 2）。使用 Logistic 回归来预测四个不同时间点的 CO 确认的 7 天点流行率戒断情况，并将双安慰剂条件 (PP) 编码为基线条件。禁欲率见表 2。分析显示，戒烟后 1 周，AA（Wald = 23.41，OR = 3.12，p < .01）和 AP（Wald = 10.38，OR = 2.15，p < .01）组更有可能比PP组禁欲。这些结果在治疗结束时（AA：Wald = 18.44，OR = 2.95，p < .01；AP：Wald = 9.17，OR = 2.17，p < .01）和戒烟后 6 个月（AA：Wald = 9.17，OR = 2.17，p < .01）也是正确的。 ：Wald = 3.78，OR = 1.71，p = .05；AP：Wald = 5.92，OR = 1.88，p = .02）。戒烟后 12 个月时，积极治疗条件与双安慰剂条件不再有统计学差异（AA：Wald = 3.21，OR = 1.67，p = .07；AP：Wald = 1.85，OR = 1.48，p = .17） 。
Survival curves for the three treatment conditions
三种治疗条件的生存曲线
Table 2 表2
7-day point prevalence abstinence rates (%) at various follow-up time points for each experimental condition
每个实验条件下不同随访时间点的 7 天点戒断率 (%)
| Active Bupropion, Active Gum 活性安非他酮、活性口香糖 | Active Bupropion, Placebo Gum (n = 224) 活性安非他酮、安慰剂口香糖 (n = 224) | Placebo Bupropion, Placebo Gum (n = 156) 安慰剂安非他酮、安慰剂口香糖 (n = 156) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time 时间 point 观点 | Total 全部的 (228) | Male 男性 (101) | Female 女性 (127) | Csn (173) | Af-Am (46) | Total 全部的 (224) | Male 男性 (89) | Female 女性 (135) | Csn (165) | Af-Am (50) | Total 全部的 (156) | Male 男性 (66) | Female 女性 (90) | Csn (114) | Af-Am (36) |
| 1 Week 1周 | 46.5 | 50.5 | 43.3 | 50.3 | 32.6 | 37.5 | 40.4 | 35.6 | 39.4 | 32.0 | 21.8 | 36.4 | 11.1 | 21.9 | 16.7 |
| End of Treatment 治疗结束 | 38.2 | 41.6 | 35.4 | 41.6 | 23.9 | 31.3 | 38.2 | 26.7 | 32.1 | 30.0 | 17.3 | 22.7 | 13.3 | 17.5 | 19.4 |
| 6 Months 6个月 | 22.8 | 24.8 | 21.3 | 26.0 | 10.9 | 24.6 | 33.7 | 18.5 | 27.9 | 16.0 | 14.7 | 19.7 | 11.1 | 15.8 | 13.9 |
| 12 Months 12个月 | 20.6 | 22.8 | 18.9 | 23.1 | 8.7 | 18.8 | 25.8 | 14.1 | 20.0 | 16.0 | 13.5 | 19.7 | 8.9 | 14.9 | 8.3 |
Csn = Caucasian; Af-Am = African America
Csn = 高加索人种； Af-Am = 非洲裔美国人
To determine whether combining 4-mg nicotine gum with active bupropion (AA) improved cessation rates above those produced by active bupropion alone (AP) logistic regression was used to analyze biochemically-confirmed 7-day point prevalence abstinence. The AA condition was coded as the baseline condition. Results revealed that relative to the individuals in the AA condition, those in the AP condition were significantly less likely to be abstinent at 1 week post-quit (Wald = 3.74, OR = .69, p = .05). However, there were no statistical differences in abstinence rates between the AA and AP groups at the end of treatment, 6-month post-quit or 12-month post-quit time points. The lack of significant differences between the two groups beyond the first week was confirmed in survival analyses.
为了确定 4 毫克尼古丁口香糖与活性安非他酮 (AA) 联合使用是否比单独使用活性安非他酮 (AP) 所产生的戒烟率有所改善，使用逻辑回归来分析生化确认的 7 天点戒烟率。 AA 条件被编码为基线条件。结果显示，相对于 AA 状态下的个体，AP 状态下的个体在戒烟后 1 周戒烟的可能性显着降低（Wald = 3.74，OR = .69，p = .05）。然而，在治疗结束时、戒烟后 6 个月或戒烟后 12 个月时间点，AA 组和 AP 组之间的戒烟率没有统计学差异。生存分析证实，第一周后两组之间没有显着差异。
In addition to analyzing relapse data, we examined latency to relapse (smoking at least one cigarette on three consecutive days) following a lapse (smoking a cigarette, even one puff). On average, participants managed to delay relapse for 47.57 (SD = 105.37) days after having their first cigarette following their quit attempt. We found that 65.7% of individuals who relapsed by the end of the study returned to daily smoking the same day they lapsed. Results of a linear regression indicated that treatment condition did not predict latency to relapse after a lapse nor did gender, depressive symptoms or nicotine dependence.
除了分析复吸数据外，我们还检查了复吸（吸一支烟，甚至吸一口）后复吸的潜伏期（连续三天至少吸一支烟）。平均而言，参与者在尝试戒烟后吸第一支烟后成功将复吸延迟了 47.57 (SD = 105.37) 天。我们发现，在研究结束时，65.7% 的复吸者在戒烟当天就恢复了日常吸烟。线性回归结果表明，治疗条件并不能预测戒烟后复发的潜伏期，性别、抑郁症状或尼古丁依赖也不能预测。
Another outcome of interest is whether particular pharmacotherapies prevent or delay weight gain following a smoking cessation attempt. A univariate ANOVA revealed no significant effects of treatment condition on weight gain between baseline and the end of treatment, with participants gaining an average of 1.53 kilograms (SD = 2.41). This was also true when weight was analyzed only in participants who were abstinent at the end of treatment. There was a main effect of gender such that women gained fewer kilograms by the end of treatment (M = 1.23, SD = 2.38) than did men (M = 1.90, SD = 2.41; t (417) = 2.85, p < .05); however, the gender by treatment interaction was not statistically significant.
另一个令人感兴趣的结果是特定的药物疗法是否可以预防或延缓戒烟尝试后的体重增加。单变量方差分析显示，治疗条件对基线和治疗结束之间体重增加没有显着影响，参与者平均增加 1.53 公斤（SD = 2.41）。当仅分析治疗结束时禁欲的参与者的体重时，情况也是如此。性别存在主要影响，即治疗结束时女性体重增加较少（M = 1.23，SD = 2.38），而男性则较少（M = 1.90，SD = 2.41；t (417) = 2.85，p < .05 ）；然而，治疗相互作用的性别差异不具有统计学意义。
Moderation of Treatment Effects
治疗效果的调节
Gender, age, race, number of cigarettes smoked per day, length of longest previous quit attempt, number of quit attempts, history of depression and dependence measures (Fagerström Test of Nicotine Dependence, Wisconsin Inventory of Smoking Dependence Motives-68 scales (WISDM-68), and Tobacco Dependence Screener) were tested as moderators using logistic regression. We modeled the main effects of treatment and the individual difference variables and the treatment by individual difference interactions on smoking status at all four follow-up time points (one week, end of treatment, six months and twelve months). There were significant main effects of gender at all three follow-up time points, after accounting for treatment, such that women were significantly more likely to be smoking than were men (one week: Wald = 7.97, OR = .61, p = .01; end of treatment: Wald = 5.75, OR = .65, p = .02; six months: Wald = 7.19, OR = .59, p = .01). There was a significant gender x treatment interaction, but only at one week post-quit (Wald = 4.46, OR = .61, p = .01). Women who received placebo pharmacotherapy were significantly more likely to be smoking (88.9%) than were men who received active (54.2%) or placebo (63.6%) pharmacotherapy or women who received active pharmacotherapy (60.7%). Length of previous quit attempts, race, the Fagerström Test of Nicotine Dependence, the WISDM-68 Automaticity subscale, the WISDM-68 Social/Environmental Goads subscale, and the WISDM-68 Tolerance subscale were all significantly related to outcome, but there were no significant interactions between these variables and treatment. There were no moderating effects for any individual difference variables.
性别、年龄、种族、每天吸香烟的数量、之前戒烟尝试的最长时长、戒烟尝试的次数、抑郁史和依赖性测量（Fagerström 尼古丁依赖测试、威斯康星州吸烟依赖动机清单 - 68 量表（WISDM- 68）和烟草依赖性筛查）作为调节因素使用逻辑回归进行测试。我们在所有四个随访时间点（一周、治疗结束、六个月和十二个月）对治疗和个体差异变量的主要影响以及个体差异相互作用对吸烟状况的治疗进行了建模。考虑到治疗后，性别在所有三个随访时间点都有显着的主效应，因此女性比男性更有可能吸烟（一周：Wald = 7.97，OR = .61，p = . 01；治疗结束：Wald = 5.75，OR = .65，p = .02；六个月：Wald = 7.19，OR = .59，p = .01）。性别与治疗之间存在显着的相互作用，但仅在戒烟后一周出现（Wald = 4.46，OR = .61，p = .01）。接受安慰剂药物治疗的女性 (88.9%) 明显高于接受活性药物治疗 (54.2%) 或安慰剂 (63.6%) 药物治疗的男性或接受活性药物治疗的女性 (60.7%)。之前戒烟尝试的长度、种族、Fagerström 尼古丁依赖性测试、WISDM-68 自动性分量表、WISDM-68 社会/环境刺激分量表和 WISDM-68 耐受性分量表均与结果显着相关，但没有这些变量和治疗之间存在显着的相互作用。任何个体差异变量都没有调节作用。
Discussion 讨论
Data from this large clinical trial constitute additional evidence that bupropion enhances smoking cessation rates for at least six months following treatment initiation. Individuals who received active bupropion were approximately 1.5 times more likely to be abstinent at one week, the end of treatment, and six months post-quit than were those who received placebo. However, by the end of the first week, fewer than half of the individuals receiving active medication were abstinent. Moreover, by 1-year post-quit, the effect of bupropion had dwindled to non-significance. Therefore, these results underscore the need to develop interventions for tobacco use and dependence that yield larger and more durable effects.
这项大型临床试验的数据构成了额外的证据，表明安非他酮在治疗开始后至少六个月内可以提高戒烟率。接受活性安非他酮治疗的个体在治疗结束一周、以及戒烟后六个月戒烟的可能性比接受安慰剂的个体高出大约 1.5 倍。然而，到第一周结束时，接受积极药物治疗的人中只有不到一半能够戒断。此外，到戒烟后一年，安非他酮的作用已降至不显着。因此，这些结果强调需要制定针对烟草使用和依赖的干预措施，以产生更大、更持久的影响。
Our hypothesis that nicotine gum would augment the efficacy of bupropion was not supported when long-term outcomes were examined. Although gum was associated with a 10% boost in abstinence rates at one week post-quit, no significant effect of gum was detected at later time points. On average participants in all three treatment groups reported chewing four pieces of gum per day, which is at the low end of the recommended dose. If withdrawal amelioration is a mechanism via which nicotine gum exerts its effects, it is possible that participants would have achieved better clinical success if they had used more gum. However, great efforts were made to encourage high levels of gum use in this study. As other researchers have found, it may be difficult to foster high levels of gum use among quitting smokers (e.g., Fortmann & Killen, 1995; Glover et al., 1996; Mooney, Babb, Jensen & Hatsukami, 2005).
我们关于尼古丁口香糖会增强安非他酮疗效的假设在长期结果检查中并未得到支持。尽管口香糖与戒烟后一周戒断率提高 10% 相关，但在以后的时间点没有检测到口香糖的显着影响。所有三个治疗组的参与者平均每天咀嚼四块口香糖，这是推荐剂量的低端。如果戒断改善是尼古丁口香糖发挥作用的一种机制，那么如果参与者使用更多口香糖，他们可能会取得更好的临床成功。然而，本研究中为鼓励高水平使用口香糖做出了巨大努力。正如其他研究人员发现的那样，在戒烟者中培养高水平的口香糖使用可能很困难（例如，Fortmann & Killen，1995；Glover 等，1996；Mooney、Babb、Jensen & Hatsukami，2005）。
As many previous studies have shown, women were less likely to stop smoking than were men (Bjornson et al., 1995; Community Intervention Trial for Smoking Cessation Research Group, 1995; Wetter et al., 1999). As in past research (c.f., Smith et al., 2003), there was some evidence that bupropion neutralizes this gender difference but this interaction between gender and treatment was significant only at the 1-week mark. In addition, while some individual difference variables were related to smoking outcome, including length of previous quit attempts, race, the Fagerström Test of Nicotine Dependence, the WISDM-68 Automaticity subscale, the WISDM-68 Social/Environmental Goads subscale, and the WISDM-68 Tolerance subscale, none of these yielded significant moderation effects. Thus, this research provides little insight into how individual difference variables can be used to develop treatment assignment algorithms.
正如许多先前的研究表明，女性戒烟的可能性低于男性（Bjornson 等，1995；戒烟社区干预试验研究小组，1995；Wetter 等，1999）。与过去的研究一样（参见 Smith 等，2003），有一些证据表明安非他酮可以中和这种性别差异，但性别和治疗之间的这种相互作用仅在 1 周时才显着。此外，虽然一些个体差异变量与吸烟结果相关，包括之前戒烟尝试的时间长度、种族、Fagerström 尼古丁依赖性测试、WISDM-68 自动性分量表、WISDM-68 社会/环境刺激分量表和 WISDM -68 容忍分量表，这些都没有产生显着的调节效果。因此，这项研究对如何使用个体差异变量来开发治疗分配算法提供了很少的见解。
Limitations 局限性
There are limitations to this study. No group received only nicotine gum. Therefore, we were unable to assess the relative efficacy of nicotine gum alone. Although we have a good representation of both Caucasian and African-American participants, we have very little representation of other racial or ethnic groups, which adversely affects our ability to generalize to other racial or ethnic populations. It should also be noted that the results of this study may not generalize to the population of smokers at large, given that these results were obtained from smokers who were highly motivated to quit and underwent a relatively intensive research experience.
这项研究存在局限性。没有一组只接受尼古丁口香糖。因此，我们无法评估单独尼古丁口香糖的相对功效。尽管我们对白人和非裔美国人参与者都有很好的代表性，但对其他种族或族裔群体的代表性却很少，这对我们推广到其他种族或族裔人群的能力产生了不利影响。还应该指出的是，这项研究的结果可能无法推广到广大吸烟者群体，因为这些结果是从戒烟积极性很高并经历了相对深入的研究经验的吸烟者中获得的。
Conclusion 结论
This study supports the efficacy of bupropion as a smoking cessation pharmacotherapy, but it does not support the use of nicotine gum as a bupropion adjuvant. Thus, while there is strong evidence that combinations of NRT drugs enhance smoking cessation rates (Fiore et al., 2000; Richmond & Zwar, 2003), there is increasing evidence that NRT does not boost the efficacy of bupropion treatment. Unfortunately, this research also demonstrates the pressing need for continued research aimed at developing new pharmacotherapies for smoking cessation; most smokers receiving active treatments had begun to smoke by the first week post-treatment. Women, in particular, were at heightened risk for cessation failure.
该研究支持安非他酮作为戒烟药物疗法的功效，但不支持使用尼古丁口香糖作为安非他酮佐剂。因此，虽然有强有力的证据表明 NRT 药物的组合可以提高戒烟率（Fiore 等，2000；Richmond & Zwar，2003），但越来越多的证据表明 NRT 并不能提高安非他酮治疗的疗效。不幸的是，这项研究还表明迫切需要继续研究，旨在开发新的戒烟药物疗法；大多数接受积极治疗的吸烟者在治疗后第一周就开始吸烟。尤其是女性，戒烟失败的风险更高。
Acknowledgments 致谢
This research was supported by NIH Grants #P50-CA84724-05 and # P50-DA0197-06.
这项研究得到了 NIH 拨款 #P50-CA84724-05 和 # P50-DA0197-06 的支持。
Footnotes 脚注
This research was conducted at the University of Wisconsin, Madison
这项研究是在威斯康星大学麦迪逊分校进行的
Contributor Information 贡献者信息
Megan E. Piper, University of Wisconsin.
梅根·E·派珀，威斯康星大学。
E. Belle Federman, RTI International.
E. Belle Federman，RTI 国际。
Danielle E. McCarthy, Department of Psychology, Rutgers University, New Brunswick, NJ.
Danielle E. McCarthy，新泽西州新不伦瑞克罗格斯大学心理学系。
Daniel M. Bolt, University of Wisconsin.
丹尼尔·M·博尔特，威斯康星大学。
Stevens S. Smith, University of Wisconsin.
史蒂文斯·史密斯，威斯康星大学。
Michael C. Fiore, University of Wisconsin.
迈克尔·C·菲奥雷 (Michael C. Fiore)，威斯康星大学。
Timothy B. Baker, University of Wisconsin.
蒂莫西·贝克 (Timothy B. Baker)，威斯康星大学。
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