患病吸烟患者的三联药物治疗：随机试验
2009/06/24
背景：患病吸烟患者出现烟草相关性并发症的风险增加。目前，对于三联药物治疗烟草依赖性的高风险吸烟患者的有效性尚缺乏临床数据支持。
目的：对标准治疗周期内单纯尼古丁贴剂治疗和延长治疗周期采用三联药物治疗的效果进行评价，检测6个月后吸烟患者的戒烟率。
设计：2005～2007年间的随机临床试验。
地点：单个初级卫生保健机构。
患者：研究对象为来源于当地社区的年龄≥18岁的吸烟患者。
干预措施：使用双盲随机分组将受试者分为尼古丁贴剂组（10周标准使用期，用量递减，n = 64）及尼古丁贴剂＋尼古丁口腔吸入剂＋丁氨苯丙酮组（n = 63）。未参与研究者运用电脑生成随机化分组表格，通过电话分配受试者。随机分组前，研究参与者均未接触该随机化分组表，确保盲法。对于治疗分配情况，研究者和受试者并未双盲。
检测指标：主要终点为通过测定戒烟后第26周7天呼出气中的一氧化碳含量，以确定该时点的戒烟率。次要终点包括到第1次复发（复吸）的间隔时间、药物使用时间及药物副作用等。以意向处理为基础，对结果进行分析，其中尼古丁贴剂组和联合治疗组的失访人数分别为13和18例，这些参与者被认定为仍处于吸烟状态。
结果：两组的基线特征相似。联合治疗组在26周后的戒断率为35％（22/63），而单纯贴剂治疗组为19％（12/64）（复发率为16％，95％ CI：1％～31％；P = 0.040）。联合治疗组的校正OR为2.57（CI, 1.05～6.32；P = 0.041）。联合治疗组复发的中位间隔时间显著长于单纯贴剂治疗组（65天vs. 23天；P = 0.005）。治疗副作用在联合治疗组中更为常见（如：失眠[25％ vs. 9％]；焦虑[22％ vs. 3％]）。但两组因为副作用而中断治疗的受试者比例相当（6％）。
局限性：约有25％的受试者失访（两组失访者比例接近）。治疗者和受试者不是完全双盲。
结论：对于门诊吸烟患者，剂量可灵活掌握的三联药物戒烟治疗在长达6个月的治疗期中，效果优于标准疗程的单纯尼古丁贴剂治疗。
（刘国梁 审校）
Steinberg MB, et al. Ann Intern Med. 2009 Apr 7;150(7):447-54
Triple-combination pharmacotherapy for medically ill smokers: a randomized trial.
BACKGROUND: Smokers with medical illnesses are at particular risk for complications caused by tobacco. Clinical trial data on the effectiveness of triple-combination pharmacotherapy for tobacco dependence treatment in these high-risk smokers are not available.
OBJECTIVE: To evaluate extended duration of a triple-medication combination versus standard-duration therapy with the nicotine patch alone and 6-month abstinence rates in smokers with medical illnesses.
DESIGN: Randomized clinical trial from 2005 to 2007.
SETTING: Single primary care setting.
PATIENTS: 127 smokers 18 years or older with predefined medical illnesses were recruited from the local community.
INTERVENTION: Participants were allocated by blocked randomization to receive either the nicotine patch alone for a standard 10-week, tapering course (n = 64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion ad libitum (n = 63). Nonstudy staff, who used computer-generated tables, assigned participants by telephone. No study staff had access to the randomization tables before randomization, thus maintaining concealment. Participants and study personnel were not blinded to treatment assignment.
MEASUREMENTS: The primary outcome was 7-day, exhaled carbon monoxide-confirmed point abstinence at 26 weeks after target quit date. Secondary outcomes were the time to first relapse, duration of medication use, and adverse effects of medications. Analyses were conducted on an intention-to-treat basis with participants who were lost to follow-up (patch alone [n = 13] and combination therapy [n = 18]) classified as still smoking.
RESULTS: Both treatment groups had similar baseline characteristics. Abstinence rates at 26 weeks were 35% (22 of 63 patients) for the combination group versus 19% (12 of 64 patients) for the patch-alone group (relapse benefit, 16% [95% CI, 1% to 31%]; P = 0.040). The adjusted odds ratio for abstinence in the combination group was 2.57 (CI, 1.05 to 6.32; P = 0.041). The median time to relapse was significantly longer in the combination group than in the patch-alone group (65 days vs. 23 days; P = 0.005). Some side effects occurred more frequently in the combination group (for example, insomnia [25% vs. 9%] and anxiety [22% vs. 3%]), but the proportion of participants who discontinued study medications because of adverse events was similar in both groups (6%).
LIMITATIONS: Approximately 25% of participants were lost to follow-up (proportions were similar between treatment groups). Treatment personnel and participants were unblinded.
CONCLUSION: Flexibly dosed triple-combination pharmacotherapy for up to 6 months was more effective than standard-duration nicotine patch therapy for outpatient smokers with medical illnesses.
PRIMARY FUNDING SOURCE: Cancer Institute of New Jersey and Robert Wood Johnson Foundation.
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