Efficacy of bupropion and predictors of successful outcome in a sample of French smokers: a randomized placebo-controlled trial
Efficacy of bupropion and predictors of successful outcome in a sample of French smokers: a randomized placebo-controlled trial
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DOI：
10.1111/j.1360-0443.2004.00814.x
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发表时间：
2004-09-01
期刊：
影响因子：
6
通讯作者：
Lagrue, G
中科院分区：
文献类型：
--
作者：
Aubin, HJ;Lebargy, F;Lagrue, G
背景先前发表的研究仅评估了安非他酮在北美吸烟者中的戒烟效果。治疗药物试验的结果并不总是直接适用于其他人群。目的证实安非他酮在欧洲吸烟者中的戒烟效果。设计一项多中心、随机、双盲安慰剂对照试验。在法国设立74家戒烟门诊。受试者包括509名有戒烟动机的吸烟者。干预受试者被随机分为安非他酮缓释剂150 mg，2次/d。(B)或安慰剂(PI)按2：1比例治疗，治疗7周，并随访2~6周。主要观察指标：6个月的时点戒断率。由自我报告和呼出的空气一氧化碳测量确定。次要观察指标：4-7周和4-26周连续戒烟率，无法戒烟的吸烟者的渴求、戒断症状、体重和吸烟情况。B组和PI组6个月的时点戒断率分别为31%和16%[优势比=2.3，可信区间(CI)：1.4~3.7]。持续戒断率分别为41%(B)和21%(P)，OR=2.5(CI 95%：1.6~3.9)；25%(B)和13%(P)，OR=2.2(CI 95%：1.3~3.6)。B组戒断症状总分与PI组比较差异无统计学意义(P>0.05)。禁欲受试者在服用B组7周时体重增加明显少于服用P1组。尼古丁依赖程度低、积极性高、没有吸烟相关疾病、戒烟尝试持续时间长、男性、目前酒精问题水平低以及夫妻生活是成功戒烟的预测因素。除婚姻状况外，没有观察到任何这些预测因素与安非他酮疗效之间的相互作用。B组继续吸烟者比P组减少至少50%的吸烟量。结论安非他酮缓释片可有效帮助欧洲吸烟者戒烟。没有确定的结果预测因素可能表明某些吸烟者亚组比其他亚组吸烟者从安非他酮治疗中受益更多。
Background Previous published studies assessed the efficacy of bupropion in smoking cessation only in North American populations of smokers. Results of therapeutic drug trials are not always directly applicable in other populations.Aims To confirm the efficacy of bupropion in smoking cessation in European smokers.Design A multi-centre, randomized, double-blind placebo-controlled trial.Setting Seventy-four smoking cessation out-patient clinics in France.Participants The study included 509 smokers motivated to quit smoking.Intervention Subjects were randomized to either slow-release bupropion 150 mg b.i.d. (B) or to placebo (PI) in a 2 : 1 ratio, treated for 7 weeks, and followed-up for 2 6 weeks.Measurements Main outcome measure: 6 months' point prevalence abstinence. determined by self-report and expired air carbon monoxide measurement. Secondary outcome measures: weeks 4-7 and weeks 4-26 continuous abstinence rates, craving, withdrawal symptoms, weight and cigarette consumption in smokers unable to quit. Adverse events were recorded systematically.Findings Six months' point prevalence abstinence rates were 31% and 16% [odds ratio = 2.3, confidence interval (Cl) 95%:1.4-3.7] in the B and PI groups, respectively. Continuous abstinence rates were 41% (B) and 21% (P) with OR = 2.5 (CI 95%: 1. 6-3.9) for weeks 4- 7, and 25% (B) and 13% (P) with OR = 2.2 (Cl 95%: 1.3-3.6) for weeks 4-26, respectively. Craving decreased significantly more with B than with PI during treatment period, but there was no difference for total withdrawal symptoms score. Abstinent subjects gained significantly less weight at week 7 with B than with Pl. Low level of nicotine dependence, high motivation, absence of smoking-related disease, long duration of previous quit attempts, male gender, low level of current alcohol problems and living as a couple were predictive of successful cessation. With the exception of marital status, no interaction was observed between any of these predictive factors and the efficacy of bupropion. More of those who continued smoking in the B group than the P group reduced their consumption by at least 50%.Conclusions Sustained-release bupropion is efficacious as an aid to smoking cessation in European smokers. No outcome predictors were identified that might indicate that certain subgroups of smokers would benefit more than others from treatment with bupropion.