Smith Stevens S, McCarthy Danielle E, Japuntich Sandra J, Christiansen Bruce, Piper Megan E, Jorenby Douglas E, Fraser David L, Fiore Michael C, Baker Timothy B, Jackson Thomas C
Department of Medicine and Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, 53711, USA.
Arch Intern Med. 2009 Dec 14;169(22):2148-55. doi: 10.1001/archinternmed.2009.426.
Randomized efficacy clinical trials conducted in research settings may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical settings. Effectiveness trials (eg, in primary care settings) are needed to estimate the benefits of cessation treatments in real-world use.
A total of 1346 primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics. Patients were randomly assigned to 5 active pharmacotherapies: 3 monotherapies (nicotine patch, nicotine lozenge, and bupropion hydrochloride sustained release [SR]) and 2 combination therapies (patch + lozenge and bupropion SR + lozenge). Patients were referred to a telephone quit line for cessation counseling. Primary outcomes included 7-day point prevalence abstinence at 1 week, 8 weeks, and 6 months after quitting and number of days to relapse.
Among 7128 eligible smokers (> or =10 cigarettes per day) attending routine primary care appointments, 1346 (18.9%) were enrolled in the study. Six-month abstinence rates for the 5 active pharmacotherapies were the following: bupropion SR, 16.8%; lozenge, 19.9%; patch, 17.7%; patch + lozenge, 26.9%; and bupropion SR + lozenge, 29.9%. Bupropion SR + lozenge was superior to all of the monotherapies (odds ratio, 0.46-0.56); patch + lozenge was superior to patch and bupropion monotherapies (odds ratio, 0.56 and 0.54, respectively).
One in 5 smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence-based counseling and medication. In this comparative effectiveness study of 5 tobacco dependence treatments, combination pharmacotherapy significantly increased abstinence compared with monotherapies. Provision of free cessation medications plus quit line counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit. Trial Registration clinicaltrials.gov Identifier: NCT00296647.
在研究环境中进行的随机疗效临床试验，在实际临床环境中使用时可能无法准确反映烟草依赖治疗的益处。需要进行有效性试验（例如在初级保健环境中）来评估戒烟治疗在实际应用中的益处。
12家初级保健诊所的医疗助理招募了1346名参加常规预约的初级保健患者。患者被随机分配到5种积极的药物治疗组：3种单一疗法（尼古丁贴片、尼古丁含片和盐酸安非他酮缓释片[SR]）和2种联合疗法（贴片+含片和安非他酮SR+含片）。患者被转介到电话戒烟热线接受戒烟咨询。主要结局包括戒烟后1周、8周和6个月时7天的点患病率戒烟情况以及复发天数。
在7128名参加常规初级保健预约的符合条件的吸烟者（每天吸烟≥10支）中，1346人（18.9%）被纳入研究。5种积极药物治疗的6个月戒烟率如下：安非他酮SR为16.8%；含片为19.9%；贴片为17.7%；贴片+含片为26.9%；安非他酮SR+含片为29.9%。安非他酮SR+含片优于所有单一疗法（优势比为0.46 - 0.56）；贴片+含片优于贴片和安非他酮单一疗法（优势比分别为0.56和0.54）。
每5名参加常规初级保健预约的吸烟者中就有1人愿意进行包括循证咨询和药物治疗的认真戒烟尝试。在这项对5种烟草依赖治疗的比较有效性研究中，联合药物治疗与单一疗法相比显著提高了戒烟率。在初级保健环境中提供免费戒烟药物并安排戒烟热线咨询有望帮助大量吸烟者戒烟。试验注册 clinicaltrials.gov 标识符：NCT00296647。
