Nakamura Masakazu, Oshima Akira, Ohkura Masayuki, Arteaga Carmen, Suwa Kiyomi
Department of Health Promotion and Prevention, Osaka Center for Cancer and Cardiovascular Diseases Prevention, Osaka, Japan.
Cancer Information Services, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan.
Clin Ther. 2014 Jun 1;36(6):918-27. doi: 10.1016/j.clinthera.2014.03.013. Epub 2014 May 5.
The efficacy of the smoking-cessation agent varenicline has been reported in Asian smokers; however, few studies have investigated factors that contribute to lapse and relapse.
This post hoc analysis aimed to identify predictors of smoking lapse and relapse.
This was a post-hoc analysis based on a double-blind, placebo-controlled, randomized, parallel-group study in which Japanese smokers (aged 20-75 years) who smoked ≥ 10 cigarettes/day and were motivated to quit were randomized to receive varenicline (0.25 mg twice daily [BID], 0.5 mg BID, 1 mg BID) or placebo for 12 weeks followed by a 40-week non-treatment follow-up. For inclusion in this analysis, participants must have been nicotine dependent (Tobacco Dependence Screener score ≥ 5) and must have successfully quit smoking continuously for 4 weeks (weeks 9-12). Lapse was defined by answering yes to ≥ 1 question in the Nicotine Use Inventory. Relapse was defined by participants having smoked for ≥ 7 days during follow-up measured by the Nicotine Use Inventory.
Of the 619 randomized individuals, 515 had a Tobacco Dependence Screener score of ≥ 5, and 277 quit smoking continuously from weeks 9 to 12. Approximately 75% were male, with a mean (SD) BMI of 23.0 (3.0) kg/m(2). Maximum length of continuous abstinence (CA) during treatment and age (both P < 0.0001) were significant predictors of lapse. Maximum CA (P < 0.0001), age (P = 0.0002), Minnesota Nicotine Withdrawal Scale (MNWS) score for urge to smoke (P = 0.0019), and having made ≥ 1 serious quit attempt (P = 0.0063) were significant predictors of relapse. For participants with a maximum CA of 4 to 6 weeks versus those with a maximum CA of 10 to 11 weeks, the ORs for lapse and relapse were 4.649 (95% CI, 2.071-10.434) and 3.337 (95% CI, 1.538-7.239), respectively. In participants aged 21-34 years versus those aged 47-72 years, the ORs for lapse and relapse were 3.453 (95% CI 1.851, 6.441) and 3.442 (95% CI 1.795, 6.597), respectively. Participants with a MNWS urge to smoke score of 2 to 4 versus 0 had an OR for relapse of 3.175 (95% CI, 1.166-8.644). Participants having made ≥ 1 versus no serious quit attempts had an OR for relapse of 2.108 (95% CI, 1.168-3.805).
Shorter maximum CA and younger age at quit attempt were associated with increased risk of lapse and relapse. Higher MNWS urge to smoke score and having made ≥ 1 serious quit attempt were associated with increased relapse risk. ClinicalTrials.gov identifier: NCT00139750.
戒烟药物伐尼克兰在亚洲吸烟者中的疗效已有报道；然而，很少有研究调查导致戒烟失败和复吸的因素。
本事后分析旨在确定戒烟失败和复吸的预测因素。
这是一项基于双盲、安慰剂对照、随机、平行组研究的事后分析，其中每天吸烟≥10支且有戒烟意愿的日本吸烟者（年龄20 - 75岁）被随机分为接受伐尼克兰（0.25毫克，每日两次[BID]；0.5毫克，BID；1毫克，BID）或安慰剂治疗12周，随后进行40周的非治疗随访。纳入本分析的参与者必须有尼古丁依赖（烟草依赖筛查得分≥5）且必须已成功连续戒烟4周（第9 - 12周）。戒烟失败定义为在尼古丁使用量表中对≥1个问题回答“是”。复吸定义为在随访期间通过尼古丁使用量表测量，参与者吸烟≥7天。
在619名随机分组的个体中，515人的烟草依赖筛查得分≥5，277人在第9至12周连续戒烟。约75%为男性，平均（标准差）体重指数为23.0（3.0）kg/m²。治疗期间连续戒烟的最长时长（CA）和年龄（均P < 0.0001）是戒烟失败的显著预测因素。最大CA（P < 0.0001）、年龄（P = 0.0002）、明尼苏达尼古丁戒断量表（MNWS）中吸烟冲动得分（P = 0.0019）以及曾进行≥1次认真的戒烟尝试（P = 0.0063）是复吸的显著预测因素。对于最大CA为4至6周的参与者与最大CA为10至11周的参与者，戒烟失败和复吸的比值比分别为4.649（95%置信区间，2.071 - 10.434）和3.337（95%置信区间，1.538 - 7.239）。在21 - 34岁的参与者与47 - 72岁的参与者中，戒烟失败和复吸的比值比分别为3.453（95%置信区间1.851，6.441）和3.442（95%置信区间1.795，6.597）。MNWS吸烟冲动得分2至4分的参与者与得分为0分的参与者相比，复吸的比值比为3.175（95%置信区间，1.166 - 8.644）。曾进行≥1次认真戒烟尝试的参与者与未进行过认真戒烟尝试的参与者相比，复吸的比值比为2.108（95%置信区间，1.168 - 3.805）。
较短的最大CA和较年轻的戒烟尝试年龄与戒烟失败和复吸风险增加相关。较高的MNWS吸烟冲动得分以及曾进行≥1次认真的戒烟尝试与复吸风险增加相关。ClinicalTrials.gov标识符：NCT00139750。
