本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.4183

摘要内容如下：

重要性

大多数吸烟的人在最初的尝试中并没有戒烟。

目的

确定伐尼克兰或联合尼古丁替代疗法（CNRT）初始治疗后不戒断的最佳后续策略。

设计、设置和参与者

采用双盲、安慰剂对照、序贯多任务随机试验，490名志愿者随机接受6周的伐尼克兰或CNRT治疗。6周后，未戒断者被重新随机分组，继续、转换或增加药物剂量6周。该研究于2015年6月至2019年10月在德克萨斯州一家烟草治疗诊所进行。

干预措施

初始治疗为2 mg/d的伐尼克兰或21 mg贴片加2 mg含片的联合替代治疗。重新随机分组的参与者要么继续他们最初的治疗，要么在伐尼克兰和CNRT之间转换，要么增加剂量至3毫克或更多的伐尼克兰或42毫克的贴剂和锭剂。所有人都接受了每周一次的简短咨询。

主要成果和措施

生化验证了12周治疗结束时的7天戒断流行率。

结果

490名随机参与者（210名女性[43%]，287名非西班牙裔白人[58%]，平均年龄48.1岁）平均每天吸烟20支。在第一阶段之后，CNRT组的54名参与者戒断并继续他们的治疗；在191名未戒断者中，151名被重新随机分组，40名未返回重新随机分组的患者被分配在第2阶段继续其最初的CNRT条件。191名第1阶段未戒断者的治疗结束戒断率为8%（95%可信区间[CRI]，6%至10%），90名（47%）继续处于剂量条件，14%（CRI，在增加剂量的50人（33%）中为10%至18%，在改用伐尼克兰的51人（34%）中为14%（95%CRI，10%至18%）（绝对风险差[RD]，6%；95%的CRI，6%至11%），超过99%的后验概率表明，任何一种策略都比继续初始剂量更有益。第一阶段结束后，伐尼克兰组的88名参与者戒酒并继续治疗；在157名未戒断的患者中，122名患者被重新随机化，35名未返回重新随机化的患者被分配继续接受伐尼克兰治疗。157名1期非戒断者的治疗结束戒断率为:39名（32%）增加伐尼克兰剂量的患者为20%（95%CRI，16%至26%），41名（34%）转换CNRT的患者为0（95%CRI，0至0），3%（95%CRI，1%至4%），其中77人（49%）被分配到持续伐尼克兰条件（绝对RD，-3%；95%CRI，-4%至-1%），超过99%的后验概率表明，继续使用初始剂量的伐尼克兰比改用更高剂量的剂量更差。此外，增加伐尼克兰剂量的绝对RD为18%（95%CRI，13%至24%），产生益处的后验概率超过99%。6个月时持续戒断的次要结果表明，只有增加CNRT和伐尼克兰的剂量比继续初始治疗剂量更有益。

结论和相关性

对于吸烟但在伐尼克兰治疗后未达到戒断的个体，增加剂量与继续治疗相比，前者可增强戒断；而对于最初接受CNRT治疗的非戒断者，增加剂量或改用伐尼克兰可增强戒断，可能是可行的补救策略。

试用注册

ClinicalTrials.gov标识符：NCT02271919。

英文原文如下：

Abstracts

Importance  Most people who smoke do not quit on their initial attempt.

Objective  To determine the best subsequent strategy for nonabstinence following initial treatment with varenicline or combined nicotine replacement therapy (CNRT).

Design, Setting, and Participants  Using a double-blind, placebo-controlled, sequential multiple assignment randomized trial, 490 volunteers were randomized to receive 6 weeks of varenicline or CNRT. After 6 weeks, nonabstainers were rerandomized to continue, switch, or increase medication dosage for 6 additional weeks. The study was conducted from June 2015 through October 2019 in a Texas tobacco treatment clinic.

Interventions  The initial treatment was 2 mg/d of varenicline or the combined replacement therapy of a 21-mg patch plus 2-mg lozenge. The rerandomized participants either continued with their initial therapies, switched between varenicline and CNRT, or increased dosages either to 3-mg or more of varenicline or to a 42-mg patch and lozenges. All received weekly brief counseling.

Main Outcomes and Measures  Biochemically verified 7-day point prevalence abstinence at the end of treatment at 12 weeks.

Results  The 490 randomized participants (210 female [43%], 287 non-Hispanic White [58%], mean age, 48.1 years) smoked an average of 20 cigarettes per day. After the first phase, 54 participants in the CNRT group were abstinent and continued their therapy; of the 191 who were not abstinent, 151 were rerandomized, and the 40 who did not return for rerandomization were assigned to continue their initial CNRT condition in phase 2. The end-of-treatment abstinence rate for the 191 phase 1 nonabstainers was 8% (95% credible interval [CrI], 6% to 10%) for the 90 (47%) who continued at the dosage condition, 14% (CrI, 10% to 18%) for the 50 (33%) who increased their dosage, and 14% (95% CrI, 10% to 18%) for the 51 (34%) who switched to varenicline (absolute risk difference [RD], 6%; 95% CrI, 6% to 11%) with more than 99% posterior probability that either strategy conferred benefit over continuing the initial dosage. After the first phase, 88 participants in the varenicline group were abstinent and continued their therapy; of the 157 who were not abstinent, 122 were rerandomized and 35 who did not return for rerandomization were assigned to continue with the varenicline condition. The end-of-treatment abstinence rate for the 157 phase 1 nonabstainers was 20% (95% CrI, 16% to 26%) for the 39 (32%) who increased their varenicline dosage, 0 (95% CrI, 0 to 0) for the 41 (34%) who switched CNRT, and 3% (95% CrI, 1% to 4%) for the 77 (49%) who were assigned to the continued varenicline condition (absolute RD, -3%; 95% CrI, -4% to -1%) with more than 99% posterior probability that continuing varenicline at the initial dosage was worse than switching to a higher dosage. Furthermore, increasing the varenicline dosage had an absolute RD of 18% (95% CrI, 13% to 24%) and a more than 99% posterior probability of conferring benefit. The secondary outcome of continuous abstinence at 6 months indicated that only increased dosages of the CNRT and varenicline provided benefit over continuation of the initial treatment dosages.

Conclusions and Relevance  For individuals who smoked but did not achieve abstinence after treatment with varenicline, increasing the dosage enhanced abstinence vs continuing, whereas for nonabstainers initially treated with CNRT, a dosage increase or switch to varenicline enhanced abstinence and may be viable rescue strategies.

Trial Registration  ClinicalTrials.gov Identifier: NCT02271919.

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