Jiménez-Ruiz Carlos A, Garcia Rueda Marcos, Martinez Muñiz Manuel A, Sellarés Jacobo, Jiménez-Fuentes Maria A, Lázaro Asegurado Lourdes, Rodríguez Gonzalez Esther, Rodriguez Garcia Concepción, Armengol Oriol, Abad Emilia, Peña Teresa, Domenech Del Rio Adolfo, Riesco Miranda Juan A
Tobacco Researching Group of the Spanish Respiratory Society, Smoking Cessation Service.
Monaldi Arch Chest Dis. 2017 Dec 19;87(3):874. doi: 10.4081/monaldi.2017.874.
A large number of COPD patients are smokers. The particular characteristics of this group as well as their need to quit usually require psychological counselling and pharmacological treatment to achieve abstinence and, often, intensively. Little information is available about this issue. The main objective of the study was to evaluate the effectiveness of varenicline after 24 weeks of treatment, with continuous abstinence between weeks 9 and 24. This study was a post-authorization, open label, observational study of prospective follow-up. Patients included were smokers with severe or very severe COPD criteria who were treated with varenicline for 24 weeks, i.e. with a 12-week extension over the usual treatment. The outcomes in the population of subjects completing 24 weeks of follow-up were at week 24: continuous abstinence 36.8%, 7 days point prevalence abstinence 65.7%, and continuous smoking 31.5%.The outcomes in the intention-to-treat population included at baseline were: continuous abstinence 17.7% of patients, 7 days point prevalence abstinence 31.6%, continuous smoking 15.1% and not valid/unknown 51.8%. The mean CAT score at week 24 was 15 and reduction from the baseline was 3.77 (paired T test, p<0.01). The most common adverse events reported were nausea, vivid dreams, stomach ache, insomnia, headache and vomiting. Patients included in VALUE were active smokers despite all of them had a severe COPD which suggests a very high degree of dependence. Although the study do not allow to infer the results to the global population of smokers with severe COPD, the outcomes have shown that, at 24 weeks follow up 36.8% of the patients were successful in quitting but from 79 patients enrolled initially only 17.7% quit.
大量慢性阻塞性肺疾病（COPD）患者是吸烟者。该群体的特殊特征以及他们的戒烟需求通常需要心理辅导和药物治疗才能实现戒烟，而且往往需要强化治疗。关于这个问题的信息很少。本研究的主要目的是评估伐尼克兰治疗24周后的有效性，在第9周和第24周之间持续戒烟。本研究是一项上市后、开放标签、前瞻性随访的观察性研究。纳入的患者为符合重度或极重度COPD标准的吸烟者，接受伐尼克兰治疗24周，即比常规治疗延长12周。完成24周随访的受试者群体的结果在第24周时为：持续戒烟率36.8%，7天时点戒烟率65.7%，持续吸烟率31.5%。意向性治疗人群在基线时的结果为：持续戒烟患者占17.7%，7天时点戒烟率31.6%，持续吸烟率15.1%，无效/未知率51.8%。第24周时的平均CAT评分是15，较基线降低了3.77（配对t检验，p<0.01）。报告的最常见不良事件是恶心、生动梦境、胃痛、失眠、头痛和呕吐。纳入VALUE研究中的患者尽管都患有重度COPD，但都是现吸烟者，这表明他们的依赖程度非常高。尽管该研究不允许将结果推断至所有重度COPD吸烟者群体，但结果显示，在24周随访时，36.8%的患者成功戒烟，但最初纳入的79名患者中只有17.7%戒烟。
