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一项为期 24 周的伐尼克兰治疗癌症患者吸烟的随机对照试验:疗效、安全性和依从性。

A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence.

机构信息

Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania.

Pulmonary, Allergy, and Critical Care Division, University of Pennsylvania, Philadelphia, Pennsylvania.

出版信息

Psychooncology. 2019 Mar;28(3):561-569. doi: 10.1002/pon.4978. Epub 2019 Jan 24.

DOI:10.1002/pon.4978
PMID:30680852
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6936106/
Abstract

OBJECTIVE

Continuing to smoke after a cancer diagnosis undermines prognosis. Yet few trials have tested Food and Drug Administration (FDA)-approved tobacco use medications in this population. Extended use varenicline may represent an effective treatment for cancer patients who smoke given barriers to cessation including a prolonged time line for relapse.

METHODS

A placebo-controlled randomized trial tested 12 weeks of varenicline plus 12 weeks of placebo (standard [ST]) vs 24 weeks of varenicline (extended [ET]) with seven counseling sessions for treatment-seeking cancer patients who smoke (N = 207). Primary outcomes were 7-day biochemically confirmed abstinence at weeks 24 and 52. Treatment adherence and side effects, adverse and serious adverse events, and blood pressure were assessed.

RESULTS

Point prevalence and continuous abstinence quit rates at weeks 24 and 52 were not significantly different across treatment arms (P's > 0.05). Adherence (43% of sample) significantly interacted with treatment arm for week 24 point prevalence (odds ratio [OR] = 2.31; 95% confidence interval [CI], 1.15-4.63; P = 0.02) and continuous (OR = 5.82; 95% CI, 2.66-12.71; P < 0.001) abstinence. For both outcomes, adherent participants who received ET reported higher abstinence (60.5% and 44.2%) vs ST (44.7% and 27.7%), but differences in quit rates between arms were not significant for nonadherent participants (ET: 9.7% and 4.8%; ST: 12.7% and 10.9%). There were no significant differences between treatment arms on side effects, adverse and serious adverse events, and rates of high blood pressure (P's > 0.05).

CONCLUSIONS

Compared with ST, ET varenicline does not increase patient risk and increases smoking cessation rates among patients who adhere to treatment. Studies are needed to identify effective methods to increase medication adherence to treat patient tobacco use effectively.

摘要

目的

癌症诊断后继续吸烟会影响预后。然而,很少有试验在这一人群中测试过美国食品和药物管理局(FDA)批准的烟草使用药物。延长使用伐伦克林可能是一种有效的治疗方法,适用于那些有吸烟习惯的癌症患者,因为戒烟存在包括复发时间延长在内的障碍。

方法

一项安慰剂对照随机试验测试了接受治疗的吸烟癌症患者(N=207)使用瓦伦尼克林 12 周加安慰剂 12 周(标准[ST])与使用瓦伦尼克林 24 周(延长[ET])的情况,共进行了 7 次咨询。主要结果是在第 24 周和第 52 周时,7 天生物化学确认的禁欲率。评估了治疗依从性和副作用、不良和严重不良事件以及血压。

结果

在各个治疗组中,第 24 周和第 52 周时的点患病率和连续禁欲戒烟率没有显著差异(P 值均>0.05)。(P=0.02)和连续(OR=5.82;95%置信区间[CI],2.66-12.71;P<0.001)禁欲。对于这两个结果,接受 ET 的依从性参与者报告的戒烟率更高(60.5%和 44.2%)比 ST(44.7%和 27.7%),但对于不依从性参与者,两组之间的戒烟率差异无统计学意义(ET:9.7%和 4.8%;ST:12.7%和 10.9%)。在副作用、不良和严重不良事件以及高血压发生率方面,两组之间没有显著差异(P 值均>0.05)。

结论

与 ST 相比,ET 伐伦克林不会增加患者风险,并增加了坚持治疗的患者的戒烟率。需要研究有效的方法来提高药物依从性,以有效地治疗患者的烟草使用。

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