Department of Psychiatry, Yale University School of Medicine, New Haven, CT;
FDNY BHS Tobacco Treatment Program, New York, NY; IntelliQuit, Mahwah, NJ;
Nicotine Tob Res. 2014 Jul;16(7):909-14. doi: 10.1093/ntr/ntu087. Epub 2014 Jun 11.
Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation.
吸烟对公众健康造成了巨大的负担。寻找新的、有效的戒烟干预措施，优化现有的干预措施，并促进已批准药物的有效使用是当务之急。当尼古丁替代疗法（NRT）按规定使用时，它可以帮助戒烟，但仍有提高其效果的空间。直到最近，NRT 使用指南建议吸烟者在戒烟日开始使用 NRT，一次只使用一种 NRT 制剂，在吸烟时避免使用 NRT，并在 3 个月内停止使用 NRT，无论进展如何。美国食品和药物管理局（FDA）最近发布了一项公告，允许制药公司对 NRT 标签进行更改，并批准了这些更改。尽管如此，当前的研究仍需要进一步修订。有强有力的证据表明，将一种长效形式（如贴片）与一种短效形式（如口含锭）联合使用比 NRT 单一疗法更有效，并且安全。此外，现有的证据表明，在戒烟尝试之前或作为戒烟尝试的一部分减少吸烟时使用 NRT 是安全的，与在戒烟日开始使用 NRT 一样有效。具体来说，戒烟前使用尼古丁贴片可以提高戒烟率，并可能吸引更多难以戒烟的吸烟者。最后，使用 NRT 超过 3 个月是安全的，并且可能对某些吸烟者预防复吸有帮助。本报告总结了 FDA 的公告，回顾了进一步修订现行 FDA NRT 指南的证据，并提出了 OTC NRT 标签的建议，以允许（1）联合使用更快起效的 NRT 药物和尼古丁贴片，（2）在戒烟日之前或作为戒烟尝试的一部分使用尼古丁贴片或 NRT 减少吸烟，以及（3）在没有医疗保健提供者咨询的情况下延长 NRT 使用时间长达 6 个月。
