基于尼古丁代谢的戒烟照护：一项先导性精准 RCT 研究。
Nicotine Metabolism-informed Care for Smoking Cessation: A Pilot Precision RCT.
机构信息
Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
出版信息
Nicotine Tob Res. 2018 Nov 15;20(12):1489-1496. doi: 10.1093/ntr/ntx235.
INTRODUCTION
Varenicline doubles cessation over nicotine replacement therapy (NRT) patch for "normal," but not "slow," nicotine metabolizers, as assessed by the nicotine metabolite ratio (NMR). Metabolism-informed care (MIC) could improve outcomes by matching normal metabolizers with non-nicotine medication (e.g., varenicline) and slow metabolizers with NRT patch.
METHODS
We conducted a feasibility randomized controlled trial of MIC versus guideline based care (GBC) among 81 outpatient adult daily smokers with medical comorbidity. Participants reported perceptions of MIC, underwent blood draw for NMR, and received expert cessation counseling. For MIC participants, medication selection was informed by NMR result (normal (≥0.31) vs. slow (< 0.31)). The primary outcome was MIC feasibility, reflected by attitudes toward MIC and by match rates between NMR and medication. Secondary endpoints (cessation confidence, medication use, smoking status) were assessed over 6 months to inform future studies.
RESULTS
Participants were median age 53 years, 46% female, 28% black, and 90% endorsed MIC. Despite high varenicline prescription rates (60%) in both arms, NMR-medication matching was higher in MIC (84%) versus GBC (58%) participants (p=0.02); unadjusted odds ratio (OR) 3.67, 95% confidence interval [1.33, 11.00; p-value=0.02]. Secondary endpoints were similar at 1, 3, and 6 months.
CONCLUSIONS
MIC, an NMR-based precision approach to smoking cessation, was acceptable to 90% of smokers and improved NMR-medication match rates more than 3-fold compared to GBC, even with generally high use of varenicline. These data support the feasibility of MIC, which could maximize efficacy of smoking cessation medication while minimizing side effects and cost.
IMPLICATIONS
Among treatment-seeking daily smokers with medical comorbidity, most viewed metabolism-informed care (MIC), guided by the nicotine metabolism ratio (NMR), favorably, and were willing to accept MIC-guided medication. Compared to GBC participants (58%), more MIC participants (84%) were prescribed NMR-matched medication (i.e., normal metabolizers received varenicline; slow metabolizers received NRT patch). MIC increased the odds of optimized matching between NMR and medication more than 3-fold over GBC. Because the number needed to treat (NNT) to help one normal metabolizer quit smoking is only 4.9 for varenicline versus 26 for patch, broad implementation of MIC will improve drug efficacy in normal metabolizers as well as minimize side effects in slow metabolizers.
简介
在尼古丁代谢率（NMR）评估中，伐伦克林（varenicline）使“正常”而非“慢”尼古丁代谢者的戒烟率翻倍，而尼古丁替代疗法（NRT）贴剂则没有。通过匹配正常代谢者使用非尼古丁药物（如伐伦克林）和慢代谢者使用 NRT 贴剂，基于代谢的护理（MIC）可以改善治疗效果。
方法
我们对 81 名患有合并症的门诊成年每日吸烟者进行了 MIC 与基于指南的护理（GBC）的可行性随机对照试验。参与者报告了他们对 MIC 的看法，进行了血液 NMR 检测，并接受了专家戒烟咨询。对于 MIC 参与者，药物选择是根据 NMR 结果（正常（≥0.31）与慢（<0.31））进行的。主要结局是 MIC 的可行性，反映在对 MIC 的态度和 NMR 与药物之间的匹配率上。次要终点（戒烟信心、药物使用、吸烟状况）在 6 个月内进行评估，以提供未来研究的信息。
结果
参与者的中位年龄为 53 岁，46%为女性，28%为黑人，约 90%的人支持 MIC。尽管在两个治疗组中，伐伦克林的处方率都很高（约 60%），但 MIC（84%）组与 GBC（58%）组的 NMR-药物匹配率更高（p=0.02）；未调整的优势比（OR）为 3.67，95%置信区间[1.33, 11.00;p 值=0.02]。在 1、3 和 6 个月时，次要终点相似。
结论
MIC 是一种基于 NMR 的戒烟精准方法，90%的吸烟者接受了 MIC，与 GBC 相比，MIC 提高了 NMR-药物匹配率三倍以上，尽管一般来说伐伦克林的使用量很高。这些数据支持 MIC 的可行性，MIC 可以最大限度地提高戒烟药物的疗效，同时最大限度地减少副作用和成本。
意义
在患有合并症的寻求治疗的每日吸烟者中，大多数人对基于尼古丁代谢率（NMR）的代谢指导护理（MIC）持有利看法，并愿意接受 MIC 指导的药物治疗。与 GBC 组参与者（58%）相比，更多的 MIC 组参与者（84%）接受了 NMR 匹配的药物治疗（即正常代谢者接受伐伦克林治疗；慢代谢者接受 NRT 贴剂）。与 GBC 相比，MIC 使 NMR 与药物之间的优化匹配几率增加了 3 倍以上。因为帮助一个正常代谢者戒烟的需要治疗人数（NNT），伐伦克林只需 4.9，而贴剂则需要 26，所以广泛实施 MIC 将提高正常代谢者的药物疗效，同时最大限度地减少慢代谢者的副作用。
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