RESUMO
INTRODUCTION: The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). METHODS: A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. RESULTS: The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%). CONCLUSIONS: This study supports a VLNC standard in cigarettes. IMPLICATIONS: Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.
Assuntos
Abandono do Hábito de Fumar , Produtos do Tabaco , Tabagismo , Adulto , Feminino , Humanos , Masculino , Nicotina , Fumantes , Classe SocialRESUMO
BACKGROUND: Ultrathin bronchoscopy guided by virtual bronchoscopy (VB) techniques show promise for the diagnosis of peripheral lung lesions. In a phantom study, we evaluated a new real-time, VB-based, image-guided system for guiding the bronchoscopic biopsy of peripheral lung lesions and compared its performance to that of standard bronchoscopy practice. METHODS: Twelve bronchoscopists of varying experience levels participated in the study. The task was to use an ultrathin bronchoscope and a biopsy forceps to localize 10 synthetically created lesions situated at varying airway depths. For route planning and guidance, the bronchoscopists employed either standard bronchoscopy practice or the real-time image-guided system. Outcome measures were biopsy site position error, which was defined as the distance from the forceps contact point to the ground-truth lesion boundary, and localization success, which was defined as a site identification having a biopsy site position error of < or = 5 mm. RESULTS: Mean (+/- SD) localization success more than doubled from 43 +/- 16% using standard practice to 94 +/- 7.9% using image guidance (p < 10(-15) [McNemar paired test]). The mean biopsy site position error dropped from 9.7 +/- 9.1 mm for standard practice to 2.2 +/- 2.3 mm for image guidance. For standard practice, localization success decreased from 56% for generation 3 to 4 lesions to 31% for generation 6 to 8 lesions and also decreased from 51% for lesions on a carina vs 23% for lesions situated away from a carina. These factors were far less pronounced when using image guidance, as follows: success for generation 3 to 4 lesions, 97%; success for generation 6 to 8 lesions, 91%; success for lesions on a carina, 98%; success for lesions away from a carina, 86%. Bronchoscopist experience did not significantly affect performance using the image-guided system. CONCLUSIONS: Real-time, VB-based image guidance can potentially far exceed standard bronchoscopy practice for enabling the bronchoscopic biopsy of peripheral lung lesions.