British American Tobacco (Investments) Ltd., R&D Centre, Southampton, UK.
Biomarkers. 2023 Feb;28(1):118-129. doi: 10.1080/1354750X.2022.2148747. Epub 2022 Dec 13.
Oral nicotine pouches (NPs) are smokeless, tobacco-free products that have a potential role in tobacco harm reduction strategies. In a cross-sectional study in Sweden/Denmark, several recognised biomarkers of potential harm (BoPHs) linked to smoking-related diseases/their initiating biological processes, and biomarkers of exposure (BoEs) to tobacco/tobacco smoke toxicants were compared among exclusive adult users of Velo NPs and current/former/never smokers. Over 24 h, participants used their usual product (Velo NP or cigarette) as normal, and BoEs/BoPHs were assessed via blood/24-h urine/exhaled breath/physiological assessments. Among the primary endpoints, total NNAL (16.9 ± 29.47 vs 187.4 ± 228.93 pg/24 h), white blood cell count (5.59 ± 1.223 vs 6.90 ± 1.758 × 10/L), and COHb (4.36 ± 0.525 vs 8.03 ± 2.173% saturation) were significantly lower among Velo users than among smokers (91%, 19% and 46% lower, respectively, all < 0.0001), while fractional exhaled NO, previously shown to be lower in smokers, was significantly higher (23.18 ± 17.909 vs 11.20 ± 6.980 ppb) among Velo users (107% higher, < 0.0001). Furthermore, sICAM-1 tended to be lower (185.9 ± 42.88 vs 204.5 ± 64.85 ng/mL) among Velo users than smokers (9% lower). Several secondary endpoints, including six BoEs (3-HPMA (246.7 ± 91.07 vs 1165.7 ± 718.35 μg/24 h), 3-OH-B[]P (82.4 ± 217.58 vs 258.3 ± 190.20 pg/24 h), HMPMA (135.1 ± 77.85 vs 368.8 ± 183.15 μg/24 h), MHBMA (0.22 ± 0.166 vs 3.39 ± 2.943 μg/24 h), S-PMA (0.10 ± 0.059 vs 3.53 ± 2.736 µg/24 h) and total NNN (7.5 ± 24.84 vs 9.7 ± 5.93 ng/24 h)), were significantly lower among Velo users (78.8%, 68.1%, 63.4%, 93.5%, 97.2% and 22.7% lower, respectively, < 0.0001-0.0011), while total nicotine equivalents was significantly higher among Velo users (22.6 ± 12.69 vs 12.1 ± 7.92 mg/24 h, < 0.0001), although Velo user levels are comparable to those previously reported among oral tobacco users, and Velo user and smoker mean levels were similar in Denmark. As compared with smokers, exclusive users of Velo NPs have significantly less exposure to tobacco toxicants and more favourable BoPHs associated with initiating biological processes of smoking-related diseases.International Standard Registered Clinical Trial number: ISRCTN16988167.
口腔尼古丁袋（NPs）是一种无烟、无烟草的产品，在减少烟草危害的策略中具有潜在作用。在瑞典/丹麦的一项横断面研究中，与吸烟相关疾病及其起始生物学过程相关的几个公认的潜在危害生物标志物（BoPHs），以及烟草/烟草烟雾毒物的暴露生物标志物（BoE），在 Velonp 独家使用者和当前/以前/从不吸烟者中进行了比较。在 24 小时内，参与者正常使用他们常用的产品（Velo NP 或香烟），并通过血液/24 小时尿液/呼气/生理评估来评估 BoE/BoPHs。在主要终点中，总 NNAL（16.9±29.47 与 187.4±228.93pg/24 h）、白细胞计数（5.59±1.223 与 6.90±1.758×10/L）和 COHb（4.36±0.525 与 8.03±2.173%饱和度）在 Velo 使用者中显著低于吸烟者（分别低 91%、19%和 46%，均 < 0.0001），而先前显示在吸烟者中较低的呼出气一氧化氮分数，在 Velo 使用者中显著较高（23.18±17.909 与 11.20±6.980ppb）（107%更高， < 0.0001）。此外，sICAM-1 在 Velo 使用者中趋于较低（185.9±42.88 与 204.5±64.85ng/mL）低于吸烟者（低 9%）。几个次要终点，包括六个 BoE（3-HPMA（246.7±91.07 与 1165.7±718.35μg/24 h），3-OH-B[]P（82.4±217.58 与 258.3±190.20pg/24 h），HMPMA（135.1±77.85 与 368.8±183.15μg/24 h），MHBMA（0.22±0.166 与 3.39±2.943μg/24 h），S-PMA（0.10±0.059 与 3.53±2.736μg/24 h）和总 NNN（7.5±24.84 与 9.7±5.93ng/24 h））在 Velo 使用者中显著较低（分别低 78.8%、68.1%、63.4%、93.5%、97.2%和 22.7%，均 < 0.0001-0.0011），而总尼古丁当量在 Velo 使用者中显著较高（22.6±12.69 与 12.1±7.92mg/24 h， < 0.0001），尽管 Velo 使用者的水平与先前报道的口腔烟草使用者相当，且丹麦的 Velo 使用者和吸烟者的平均水平相似。与吸烟者相比，Velo NP 的独家使用者暴露于烟草毒物的程度明显较低，与吸烟相关疾病起始生物学过程相关的 BoPHs 也更有利。国际标准注册临床试验编号：ISRCTN16988167。
