Method for determining integral nicotine load index in users of electronic nicotine delivery systems

Abstract

FIELD: hygiene; toxicology; preventive medicine.SUBSTANCE: used for quantitative assessment of the total nicotine load in individuals using electronic nicotine delivery systems (ENDS). The average daily volume of liquid consumed, the concentration of nicotine in it, and the length of time of ENDS use in years are determined. The obtained data is processed by calculating the integral nicotine load index (INLI) in conventional units of “vape-years” using an original mathematical formula, taking into account the standard daily dose of nicotine.EFFECT: method ensures the objectification of risk stratification and increases the effectiveness of clinical observation of ENDS users through a quantitative assessment of the accumulated toxic load, taking into account the totality of the period of use and the physical and chemical parameters of the consumed liquid.1 cl, 3 ex

Description

[0001] The method for determining the integral nicotine load index in users of electronic nicotine delivery systems (ENDS) relates to medicine, in particular to hygiene, toxicology and preventive medicine, and can be used in practical healthcare for the quantitative assessment of the total nicotine exposure in ENDS users.

[0002] In recent years, there has been a significant increase in the popularity of ENDS, especially among young people, against the backdrop of a steady decline in the consumption of traditional tobacco products. According to epidemiological monitoring, the proportion of ENDS users in the 18-25 age group has more than tripled over the past decade, which indicates not a decrease in nicotine consumption, but a change in its forms and delivery methods (Salagay O.O., Antonov N.S., Sakharova G.M. Analysis of trends in the consumption of tobacco and nicotine-containing products in the Russian Federation based on the results of online surveys in 2019-2023 / / Preventive Medicine. 2023; 26 (5): 7-16).

[0003] Despite the widespread perception of vaping as a “less harmful alternative” to smoking (Tremyasov M.A., Mokerova N.A. Harm of electronic cigarettes and the formation of an alternative smoking habit among young people / / Health of the nation in the 21st century. 2023; (4): 86-91), more and more clinical and experimental data indicate the potential toxicity of inhalation aerosol components, including propylene glycol, glycerin, flavorings and nicotine (Andreeva O.P., Terekhov A.A. Electronic cigarettes: an alternative to smoking or harm / / Science and education. 2022; 5 (2): 197). Long-term use of ENDS is associated with the development of organ-specific changes affecting the respiratory system (bronchial inflammation, damage to the lung parenchyma) (Sinyakov I.A., Shestakova M.A., Byshlyaga O.Yu., Batalova T.A. The main pathological effects of exposure to highly dispersed aerosol from electronic cigarettes on lung cells and respiratory epithelium: a literature review / / Medicine.2024;12(1):72-87), the cardiovascular system (increased blood pressure, endothelial dysfunction) (Skorodumova E.G., Obrezan A.G., Skorodumova E.A. Smoking harm reduction strategy: impact on target systems / organs (umbrella literature review) / / Cardiology: News. Opinions. Training. 2024;12(3):43-51; Uryadova G.T., Rusetskaya N.Yu. Impact of tobacco products and electronic smoking devices on the regulation of heart rate and the cardiovascular system of smokers / / Ulyanovsk Medical and Biological Journal. 2024;(2):119-127), the gastrointestinal tract (nausea, vomiting, periodontitis, caries) (Soule E.K., Brennan E., Ambrose B.B. et al. Adverse Effects of Electronic Cigarette Use: A Concept Mapping Approach / / Nicotine Tob Res. 2016;18(5):678-685; Romanenko I.G., Gorobets I.V., Bobkov E.O., Gorobets S.M. Risk factors for the development of dental caries in e-cigarette users / / Medical Bulletin of the North Caucasus. 2024;19(3):272-277), as well as the central nervous system (Chinchiev R.T., Kantemirov A.Kh. Components of electronic cigarettes and their effects on the body / / Young scientist. 2023; (27): 54-56). These effects correlate with the duration and intensity of use, which emphasizes the need for an objective assessment of the total nicotine load for the timely identification of individuals at high risk of developing chronic diseases.

[0004] In clinical practice and scientific research, the smoker's index (SI)—"pack-years"—is widely used to assess the degree of tobacco use in traditional smokers. It has been proposed as a standard method for quantifying cumulative tobacco smoke exposure. It is calculated using the formula:

[0005]

[0006] This indicator is an independent predictor of the development of chronic obstructive pulmonary disease, lung cancer, cardiovascular diseases and other conditions associated with smoking (Flenkin A.A., Nevzorova E.V., Gulin A.V. Integral indicator of human smoking as a marker of regular smoking / / Bulletin of Russian Universities. Mathematics. 2015; 20 (2): 366-368). Its value lies in its simplicity, interpretability and the possibility of direct correlation with the risk of morbidity and mortality. However, with the transition to new forms of nicotine consumption - such as electronic cigarettes and other ENDS - the use of CI ("pack-years") becomes impossible, since there is no equivalent of "smoking one pack", and nicotine consumption depends on many factors: the type of device, the frequency of puffs, the volume of liquid consumed, the concentration of nicotine in the liquid.

[0007] In the dissertation of A.A. Flenkin (Flenkin A.A. Improving the comprehensive diagnostics of early changes in periodontal tissues in individuals using nicotine-containing products: dis. ... Cand. Sci. (Medicine) / FSBEI HE MGMU named after A.I. Evdokimov, Ministry of Health of the Russian Federation; scientific director S.N. Ermoliev. - M., 2023. - 133 p.) a nicotine load index is proposed, calculated as the product of daily nicotine consumption (mg / day) and the duration of use (years), which makes it possible to estimate the exposure when using cigarettes, electronic tobacco heating systems and ENDS.However, this approach has significant limitations: the result is expressed in absolute units, does not provide a clinically understandable scale of comparability with the IR (“pack-years”), does not take into account differences in nicotine bioavailability between delivery forms (cigarettes, electronic tobacco heating systems, ENDS), and the difficulty of accurately determining the daily dose in vapers, including the phenomenon of compensatory increase in the frequency or volume of inhalations when using highly concentrated liquids and nicotine boosters.

[0008] These shortcomings reduce the validity of the index in everyday clinical practice and epidemiological studies, which necessitates the development of a standardized, normed and clinically interpretable indicator (“vape-lets”) adapted to the specifics of ENDS.

[0009] The objective of the claimed invention is to create a standardized quantitative indicator—an integrated nicotine load index (ILLI)—for vapers measured in "vape years." This indicator allows for the objective assessment of the total nicotine exposure of ENDS users based on anamnestic data: average daily volume of e-liquid consumed, nicotine concentration, and duration of regular device use. The proposed index provides direct clinical comparability with the traditional pack-year indicator, enabling standardized risk assessment of nicotine-associated diseases in preventive, diagnostic, and scientific practice.

[0010] The solution to this problem is the development of an NINN formula based on parameters easily determined in everyday clinical practice. The following parameters are determined for the ENDS user: average daily liquid consumption (ml / day), nicotine concentration in the liquid (mg / ml), and the length of regular device use (years).

[0011] Based on this data, the Individual Taxpayer Identification Number (ITIN) is calculated using the formula:

[0012] ,

[0013] where V is the average daily volume of liquid consumed (ml / day); C is the concentration of nicotine in the liquid (mg / ml); N is the standard daily dose of nicotine, equivalent to one pack of cigarettes, taken as 20 mg / day (which corresponds to the average nicotine content in 20 cigarettes of 1 mg each); S is the length of time of ENDS use in years.

[0014] The result is expressed in "vape-years", where 1 "vape-year" means one year of daily nicotine consumption equivalent to one pack of cigarettes per day.

[0015] Application examples

[0016] Example 1:

[0017] The user consumes 3ml of liquid per day with a concentration of 10mg / ml for 2 years.

[0018]

[0019] Example 2 (using booster):

[0020] The user mixes the liquid themselves: 8 ml of base (0 mg / ml) + 2 ml of booster (20 mg / ml) → the final volume is 10 ml, the resulting concentration is 4 mg / ml. Consumes 5 ml of liquid per day, has been using for 5 years.

[0021]

[0022] Example 3 (mixed usage):

[0023] The patient smokes 10 traditional cigarettes per day for 3 years and additionally uses ENDS: 4 ml of liquid per day with a nicotine concentration of 15 mg / ml, for 3 years.

[0024] 1.Traditional cigarettes:

[0025]

[0026] 2. ENDS:

[0027]

[0028] 3. Total nicotine load index: 1.5 + 9 = 10.5 "conventional pack-years"

[0029] Thus, the claimed invention represents a simple and clinically validated method for calculating the ITN in "vape-years" based on three anamnestic parameters: the volume of e-liquid consumed while vaping, the nicotine concentration, and the duration of ENDS use. The formula ensures direct comparability with "pack-years," adapting the familiar risk scale to new forms of nicotine consumption. The method does not require laboratory analysis and is easily integrated into routine clinical practice for screening, prevention, and personalized patient management.

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