RU2536018C2 - METHOD FOR PREDICTION OF INCIDENCE OF Helicobacter pylori ANTIGENS FOR PERIOD FROM 2013 TO 2019 - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: estimating a probability of the Helicobacter pylori infection is ensured by taking a biomaterial (K₄), diagnosing a gastrointestinal disease (K₃), age (K₁) and H.pylori O-antigen (O_ag) in the biomaterial by the co-agglutination reaction followed by deriving a coefficient (K₂) depending on the current calendar year; thereafter, PI_O is calculated by formula PI_O= SF×K₁×K₂×K₃×K₄, wherein SF, a seasonal fluctuation, makes 50 in the first month of the year, 61 in the 2^nd, 55 in the 3^rd, 31 in the 4^th, 28 in the 5^th, 14 in the 6^th, 12 in the 7^th, 15 in the 8^th, 25 in the 9^th, 45 in the 10^th, 64 in the 11^th, 58 in the 12^th; K₁ makes 0.5, if the patient is aged one year or less, or K₁ makes 1.0, if the patient is aged more than one year; K₂ makes O_ag 0.5 in 2013; O_ag 0.4 in 2014; O_ag 0.3 in 2015; O_ag 0.4 in 2016; O_ag 0.5 in 2017; O_ag 0.6 in 2018; O_ag 0.6 in 2019; depending on a disease K₃ makes: - apparently healthy - 1.0; - gastrointestinal diseases - 1.2; - non-ulcer dyspepsia - 1.3; - chronic gastroduodenitis - 1.5; - gastric and duodenal ulcer - 1.8; - atrophic gastritis - 1.3; depending on the biomaterial, K₄ makes: - coprofiltrate - 1.0; - saliva - 1.2; - blood serum circulating immune complex - 1.4, and if PI_O falls within the range of 1 to 9%, the probability of H.pylori infection is considered to be doubtful, the PI_O value of 10 to 19% shows the low probability; the PI_O value of 20 to 39% shows the moderate probability, while if the PI_O value is 40 to 100%, the probability is high.

EFFECT: method enables estimating the probability of the Helicobacter pylori infection by the non-invasive method.

2 tbl, 4 ex, 1 dwg

Description

Appointment: medicine, gastroenterology. The method can be used to verify diagnostics, prognosis and retrospective studies, evaluate the effectiveness of treatment and prevention of exacerbations of helicobacteriosis, as well as in heliobiology as a highly sensitive non-invasive model.

The essence of the invention: calculate the frequency of occurrence of the species O-antigen Helicobacter pylori in biosubstrates (coprofiltrate, saliva or blood serum) using the Table and Formulas, allowing to take into account the effects of various internal and external factors (age, type of biomaterial, the presence of clinical symptoms of a disease of the gastrointestinal tract seasonal seasonal fluctuations in antigen circulation, year of solar activity).

Since 1999, through long-term monitoring studies, we have established cyclic fluctuations in the frequency of occurrence of pathogenetically significant H. pylori antigens with chronic persistence in the body at various time periods (daily, monthly, annual (seasonal), long-term) due to constantly changing internal and external factors of influence ( 1-3). In critical time periods of annual and seasonal cycles, with an increase in the frequency of occurrence of O-antigen, clinical exacerbations of helicobacteriosis are possible.

In 2007, a method was proposed for determining the likelihood of infection with Helicobacter pylori taking into account the main internal and external factors of exposure. Formula and Table for calculating Helicobacter pylori O-antigen in biological fluids (1).

A comparison of the previously predicted and actual results of the average annual incidence of O-antigen in subsequent years of a rise in solar activity in the 24th Solar cycle showed their high direct reliable correlation (r = 0.95, p = 0.0014), which indicates its legitimacy application.

The method for calculating the infection of Helicobacter pylori (Patent 2360251 dated December 18, 2007) developed by us is closest in essence and is selected as an analogue of the present invention.

The present invention contains adjusted indicators of the coefficient K ₂ in accordance with the formation of immunity in various years of solar activity.

The aim of the present invention is to develop a method for determining the frequency of occurrence of Helicobacter pylori O-antigen in connection with the influence of certain internal and external factors during the period of solar activity of the 24th Solar cycle.

The goal is achieved by calculating the probability index of Helicobacter pylori infection by O-antigen (IVI _O ), taking into account the seasonality of antigen fluctuations in the body (C - seasonality) and correction factors: K ₁ - age, K ₂ - year of the solar cycle, K ₃ - clinical forms of the gastrointestinal tract -intestinal disease (ZhKZ), K ₄ - a type of biomaterial.

To calculate IVI _O, a Table (Table 1) is proposed that contains the monthly averaged indicators of the frequency of occurrence of O-antigen in different seasons of the year (C is seasonality) and correction factors:

K ₁ - depending on the age of the patient;

K ₂ - depending on the year of study during the 11-year 24th solar cycle;

K ₃ - depending on the presence of clinical symptoms of ZHKZ (diagnosis);

K ₄ - depending on the type of biomaterial (coprofiltrate, saliva, blood serum).

The calculation of IVI _{O is} carried out using the Formula

IVI _O = C × K ₁ × K ₂ × K ₃ × K ₄

and a value of IVI _O 1 to 9% probability of H. pylori infection identified as doubtful, from 10 to 19% - low, from 20% to 39 - average 40 to 100% - highest.

Table 1 Determination of the probability of occurrence of O-antigen
Helicobacter pylori for the period 2009-2019. month one 2 3 four 5 6 7 8 9 10 eleven 12 Avg / month FROM fifty 61 55 31 28 fourteen 12 fifteen 25 45 64 57 38 K ₁ Age up to 1 year 1 year and older 0.5 10 K2 year 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 0.8 0.9 1,1 1,2 1,1 0.7 0.5 0.4 0.5 0.6 0.6 K3 Db OKI NJ Chr. mr I WOULD Atr mr 1,0 1,2 1.3 1,5 1.8 1.3 K4 Coprofiltrate Saliva Blood serum 1,0 1,2 1.4 Designations: C - seasonality,%; K ₁ is the age; K ₂ - solar activity in the years of the 24th solar cycle; K ₃ - clinical symptoms of ZhKZ (diagnosis); To ₄ - type of biomaterial; DB - asymptomatic volunteers (practically healthy individuals); OKI - acute intestinal infections; NAD - non-ulcer dyspepsia; Chr. gd - chronic gastroduodenitis; YAB - peptic ulcer of the stomach and duodenum; Atr gt - atrophic gastritis.

Thus, the method for determining the frequency of occurrence of Helicobacter pylori O-antigen includes determining the age of the patient, month (season) and year of study, the presence of clinical symptoms of gastrointestinal tract, the type of biomaterial and their indicators according to the attached Table, followed by calculation according to the attached Formula.

The method can be used to optimize the diagnosis of H. pylori infection, to prescribe and evaluate the effectiveness of therapeutic and preventive measures, to predict possible clinical exacerbations of helicobacteriosis and retrospective studies, as well as in the field of heliobiology.

The technical result achieved by using the proposed method is a significant simplification in obtaining diagnostic data, treatment and prognosis of chronic persistence of helicobacteriosis.

Industrial applicability is obvious, since the proposed method can be carried out using calculations using the proposed Formula and Table (without laboratory tests by the coagglutination reaction). It does not require special tools and equipment, greatly simplifying and accelerating the receipt of the necessary information. The method can provide a high economic effect.

A method for determining the frequency of occurrence of Helicobacter pylori O-antigen is presented in the examples.

Example 1

It is necessary to determine the frequency of occurrence of H. pylori O-antigen in a patient aged 86 with a clinical diagnosis of Chronic gastroduodenitis in 2011 in coprofiltrate.

Using Table 1, the average annual C ₁ (38%), coefficient K ₁ (1.0), K ₂ (1.1), K ₃ (1.5), K ₄ (1.0) were determined. When calculated according to the formula IVI, _O = 38 × 1.0 × 1.1 × 1.5 × 1.0 = 62.7%.

Conclusion: the frequency of occurrence of H. pylori O-antigen in feces is high. The average annual incidence rate of O-antigen in this patient during monitoring studies during 2011 is also high (68%).

Example 2

It is necessary to determine the frequency of occurrence of O-antigen in a patient with 86 years of chronic gastroduodenitis in a saliva sample in January 2013.

We determine IVI _O using the data of Table 1 and the values of C and the coefficients K ₁ -K ₄ indicated in it:

in January 2013, C is 50%, K ₁ is 1.0, K ₂ is 1.1, K ₃ is 1.5, K ₄ is 1.2, Calculate: IVI _O = 50 × 1.0 × 1 , 1 × 1.5 × 1.2 = 99%.

Conclusion: Helicobacter pylori - infection - high.

Example 3

It is necessary to determine the frequency of occurrence of H. pylori O-antigen in the feces throughout the 24th Solar cycle: in a patient with 86 years of chronic gastroduodenitis. Using Table 1, we determine the values of the indicator C, the coefficients K ₁ -K ₄ and calculate, according to the formula, the estimated average annual frequency of O-antigen for each year of the 24th Solar cycle.

As a result, IVI _O in feces

in 2009 is 38 × 1.0 × 0.8 × 1.5 × 1.0 = 46%

in 2010 - 38 × 1.0 × 0.9 × 1.5 × 1.0 = 51%

in 2011 - 38 × 1.0 × 1.1 × 1.5 × 1.0 = 63%

in 2012 - 38 × 1.0 × 1.2 × 1.5 × 1.0 = 68%

in 2013 - 38 × 1.0 × 1.1 × 1.5 × 1.0 = 63%

in 2014 - 38 × 1.0 × 0.7 × 1.5 × 1.0 = 40%

in 2015 - 38 × 1.0 × 0.5 × 1.5 × 1.0 = 28%

in 2016 - 38 × 1.0 × 0.4 × 1.5 × 1.0 = 23%

in 2017 - 38 × 1.0 × 0.5 × 1.5 × 1.0 = 28%

in 2018 - 38 × 1.0 × 0.6 × 1.5 × 1.0 = 34%

in 2019 - 38 × 1.0 × 0.6 × 1.5 × 1.0 = 34%

As can be seen from these data, O-antigen values increase during the period of increasing solar activity in the 24th Solar cycle, become maximum in 2012 and quite high in 2013, then significantly decrease until 2015 and then increase slightly by 2019 g.

Example 4

A similar dynamics of the circulation of Helicobacter pylori O-antigen is also expected in case of duodenal ulcer (ULC), acute intestinal infections (OKI), in asymptomatic volunteers (DB), the difference between these groups of patients is only in the different amplitude of fluctuations in the frequency of occurrence of antigen (Table 2).

table 2 The frequency of occurrence of Helicobacter pylori O-antigen in patients with duodenal ulcer, acute intestinal infections and in healthy volunteers in saliva (calculation by the formula,%) Groups / Years 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 I WOULD 66 74 90 98 90 57 41 33 41 49 49 OKI 44 49 60 66 60 38 27 22 27 33 33 Db 37 41 52 56 51 32 23 eighteen 23 28 28 Abbreviations: YAB - peptic ulcer of the stomach and duodenum; OKI - acute intestinal infections; DBs are asymptomatic volunteers.

The frequency of occurrence of free O- and Helicobacter pylori VacA antigens bound to immune complexes in chronic gastroduodenitis is shown in the figure.

Literature

1. Belaya Yu.A., Petrukhin V.G., Vakhrameeva M.S., Beliy Yu.F., Belaya O.F. A method for determining the likelihood of infection with Helicobacter pylori. Patent 2360251, December 16, 2007. Publ. 06/27/2009

2. Belaya Yu.A., Belaya O. F., Petrukhin V. G., Bystrova S. M., Vakhrameeva M. S. Patterns of circulation of Helicobacter pylori antigens with persistence in the body // Infectious diseases, 2012. - V. 10. Appendix No. 1. - S. 45-46.

3. Belaya Yu.A., Belaya O.F., Petrukhin V.G. Solar activity as a dominant factor in the external effect on the persistence of Helicobacter pylori in the body // Abstract. International conference "The influence of space weather on man in space and on Earth" M., June 4-8, 2012, IKI RAS. S.60-61. Presentation - SWH_2.20_Belaya.pps 7.29 Mb.

Claims (1)

A method for determining the probability of infection of an organism of H. pylori (IVI _O ) of a patient, including taking biomaterial (K ₄ ), determining the presence of a gastrointestinal disease (K ₃ ), determining age (K ₁ ) and determining O-antigen (O _ag ) H. pylori in the biomaterial by the coagglutination reaction with the subsequent determination of the coefficient (K ₂ ) depending on the current calendar year, after which IVI _O is calculated according to the formula
IVI _O = C × K ₁ × K ₂ × K ₃ × K ₄ ,
where C - seasonality - is in the 1st month of the year -50, in the 2nd -61, in the 3rd -55, in the 4th -31, in the 5th -28, in the 6th -14, in the 7th -12, in the 8th -15, in the 9th -25, in the 10th -45, in the 11th -64, in the 12th -58;
K ₁ , if the patient is under the age of one year, is 0.5, if the patient is more than a year old - 1.0;
To ₂ is in 2013, OAG - 0.5; 2014 Oag - 0.4; 2015 Oag - 0.3; 2016 Oag - 0.4; 2017 Oag - 0.5; 2018 Oag - 0.6; 2019 Oag - 0.6;
K ₃ depending on the disease is:
- almost healthy - 1.0;
gastrointestinal diseases - 1.2;
- non-ulcer dyspepsia - 1.3;
- chronic gastroduodenitis - 1.5;
- peptic ulcer of the stomach and duodenum - 1.8;
- atrophic gastritis - 1.3;
To ₄ depending on the type of biomaterial is:
- coprofiltrate - 1.0;
- saliva - 1.2;
- CEC of blood serum - 1.4,
and with IVI _O values from 1 to 9%, the probability of H. pylori infection is estimated as doubtful, from 10 to 19% - low, from 20 to 39% - medium, from 40 to 100% - high.

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