RU2569246C1 - Method for determining diagnostic ultrasound effect in human - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: method involves performing Akabane test and/or diagnosing functional heart rhythm variations by recording a continuous sequence of 600 cardiac cycles immediately prior to, immediately after and 1 hour after an ultrasonic exposure. That is followed by comparative analysis of the findings. If observing the changes 1 hour after the ultrasonic exposure, particularly the changes in three or more canals by Akabane test and/or heart rhythm variability shift to sympathicotonia or vagotonia, adaptability failure and ultrasound hypersensitivity are stated.

EFFECT: method enables the real-time determination of the diagnostic ultrasound effect in human.

2 cl, 3 tbl, 3 ex

Description

The invention relates to experimental and diagnostic medicine and can be used to monitor the effectiveness of measures to protect a person from diagnostic ultrasound under modeling conditions in preclinical experiments, as well as for rapid screening of the effect of high-frequency low-intensity ultrasound on both the patient and the ultrasonography operator. Diagnostic ultrasound is a high-frequency ultrasound of low intensities (ultrasound with an oscillation frequency of 1.0-31.5 MHz and an intensity of not more than 110 dB or 0.1 W / cm ² (Hygiene requirements when working with air and contact ultrasound sources of industrial, medical and SanPiN 2.2L. / 2.1.8.582-96) used in diagnostic installations of medical institutions.

Ultrasound is the most affordable and painless way to diagnose many diseases. On average, the procedure lasts 20 minutes. To prevent the undesirable effect of ultrasonic energy on the human body, various technological tools and working methods are used to protect against ultrasound (gloves, fractional operation, shielding devices). The term "security" implies the complete absence of undesirable effects, i.e. the procedure should eliminate any risk. However, when assessing the impact of diagnostic ultrasound on a person, there are a number of problems. There is no equivalent parameter for predicting ultrasonic effects. Ultrasound, by definition, is not directly perceived by the human senses, therefore it is necessary to use some kind of physical effect or a sequence of such effects so that the action of ultrasound can manifest itself, moreover, quantitatively. So, it is impossible to determine the assessment of the level of radiation received by the patient, because the amount of ultrasonic energy received varies depending on the type of apparatus and research modes, on the one who conducts the study (on the qualifications of the doctor and on his experience). The effect of diagnostic ultrasound on the operators of ultrasound diagnostics has not been sufficiently studied.

It is known that ultrasonic energy is much denser than ordinary sound, since the frequency of oscillations of such waves is higher than that of ordinary sound. Just this factor explains the strong influence of ultrasonic radiation on the human body.

Results of comprehensive research at the Research Institute of Occupational Medicine RAMS [Russian Encyclopedia on Labor Protection / Ministry of Health and Social Development of the Russian Federation; Total ed. N.I. Markin; 2nd ed., T. 1., M., 2007] showed that ultrasonic waves can cause multidirectional biological effects, the nature of which is determined by the intensity of ultrasonic vibrations, frequency, temporary oscillation parameters (constant, pulsed), duration of exposure, tissue sensitivity. The studies used regulated examination methods (determination of vibration and pain sensitivity, critical frequency of light flickering, sensorimotor reaction, thermometry, photoplethysmography, heart rate monitoring, tonometry, electrocardiography, stabilography, audiometry, electroencephalography). Effects are conventionally divided into:

- mechanical, caused by alternating displacement of the medium, radiation pressure, etc .;

- physico-chemical, associated with the acceleration of diffusion processes through biological membranes, a change in the rate of biological reactions;

- thermal, which are the result of heat generation during the absorption of ultrasonic energy by the tissues and accompanied by an increase in temperature at the boundaries of tissue structures, heating on gas bubbles;

- effects associated with the occurrence of ultrasonic cavitation in tissues (formation with subsequent collapse of vapor-gas bubbles in the medium).

The most studied physical effects of ultrasound, which cause undesirable consequences, are mechanical effects, when the ultrasound pressure exceeds a certain limit and there is a cavitation effect and thermal effect due to the viscosity of soft tissues and absorption of a significant part of the power of ultrasonic (ultrasound) vibrations. Due to the peculiarities of biological tissues, to absorb ultrasound energy with its transformation into heat, a local temperature increase can be observed if the rate of heat generation exceeds the rate of its removal. The consequence of the above processes from exposure to ultrasound is uncontrolled chemical reactions in the wave propagation medium [Makino K, Mossoba MM, Riesz Chemical, Chemical effects of ultrasound on aqueous solutions. Formation of hydroxyl radicals and hydrogen atoms, J Phys Chem, Apr 14; 87 (8): 1369-1377, 1983].

Data on the effect of high-frequency ultrasound on the human body indicate polymorphic changes in almost all tissues, organs and systems. At the Chuvash State University named after I.N. Ulyanova studied the health status of 85 ultrasound doctors in comparison with a similar control group of doctors. Ultrasound diagnostics doctors revealed various disorders, including the cardiovascular system (including arrhythmias), the nervous system in the form of dysfunction of vegetative centers, a change in intestinal microbiocenosis, macro- and microelement composition of blood serum in the form of a decrease in iron and phosphorus , calcium, chlorine. The number of violations of various indicators is 30% higher compared to the control group [Suvorova NB Hygienic study of working conditions and the health of doctors of ultrasound diagnostics. Abstract dis. Cand. Medical Sciences: 14.00.07, Kazan, 2007].

At the Belarusian Research Institute of Cardiology, the effect of a single exposure to the precardial region of the ultrasound with a frequency of 2640 kHz (2.6 MHz) in a continuous mode, with a power of 0.4 W / cm on the main indicators of CHD and some electrophysiological parameters of cardiac activity was studied (ECG parameters were analyzed) in healthy and sick people stable angina pectoris. A significant increase in blood pressure syst. and HELL cf. in patients with exertional angina, the sinus node function varies ambiguously: in healthy people, the recovery time of the sinus node is shortened, and in patients with stable angina, the direction and severity of changes in the parameters of CHD in patients with stable exertional angina under the influence of ultrasound depends on the initial type hemodynamics, but the effect of ultrasound on hemodynamic parameters is undoubted [Rudenko E.V. The effect of ultrasound on the functional state of the cardiovascular system in healthy and patients with stable exertional angina. Abstract of the diss. Medical Sciences: 14.00.06, Minsk 1992].

The results of clinical and physiological studies suggest that it is possible to develop generalized reflex-vascular changes when exposed to contact ultrasound.

A well-known study at the University of Washington, Seattle, "Changing the behavioral instincts of mice under the influence of ultrasound with the characteristics used in ultrasound diagnostics" (Abbi M. McClintic, Bryan H. King, Sara J. Webb, and Pierre D. Mourad, publ. 18 NOV 2013, International Society for Autism Research, Wiley Periodicals.lnc. [Electronic resource] http://onlinelibrary.wiley.com/doi/10.1002/aur.1349/). In the work of American researchers on 8 standard pregnant mice, the influence of ultrasound was analyzed (ultrasound source Sonosite MicroMaxx, with P17 / 5-1, I_spta 0.62 ± 0.22 W / cm), and tissue temperature was measured. During ultrasound exposure, thermocouple needles were inserted into the abdominal cavity under mice under anesthesia.

Studies conducted to date to assess the effect of ultrasonic fields of high-frequency low-intensity ultrasound are either epidemiological or conducted in animals. However, the aforementioned and similar studies cannot provide a real-time assessment of the effect of ultrasound directly on a person in vivo.

It is known that to assess the dynamics of the state of the regulatory mechanisms of heart rhythm, as well as to assess the response of the cardiovascular system to stress, medication and physiotherapy use an analysis of the heart rate (patent Rf 2077864, IPC A61B 5/04, A61B 5/0402, publ. . 04/27/1997).

A known method for early diagnosis of the functional state of body systems (RF patent 2039523, IPC A61B 5/04, publ. 07/20/1995), including the allocation of the RR-interval and spectral analysis of its envelope; the sample contains a minimum of 360 ° RR-intervals, and the spectrum is built on a logarithmic frequency scale. At the same time, the spectral density minima are determined, and the cardiac, pulmonary, vascular and metabolic functional systems are distinguished by them. The described method allows to increase the accuracy of determining the state of regulatory processes of functional systems of the human body and identifying deviations in their work at an early stage during a period of hidden changes.

A known method and device for identifying and analyzing specific informative signs of a functional state, in particular pathological conditions caused by exposure to toxic agents, according to a cardiac rhythmogram (RF patent 2128004, IPC A61B 5/0452, publ. 03/27/1999). In this case, a cardiorhythmogram of RR intervals is removed, and sequences of equal-interval waves are used as specific informative signs of a functional state.

An adequate prototype of the proposed method for determining the impact of diagnostic ultrasound on a person in the analyzed literature was not found.

The objective of the invention is to provide a quick (in real time) determination of the harmful effects of ultrasound on the human body, exposed to high-frequency ultrasound of low intensity.

The solution to this problem is achieved by the fact that in the method for determining the influence of diagnostic ultrasound on a person three times: immediately before, immediately after and 1 hour after ultrasonic exposure, the Akabane thermopuncture test and / or the diagnosis of functional changes in heart rate are performed by recording a continuous sequence of 600 cardiocycles, then a comparative analysis of the results of studies and in the presence after 1 hour of changes that appeared after ultrasonic exposure, and names in the presence of changes in the three or more channels of the test Akabane and / or shear variability of heart rate toward the sympathic or vagotonia, increasing rigidity rhythm conclude disrupting adaptation capabilities of the organism and increased susceptibility to the effects of ultrasound. In this case, the diagnosis of functional changes in the heart rhythm is carried out using the diagnostic complex "Cardiac Analyzer Expert-01".

The claimed method is implemented as described in the examples.

Example 1. First, immediately before exposure to the body with ultrasound, thermopuncture testing is carried out using the device "Reflexomaster RM-07M" design V.G. Muzhikova. Testing is a standard Akabane test. Testing takes about 10 minutes. Next, the same study is repeated immediately after exposure to the body with ultrasound (ultrasonography of the thyroid gland on a stationary ultrasound scanner DP-9900 Plus Mindray (PRC) (real-time mode B). Then, such a study is carried out 1 hour after exposure. In channels in which the ratio of the left and right sides of D / S or S / D≥2, or the conditional channel testing time exceeds 50 units - there is an imbalance Based on the results of these studies, the state of the organism is compared before, immediately after and 1 hour after exposure to op anism by diagnostic ultrasound. The examination time is determined on the basis of the results of a series of experiments: changes (imbalance) in the channels that occurred after exposure to ultrasound usually disappear within 1 hour after exposure. In the presence of changes after ultrasonic exposure after 1 hour, they conclude that the effect of medical ultrasound on the human body.

As a test to study the effects of ultrasound on a person, the Akabane thermopuncture test is used. The Akabane test is approved for use by the Russian Ministry of Health. It is widely used in the analysis of the condition of channels (meridians according to Chinese tradition) in the practice of acupuncture. When working with electric current or an infrared ray, the information received reflects the condition of the skin, which is then used to judge the state of the internal structures of the body. The time difference becomes a criterion for diagnostic evaluation. In a perfectly functioning organism, impulses travel from every point to the sensitive areas of the cerebral cortex in a strictly defined period of time. If there is a pathological focus, then the transit time of the pulses varies, and this difference, in comparison with the ideal value, reflects the essence of the processes occurring in the organ, as well as the nature of the dynamics of its state. The test result is expressed in the change in the heat sensitivity of the end points of the meridian, mainly on the sick side, and reflects the asymmetry of the heat sensitivity of the right and left branches of the tested meridian. The result obtained depends on the patient's subjective response “It hurts - it doesn’t hurt” during warming up. In the Akabane test, only response times at symmetrical points are compared. Such an approach to interpretation is due to the fact that no matter how the thresholds of excitability in the test points are changed when the patient is subjected to painful irritation, at symmetrical points, the change in the intensity of the response should be the same. In channels in which the ratio of the left and right sides of D / S or S / D≥2, or the conditional channel testing time exceeds 50 units, there is an imbalance.

In the table. 1 shows for comparison examples of experimental data obtained as a result of studies using thermopuncture diagnostics.

where: P - channel of the lungs, GI - channel of the large intestine, C - channel of the pericardium, RP - channel of the spleen - pancreas, F - channel of the liver, E - channel of the stomach, R - channel of the kidneys, V - channel of the bladder.

From the data given in the table, it can be seen that regardless of the absence of imbalance or its presence in a number of channels before ultrasonic treatment, all subjects experience an imbalance in other channels after exposure to diagnostic ultrasound. Changes in the meridional system return to their original state in most cases within 1 hour, without affecting the patient’s health status. The experimental results can be explained from the perspective of the “Aquaparadigma” theory, from which it follows that water is sensitive to acousto-electromagnetic influences, which can affect the cluster structure of intracellular water, as well as the water included in the structure of “aqua waveguides”. According to Professor Slesarev V.I. channels are “aqua waveguides”. [Slesarev V.I., Shabrov A.V. Structural and informational property of water and the phenomenon of aquacommunication // Bulletin of the St. Petersburg State Medical Academy named after II. Mechnikov. - SPb., 2001, No. 4].

The experiments carried out made it possible to reveal the fact of the transmission of the impact of diagnostic ultrasound to the human meridian system and to determine the peaks of this effect in time. Based on these results, a method has been developed to determine the effect of diagnostic ultrasound on the body in real time.

According to the second option, to assess the effect of ultrasound on a person, the functional changes in the heart rhythm are diagnosed using the method described in Example 2.

For research, use the hardware-software complex for diagnosing functional changes in heart rhythm "Cardiac Analyzer Expert-01" head. No. 17-2008, Reg. Beats RZN No. FS 022a / 3772-06 using ISKIM 6 software of the standard PAC Varicard 2.51, Reg. Beats РЗН No. ФСР 2008/03109. A method for diagnosing functional changes in heart rhythm at the Expert-01 Cardioanalyzer complex is based on recognition and measurement of RR intervals of an electrocardiogram, construction of dynamic series of cardiointervals (cardiointervalograms), and subsequent analysis of the obtained numerical series.

Diagnosis of functional changes in heart rhythm is carried out by recording a continuous sequence of 600 cardiocycles. Various studies of short-term heart rate variability are standardized by the European Association of Cardiology and the North American Association of Rhythmology and Electrophysiology. In this case, it is optimal to use records of r-r intervalograms of 600 cardiocycles - which on the time scale is about 6-8 minutes. [Heart rate variability. Standards for measurement, physiological interpretation and clinical use / working group of the European Cardiology Society and the North American Society of Stimulation and Electrophysiology. // Bulletin of arrhythmology, 1999. No. 11. p. 53-78].

Analysis of heart rate variability (HRV) is a way of assessing the state of the mechanisms of regulation of physiological functions in humans and animals, in particular, the total activity of regulatory mechanisms, neurohumonal regulation of the heart, the relationship between the sympathetic and parasympathetic parts of the autonomic nervous system.

Parameters recommended by the Standards [Heart Rate Variability. Standards for measurement, physiological interpretation and clinical use / working group of the European Cardiology Society and the North American Society of Stimulation and Electrophysiology. // Bulletin of arrhythmology, 1999. No. 11. p. 53-78]. In the course of HRV analysis, the following characteristics are evaluated: characteristics of the periodic components of HRV (spectral analysis), statistical characteristics of the total heart rate variability (statistical analysis), geometric characteristics of HRV and Baevsky indices calculated on their basis.

In spectral analysis, the absolute spectral powers of three standard ranges are taken into account: high frequency range; low frequency range; range of "very" low frequencies. Statistical analysis takes into account SDNN, the standard deviation for all NN intervals, and AMo (%) is the mode amplitude. Geometric analysis takes into account the adequacy of regulatory processes (CAD); voltage index of regulatory systems (stress index, IN) [Yabluchansky N.I., Martynenko A.V. Heart rate variability. Kharkov, 2010, 131 pp.]. As an indicator of the level of activity of the parasympathetic division of the ANS, SDNN is used. As indicators that most fully characterize the level of activity of the sympathetic division of the ANS, heart rate and PAPR are used. AMO is used as an indicator reflecting the stabilizing effect of the sympathetic nervous system, characterized by resistance to artifacts and sensitivity to changes in functional state. As an integral indicator of the overall level of activity of the ANS and the functional state of the body, characterizing the reserve of functional reserves and the degree of tension of regulatory processes, use the stress index (IN) [Bayevsky P.M. Analysis of heart rate variability when using various electrocardiographic systems: guidelines. Chelyabinsk, 2002, 64 p.].

Example 2. First, after a ten-minute rest and immediately before exposure to the body with ultrasound, a background screening of the patient’s functional state is carried out using the Expert-01 Cardioanalyzer complex. In this case, a cardiac rhythmogram is taken from a continuous sequence of 600 cardiocycles with an accuracy of +/- 0.3 ms. Position during the experiment: the subject lying on the couch, the second non-standard abduction: left arm - right leg. Registration and analysis time 15 minutes. Measuring artifacts in the analysis are corrected while maintaining the basic structure of the cardiac rhythmogram. The statistical parameters of variability of neighboring intervals are averaged over three cardiac rhythmograms and organization levels of sympathetic parasympathetic tone.

Further, the same study is repeated immediately after exposure to the body with ultrasound (ultrasonography of the thyroid gland on a stationary ultrasound scanner DP-9900 Plus Mindray (China)).

Then conduct such a study 1 hour after exposure. According to the results of these studies, a comparison is made of the state of the body before, immediately after and 1 hour after exposure to the body with diagnostic ultrasound. If after 1 hour there are changes that appeared after ultrasonic exposure, a conclusion is drawn about the harmful effects of ultrasound on the body.

In the table. 2 are given for comparing the characteristics of experimental data obtained as a result of studies of functional changes in heart rhythm using the "Cardiac Analyzer Expert - 01".

where: HRV - heart rate variability, heart rate - heart rate, SDNN - standard deviation for all NN intervals, AMo - the number of cardio intervals in the fashion range, PAPR - an indicator of the adequacy of regulation processes, IN - voltage index of regulatory systems, degree of centralization of heart control rhythm.

From the data given in the table it can be seen that according to the main indicators of the North American and European standard of cardiac rhythmography and indicators of variability of R.M. Baevsky ultrasound causes a shift in HRV indices towards pronounced sympathicotonia (SDNN decreases, heart rate, PAPR, IN increases), rhythm rigidity and a decrease in HRV are observed (AMo increases). The results of the experiments show that, after working with contact ultrasound, operators have an increase in heart rate rigidity much more pronounced than in patients who underwent ultrasound examination. Changes become comparable with the original data after 1 hour. A comparative analysis of cardiac rhythmograms confirms the conclusions about the registration of reactive changes within 1 hour after exposure to diagnostic ultrasound.

According to the presented experimental results, it can be seen that low-intensity high-frequency ultrasound affects the cardiovascular and autonomic systems of those examined on an ultrasound scanner. Under the influence of low-intensity high-frequency ultrasound, metabolic degradation processes occur, similar to malignant processes. The detected changes are observed in all participants in the experiment by the presence of a large number of rigid and an increased number of shortened chains of 2 shock waves of the first, second, and third orders. If after 1 hour there is a shift in HRV indices towards sympathicotonia (vagotonia), rhythm rigidity and a decrease in HRV after ultrasound examination, it is concluded that there is a harmful effect of ultrasound on the body. An analysis of the obtained data suggests that in the case of the presence of a harmful effect, the regulatory systems are overstrained and their asthenization subsequently occurs.

Example 3 shows the joint use of the Akabane thermopuncture test and the diagnosis of functional changes in heart rhythm to determine the effect of diagnostic ultrasound on a person.

Example 3. First, immediately before exposure to the body with ultrasound, thermopuncture control testing of the patient is carried out using the device "Reflexomaster RM-07M" design V.G. Muzhikova (Akabane test) for 10 minutes. After that, using the “Cardioanalyzer Expert-01” complex, a cardiac rhythmogram is taken from a continuous sequence of 600 cardio intervals for 6-8 minutes. Further, these same studies are repeated immediately after exposure to the body with ultrasound (ultrasonography of the thyroid gland on an ultrasonic stationary scanner DP-9900 Plus Mindray (China)).

Then conduct such studies 1 hour after exposure. Next, a comparative analysis of the results of the thermopuncture test and a comparative analysis of the functional changes in heart rate are carried out. In this case, the results obtained before, immediately after and 1 hour after exposure to the body by diagnostic ultrasound are compared. If after 1 hour there are changes that appeared after ultrasonic exposure, a conclusion is drawn about the harmful effects of ultrasound on the body.

In the table. 3 are given for comparing the characteristics of the experimental data obtained as a result of testing the proposed evaluation method.

where: P - channel of the lungs, GI - channel of the large intestine, C - channel of the pericardium, RP - channel of the spleen - pancreas, F - channel of the liver, Ε - channel of the stomach, R - channel of the kidneys, V - channel of the bladder, HRV - variability heart rate, heart rate - heart rate, SDNN standard deviation for all NN intervals, AMo - the number of cardio intervals in the fashion range, PAPR - an indicator of the adequacy of regulatory processes, IN - index of the voltage of regulatory systems, the degree of centralization of heart rate control.

From the data given in the table it is seen that under the influence of ultrasound, a decrease in HRV and imbalance in the meridional system occur. Ultrasound causes a shift in HRV indices towards pronounced sympathicotonia (vagotonia), increasing the rigidity of the rhythm and reducing HRV. Changes become comparable to the original after 1 hour. In the meridional system of subjects after exposure to ultrasound, an imbalance appears in new channels. Changes in the meridional system return to their original state in most cases within 1 hour.

According to the results of the examination using the inventive method based on the joint use of the Akabane thermopuncture test and diagnosis of functional changes in the heart rhythm of the examined patient (or future ultrasonography operator), one can refer to one of three groups:

- Signs of adverse effects of ultrasound were not found. The thermopuncture test shows no changes or changes occur in 1-2 channels immediately after exposure to ultrasound. These changes are leveled after 1 hour, or imbalances disappear in the meridional system, HRV indicators do not change, or they change insignificantly;

- Signs of moderate exposure to ultrasound were detected. Changes are observed in 3 or more channels after exposure to ultrasound, but return to their original state (or imbalances disappear) 1 hour after ultrasonic irradiation. HRV indicators change to a large extent, after 1 hour there is a return to values close to the original. It is recommended to limit contact with sources of ultrasonic waves;

- signs of disruption of adaptive capabilities in the human body at the time of the study were found (the subject can be attributed to a group of increased susceptibility to ultrasonic fields). Changes occur immediately after exposure in 3 or more channels, the changes do not disappear (or amplify) 1 hour after ultrasonic irradiation compared with the initial state. In the HRV indices, a significant shift towards sympathicotonia (vagotonia), increased rigidity of the rhythm is observed. After 1 hour, the “dangerous state” persists, there is no tendency to return.

Thus, the conducted experiments confirm the fact of the transmission of the impact of diagnostic ultrasound on the human body and allow us to identify the peaks of this effect in time, which allowed us to determine the optimal time for research to obtain reliable results. With this in mind, the inventive method has been developed that allows real-time determination of the effect of ultrasonic exposure on living people. All studies are performed without a patient preparation protocol. Three days before the measurement of cardiac rhythm, it is recommended to stop physiotherapeutic procedures, invasive studies and treatment, and exclude alcohol from the diet. The method allows to predict the consequences of repeated exposure to diagnostic ultrasound in professional activities in the operators of ultrasound diagnostics and in patients undergoing ultrasonography (examination of pregnant women is especially important). All variants of the method give the complex the most complete picture for determining the effect of ultrasound on a person, each of them individually can be used as a quick screening of the effect of high-frequency low-intensity ultrasound on both the patient and the ultrasonography operator. The method is implemented on publicly available equipment and does not require highly qualified staff.

Claims (2)

1. A method for determining the effect of diagnostic ultrasound on a person, characterized in that three times: immediately before, immediately after and 1 hour after ultrasonic exposure, an Akabane thermopuncture test and / or diagnosis of functional changes in heart rhythm are carried out by recording a continuous sequence of 600 cardiocycles, then a comparative analysis of the results of the studies and in the presence after 1 hour of changes that appeared after ultrasonic exposure, namely, in the presence of changed th three or more channels on the test Akabane and / or shift the variability of heart rate toward sympathicotonia or vagotonia, increasing the rigidity of a rhythm, conclude the breakdown of adaptive abilities of the body and an increased susceptibility to the effects of the ultrasound. 2. The method according to p. 1, characterized in that the diagnosis of functional changes in heart rhythm is carried out using the diagnostic complex "Cardiac Analyzer Expert-01".