RU2351283C1 - Method of determination of acquired hypogonadism at men with ischemic heart disease - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention concerns medicine, namely to cardiology, and can be used for revealing of the age acquired hypogonadism at men with ischemic heart disease. Level of indicator of hypogonadism is calculated with use of the equation of plural regress: HI=4.1+0.13×age (years)+0.28×prescription diseases (years)+6.3×waist circumference/hips circumference - 1.32×depression (point). The waist and hips circumference is measured in centimetres. Depression level is measured according HADS the scale. Prescription of disease and age of the patient is measured in years. The indicator less or equal to 8 points corresponds to hypogonadism presence, the indicator in a range of 8.1 - 11.9 points corresponds to borderline case demanding additional inspection, the indicator of 12 points and above corresponds to absence of hypogonadism.

EFFECT: method provides simplicity and noninvasive approach of diagnostics, raises efficiency of treatment-and-prophylactic actions.

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Description

The invention relates to medicine, namely to cardiology, and can be used to detect age-related acquired hypogonadism in patients with coronary heart disease (CHD).

According to the literature, acquired age-related hypogonadism in men contributes to the early development of coronary artery atherosclerosis, IHD (Malkin CJ, Pugh PJ, Jones T.N. et al. Testosterone for secondary prevention in men with ischaemic heart disease QJ Med. 2003; 96 (7 ): 521-529), arterial hypertension, obesity, depressive disorders (Andrology. Men's health and reproductive system dysfunction: Translated from English / Edited by E. Nishlag, G. Bere. - Medical Information Agency LLC , 2005 .-- 554 p.).

In this regard, the early detection of sex hormone deficiency in men will allow timely prescribing hormone replacement therapy with testosterone preparations for primary and secondary prevention of coronary heart disease.

A known method for the diagnosis of hypogonadism using the “Questionnaire for assessing androgen status in men” (authors Heinemann LAJ, Zimmermann T, Vermeulen A, Thiel C. A New ′ Aging Male′s Symptoms ′ (AMS) Rating Scale. The Aging Male 1999; 2 : 105-114) and published in the Russian version by A. Vertkin and Kalinchenko S.Yu. (Medical newspaper No. 17, dated March 10, 2006).

The method consists in analyzing the answers obtained as a result of individual filling in the questionnaire by patients. The presence or absence of hypogonadism is assessed by the sum of the points scored when answering 17 questions relating to the psychological, somatic and sexual problems of the patient. Symptoms of hypogonadism are considered unexpressed when the number of points is from 17 to 26, weakly expressed - from 27 to 36 points, moderate - from 37 to 49, expressed - when the total score is more than 50.

The disadvantage of this method is the subjectivity of the assessment of hypogonadism, based solely on the questionnaire data of the patient.

A known method for the diagnosis of hypogonadism, which consists in measuring the concentration of male sex hormone testosterone in blood serum. According to international recommendations, for the diagnosis of hypogonadism, it is considered sufficient to measure the concentration in the blood serum of one of the androgens - testosterone (Investigation, Treatment, and Monitoring of Late-Onset Hypogonadism in Males: ISA, ISSAM, and EAU Recommendations. The International Journal of Andrology. 2005, 28: 125-127). Determination of serum testosterone concentration is carried out using enzyme immunoassay analyzers according to the method described in the publication: Vermeulen A, Kaufman JM. Aging of the hypothalamo-pituitary-testicular axis in men. Horm Res 1995, 43:25. The principle of the method is based on the competition of testosterone from the measured sample and peroxidase labeled testosterone for the binding sites of testosterone-specific antibodies immobilized on the surface of the holes of the polystyrene plate. The amount of bound testosterone peroxidase conjugate is detected using a substrate solution (tetramethylbenzidine with the addition of hydrogen peroxide). The color intensity of the oxidation product of the substrate is inversely proportional to the concentration of testosterone contained in the analyzed sample. Reproducibility of results: successive measurements of the concentration of testosterone in the same serum sample give a range of values within 8%.

The disadvantages of this method:

1. For the collection of venous blood of a patient requires the presence of specially trained medical personnel.

2. Work with biological substrates should include the availability of a treatment room and equipment for the collection, storage and disposal of blood samples.

3. It is necessary to have special expensive equipment: a biochemical analyzer, a set of reagents for enzyme immunoassay.

4. It takes time to take blood, treatment, analysis.

The purpose of the invention is to determine the acquired non-invasive method of hypogonadism to increase the effectiveness of treatment and preventive measures in men suffering from coronary heart disease.

The goal is achieved by determining the patient’s waist and hips, the level of depression according to the HADS questionnaire and the duration of the disease, followed by the construction of the multiple regression equation.

The method is as follows:

1) Measure the waist circumference of the patient (cm).

2) Measure the circumference of the patient's hips (cm).

3) The ratio of the waist circumference to the hip circumference is calculated.

4) HADS questionnaire is filled out (Zigmond A.S., Snaith R.P. The Hospital Anxiety and Depression scale. // Acta Psychiatr. Scand. 1983 - Vol.67 - P.361-370), the total score for the depression subscale (7 questions in total) is calculated.

5) Determine the duration of the disease (in years, including incomplete) according to the patient’s medical records, or, in its absence, by interviewing the patient).

6) The hypogonadism index (GH), which reflects the concentration of testosterone in the blood, is obtained using the equation:

GH = 4.1 + 0.13 × Age (years) + 0.28 × Prescription of the disease (years) + 6.3 × Waist circumference / Hip circumference - 1.32 × Depression (score).

The age value is presented in full years at the time of the survey.

If the calculated indicator is less than or equal to 8, then this is regarded as the presence of acquired age-related hypogonadism and means the need for hormone replacement therapy with testosterone preparations; indicators of 12 or more - about the absence of hypogonadism, when treatment is not required. If the indicator is in the range of 8.1-11.9, then the question of the appointment of hormone therapy is decided individually, taking into account the severity of the clinical picture of hypogonadism and additional biochemical studies (determination of sex steroid-binding globulin and the level of bioavailable testosterone). The interpretation of the hypogonadism index is given according to the source: Investigation, Treatment, and Monitoring of Late-Onset Hypogonadism in Males: ISA, ISSAM, and EAU Recommendations. The International Journal of Andrology. 2005, 28: 125-127

To verify the proposed method, we determined the correlation coefficient of the serum concentration of testosterone in 28 patients with coronary artery disease and the hypogonadism index calculated using our method. The correlation coefficient r = 0.91; its confidence level p = 0.000003.

Thus, our proposed method for indirectly determining hypogonadism accurately reflects this indicator determined by direct methods.

The following are examples of the use of the claimed method.

Example 1

Patient B., medical history No. 5015. Clinical diagnosis: IHD, progressive angina pectoris. Hypertension of the III stage, the risk of cardiovascular complications 4 (very high). CHF I, FC2.

Age - 51 years, disease duration - 10 years, waist circumference - 83 cm, hip circumference - 91 cm, depression level - 5 points. The concentration of testosterone in the blood is 12.5 nmol / L.

To determine the presence of hypogonadism, the regression equation is solved:

GH = 4.1 + 0.13 × 51 + 0.28 × 10 + 6.3 × 0.912-1.32 × 5.

The resulting indicator is 12.7, which indicates the absence of androgen deficiency and indications for hormone replacement therapy.

Example 2

Patient Y., case history No. 15260. Clinical diagnosis: IHD, progressive angina pectoris. Hypertension of the III stage, the risk of cardiovascular complications 4 (very high). CHF 0, FC1.

Age 60 years, disease duration - 3 years, waist circumference - 96 cm, hip circumference - 104 cm, depression level - 9 points. The concentration of testosterone in the blood is 7.0 nmol / L.

To determine hypogonadism, the regression equation is solved:

GH = 4.1 + 0.13 × 60 + 0.28 × 3 + 6.3 × 0.923-1.32 × 9.

The resulting indicator is 6, 7, which indicates the presence of hypogonadism and the need for hormone replacement therapy with testosterone preparations.

The proposed method can be effectively used by practitioners to identify acquired age-related hypogonadism in men with coronary heart disease without determining the concentration of testosterone in the blood with the aim of timely inclusion of hormone replacement therapy with testosterone drugs in the plan of therapeutic and preventive measures.

Literature

1. Heinemann LAJ, Zimmermann T, Vermeulen A, Thiel C. A New ′ Aging Male′s Symptoms ′ (AMS) Rating Scale. The Aging Male 1999; 2: 105-114.

2. Vertkin A.L., Kalinchenko S.Yu. Acquired age-related androgen deficiency. // Medical newspaper No. 17, March 10, 2006

3. Investigation, Treatment, and Monitoring of Late-Onset Hypogonadism in Males: ISA, ISSAM, and EAU Recommendations. The International Journal of Andrology. 2005.28: 125-127.

4. Vermeulen A, Kaufman JM. Aging of the hypothalamo-pituitary-testicular axis in men. Horm Res 1995.43: 25.

5. Malkin C.J., Pugh P.J., Jones T.N. et al. Testosterone for secondary prevention in men with ischaemic heart disease? Q J Med 2003; 96 (7): 521-529.

6. Andrology. Men's health and reproductive system dysfunction: Per. from English / Ed. E. Nishlaga, G.M.Bere. - Medical Information Agency LLC, 2005. - 554 p.

7. Zigmond A.S., Snaith R.P. The Hospital Anxiety and Depression scale. // Acta Psychiatr. Scand. 1983 - Vol. 67 - P.361-370.

Claims (1)

A method for determining acquired hypogonadism in men with coronary heart disease, namely, that the level of hypogonadism index is calculated using the multiple regression equation: PG = 4.1 + 0.13 × age (years) + 0.28 × disease duration (years) + 6.3 × waist circumference / hip circumference - 1.32 × depression (point), where the waist circumference and hip circumference are measured in centimeters, the level of depression is measured on the HADS scale, the duration of the disease and the patient's age are measured in years, and the rate is less than or equal to 8 points s corresponds to the presence hypogonadism index in the range of 8,1-11,9 points corresponds to the border condition requiring further investigation, the indicator 12 points above corresponds to the lack of hypogonadism.