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Method of diagnosing androgenic deficiency

IPC classes for russian patent Method of diagnosing androgenic deficiency (RU 2439578):
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FIELD: medicine.

SUBSTANCE: in blood serum bioavailable testosterone fraction bound to albumin is determined. If its value is lower than 185.7 pg/ml, disease is diagnosed.

EFFECT: method application ensures increase of androgenic deficiency diagnostics accuracy and gives possibility to carry out early disease diagnostics.

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The invention relates to the field of clinical medicine, namely, endocrinology, and can be used for the diagnosis of androgen deficiency.

A known method for the diagnosis of androgen deficiency using the quantitative determination of total and free testosterone, which is the bioavailable fraction of testosterone in serum (Nevarakka. Verification of androgen deficiency in men: clinical and laboratory aspects. The journal "Medical news". Archive No. 16, 2009).

The disadvantages of the method: the lack of accuracy of the method, as it does not take into account the fraction of bioavailable testosterone bound to albumin, due to the fact that albumin is not detected in serum, and its quantity is taken as a constant, late diagnosis.

Technical result: earlier diagnosis of androgen deficiency, improving the accuracy of the method.

This result is achieved by the determination of albumin in serum, by calculating the fraction of bioavailable testosterone bound to albumin, and when the value of testosterone bound to albumin less 185,7 PG/ml, diagnosed the disease.

The method is as follows: from 7 to 11 o'clock in the morning on an empty stomach from the cubital vein of the subject take 5 ml of blood in a dry test tube. The blood is centrifuged at 1000 g for 10 minutes and separated savoro the ku from the precipitate formed elements of blood. In serum to determine the number of albumin method with bromcresol green, the number of total testosterone and SHBG immunochemiluminescent way. Bioavailable fractions of testosterone (testosterone bound to albumin, and free testosterone) is determined by way of calculation by mathematical formulas (Alex Vermeulen, Verdonck Lieve, Kaufman Jean M. A Critical Evaluation of Simple Methods for the Estimation of Free Testosterone in Serum. - J. Clin Endocrinol Metab., 1999. No. 84. P.3666-3672):

TCB=(Tobs-(N×TCB)/(CT×(SHBG-Tabs+N×TCB))

TA=Ka×Ca×TSV

TCB - testosterone free,

The testosterone bound to albumin,

Tabs - total testosterone,

N=CA×Ca+1,

Ka is a constant,

Ca is the concentration of albumin,

CT is a constant,

Gspg - globulin that binds sex hormones.

And when the value of testosterone bound to albumin less 185,7 PG/ml, determine androgen deficiency.

Examples of specific performance.

Example 1.

Patient O., 37 years. He complained of weakness, sweating, inability to lose weight on the background diet, increasing the pressure to 150/90 mm Hg, decreased libido.

Overall status: Height - 190 cm Weight - 139 kg, BMI 38 kg/m2, waist - 135 cm, AD - 135/90 mm Hg

Tests: fasting glucose - 6,9 mmol/l, dyslipidemia. Fractions of testosterone: total testosterone - 384 PG/ml (normal 344-2100), free testosterone - 7,46 (norm-5,5-42, testosterone bound to albumin, is 177,99 (norm 185,7-1260). Conclusion: Laboratory notes relative androgen deficiency by reducing the fraction of bioavailable testosterone (bound to albumin).

Based on a survey of diagnosis: impaired glucose tolerance. Obesity II senior Dyslipidemia. Androgen deficiency.

A comprehensive survey has established that the patient has a decrease in bioavailable testosterone (bound to albumin). Appointed substitution androgenicity.

Example 2.

Patient Z., 54 years old. Complained of rapid weight gain (30 kg for 5 years), shortness of breath with little exertion, fatigue, sexual dysfunction, reduced libido, the pressure rises to 180/105 mm Hg

Overall status: Height - 175 cm, Weight - 146 lbs, BMI of 47 kg/m2, waist - 143 cm, AD - 160/95 mm Hg

Tests: glucose - 6.0 mmol/l, lipid - dyslipidemia. Fractions of testosterone: total testosterone - 440 PG/ml (normal 344-2100), free testosterone - 6,17 (norm-5,5-42), testosterone bound to albumin, is 158,98 (norm 185,7-1260). Conclusion: Laboratory notes relative androgen deficiency by reducing the fraction of bioavailable testosterone (bound to albumin).

The survey has allowed to establish graduate from the local diagnosis: Obesity III senior Dyslipidemia. Androgen deficiency.

Assigned testosterone replacement treatment.

Example 3.

Patient P., aged 40. He complained of excess weight, fatigue and shortness of breath during physical activity.

Overall status: Height - 176 cm, Weight 113 kg, BMI of 36 kg/m2, waist - 122 cm, BP - 130/80 mm Hg

Tests: glucose, lipid profile is normal. Fractions of testosterone: total testosterone - 328 PG/ml (normal 344-2100), free testosterone of 8.37 (norm-5,5-42), testosterone bound to albumin, is 221,64 (norm 185,7-1260). Conclusion: Laboratory celebrated ermogenis at lower total testosterone.

The patient diagnosed with Obesity II Art. Assigned therapy aimed at reducing weight. Replacement therapy with testosterone is not required.

The proposed method was used in 38 patients aged from 27 to 59 years with suspected androgen deficiency.

Shows most informative of this method in comparison with the prototype. An increasing number of persons with laboratory-confirmed androgen deficiency by determining the fraction of testosterone bound to albumin. So, out of 11 cases (29%) laboratory diagnosed androgenetica in all 11 samples was determined with a reduced level of testosterone bound to albumin, but only 2 of them had snizhenievrednye testosterone.

The positive effect from the use of this method is to significantly improve the diagnosis of androgen deficiency and therefore the timeliness of the appointment of replacement therapy with testosterone, which increases the effectiveness of treatment and improve prognosis.

Method for the diagnosis of androgen deficiency by determining the fractions of testosterone in blood serum, wherein determine the bioavailable fraction of testosterone bound to albumin, and when it is less 185,7 PG/ml diagnose the disease.

 

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