Difficulties with hormone therapy (androgen therapy) in F / M transsexualism, as a rule, does not arise. Patients themselves come to the endocrinologist for the purpose of treatment, because they understand that they have no source of male sex hormones in the body. Treatment usually begins several years before the surgical correction of the genitals, a number of patients generally stop only at this stage of therapy, without performing surgical correction of the genitals. Subsequently, patients with transsexualism carefully monitor the regularity of injections, fearing the disappearance of the male phenotype, however, if this is not under the supervision of a physician, side effects are often associated either with overdose (acne, edema, lipid metabolism), or with an insufficient dose of the injected drug (in patients with gonadectomy, obesity, osteopenia and osteoporosis).
Despite the presence of a certain, albeit small, choice of androgenic drugs (oral, dermal and intramuscular forms), in patients with transsexualism, the ONLY EFFECTIVE FORM ARE INSIDE INTERSTING PREPARATIONS! Until recently, only one drug Sustanon-250 (Oggapop) and its licensed form Omnadren-250 (Polfa) were presented on the Russian market – a mixture of testosterone esters with different pharmacokinetic properties, which is quite an effective drug, but with several side effects:
- an increase in testosterone level above the supraphysiological level in the 1st week after administration, which is accompanied by a sharp increase in libido, the appearance of acne, aggressiveness and mood swings, in some patients – an increase in hematocrit;
- too frequent need for injections – from 2 to 4 times a month. With the advent of the new, prolonged, non-peak androgenic drug Nebido (schering), all patients with transsexualism should be transferred to its use.
- To select the dose of any androgenic drug (Sustanon-250, Omnadren-250, Nebido) in each case must be individually, under the control of hormone levels (LH, testosterone) in the blood plasma, because, as shown by our studies of the drugs Sustanon-250 and Omnadren-250 , the time of drug withdrawal from the body individually and varies widely (from 1 to 5 weeks), and the appointment of an inadequate dose can lead to undesirable side effects. The basis of the methods of hormone-therapeutic monitoring using immunity on-enzymatic determination of hormones in the blood plasma is as follows:
- determination of the basal level of the spectrum of hormones in the blood plasma (ELISA method): LH, FSH, estradiol, testosterone, 17-OPK, cortisol, prolactin;
- identification of dynamic changes and ratios of testosterone, LH during androgen therapy. The drug Sustanon-250 was administered once at a dose of 250 mg. The plasma testosterone concentration was measured immediately before the administration of the drug, after 1 day, after 1, 2, 3, 4 weeks. after drug administration. Determination of the concentration of the drug was carried out by enzyme immunoassay using kits and in accordance with WHO standards. According to the description of the technique and the reagents used, the accuracy of determining concentrations using this method when conducting 3-year studies is ± 15%. A total of 65 patients were examined.
The purpose of the study was as follows:
- to identify the average temporal dependence of testosterone concentration in the blood plasma after a single injection of an oil solution of a prolonged testosterone preparation – Sustanon-250 (at a dose of 250 mg);
- select different groups of patients in accordance with the dynamics of reducing the concentration of testosterone in the blood plasma;
- In accordance with the patterns shown, justify the need to monitor the concentration of testosterone at the beginning of androgen therapy.
In turn, this contributes to the optimal frequency of administration of androgens in each individual patient, which helps to avoid unwanted side effects as a result of overdosing of the drug or due to a sharp drop in testosterone concentration.
The distribution of the examined patients according to testosterone concentration values at different time intervals after drug administration is presented.
On these histograms, the abscissa shows the concentration of testosterone, the ordinate, the number of patients. Each column of the histogram covers with its base an interval of concentration values on the x-axis. The height of the column (ordinate) corresponds to the number of patients in whom the concentration of testosterone lies in this concentration range. For each histogram, the mean concentration value and the interval of one standard measurement error (15%) to the left and to the right of the mean value are also indicated there.
The dependence of testosterone concentration on the times of each individual patient can be represented as a smooth curve on the graph. However, such a representation is quite conditional due to the low accuracy of measuring testosterone concentrations by the method used (± 15%) and a small number of measurements.
Plotting was performed by performing a smooth curve on 5 points, corresponding to the time (1 day, 1, 2, 3, and 4 weeks) after drug administration. The method of such a curve does not affect the accuracy of the construction too much due to the low accuracy of the measurement results themselves. In computer processing, it is important, for example, to recommend quadratic interpolation at three neighboring points or using higher degree polynomials.
More reliable confirmation of this fact follows from the analysis of histograms on. Histograms A, B, C, corresponding to the time of 1 day, 1 and 2 weeks. after administration of the drug, show the measured values of concentrations and are grouped in the field of average values. The number of measurements that differ from the average value by less than 1 standard measurement error is 85% for histogram B, 88% for histogram B.
Histogram G, corresponding to 3 weeks. after administration of the drug, it shows that 89% is grouped in a narrow range near the average value, however, there is a group that includes 11% of measurements for which the indicators are significantly lower than the average value.
Histogram D, corresponding to 4 weeks. after drug administration, it shows that only 43% of measurements lie close to the mean value (closer than 1 standard measurement error). 57% of measurements differs from the average value by more than 1 standard measurement error.
These results show that with a long time after drug administration (3-4 weeks), there is a significant variation in concentration measurement results for different patients. Their deviations from the average concentration may be several times higher than 1 standard measurement error.
Thus, with a long time after administration of the drug (3-4 weeks), the use of universal, averaged dependence of concentration on time leads to significant errors in estimating the concentration of testosterone, which is fraught with the occurrence of gross errors in dosage with repeated administration of the drug. A way out of this situation is to recognize the need for a preliminary measurement for each patient of an individual dependence of testosterone concentration on time after drug administration and the use of this dependence in the further treatment of the patient.
The following circumstance should be noted. The method that makes it possible to absolutely reliably separate the effect of the effect of testosterone administered from the outside is the use of a radioactive label that marks the preparation injected from the outside. On the other hand, the method used by us gives an idea of the change in the dynamics of total (endogenous and externally administered) testosterone, which ensures a fairly high accuracy of the final results.