RU2275923C1 - Preparation for regulating menstrual cycle in case of secondary normogonadotropic amenorrhea and oligomenorrhea and method for therapy - Google Patents

Abstract

FIELD: medicine, gynecology.

SUBSTANCE: as a suggested preparation one should apply dried defibrinated or non-defibrinated blood of Siberian stags or spotted deer. The preparation suggested should be prescribed perorally per 25 mg (1 capsule) twice daily, therapy course corresponds to 25-35 d. Application of this preparation in women at normal level of gonadotropins, positive gestagen-test, with no hyperandrogenia and hyperprolactinemia at the absence of menstrual cycle of more than 3 mo provides the onset of menstruations at stable positive effect. After carrying out 3 therapeutic courses no relapses had been observed.

EFFECT: higher efficiency for regulating menstrual cycle.

3 cl, 2 ex, 3 tbl

Description

The invention relates to medicine, specifically to gynecology, and relates to a means of regulating the menstrual cycle with secondary normogonadotropic amenorrhea and oligomenorrhea and the implementation of the treatment method.

Known means for the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea: preparations of ovarian hormones, gonadotropins, antiestrogens and non-hormonal agents [1, 2, 3]. Known methods of treating secondary normogonadotropic amenorrhea and oligomenorrhea by prescribing these drugs [1, 2, 3].

The closest in origin (prototype) is a remedy for the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea Remens, a herbal preparation, and a method for treating secondary normogonadotropic amenorrhea and oligomenorrhea by appointing Remens 20 drops 3 times a day, 30 minutes before meals, course 6 -14 weeks [3].

Herbal remedy Remens contains (per 100 ml): Cimicifuga D1 - 5 ml, Sanguinaria D6 - 10 ml, Aristolochia D6 - 10 ml, Sepia D12 - 10 ml, Lachesis D12 - 10 ml, ethanol 43% by weight. The drug is approved by the pharmacological committee of the Ministry of Health of Russia (dated June 14, 2001), registration number is P No. 013177 / 01-2001.

However, the use of this drug is not effective enough (restoration of menstruation in 50% of cases), an unstable result of treatment (recurrence of amenorrhea and oligomenorrhea after drug withdrawal in 64.3% of cases). In addition, some adverse events were noted in the form of pain in the lumbar region (10.7%), an increase in blood glucose in patients with impaired glucose tolerance (3.6%).

The problem solved by the invention is to eliminate the disadvantages of the prototype, increasing the effectiveness of treatment, reducing side effects, the frequency of relapse and expanding the arsenal of non-hormonal drugs used to treat secondary normogonadotropic amenorrhea and oligomenorrhea.

The task is achieved in that, according to the invention, as a means for regulating the menstrual cycle in the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea, dried defibrinated or non-defibrinated blood of maral, red deer or sika deer (female or male) is used [4, 5]. The drug is prescribed orally at 25 mg (1 capsule) once a day, the course of treatment is 15-25 days, the interval between courses is 3-7 days, the number of courses is 3.

From the literature we have analyzed, the biogenic property is known (improving mental and physical performance, metabolic activation, accelerating tissue regeneration) of a product containing dried defibrinated blood and a nootropic and adaptogenic property of a product containing dried non-defibrinated blood of deer, red deer or sika deer [4, 5] , but its new property is not known, which contributes to the regulation of the menstrual cycle with secondary normogonadotropic amenorrhea and oligomenorrhea. The combination of distinctive features does not follow explicitly for a specialist from the prior art.

The technical solution can be successfully used in clinical gynecology as a means for regulating the menstrual cycle in the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea.

Thus, the proposed technical solution meets the criteria of the invention of "novelty", "inventive step" and "industrially applicable".

The use of dried defibrinated or non-defibrified blood of maral, deer or sika deer for the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea has become possible thanks to clinical trials.

Dried defibrinated or non-defibrinated blood of deer, deer or sika deer is deer, deer or sika deer blood separated (defibrinated blood) and undivided (non-defibrinated blood) from fibrin. Upon receipt of defibrinated blood, blood taken from maral, red deer or sika deer is separated from fibrin and dried to reach a moisture content of 4-5% in a vacuum container with walls heated to 45 ° C [4]. To obtain non-deferred blood, the blood of deer, red deer or sika deer immediately after collection is loaded into the drying apparatus and dried to reach a moisture content of 4-5% in the apparatus with walls heated to 45-50 ° C [5].

It is shown for the first time that the use of dried defibrinated or non-defibrinated blood of maral, red deer or sika deer leads to the regulation of the menstrual cycle and the onset of pregnancy.

A survey of a group of women. The total number of examined was 23 people: women aged 17 to 35 years, suffering from secondary amenorrhea and oligomenorrhea with normal levels of gonadotropins, a positive gestagen test, without hyperandrogenism and hyperprolactinemia. The survey was conducted according to the WHO protocol. The duration of the disease was 6.2 ± 2.8 months.

The study was carried out according to the following parameters:

1. History data (general, obstetric-gynecological, medical history).

2. Somatic examination (including examination of the mammary glands and counting of the hirsut number), gynecological examination (bimanual examination, examination in the mirrors).

3. Determination of the level of follicle-stimulating hormone of the pituitary gland, luteinizing hormone of the pituitary gland and prolactin in the blood serum; according to indications - the level of thyroid-stimulating hormone of the pituitary gland, thyroid hormones, testosterone.

4. Ultrasound of the pelvic organs (length, width and anteroposterior size of the uterus; endometrial thickness, ovarian volume, follicle size).

5. Measurement of basal body temperature during treatment.

All women received, for the purpose of regulating the menstrual cycle, a product containing dried defibrinated or non-defibrinated blood of maral, red deer or sika deer. The drug was administered orally daily 1 time per day at a dosage of 25 mg (1 capsule), a course of 15-25 days, 3 courses of treatment with an interval of 3-7 days.

The study revealed a sufficiently pronounced effect of dried defibrinated or non-defibrinated blood of deer, red deer or sika deer: the onset of menstruation (73.9%), the onset of pregnancy (13%), which allowed the use of this tool as a means for regulating the menstrual cycle in the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea. Table 1 gives a comparative description of the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea with the herbal preparation Remens and a product containing dried defibrinated or non-defibrinated blood of deer, red deer or sika deer. Table 2 shows the pregnancy rate in the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea with the herbal preparation Remens and a product containing dried defibrinated or non-defibrified blood of deer, red deer or sika deer.

The method is as follows. After the diagnosis of secondary normogonadotropic amenorrhea and oligomenorrhea is established according to clinical and paraclinical criteria, the patient is prescribed a remedy containing the dried defibrinated or non-defibrinated blood of maral, red deer or sika deer orally 25 mg (1 capsule) once a day to regulate the menstrual cycle 15-25 days. The course of treatment is repeated 3 times with a break between courses of 3-7 days. Conditions for starting treatment: absence of menstruation for more than 3 months; normal levels of follicle-stimulating and luteinizing hormones of the pituitary gland, prolactin, as well as a positive gestagen test.

Justification of the regime. The regimen of the drug was selected based on previously conducted experimental and clinical studies.

The appointment of 25 mg once a day for 15-25 days is enough to obtain the desired positive effect. To achieve a persistent positive effect allows 3 courses of prescribing, less than 3 courses causes a relapse of the disease. So, according to clinical studies in women who received only 1 course of therapy by the proposed method, relapses were observed after 3-5 months, in women who received 2 courses, relapses occurred after 5-7 months. In women who received 3 courses, no relapse was noted. The interval between courses is due to the duration of menstruation.

In most women (56.5%), a positive effect was observed after 1 course of taking the drug. However, as clinical studies have shown, to achieve a lasting positive effect, the drug was prescribed for 3 courses of treatment. Table 3 shows a comparison of the effectiveness of a different number of treatment courses for secondary normogonadotropic amenorrhea and oligomenorrhea using an agent containing dried defibrinated or non-defibrified blood of maral, red deer or sika deer.

The use of the proposed drug for a new purpose - in gynecology, as a tool for the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea became possible due to our new property that we identified.

Specific examples confirming the effect of the drug on the regulation of the menstrual cycle and the implementation of the method.

1. Patient B., 27 years old. When applying complained of the absence of menstruation within 2 years after the birth of the child.

Anamnesis: Menarche at age 13, menstruation established immediately, for 3-4 days, after 28 days, moderate, painless. Pregnancy - 1, childbirth - 1, at the age of 20 (cesarean section).

Objective status. The condition is satisfactory. The physique is correct. The skin is unchanged. Subcutaneous fat is moderately developed, evenly distributed. Mammary glands: symmetrical, painless on palpation, there is no discharge from the nipples, no seals have been identified. Hirsut number 5 points (according to the Ferriman-Hollway scale).

Status genitalis. The external genitalia are developed correctly. Hair growth by female type. The uterus is normal in size, mobile, painless. Appendages are not enlarged, painless. The cervix is not visually changed. The vaginal mucosa is pink. White mucous membranes. Symptom of the pupil "+". Elongation of cervical mucus 2 cm.

Laboratory studies of hormones in serum. Follicle-stimulating hormone - 6.6 IU / l, luteinizing hormone - 1.44 IU / l, prolactin - 132 mlu / ml, thyroid tropic hormone - 0.877 mlu / ml, T ₄ - 61.1 nmol / l, T ₃ - 0.82 nmol / L. The gestagen test is positive.

Diagnosis: Secondary normogonadotropic amenorrhea.

According to the method proposed by the authors, for the purpose of regulating the menstrual cycle, the patient was prescribed an agent containing dried defibrinated blood: orally, daily, 1 time per day, at a dosage of 25 mg (1 capsule), the course was 20 days, the interval between courses was 7 days. Conducted two courses of treatment. After the second course of taking the drug, the patient received menstruation. A third course was appointed, 6 days after the second course. Conducted a checkup after 3, 6 and 12 months. The woman has a regular menstrual cycle.

2. Patient K., 19 years old. Complaints about the absence of menstruation within 4 months.

Anamnesis: Menarche at age 13, during the year menstruation came regularly - after 30 days, 5 days, moderate, painless. Then there were delays in menstruation for 3-8 months.

Status genitalis. The external genitalia are developed correctly. Hair growth by female type. The uterus is not enlarged, painless, mobility preserved. Appendages are not palpable. The cervix is not visually changed. The vaginal mucosa is pink. White mucous membranes. Symptom of the pupil "+". Elongation of cervical mucus 3 cm.

Objective status: Satisfactory condition. The physique is correct. Skin clean. Subcutaneous fat is poorly developed, evenly distributed. The mammary glands are developed symmetrically, painless on palpation, there is no discharge from the nipples. Hirsut number 4 points (according to the Ferriman-Gollway scale).

Laboratory studies of hormones in serum. Follicle-stimulating hormone - 6.5 IU / l, luteinizing hormone - 3.93 IU / l, prolactin - 403 mlu / ml. The gestagen test is positive.

Diagnosis: Oligomenorrhea with a normal level of gonadotropins.

According to the method proposed by the authors, the patient was prescribed an agent for regulating the menstrual cycle containing dried non-defibrated blood orally daily once a day in a dosage of 25 mg (1 capsule), course - 25 days. After the first course of taking the drug, the patient received menstruation. The second and third courses were appointed with interruptions of 5 and 7 days, respectively. For six months, the menstrual cycle was regular, then pregnancy began.

Thus, the obtained results allow us to conclude that dried defibrinated or non-defibrinated blood of maral, red deer or sika deer affects women of early reproductive age with secondary normogonadotropic amenorrhea and oligomenorrhea on the regulation of the menstrual cycle and increases the effectiveness of treatment, reduces side effects, the frequency of relapse and expands the arsenal of non-hormonal drugs used to regulate the menstrual cycle in the treatment of secondary normogonadotropic a menorrhea and oligomenorrhea.

Table 1 Treatment method Menstruation Absolute number % Dried defibrinated or non-defibrated blood (n = 23) 17 73.9 * Remens (n = 28) fourteen fifty * Note: there is a statistically significant difference in the relative frequencies of menstrual recovery in women treated with a product containing dried defibrinated or non-defibrinated blood when compared with a group of women taking Remens as a treatment. The achieved level of significance p = 0.0434 (critical level p = 0.05). To compare the relative frequencies, the Z-statistics of the normal distribution with the Yeats correction was used. table 2 Treatment method Menstruation Absolute number % Dried defibrinated or non-defibrated blood (n = 23) 3 13.0 Remens (n = 28) 0 0 Table 3 The number of treatment courses Menstruation Absolute number % Course 1 13 56.5 2 courses 3 13.0 3 courses one 4.3 Total 17

Bibliography

1. Regulation of the generative function of man. WHO Symposium, 1976 / Ed. Persianinova L.S. Manuylova I.A. Russian edition. - Copenhagen: Scriptor. - 1978. - 140 p.

2. Runnebaum B., Rabe T. Gynecological Endocrinology. - Springer-Verlag Berlin Heidelberg. - 1997. - V.1. - P.223, 209, 225.

3. Evtushenko I. D., Bolotova V. P., Gayfulina J. F., Kutsenko I. G. The effectiveness of the use of the new non-hormonal drug Remens in the treatment of secondary amenorrhea // New non-synthetic drugs. - Moscow. - 2000. - p.17-23.

4. Biogenic preparation, food supplement based on it and the method for their preparation. RF patent №2163813. - Inventions. Utility models (official bulletin of the Russian Agency for Patent and Trademarks). - Moscow. - FIPS. - No. 7. - vol. II. - 2001. - S. 170-171.

5. A tool with nootropic and adaptogenic action, and a method for its preparation. RF patent No. 2130314. - Inventions (official bulletin of the Russian Agency for Patent and Trademarks). - Moscow. - FIPS. - No. 14. - vol. III. - 1999. - S. 472.

Claims (3)

1. The use of dried defibrinated or non-defibrified blood of maral, deer or sika deer as a means of regulating the menstrual cycle in the treatment of secondary normogonadotropic amenorrhea and oligomenorrhea. 2. A method of treating secondary normogonadotropic amenorrhea and oligomenorrhea by administering oral pharmacotherapy, characterized in that the prescribed defibrinated or non-defibrified blood of maral, red deer or sika deer is prescribed in a dose of 25 mg for 25-35 days. 3. The method according to claim 2, characterized in that the drug is presented in the form of capsules of 25 mg, which are prescribed 2 times a day.