Preparation for regulating menstrual cycle in case of secondary normogonadotropic amenorrhea and oligomenorrhea and method for therapy

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

 

The invention relates to medicine, specifically to the gynecologist, and for funds that contribute to the regulation of the menstrual cycle when the secondary normogonadotrophic amenorrhea and oligomenoree and execution of treatment method.

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

The closest to the origin (the prototype) is a treatment for secondary normogonadotrophic amenorrhea and oligomenorrhea Remains, the drug of plant origin, and method of treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea by assigning Remainsa 20 drops 3 times a day, 30 minutes before a meal, the rate of 6-14 weeks [3].

Medium plant origin Remains 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 Ministry of health of Russia (June 14, 2001), registration number - P # 013177/01-2001.

However, the use of this tool is not effective (restore menstruation in 50% of cases), an unstable result of treatment (relapse Amen is Rhea and oligomenorrhea after discontinuation of the drug in 64.3% of cases). Furthermore, it is noted some adverse effects in the form of occurrences of pain in the lumbar region (10,7%), increase of blood glucose level in patients with impaired glucose tolerance (3,6%).

The problem solved by the invention is to eliminate the disadvantages of the prototype, improve treatment, reduce side effects, frequency of relapse and expanding Arsenal of non-hormonal means used for the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea.

This object is achieved in that, according to the present invention as a means for regulation of the menstrual cycle in the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea use dried defibrinating or nedifferentsirovannoi the blood of the deer, the deer or spotted deer (female or male) [4, 5]. The tool is given orally at 25 mg (1 capsule) 1 times a day, the course of treatment is 15-25 days break between courses 3-7 days, the number of courses 3.

From the analyzed literature known biogenic property (improved mental and physical performance, activation of metabolism, accelerate tissue regeneration) products containing dried defibrinating blood and adaptogenic and nootropic property products containing dried nedifferentsirovannoi cu is V deer, the deer or Sika deer [4, 5], but does not know his new property, contributing to the regulation of the menstrual cycle when the secondary normogonadotrophic amenorrhea and oligomenorrhea. The set of distinctive features is not obvious to a person skilled in the art.

Technical solution can be successfully used in clinical gynecology as a means for regulation of the menstrual cycle in the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea.

Thus, the proposed solution meets the criteria of the invention of "novelty", "inventive step" and "capable of industrial application".

The use of dried defibrinating or nedifferentsirovannoi deer blood, deer or Sika deer for the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea became possible thanks to the conducted clinical research.

Dried defibrinated or nedifferencirovannaja the blood of the deer, the deer or axis deer is a deer blood, deer or spotted deer, separated (defibrinated blood) and undelimited (nedifferencirovannaja blood) from fibrin. Upon receipt defibrinated blood blood taken from a deer, the deer or spotted deer, separated from fibrin and dried to achieve a moisture content of 4-5% in vacuum, e is the bone with the walls, heated to 45° [4]. To obtain nedifferentsirovannoi blood, the blood of the deer, the deer or spotted deer immediately after the capture is loaded into the drying apparatus and dried to achieve a moisture content of 4-5% in the apparatus to walls, heated to 45-50° [5].

First it is shown that the use of dried defibrinating or nedifferentsirovannoi deer blood, deer or spotted deer leads to the regulation of the menstrual cycle and pregnancy.

A survey of a group of women. The total number of surveyed amounted to 23 people: women aged 17 to 35 years, suffering from secondary amenorrhea and oligomenorrhea with normal levels of gonadotropins, positive gestagen test without giperandrogenii and hyperprolactinemia. The survey was conducted according to the who Protocol. Disease duration was 6.2±2.8 months.

The study was conducted according to the following parameters:

1. History (General, obstetric, medical history).

2. General physical examination (including examination of mammary glands and counting hirsute number), gynecological examination (bimanual examination, inspection mirrors).

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

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

5. Measurement of basal body temperature during treatment.

All women received for regulation of the menstrual cycle remedy containing dried defibrinating or nedifferentsirovannoi the blood of the deer, the deer or spotted deer. The tool is administered orally daily 1 time per day in a dosage of 25 mg (1 capsule), the rate of 15-25 days, 3 courses of treatment with an interval of 3-7 days.

The study made it possible to identify a sufficiently pronounced effects dried defibrinating or nedifferentsirovannoi deer blood, deer or Sika deer: the onset of menstruation (73,9%), pregnancy (13%), which allowed us to use this tool as a means for regulation of the menstrual cycle in the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea. Table 1 provides a comparative analysis of treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea herbal drug Remains and product containing dried defibrinating or nedifferentsirovannoi the blood of the deer, the deer or spotted deer. Table 2 shows the frequency of us is upline pregnancy in the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea herbal drug Remains and means containing dried defibrinating or nedifferentsirovannoi the blood of the deer, the deer or spotted deer.

The method is as follows. After diagnosis secondary normogonadotrophic amenorrhea and oligomenorrhea according to clinical and paraclinical criteria the patient for regulation of the menstrual cycle prescribe a product containing dried defibrinating or nedifferentsirovannoi the blood of the deer, the deer or spotted deer orally 25 mg (1 capsule) once a day, within 15-25 days. The treatment was repeated 3 times, with an exchange between 3-7 days. Conditions for the start of 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 positive gestagen test.

Justification mode. The mode of drug was selected on the basis of earlier experimental and clinical studies.

The purpose of the tool 25 mg once a day for 15-25 days is sufficient to obtain the desired positive effect. To achieve long-lasting positive effect allows 3 course assignment means less than 3 courses causes a relapse of the disease. So, according to clinical studies in women who received only 1 course of therapy on the proposed method, che is ez 3-5 months was observed relapses, women who received 2 courses, recurrences occurred in 5-7 months. Women who received 3 courses, recurrences are not marked. The interval between courses due to the duration of menstruation.

Most of the women (56.5%) positive effect was observed after 1 year of receiving the funds. However, as has been shown in clinical studies to achieve a lasting positive effect tool was administered on 3 courses of treatment. Table 3 shows the comparison of efficiency of different number of courses of treatment secondary normogonadotrophic amenorrhea and oligomenorrhea with the use of products containing dried defibrinating or nedifferentsirovannoi the blood of the deer, the deer or spotted deer.

The application of the proposed funds for a new purpose in gynecology, as a means for the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea became possible thanks revealed his new property.

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

1. Patient B., aged 27. When the treatment complained of the absence of menstruation for 2 years after the birth of a child.

History: Menarche at age 13, menstruation was established after 3-4 days, after 28 days, moderate, painless. Pregnancy - 1, childbirth is 1 in 20 years (asked them whose likeness the section).

Objective status. The condition is satisfactory. The shape correct. The skin intact. Subcutaneous fat is developed moderately, evenly distributed. Mammary glands: symmetric, painless on palpation, discharge from the nipple no, seals are not identified. Hirsute 5 points (on a scale of Ferriman-Gallwey).

Status genitalis. External genitals are developed correctly. Hair growth on the female type. The uterus is normal in size, mobile, painless. The appendages are not enlarged, bezboleznennyy. The cervix is not visually changed. Vaginal mucosa is pink. Beli mucous. Symptom pupil "+". The elongation of the cervical mucus 2 see

Laboratory studies of hormones in the serum. Follicle-stimulating hormone and 6.6 IU/l, LH - 1,44 IU/l, prolactin - 132 mlu/ml, tireo genotype hormone - 0,877 mlu/ml, T4- 61,1 nmol/l, T3- 0.82 nmol/L. Gestagen test positive.

Diagnosis: Secondary normogonadotropic amenorrhea.

According to the proposed method the patient for regulation of the menstrual cycle was appointed means containing dried defibrinating blood: oral, daily, 1 times a day, the dosage of 25 mg (1 capsule), course - 20 days, a break between courses 7 days. Conducted two courses of treatment. After the second course of the drug at which aziende came menstruation. Appointed third year, 6 days after the second course. Conducted a follow-up examination after 3, 6 and 12 months. The woman remains a regular menstrual cycle.

2. Patient K., 19 years. Complaints about the lack of menstruation for 4 months.

History: Menarche at the age of 13, during the years of menstruation came regularly after 30 days, 5 days, moderate, painless. Then there were delays menstruation 3-8 months.

Status genitalis. External genitals are developed correctly. Hair growth on the female type. The uterus is not enlarged, painless, mobility stored. The appendages are not palpated. The cervix is not visually changed. Vaginal mucosa is pink. Beli mucous. Symptom pupil "+". The elongation of the cervical mucus 3 see

Objective status: satisfactory Condition. The shape correct. Skin clean. Subcutaneous fat is poorly developed, evenly distributed. The breast is developed symmetrically, painless on palpation, discharge from the nipple there. Hirsute number 4 points (on a scale of Ferriman-Gallwey).

Laboratory studies of hormones in the serum. Follicle stimulating hormone is 6.5 IU/l, LH - 3,93 IU/l, prolactin - 403 mlu/ml. Gestagen test positive.

Diagnosis: Oligomenorrhea with normal levels of gonadotropins.

According to offer and is by the way the patient to regulate the menstrual cycle was appointed means, containing dried nedifferentsirovannoi blood oral daily 1 time per day in a dosage of 25 mg (1 capsule), the rate - 25 days. After the first course of the drug, the patient came menstruation. Assigned to the second and third courses with breaks at 5 and 7 days, respectively. Within six months of the menstrual cycle was regular, then pregnancy.

Thus, the obtained results allow to conclude that dried defibrinated or nedifferencirovannaja the blood of the deer, the deer or spotted deer affects women early reproductive age with secondary normogonadotrophic amenorrhea and oligomenorrhea on the regulation of the menstrual cycle and increases the effectiveness of treatment, reduce side effects, the frequency of relapse and expands the Arsenal of non-hormonal means used to regulate the menstrual cycle when treatment secondary normogonadotrophic amenorrhea and oligomenorrhea.

Table 1
TreatmentThe onset of menstruation
The absolute number%
Dried defibrinated or nedefinirana blood (=23) 1773,9*
Remains (n=28)1450
* Note: there is a statistically significant difference relative frequencies of recovery of the menstrual cycle in women treated product containing dried defibrinating or nedifferentsirovannoi blood when compared with a group of women, who as a treatment drug Remains. The achieved significance level of p=0,0434 (critical p=0,05). To compare the relative frequencies were used Z-statistics normal distribution with the amendment of Iatse.
Table 2
TreatmentThe onset of menstruation
The absolute number%
Dried defibrinated or nedefinirana blood (n=23)313,0
Remains (n=28)00
Table 3
The number of treatment coursesThe onset of menstruation
The absolute number%
1 year1356,5
2 course313,0
3 course14,3
Only17

References

1. Regulation of the generative functions. The who Symposium, 1976 / edited Persianinova PS the manuylova playing I.A. Russian edition. - Copenhagen: Scriptor. - 1978. - 140 C.

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

3. Yevtushenko I.D., Bolotov VP, Gaifulina IF, Kutsenko WAS the Effectiveness of the application of the new non-hormonal drug Remains in the treatment of secondary amenorrhea // New non-synthetic drugs. - Moscow. - 2000. - p.17-23.

4. Biogenic drug, food additive based on it and the way they are received. RF patent №2163813. - Invention. Utility models (the official Bulletin of the Russian Agency for patent and trademarks). - Moscow. - FIPS. No. 7. - t.ii. - 2001. - S-171.

5. The agent with neuroprotective and adaptogenic action, and how to obtain it. RF patent №2130314. - Inventions (official Bulletin of the Russian Agency for patent and trademark is m). - Moscow. - FIPS. No. 14. - vol. - 1999. - P.472.

1. The use of dried defibrinating or nedifferentsirovannoi deer blood, deer or Sika deer as a means of regulating the menstrual cycle in the treatment of secondary normogonadotrophic amenorrhea and oligomenorrhea.

2. A method of treating secondary normogonadotrophic amenorrhea and oligomenorrhea involves oral administration of pharmacotherapy, characterized in that designate dried defibrinating or nedifferentsirovannoi the blood of the deer, the deer or spotted deer at 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.



 

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