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INVENTION
Russian Federation Patent RU2148994

METHOD acne treatment in women

METHOD acne treatment in women

Name of the inventor: Rudykh NM
The name of the patentee: Irkutsk State Medical University
Address for correspondence: 664003, Irkutsk, ul. Red 1 Uprising, ISMU, patent department
Starting date of the patent: 1998.07.14

The invention relates to medicine, namely to dermatology. It is proposed to introduce bromocriptine at 5.0-7.5 mg per day and inside a -tiroksin by 25-75 mg per day into the entire course of treatment. In addition to the main drug prescribed antistrumin to 2000 mg per week orally for 3-6 months, and vitamin E intramuscularly in 1.0 ml for 20 days. The method improves the efficiency of the treatment due to a stable remission, reduce the likelihood of side reactions.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely to dermatology.

For the treatment of acne in women using different methods and preparations as a system band, and outdoor applications. The most effective methods of treatment are considered system, and a combination thereof with the external.

It is known that in the pathogenesis of the disease plays a major role giperandrogenemiya. Androgens (male sex hormones), as regulators of secretion of the sebaceous glands in both sexes, increase it, creating the conditions for a breach of the spectrum of sebum, increased proliferation of the basal layer of the epithelium and sebaceous gland blockage excretory duct. Violation of drainage leads to the development of the inflammatory process and the persistence of the anaerobic flora (Propionebacteria acne) and Staphylococcus aureus, supporting inflammatory changes. In parallel, an increased level of androgens cause changes in endocrine-dependent organs and reproductive system, forming pathological self-sustaining system.

There is a method of therapy of acne, which includes long-term use of antibacterial drugs (tetracycline, erythromycin, clindamycin) - for 1-3 months or more in the form of tablets with a gradual reduction of the dose and the abolition of the drug. The course of treatment, if necessary, repeated after the break. The method is based on the inhibition of lipases Corynebacterium acne and lowers the level of free fatty acids in the sebum, which leads to a reduction in the inflammatory response. The method of treatment is accompanied by inhibition of intestinal autoflora with the development of goiter, candidiasis, and suppresses the phagocytic part of immunity that can lead to failure imunologicheskoy. Complete cure is achieved is not always and not persistent (see Driscoll MS, Rothe MG, Abrahamian L et al Long term oral antibiotics for acne: is laboratory monitoring necessary J. Am Acad Dermatol 1993; 28:..?.. 596-602 . See Eady EA, Cove JN, Holland KT, Cunliffe WJ Superior antibacterial action and reduced incidence of bacterial resistance in minocycline compared to tetracycline-treated acne patients Br J. Dermatol 1990; 122:... 233-244).

A method of treating by assigning aromatic retinoid Roaccutane (13-cis-retinoic acid), produced in Switzerland by "F.Hoffman - La Roche Ltd", which is applied for 4-6 months or more inside capsules. If necessary, repeat the treatment. The therapeutic effect is carried out by pronounced inhibition of secretion of the sebaceous glands, suppressing the processes of keratinization and bactericidal effect on gram-negative flora. Use of the drug is highly effective, but it is advisable to treat severe forms of acne because of its serious side effects, the main of which are symptoms of hypervitaminosis A (cheilitis, dryness of mucous membranes of the mouth, nose and eyes, conjunctivitis, epistaxis, pruritus, photosensitivity) hepatotoxicity and teratogenicity (See. Farrel LN, Strauss JS, Stranieri AM the treatment of severe cystic acne with 13-cis-retinoic acid. Evalution of sebum production and the clinical response in a muliple-dose trial. J. Am. Acad. Dermatol 1980; 3: 602-611).

Other treatments are optional and can be part of a complex therapy, including specific immunomodulators (bacteriophages antifagin, toxoids, etc.), thymic preparations, nonsteroidal anti-inflammatory drugs are metronidazole, zinc, vitamins (A and its precursor).

The closest we have adopted and the prototype is a method of treatment by the appointment of a combined preparation Diane-35, which comprises 2 mg of antiandrogen cyproterone acetate and 0.035 mg of estrogen - ethinyl estradiol. He has a pronounced anti-androgenic, antigonadotropnym, progestogen contraceptive properties. It is used for the treatment of hyperandrogenic syndromes in women, particularly for the treatment of hirsutism and acne. Treatment is carried out in cycles of 3-6 months, the number of individual cycles (See. Shahmeyster IJ, G.Ya.Shvarts. New drugs in dermatology. Tula, "Leo Tolstoy", 1995, 66 p .; See. E. M. Vikhlyaeva. Manual endocrine gynecology. M .: Medinformagenstvo, 1997, 764 s). Side effects of the drug are the same as all of the combined estrogen-progestin drugs (violation of rheological properties of blood, high blood pressure, mild hepatotoxicity, proonkogenny effect on tumors in organs endokrinnozavisimyh) (Sm.D.R. Lawrence, Bennett PN. Clinical pharmacology. M .: Medicine, 1991, Volume 2, 700).

In most of the preparations with antiandrogenic activity (Diana 35 among them) are synthetic steroids and therefore exhibit anabolic steroids and other side effects. Cyproterone acetate is itself a weak androgen and a proportion of patients with high sensitivity to provoke them aggravation of acne. The estrogen ethinyl estradiol, which is part of Diane-35, and other drugs, is an additional source hyperestrogenism (in patients with hyperandrogenism syndrome detected relative hyperestrogenia). No combination with estrogens cyproterone acetate (drugs Androkur Androkur 10 and 50) there is a risk of uterine bleeding.

Positively acting on peripheral mechanisms of hyperandrogenism, agents such as cyproterone acetate, estrogens and other negatively affect some of the central mechanisms of endocrine regulation, increasing the secretion of prolactin and dopamine depleting reserves. Helping to increase the synthesis of thyroxine binding globulin, long used products containing in its composition estrogens provoke hypothyroidism clinic.

The technical result of the proposed method of treatment is to improve the efficiency of treatment by achieving stable remission and reduction of side effects in the treatment of non-hormonal drugs.

Technical result is achieved by prescribing and external therapy.

New in the achievement of the technical result is that bromocriptine is prescribed by 5-7.5 mg daily inside and a -tiroksin by 25-75 mg per day into the entire course of treatment.

What is new is the fact that in addition to the main drug prescribed antistrumin to 2000 mg per week orally for 3-6 months, and vitamin E intramuscularly in 1.0 ml for 10 days.

The author in the study of women with acne, revealed the presence of dysfunction of the pituitary gonadotropins, increased levels of prolactin, a violation of the electrophysiological activity of the brain involving the hypothalamic structures, hypertonicity cerebral arteries with veins simultaneously hypotension, decreased thyroid function. These symptoms manifest themselves dysfunction hypothalamic syndrome (disorders of the menstrual cycle and reproductive function, vegetative-vascular dystonia, psycho-emotional disorders, etc.).

Appointment of bromocriptine at 5-7.5 mg once inside in the evening during the entire course of treatment stimulates dopamine receptors in the hypothalamus and pituitary glands to normalize the levels of pituitary gonadotropins (especially - luteinizing hormone) and prolactin, thereby reducing the level of hyperandrogenaemia and reproductive disorders, and and indirectly - autonomic dysfunction and emotional and personality disorders.

The author has found that administration of a dose of less than 5 mg of bromocriptine not effective, and more than 7.5 mg dose impractical.

Assigning a -tiroksina leads to a correction of thyroid function to normalize reproductive disorders, psycho-vegetative changes, increasing the activity of phagocytic immunity, metabolism of phospholipids correction. With the same purpose prescribed antistrumin.

In order to reduce the damaging effects of free radicals, patients receive injections of vitamin E.

It follows from the above that the proposed method of treatment is different from the prototype that bromocriptine is prescribed to patients for 5-7.5 mg daily inside and a -tiroksin at 25-75 mg duck inside the whole course of treatment, and a further 2,000 antistrumin mg per week administered for 3-6 months, and vitamin E, 1 ml intramuscular injection for 10 days, which corresponds to the criterion "novelty".

The new set of features ensures the achievement of a higher positive effect is to increase the effectiveness of treatment by achieving stable remission of the disease and reduce the side effects in the treatment of non-hormonal drugs that meets the criterion of "industrial applicability".

In the analysis of the known methods it was found that they lack information on the impact of the distinguishing features of the claimed method to achieve a technical result, therefore, the invention corresponds to the "inventive step".

The proposed method for the treatment of acne in women is as follows.

Women are recommended to carry out the following studies: general blood and urine tests, biochemical tests, containing serum pituitary hormones (luteinizing hormone, follicle, thyroid, prolactin), PSM thyroid PSM thyroid PSM pelvic and breast, side kraniogramme, consult an endocrinologist, gynecologist, endocrinologist, neurologist. When the content of prolactin 1000 mIU / L is assigned a computer (or magnetic resonance) tomogram to exclude pituitary adenoma.

Assign bromocriptine depending on the level of prolactin, luteinizing hormone pituitary gland and severity of skin process: 5 - 6.25 mg - once inside in the evening in order to suppress the secretion of gonadotropins night; at a dose of 7.5 mg - orally in two divided doses, most taken in the evening. To reduce the side-effects (drowsiness, lethargy, low blood pressure), the drug start with 1/4 tablet, increasing the dose by 1/4 pills 3-4 days, bringing it up to medical. a -tiroksin appoint the following indications: decreased thyroid function in the parameters of the pituitary thyroid stimulating hormone, according to the PSM, the presence of clinical symptoms of hypothyroidism in the dose of 25 mg, 50 mg, 75 mg once a day inside, in accordance with the biorhythms in the morning. Antistrumin administered in a dose of 1000 mg orally once in the morning, twice a week for 3-6 months.

The dose of bromocriptine and thyroid agents in the treatment individually adjusted in accordance with the sensitivity to the drug in each case, as determined by the dynamics of the process and of cutaneous manifestations of clinical by the reproductive organs, and thyroid.

Vitamin E in the form of injections administered by intramuscular injection of 1 ml of N 10. For further therapy was based on the correction related violations identified in patients with gastro-intestinal tract, liver, upper respiratory tract and kidneys. Cream "Skinoren" is used for topical treatment (Schering, Germany), once a day.

Monitoring of the treatment is carried out by observation of the general state of the patients and the dynamics of skin process.

The criterion for efficacy was the duration of the existence of active cutaneous manifestations and the degree of normalization of hormonal disturbances, restoration of the menstrual cycle, reducing the amount of vegetative complaints, take into account the timing and extent of hair loss in girsutnyh areas.

The treatment course of 6 months. When torpid during the process and / or the absence of the dynamics of endocrine disorders, prescribe a second course of treatment after 3-4 month break.

The positive effect of varying severity were observed in 100% of patients.

The proposed method of treating clinical example is explained as follows

Patient B., 18 years old. A resident of the city of Irkutsk, a student. He fell ill at 13 years of age. 2 months after the onset of menses appeared acne on the face, the skin became oily, porous. For a continuous illness, notes the aggravation of 7-3 days before menstruation, in the summer there is a short-term improvement in skin condition.

The history: in childhood - chicken pox, frequent respiratory infections. Bad habits are not allowed. Mother operated on for uterine fibroids, in his youth suffered acne vulgaris. Acne vulgaris notes in 14-year-old sister.

When handling complaints of frequent headaches, hair loss, irritability, mood instability, poor memory, constipation.

Gynecological history. Menstruation 13 years, irregular, painful, abundant. Before beginning their 7-10 days notice bloating and breast tenderness, a feeling of heaviness in the abdomen. At the same time, notes the appearance of swelling in the feet, increased appetite, thirst, crying, depressed, unmotivated aggression.

On examination, the general condition is satisfactory, the figure is correct, normostenik. Secondary sexual characteristics are developed on the basis of the female. According to the white line of the abdomen below the navel and around nipples halo observed few coarse hair growth up to 1 cm. On palpation of the right breast is determined by compaction hearth in the middle-right quadrant.

Leather shoulder, back dry. On the skin of the buttocks and lower back - multiple branching "pearl" striae width of 1 - 1.5 mm, arranged horizontally. Peripheral lymph nodes were not enlarged. The mucous pale pink. In the lungs vesicular breathing. Heart sounds are muffled, rhythmic. BP-120/80 mm Hg Abdomen soft, painless. Symptom Pasternatskogo negative.

The facial skin is oily, shiny, hole enlarged sebaceous glands. On the skin of the cheeks, chin - numerous pustules, the size of 2-3 mm, single infiltration from 4 to 6 mm diameter round-shaped brownish-bluish color.

In general and biochemical blood tests and urine tests revealed no pathology.

Pituitary hormones content in serum in the first phase of the menstrual cycle (day 5-8): luteinizing hormone (LH) - 12.2 mIU / L, follicle stimulating hormone (FSH) - 5.8 mIU / L, prolactin (PRL) - 880 mIU / l, thyroid stimulating hormone (TSH) - 3,2 mIU / l.

PSM thyroid. Conclusion: The increase of the thyroid gland of 2 degrees, the symptoms of chronic thyroiditis.

PSM pelvic organs in the 17 day cycle. Conclusion: bilateral ovarian enlargement, multiple follicles with no signs of dominance.

PSM breast. Conclusion: fibroadenoma of the right breast.

The electroencephalogram (EEG). Conclusion: The signs of dysfunction verhnestvolovyh structures.

Reoentsefalogramma (REG). Conclusion: gipertonus arteries, veins hypotension with symptoms of venous plethora.

Side kraniogramme. Conclusion: The signs umerennovyrazhennogo hypertensive syndrome.

Conclusion endocrinologist: hypothalamic syndrome of puberty, neuro-endocrine form with gonadotropic dysfunction. Endemic goiter grade 2. Hashimoto's thyroiditis. Easy hypothyroidism.

Conclusion gynecologist-endocrinologist: hyperandrogenism ovarian dysfunction with hyperprolactinemia. Anovulation. Dishormonal breast. Premenstrual syndrome.

Conclusion neurologist: vegetative-vascular dystonia, paroxysmal character permanently.

Clinical diagnosis: acne, pustuleznoindurativnaya form.

Treatment.

Bromkriptin 6.25 mg (2.5 tablets) - 2 of them in the evening, 0.5 - in the afternoon. Start with 1/4, up 1/4 every 3-4 days. The treatment course of 6 months with the gradual abolition. a -tiroksin 50 mg (start with 25 mg for 2 weeks) 30 minutes before breakfast. The treatment course of 6 months.

Vitamin E 1,0 intramuscularly N 10 from 15 to 26 days of the menstrual cycle.

Essentiale capsule 1 - 3 times a day for 20 days.

Outdoor hygienic treatment of the skin.

The results of treatment.

Home flattening rash observed in 1 month. Tolerability of treatment is good. On the skin - a significant reduction in lesion area, stopped the reappearance of infiltration, but not all infiltrates completely compacted. After 3 months of treatment the content of PRL in serum - 90 mIU / L.

After 6 months, the skin became less oily, infiltrates compacted, noted occasional occurrence of single superficial pustules before menstruation with their fast reverse development. Feeling good: no headaches, memory improvement notes, mood, emotional stability, a significant reduction in the symptoms of premenstrual syndrome. Parents noted improvement in performance. The menstrual cycle is regular, monthly less abundant than before treatment, painless. After 4 weeks post-treatment: N-6.8 mIU / L FSH 4.6 mIU / L, PRL-850 mIU / L (no dynamics), 1,6-TSH mIU / L. PSM thyroid: reducing the size of the thyroid gland, thyroiditis symptoms persist.

There was a good dynamics of skin process, the treatment is over, but on the advice of an endocrinologist, the patient has received 1 course of treatment for 6 months, after a 4-month break due to absence of the dynamics and level of BPD symptoms of chronic thyroiditis. After 2 courses marked persistent clinical improvement - the complete absence of lesions on the skin for 5 months. With regard to the endocrine pathology the patient is taken under the supervision of an endocrinologist.

CLAIM

A method for treating acne in women by prescribing, characterized in that bromocriptine administered at 5 - 7.5 mg per day a inwards and -tiroksin 25 - 75 mg daily by mouth for the whole course of treatment, and a further 2000mg antistrumin during the inward and vitamin E intramuscularly 1 ml for 10 days.

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Publication date 01.04.2007gg