RU2188661C1 - Method for treating placental deficiency - Google Patents

Abstract

FIELD: medicine, obstetrics. SUBSTANCE: it is conducted the correction of hemostasis system values in pregnant women by using phytopharmacopreparation being distinct in the fact that immediately after diagnosis a three-stage therapy course is carried out in which the first stage deals with simultaneous peroral intake of pyrroxane for 7-14 d at a single dose of 15 mg twice daily, in the morning and in the evening 30 min before meals or 1.5 h after the meals and alcoholic extract of phytoecdysteroids at the rate of 10 mg preparation/10 kg body weight of pregnant woman diluted in 25 ml drinking water, in the morning to an empty stomach 30 min before meals. During the second stage one should continue the monotherapy with alcoholic extract of phytoecdysteroids for 14-21 d taking into account the fact that duration of both stages should not exceed 28-30 d. The third stage deals with a 28-30-d-long peroral intake of levetone at a single dose of 0.3 mg thrice daily 30 min before meals or 1.5 h after the meals. EFFECT: higher efficiency in treating placental deficiency. 2 cl, 2 ex

Description

 The invention relates to medicine, in particular to obstetrics and gynecology. It can be used to treat placental insufficiency in the first and second trimesters of pregnancy.

 There is a method of treating miscarriage (RF Patent 2086242 from 30.06.93, IPC 6 A 61 K 33/00), which consists in the fact that if there is a threat of termination of pregnancy in complex treatment include intravenous administration of ozonized saline (5 days course), which has ability to correct metabolism and immunity.

 However, it is known that ozonized saline in itself is a fairly toxic drug and therefore it is impossible to exclude its negative effect on the mother and fetus, especially during organogenesis, despite its ability to correct metabolism and immunity (as the authors indicate).

 A known method of treating the threat of termination of pregnancy (RF Patent 2008003 from 03/31/86, IPC 5 A 61 K 31/405) by introducing pregnant indomethacin against the background of rest and psychotherapy for 7 days. However, the administration of indomethacin during pregnancy, especially in the early stages of gestation, during organogenesis, is undesirable. Indomethacin has such side effects as headache, dizziness, nausea, vomiting, loss of appetite, pain in the epigastric region, ulcerogenic effect, allergic reactions. During pregnancy, these manifestations can be more pronounced.

 Closest to the claimed is a method of correction of hemostasis during miscarriage (RF Patent 2146527 from 07.23.1996, IPC 7 A 61 K 35/78, A 61 P 7/02). According to this method, it is proposed to use the extract of Scutellaria baicalensis liquid in pregnant women with fetoplacental insufficiency for the correction of hemostasis. However, with placental insufficiency, not only hemostasis indicators, but also antioxidant and immune systems, as a minimum, change. Depression of antioxidant, anticoagulant blood systems, activation of the body's immune system, i.e. adaptation programs of the catatoxic type are being developed, aimed at removing the fetal egg from the mother’s body, so the correction of only hemostasis indicators, in our opinion, is not sufficient for the effective treatment of placental insufficiency.

 The objective of the present invention is the creation of a new, fast-acting, highly effective, non-negative effect on the mother and fetus, the method of correction of disadaptive processes in the body of a pregnant woman, the manifestation of which is placental insufficiency.

 The essence of the proposed method lies in the fact that immediately after diagnosis, a course of drug treatment of placental insufficiency begins, consisting of three stages. In the course of treatment at the first stage, simultaneously administered orally from 7 to 14 days pyrroxan in a single dose of 15 mg 2 times a day in the morning and in the evening 30 minutes before meals or 1.5 hours after meals and alcohol extract of phytoecdysteroids at the rate of 10 mg of the drug per 10 kg of body weight of a pregnant woman, diluted in 25 ml of drinking water, in the morning on an empty stomach 30 minutes before meals. After that, at the second stage of treatment, continue monotherapy with an extract of phytoecdysteroids for 14-21 days, taking into account that in total the duration of the first and second stages does not exceed 28-30 days. At the third stage of treatment, immediately after the second stage, oral administration of leveton in a single dose of 0.3 mg 3 times a day 30 minutes before meals or 1.5 hours after meals is prescribed for 28-30 days. 4-6 weeks after the end of the indicated course, a repeated, similar course of treatment is carried out with a preventive purpose.

 At the beginning of treatment, pyrroxan is introduced - a central and peripheral α-blocker, which allows immediately, in the first hours of treatment, to interrupt the pathological impulse entering the brain by blocking the adrenergic structures of the brain, which improves the functional state of the mother's body. Pyroxan quickly includes syntactic adaptation programs aimed at empathizing the body of the mother and fetus. However, as practice shows, the use of pyroroxan for more than 14 days in pregnant women is undesirable, and this period is not enough for a full correction. Therefore, in parallel with pyroroxan, a woman begins to take an oral composition of phyto-collections containing phytoecdysteroids. Phytoecdysteroids are biologically active substances of natural origin from the group of low molecular weight bioregulators of the polyoxysteroid structure. In the human body, they exhibit anabolic effects by stimulating protein synthesis, increasing the activity of certain enzyme systems involved in lipid and carbohydrate metabolism (Akhrem A.A., Kovganko N.V. Ecdysteroids: chemistry and biological activity. - Mn .: Science and technology , 1989. - 327 pp.), And syntactic action (Morozov V.N., Rachkov A.K., Rachkova M.A. Biochemical effects of biologically active substances of natural origin of the syntoxic type of action.// Vestnik NMT, Tula, 1999. -T.VI, 1.- S.60-62). Syntoxins, acting through neurohumoral mechanisms, activate syntoxic adaptation programs - restore normal physiological functions in the body of a pregnant woman.

 The effect of the alcoholic extract of phytoecdysteroids is cumulative, that is, it develops gradually and persists for some time after the end of the drug, therefore the combined use of these drugs creates a favorable background for the formation or normal functioning of the already formed fetoplacental complex in the woman’s body. These drugs are the basis in the ongoing course of treatment. However, as practice shows, the use of a complex consisting only of pyroxan and phyto-collections containing phytoecdysteroids has a positive, but short-lasting effect, and relapse is possible some time after the cessation of treatment. Therefore, it was experimentally confirmed the necessity of introducing into the medical complex a third drug - leveton, which has the ability to maintain the body of a pregnant woman for a long time at the functional level achieved with pyroroxan and alcohol extract of phytoecdysteroids. Leveton is a therapeutic and prophylactic drug / TU-48700001927-272-93 /, consisting of polymorphic pollen, dry extract from the roots of leuzea, vitamin E and ascorbic acid.

 The inventive method is as follows. When a pregnant woman is diagnosed with a threatening abortion clinic (which indicates the dominance of catatoxic adaptation programs aimed at rejecting the ovum, which are manifested by immune activation, depression of the anticoagulant and antioxidant potential of the blood), treatment is carried out according to the following scheme: at the first stage, oral administration of pyroxan is prescribed (α-adrenergic blocker of peripheral and central action) 15 mg 2 times a day in the morning and in the evening 30 minutes before meals or after 1.5 hours after a meal and an alcoholic extract of phytoecdysteroids at the rate of 10 mg of the drug per 10 kg of body weight of a pregnant woman, diluted in 25 ml (tablespoon) of drinking water, in the morning on an empty stomach from 7 to 14 days. The duration of taking priroxan is determined by the dynamics of changes in the parameters of the antioxidant, anticoagulant blood system (blood sampling is performed on the 7th day of treatment). If, according to the results of the analysis, a progressive increase in the antioxidant and anticoagulant activity of the blood is noted, then you can limit yourself to a seven-day intake of pyroxan, in the absence of such dynamics, treatment with pyroxan can be extended to 14 days. At the second stage of treatment, monotherapy with an extract of phytoecdysteroids is continued for 14-21 days, taking into account that in total the duration of the first and second stages does not exceed 28-30 days.

 At the third stage of treatment, immediately after the second stage, oral administration of leveton in a single dose of 0.3 mg 3 times a day 30 minutes before meals or 1.5 hours after meals is prescribed for 28-30 days.

 4-6 weeks after the end of the indicated course, a repeated, similar course of treatment is carried out with a preventive purpose.

 Clinical data confirmed the effectiveness of the selected doses of drugs used in the course of treatment. The appointment of smaller doses did not give a lasting clinical effect, the use of large doses of drugs is impractical.

 In the clinic, more than 200 pregnant women with primary placental insufficiency of non-infectious genesis received treatment according to this scheme. Almost all women, 4-6 weeks after the end of the first course, a second course of treatment was carried out with a preventive purpose. Since the start of treatment under this scheme, a woman was not prescribed a single drug not specified in the scheme in order to correct the function of the fetoplacental complex. In 98% of women, the pregnancy is full-term, and the delivery is terminated by a living child.

 The purpose of pyroxan, phytoecdysteroids, and levetone according to this scheme is accompanied by activation of antioxidant, anticoagulant blood potentials with immunosuppression effects and is typical for the dominance of syntactic adaptation programs aimed at empathizing the mother and fetus.

 Example 1: Pregnant B., 25 years old, was admitted to the clinic on January 20, 1997 with complaints of cramping in the lower abdomen, bloody vaginal discharge in small amounts. Pregnancy is 8 weeks. From the anamnesis: pregnancy the third, first and second pregnancy ended in miscarriages in the period of 8-10 weeks. The diagnosis was made: pregnancy III, 8 weeks, primary placental insufficiency, miscarriage that began. Treatment was started immediately: at the first stage, at the same time, 15 mg of pyrroxan was prescribed 2 times a day in the morning and in the evening 30 minutes before meals or 1.5 hours after meals and alcohol extract of phytoecdysteroids at the rate of 10 mg of the drug per 10 kg body weight of a pregnant woman, diluted in 25 ml of drinking water. On the 7th day of treatment, blood was drawn. A progressive increase in the antioxidant and anticoagulant activity of the blood was noted, therefore, the administration of pyroxan lasted only 7 days. At the second stage of treatment, monotherapy with phytoecdysteroid extract was continued for 21 days. At the third stage of treatment, immediately after the second stage, oral administration of leveton in a single dose of 0.3 mg 3 times a day 30 minutes before meals or 1.5 hours after meals was prescribed for 30 days. 4 weeks after the end of the first course, a second course of treatment was carried out with a preventive purpose. Pregnancy is full-term, delivery on time by a living healthy child.

 Example 2: Pregnant G., 27 years old, was admitted to the hospital on 04/16/98 with complaints of cramping pains in the lower abdomen and lower back. On examination: the size of the uterus corresponds to 18 weeks of pregnancy, the uterus is excitable by palpation. From the anamnesis: the fourth pregnancy, the first three ended in spontaneous miscarriages in the period from 8 to 22 weeks. The course of this pregnancy was complicated by a threatening miscarriage in terms of 14 and 16 weeks. Conventional treatment was carried out: turinal, microfollin, vitamin therapy. The diagnosis was made: IV pregnancy, 18 weeks, threatened abortion, placental insufficiency, burdened obstetric history, habitual miscarriage. The treatment was started immediately according to the above scheme, but the duration of taking pyroroxan was 14 days, because according to the results of a blood test performed on the 7th day of treatment, although an increase in the activity of the antioxidant and anticoagulant blood systems was noted, however, this increase was insignificant and showed a steady character. Two courses of treatment were carried out with an interval between courses of 4 weeks. Pregnancy was full-term, giving birth on time to a living healthy baby.

 The proposed method allows for highly effective timely treatment of placental insufficiency with a complex of drugs that do not have a negative effect on the mother and fetus. In addition, the method is simple to implement, has no contraindications for use, with the exception of the individual intolerance of the drugs used.

Claims (2)

 1. A method for the medical treatment of placental insufficiency by correcting the indicators of the hemostatic system in pregnant women, including the use of a phytopharmacological preparation, characterized in that immediately after diagnosis, a three-stage course of treatment is implemented, in which at the first stage, a single dose of pyroroxan is administered orally for 7 to 14 days in a single dose 15 mg 2 times a day in the morning and in the evening 30 minutes before meals or 1.5 hours after meals and alcohol extract of phytoecdysteroids at the rate of 10 mg of the drug per 10 kg of body weight of a pregnant woman, dosed in 25 ml of drinking water in the morning on an empty stomach 30 minutes before meals, after which, at the second stage of treatment, monotherapy with alcohol extract of phytoecdysteroids is continued for 14-21 days, taking into account that in total the duration of the first and second stages does not exceed 28-30 days , at the third stage of treatment, immediately after the second stage, oral administration of leveton in a single dose of 0.3 mg 3 times a day 30 minutes before meals or 1.5 hours after eating is prescribed.  2. The method according to p. 1, characterized in that after 4-6 weeks after the indicated course, a repeated similar course of treatment is carried out for prophylactic purposes.