Arterial hypertension (AH) is the most common and of great social importance among cardiovascular disease . According to the American Heart Association, approximately half of all patients with hypertension are menopausal women. There is a relationship between the onset of menopause and the development or worsening of the course of a pre-existing hypertension . And so, women in menopause are a high-risk category for the development of high blood pressure. A decrease in ovarian function, accompanied by a deficiency of estrogens with cardioprotective properties, makes a certain contribution to the development of hypertension in women in this age period. In addition, the hormonal imbalance in the menopause is accompanied by a decrease in the threshold of excitability of the hypothalamic-pituitary system and an increase in the activity of the sympathetic nervous system. . The main goal of treating hypertension patients is to minimize the risk of developing cardiovascular complications and death from them, which is achieved by lowering blood pressure to target levels. The treatment of autonomic and anxiety disorders is based on an integrated approach. On the one hand, it is necessary to use vegetotropic drugs, on the other hand, to carry out correction of the emotional state with the help of psychotropic ones. One of these drugs is Adaptol (tetramethyltetraazabicyclooctandion), a central adaptogen with anxiolytic and nootropic properties. In its chemical structure, it is a derivative of urea, i.e. close to the body’s natural metabolites — urea and purines. Adaptol has a complex multifaceted effect on the body, in particular on the central nervous system. Unlike benzodiazepines, it does not have a muscle relaxant effect, does not inhibit the contractile function of the myocardium, does not cause undesirable central effects — oppression, lethargy, drowsiness, emotional indifference, its use does not impose restrictions on the professional and social activities of the person (driving, working with difficult systems, intense mental activity) and, very importantly, it is not addictive, addicted and the development of withdrawal syndrome.
Aim: to determine the efficacy and safety of the use of the daily tranquilizer and anxiolytic Adaptol in the treatment of hypertension in women in the menopause.
Materials and methods: The study included 30 women in the menopausal period (average postmenopausal duration 1.4 ± 0.5 years) aged 45–55 years (average age 50.3 ± 0.2 years) with I-III degree AH not reaching the target values of blood pressure and not having associated clinical conditions. The duration of hypertension averaged 4.0 ± 2.5 years. Patients were divided into 2 groups: the main one was 15 women who, on the background of antihypertensive therapy (AHT), received Adaptol 500 mg twice a day (morning and evening) inside, regardless of food intake; the control group consisted of 15 women receiving only AHT. The criteria for inclusion in the study were the presence of natural menopause lasting up to 2 years, the absence of achieving the target blood pressure level against the background of AHT. Of the 5 main groups of antihypertensive drugs, β-blocker, angiotensin II receptor blockers, calcium antagonists or ACE inhibitors as monotherapy for hypertension were most often prescribed, the most common combinations were ACE inhibitors + diuretic, calcium antagonists + β-blockers and ACE inhibitors + β-blockers. All patients included in the study were on constant AHT, the duration of which before inclusion in the study averaged 5.0 ± 1.4 weeks. For an objective assessment of the effectiveness of the therapy, in addition to office measurements of blood pressure, an ABPM was performed using a portable ABPM system (Contec Ltd., Germany). The intervals between measurements were 15 min during wakefulness and 30 min during night sleep. As an indicator of the variability of blood pressure and heart rate, the standard deviation from the mean value was evaluated. All patients underwent an assessment of their psychoemotional status using the differential self-assessment test (SAT) of their functional state (well-being, activity, mood) and an assessment of autonomic disorders using the A. M. Wayne questionnaire. The SAT questionnaire consists of 30 lines, of which 10 lines characterize the well-being of the subject, 10 — activity, 10 — mood. Well-being lower than 5.4 points, activity below 5.0 points, moods below 5.1 points, we regarded as low (below normal). In accordance with the questionnaire by A. M. Wayne, autonomic dysfunction syndrome was diagnosed in patients with a total score of 15 or more. The effectiveness of therapy, psychoemotional status and autonomic disorders were monitored before treatment and 6 weeks after the start of therapy. At the same visits, self-assessments of the functional state — SAT (well-being, activity, mood) and the assessment of autonomic disorders using the questionnaire by A. M. Wayne were determined.
Results: All patients completed the study. After 6 weeks of therapy according to the Arterial blood pressure monitoring (ABPM), in both groups there was a decrease in the average daily Systolic blood pressure (SBP) (in the main group — from 173.9 ± 7.9 to 128.6 ± 4.4 mm Hg, p <0.05; in control — from 176.2 ± 5.9 to 144.8 ± 7.0 mm Hg, p> 0.05). The average daily heart rate during therapy decreased statistically significantly in both groups (in the main group — from 76.9 ± 8.8 to 72.9 ± 5.5 beats / min, in the control — from 71.3 ± 7.9 to 69, 9 ± 6.7 bpm, p <0.05). The analysis of indicators of the psychological test of SAT also showed an overall improvement in the functional state in the main group, an increase in activity indicators from 4.3 ± 0.1 to 5.2 ± 0.5 (p <0.05) and well-being from 4 4 ± 0.2 to 5.5 ± 0.2 (p <0.05), reaching normal values in the main group. In the control group, there were no statistically significant changes for 6 weeks; mood, activity, and well-being remained reduced. Most women of both groups studied (86 %) showed somatovegetative disorders according to the questionnaire by A. M. Wayne. The most common manifestations of autonomic dysfunction in both groups were a tendency to redness of the face, hot flashes, increased sweating, a feeling of increased heart rate and a disturbance in the heart rhythm, numbness and cooling of the fingers and toes, shortness of breath, shortness of breath, dysfunction of the gastrointestinal tract (GIT) in the form of diarrhea or constipation, decreased performance and increased fatigue, sleep disturbance. The total score according to the questionnaire of A. M. Vein in patients of the main group for 6 weeks of treatment decreased from 47.1 ± 2.06 to 34.45 ± 4.8 (p <0.001), and the control — from 46.65 ± 4, 2 to 42.8 ± 4.2 (p <0.05). When comparing this indicator in the main and control groups, a statistically significant improvement was revealed in patients taking Adaptol (p <0.001). When re-examined, most women in the main group showed normalization of skin color, a decrease in local and generalized sweating, a decrease or disappearance of tachycardia and interruptions in the heart, and feelings of insufficient inspiration. They noted an improvement in bowel function, normalization of stool. Asthenic symptoms decreased: fatigue and decreased working capacity became less disturbing.
According to the subjective assessment of patients, a significant effect of Adaptol was observed in 6 (40 %) patients, moderate in 7 (50 %), and insignificant in 2 (10 %).
Conclusion: The elimination of autonomic and psychoemotional manifestations of menopausal symptoms improves the course and prognosis of cardiovascular diseases. The inclusion of the anti-anxiety and vegetostabilizing drug Adaptol in AHT statistically significantly reduces the severity of anxiety and manifestations of autonomic dysfunction (sweating, tachycardia and interruptions in the heart, a feeling of insufficient inspiration, impaired bowel function). An additional positive effect on the daily profile of blood pressure had an improvement in indicators of vegetative and psychoemotional status.
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