Climacteric syndrome. Novelty in the therapy of menopause (Russian experience)

Vera Prilepskaya (RU), Ludmila Blasl (AT)

[Prilepskaya] Research center for obstetrics, gynecology and perinatology, [Blasl]

Matters of women's reproductive system regulation constitute a basis knowledge for any gynaecologist since it is impossible to be a competent clinician without deep knowledge on the pituitary-hypothalamic- gonadal axis physiology. The reproductive axis integrates information from multiple systems in the body as well as external factors by direct and indirect neurochemical associations converting stimuli into neuroendocrine signals. The beginning of the 21st century witnessed discoveries of new links in central mechanisms such as kiss-neurons prevailing over GnRH neurons. It is their activity namely that determines a negative feedback loop of sex steroids and gonadotropins procuring tonic and pulsation secretion of GnRH as well as positive feedback loop for initiation of pre-ovulation peak of GnRH. It is well known that estrogen deficit causes hyperergic reaction in central regulating regions that is expressed as higher levels and amplitude of the neuroendocrine system impulses. So-called KND neurons producing kiss peptins, dynorphin and neurokinin В are anatomically close to the thermo-regulating and vasculomotor centers. Prescribing estrogen drugs with a negative feedback mechanism reduces hyperactivity of the central regulating regions and ensures therapeutic effect. However, in recent years, higher-level regions of the central regulation links were discovered and specified; and the role of melatonin was identified The results of a multicenter, double-blind, placebo-controlled, randomized trial of the therapeutic efficacy and safety of the preparation of the peptide structure Pineamin ® in neurovegetative and psychoemotional manifestations of climacteric syndrome in women. Materials and methods. Under observation, there were 120 women aged 45-60 years in postmenopausal women (more than 1 year after the last menstruation) with neurovegetative and psychoemotional symptoms. After the screening phase, the patients corresponding inclusion / non-inclusion criteria were randomized into 3 groups in a 1: 1: 2 ratio, namely: - placebo group - 30 patients (placebo 1 mg daily, intramuscularly, 10 days); - Pineamin-1 group (P-1) - 30 patients (one course of Pineamin ® 10 mg daily, intramuscularly, lasting 10 days) and Pineamine-2 (P-2) group - 60 patients, with two ten-day courses of Pineamine ® 10 mg daily, intramuscularly, lasting 10 days). On the 90th day, all patients underwent a repeated 10-day course: - placebo group - placebo drug 10 mg, intramuscularly; Group P-1 - placebo preparation 10 mg, intramuscularly; group P-2 - 60 people - intramuscular injection of Pineamine ® 10 mg each. Seven (seven) visits were made during the study. The main method, confirming the effectiveness of the drug, was the dynamics of the Kupperman index (vegetative and psychoemotional symptoms). In addition, the number of adverse events and adverse reactions associated with the use of the drug was studied. The vital signs (blood pressure, heart rate, respiration rate, ECG) and the whole spectrum of standard and special hematological and biochemical blood indices, levels of thyroid hormones, female sex hormones were studied. EEG was performed. A thorough control of the state of the endometrium was carried out according to the data of ultrasound of the pelvic organs and endocervix according to the data of a cytological study (Pap smear). All patients underwent densitometry of the femur and spine. %