Functional state of the vascular wall and plasma hemostasis in women of early postmenopausal period under long-term menopausal hormone therapy

2020 ◽  
Author(s):  
С.Н. Толстов ◽  
И.А. Салов ◽  
А.П. Ребров
Keyword(s):  
Hormone Therapy ◽  
Functional Activity ◽  
Low Dose ◽  
Vascular Wall ◽  
Menopausal Hormone Therapy ◽  
Control Group ◽  
Coronary Syndrome ◽  
Postmenopausal Period ◽  
Increased Risk

Цель исследования: оценка изменений функциональной активности сосудистой стенки и плазменного звена гемостаза у женщин раннего постменопаузального периода на фоне длительной низкодозовой менопаузальной гормональной терапии (МГТ). Материалы и методы: Обследовано 162 женщины в ранней постменопаузе. В основную группу вошли 84 пациентки, которым была назначена низкодозовая МГТ: 1 мг 17β-эстрадиола (E2) и 2 мг дроспиренона (ДРСП) — препарат Анжелик® (Байер Фарма, Германия). Контрольную группу составили 78 женщин, не получавших МГТ. Длительность наблюдения составила 5,2 [4,8; 5,7] лет. Исследовали антитромбогенную активность сосудистой стенки, лабораторные маркеры эндотелиальной дисфункции. Результаты: Несмотря на увеличение агрегационной активности тромбоцитов и более низкие значения активности антитромбина III у женщин на фоне МГТ, не было отмечено увеличения риска развития венозного тромбоза и эмболий, ишемического инсульта и случаев острого коронарного синдрома. К окончанию наблюдения установлено снижение антиагрегационного потенциала сосудистой стенки, более выраженное у женщин группы кон-троля. У женщин, принимавших МГТ, выявлено снижение концентрации фибриногена крови к окончанию исследования. На фоне МГТ отмечено значимое возрастание уровня метаболитов оксида азота, снижение уровней эндотелина-1 и асимметричного диметиларгинина к 12 мес наблюдения, но в дальнейшем отмечено повышение их уровней, не достигшее исходных значений. Заключение: Изменения функциональной активности эндотелия свидетельствуют об отсутствии негативного влияния на эндотелий сосудов длительной низкодозовой МГТ (1 мг E2/2 мг ДРСП). Objectives: to assess changes in the functional activity of the vascular wall and plasma hemostasis in women of early postmenopausal period under long-term low-dose menopausal hormone therapy (MHT). Patients/Methods: We examined 162 women in early postmenopause. The main group included 84 patients; they were prescribed a low-dose MHT: 1 mg of 17β-estradiol (E2) and 2 mg of drospirenone (DRSP) — Angelique® (Bayer Pharma, Germany). The control group consisted of 78 women did not taking MHT. The duration of observation was 5.2 [4.8; 5.7] years. Antithrombogenic activity of the vascular wall and laboratory markers of endothelial dysfunction were examined. Results: In women taking MHT we found increasing of platelet aggregation activity and lower antithrombin III activity, but did not reveal increased risk of venous thrombosis and embolism, ischemic stroke, and cases of acute coronary syndrome. By the end of observation decreasing of antiplatelet potential of the vascular wall, more expressed in women of the control group, was noted. In women taking MHT, blood fi brinogen concentration decreased by the end of the study. After 12 months of observation in women taking MHT we revealed significant increasing of nitric oxide metabolites, decreasing of endothelin-1 and asymmetric dimethylarginine; later their levels increased but did not reach the initial values. Conclusions: Changes in endothelial functional activity showed no adverse effect of long-term low-dose MHT (1 mg E2/DRSP 2 mg) on the vascular endothelium.

scholarly journals CHANGES OF CARDIOMETABOLIC RISK FACTORS IN EARLY AND LONG-TERM USE OF MENOPAUZAL HORMONE THERAPY IN WOMEN OF THE CLIMACTERIC PERIOD

2018 ◽  
Vol 33 (2) ◽  
pp. 56-63 ◽  
Author(s):  
S. N. Tolstov ◽  
I. A. Salov ◽  
A. P. Rebrov
Keyword(s):  
Waist Circumference ◽  
Hormone Therapy ◽  
Abdominal Obesity ◽  
Cardiometabolic Risk ◽  
Menopausal Hormone Therapy ◽  
Control Group ◽  
Immunoreactive Insulin ◽  
Thigh Circumference ◽  
17Β Estradiol

Aim:changes in the main cardiometabolic risk factors in women of the climacteric period in early and long-term use of combined drospirenone-containing menopausal hormone therapy.Material and Methods.The study included 210 menopausal women divided into 3 groups: 1 group (n=48) included women who, after reaching menopause, switched from a drospirenone-containing hormonal contraceptive to taking menopausal hormone therapy; in the second group (n=84) — women who started taking hormone therapy in the period of early postmenopause. Menopausal hormone therapy was used for 1 mg of 17β-estradiol and 2 mg of drospirenone-“Angeliq®”. The control group (n=78) included women in early postmenopausal women who did not take hormonal therapy. The duration of follow-up is 5.2 (4.8, 5.7) years. Lipid metabolism, uric acid, immunoreactive insulin and C-peptide, oral glucose tolerance test, HOMA-IR index were calculated. The waist circumference and waist circumference/thigh circumference were determined.Results.Against the backdrop of prolonged menopausal hormonal therapy, a decrease in the atherogenicity of blood plasma was noted. In women of the control group, an increase in atherogenic lipid fractions was revealed by the end of the study. Patients of the first group of significant changes in the circumference of the waist and the ratio of waist circumference/thigh circumference were not detected. In women of the second group with initially higher values of the waist circumference and the ratio of the waist circumference/thigh circumference than in the patients of the 1st group, a decrease in the severity of abdominal obesity was established. Women of the control group noted an increase in the value of these indicators by the end of the study. In women receiving menopausal hormone therapy, there was a significant decrease in immunoreactive insulin and C-peptide, a decrease in the HOMA-IR index, combined with a decrease in basal and postprandial blood glucose levels. In women of the control group, as the abdominal obesity progresses, the increase in the studied indicators is noted.Conclusion.The study suggests the possibility of using a combination of 1 mg of 17β-estradiol and 2 mg of drospirenone for prolonged menopausal hormone therapy in patients with early postmenopausal metabolic disorders. Early and longterm use of menopausal hormone therapy has some additional advantages before prescribing hormone therapy in the early postmenopausal period with more favorable changes in the lipid spectrum of the blood, less pronounced abdominal obesity and insulin resistance.

scholarly journals Long-Term Consequences of Menopause Victor manuel vargas hernandez Academic of the Mexican Academy of Surgery Secretary of the Mexican Association for the study of Climacteric

2020 ◽  
Vol 4 (3) ◽  
pp. 01-06
Author(s):  
Víctor Manuel Vargas Hernández
Keyword(s):  
Hormone Therapy ◽  
Healthy Aging ◽  
Hot Flashes ◽  
Physiological Role ◽  
Menopausal Hormone Therapy ◽  
Estrogen Exposure ◽  
Increased Risk ◽  
Lifestyle Measures ◽  
Long Term Consequences

The dramatic changes in sex hormone levels that occur during the transition to menopause and beyond are responsible for the long-term consequences, which are of primary importance to healthy aging in women. Sex hormones have a vital physiological role in maintaining the health and normal functioning of various organs; like bone, heart and brain. Disease activity is highly dependent on estrogen exposure; cardiovascular and musculoskeletal disorders frequently occur during postmenopause. Even cognitive decline is related to hypoestrogenism during the menopausal transition. Several lines of evidence indicate that the presence, duration and severity of menopausal vasomotor symptoms, especially hot flashes, not only have an impact on quality of life, but are biomarkers of increased risk of chronic conditions, which require prevention strategies, including menopausal hormone therapy. Nutrition, exercise, and other lifestyle measures, use of appropriate hormonal treatments in symptomatic women during the "window" of opportunity (under 60 years or within 10 years after menopause) can significantly counteract the process of aging of the female body. Meanwhile an individualized menopausal hormone therapy helps postmenopausal women overcome the burden of symptoms, including those related to Genitourinary Menopause Syndrome.

scholarly journals Evolution of menopausal hormone therapy: from standard to ultra-low doses

2016 ◽  
pp. 74-78 ◽  
Author(s):  
V. E. Balan ◽  
A. S. Zhuravel ◽  
O. V. Lopatina ◽  
S. A. Orlova
Keyword(s):  
Hormone Therapy ◽  
Low Dose ◽  
Term Treatment ◽  
Menopausal Hormone Therapy ◽  
Vasomotor Symptoms ◽  
Hot Flushes ◽  
Low Doses ◽  
Long Term Treatment ◽  
Post Menopausal

The article tells about the incidence and severity of menopausal symptoms in women during pre-, peri- and post-menopausal periods as well as the rationale for their treatment. It was found that the use of menopausal hormone therapy (MHT) should be individualized and should not be cancelled solely due to the woman's age. The results of numerous studies of women in the transition from pre- to peri- and further to postmenopause are demonstrated. Limitations in the duration of MHT therapy are considered, and the need to develop safer therapies for long-term treatment of hot flushes is substantiated. It is proved that ultra-low-dose medication is effective for the treatment of both moderate and severe vasomotor symptoms.

Short- and long-term outcomes of preterm spontaneous twin anemia-polycythemia sequence

2020 ◽  
Vol 48 (4) ◽  
pp. 329-334
Author(s):  
Soo Jin Han ◽  
Seung Mi Lee ◽  
Sohee Oh ◽  
Subeen Hong ◽  
Jeong Won Oh ◽  
...  
Keyword(s):  
Cord Blood ◽  
Neonatal Morbidity ◽  
Adverse Outcomes ◽  
Control Group ◽  
Long Term Outcomes ◽  
Neurodevelopmental Outcomes ◽  
Monochorionic Twin ◽  
Increased Risk ◽  
Study Population

AbstractBackgroundIn monochorionic twin pregnancy, placental anastomosis and inter-twin blood transfusion can result in specific complications, such as twin-twin transfusion syndrome (TTTS) and twin anemia-polycythemia sequence (TAPS). It is well established that adverse outcomes are increased in TTTS, but reports on the neonatal and long-term outcomes of TAPS are lacking. The objective of this study was to evaluate the neonatal and neurodevelopmental outcomes in spontaneous TAPS.MethodsThe study population consisted of monochorionic twin pregnancies with preterm birth (24–37 weeks of gestation) between November 2003 and December 2016 and in which cord blood was taken at the time of delivery. According to the result of hemoglobin in cord blood, the study population was divided into two groups: a spontaneous TAPS group and a control group. Neonatal and neurodevelopmental outcomes were compared between the two groups.ResultsDuring the study period, 11 cases were diagnosed as spontaneous TAPS (6.4%). The TAPS group had lower gestational age at delivery and had a higher risk for cesarean delivery. However, neonates with TAPS were not at an increased risk for neonatal mortality and significant neonatal morbidity. In addition, the frequency of severe cerebral lesion during the neonatal period and the risk of cerebral palsy at 2 years of age were not different between the two groups.ConclusionThe spontaneous TAPS diagnosed by postnatal diagnostic criteria was not associated with the increased risk of adverse neonatal and neurodevelopmental outcomes. Further studies are needed to evaluate the morbidity of antenatally diagnosed TAPS.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044695
Author(s):  
Mu Chen ◽  
Qunshan Wang ◽  
Jian Sun ◽  
Peng-Pai Zhang ◽  
Wei Li ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Ethics Committee ◽  
Aspirin Therapy ◽  
Atrial Appendage ◽  
Control Group ◽  
Coronary Syndrome ◽  
Left Atrial Appendage Occlusion ◽  
Increased Risk

IntroductionIt is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to increased risk of bleeding. Therefore, aspirin discontinuation after LAAO in atrial fibrillation (ASPIRIN LAAO) trial is designed to assess the uncertainty about the risks and benefits of discontinuing aspirin therapy at 6 months postimplantation with a Watchman LAAO device in NVAF patients.Methods and analysisThe ASPIRIN LAAO study is a prospective, multicentre, randomised, double-blinded, placebo-controlled non-inferiority trial. Patients implanted with a Watchman device within 6 months prior to enrollment and without pre-existing conditions requiring long-term aspirin therapy according to current guidelines are eligible for participating the trial. Subjects will be randomised in a 1:1 allocation ratio to either the Aspirin group (aspirin 100 mg/day) or the control group (placebo) at 6 months postimplantation. A total of 1120 subjects will be enrolled from 12 investigational sites in China. The primary composite endpoint is stroke, systemic embolism, cardiovascular/unexplained death, major bleeding, acute coronary syndrome and coronary or periphery artery disease requiring revascularisation at 24 months. Follow-up visits are scheduled at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment.Ethics and disseminationEthics approval was obtained from the Ethics Committee of Xinhua Hospital, Shanghai, China (reference number XHEC-C-2018-065-5). The protocol is also submitted and approved by the institutional Ethics Committee at each participating centre. Results are expected in 2024 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.Trial registration numberNCT03821883.

scholarly journals Combined low-dose everolimus and low-dose tacrolimus after Alemtuzumab induction therapy: a randomized prospective trial in lung transplantation

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alberto Benazzo ◽  
Ara Cho ◽  
Anna Nechay ◽  
Stefan Schwarz ◽  
Florian Frommlet ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lung Transplantation ◽  
Kidney Function ◽  
Induction Therapy ◽  
Low Dose ◽  
Prospective Trial ◽  
Control Group ◽  
Long Term Outcomes ◽  
Maintenance Immunosuppression

Abstract Background Long-term outcomes of lung transplantation are severely affected by comorbidities and development of chronic rejection. Among the comorbidities, kidney insufficiency is one of the most frequent and it is mainly caused by the cumulative effect of calcineurin inhibitors (CNIs). Currently, the most used immunosuppression protocols worldwide include induction therapy and a triple-drug maintenance immunosuppression, with one calcineurin inhibitor, one anti-proliferative drug, and steroids. Our center has pioneered the use of alemtuzumab as induction therapy, showing promising results in terms of short- and long-term outcomes. The use of alemtuzumab followed by a low-dose double drug maintenance immunosuppression, in fact, led to better kidney function along with excellent results in terms of acute rejection, chronic lung allograft dysfunction, and survival (Benazzo et al., PLoS One 14(1):e0210443, 2019). The hypothesis driving the proposed clinical trial is that de novo introduction of low-dose everolimus early after transplantation could further improve kidney function via a further reduction of tacrolimus. Based on evidences from kidney transplantation, moreover, alemtuzumab induction therapy followed by a low-dose everolimus and low-dose tacrolimus may have a permissive action on regulatory immune cells thus stimulating allograft acceptance. Methods A randomized prospective clinical trial has been set up to answer the research hypothesis. One hundred ten patients will be randomized in two groups. Treatment group will receive the new maintenance immunosuppression protocol based on low-dose tacrolimus and low-dose everolimus and the control group will receive our standard immunosuppression protocol. Both groups will receive alemtuzumab induction therapy. The primary endpoint of the study is to analyze the effect of the new low-dose immunosuppression protocol on kidney function in terms of eGFR change. The study will have a duration of 24 months from the time of randomization. Immunomodulatory status of the patients will be assessed with flow cytometry and gene expression analysis. Discussion For the first time in the field of lung transplantation, this trial proposes the combined use of significantly reduced tacrolimus and everolimus after alemtuzumab induction. The new protocol may have a twofold advantage: (1) further reduction of nephrotoxic tacrolimus and (2) permissive influence on regulatory cells development with further reduction of rejection episodes. Trial registration EUDRACT Nr 2018-001680-24. Registered on 15 May 2018

The effect of experimental low zearalenone intoxication on ovarian follicles in pre-pubertal bitches

2013 ◽  
Vol 16 (1) ◽  
pp. 45-54 ◽  
Author(s):  
M. Gajęcka
Keyword(s):  
Low Dose ◽  
Companion Animals ◽  
Ovarian Follicles ◽  
Apoptotic Index ◽  
Proliferation Index ◽  
Control Group ◽  
Average Body ◽  
Proliferative Ability

AbstractCompanion animals, including bitches, may be exposed to zearalenone (ZEN) toxins that are often present in feed, and ZEN intoxication may lead to ovarian dysfunction. This study involved evaluation of the degree of ZEN-induced hypo stimulation of ovary by determination of proliferative and apoptotic indices and description of the ultra-structural organization of ovarian follicles in pre-pubertal bitches subjected to experimental, long-term exposure to low-dose ZEN mycotoxicosis. The experiment involved 30 clinically healthy, immature Beagle bitches aged approximately 70 days with initial average body weight of 8 kg, randomly divided into three groups of 10 animals each: two experimental groups (EI and EII) and a control group (C). Over a period of 42 days, ZEN was administered per os to EI animals at a dose of 50 μg/kg BW, and to EII bitches at a dose of 75 μg/kg BW. Control group animals were fed placebo containing no ZEN for 42 days. Analytical samples of the mycotoxin were administered daily in gelatin capsules before morning feeding. All the bitches were subjected to ovario-hysterectomy at the end of the experiment. Proliferation index (PCNA method) and apoptotic index (TUNEL test) values were determined by immune-histological analyses. The median for apoptotic index was determined at 13.45 for group EI, 17.84 for group EII, and 8.59 for group C. The median for proliferation index was determined at 35.25 for group EII, 42.44 for group EI, and 70.60 for group C. The results of ultra-structural examinations of the ovaries revealed that experimental, ZEN-induced hyperestrogenism enhanced apoptosis and lowered the proliferative ability of follicular cells what contributed to organelle destruction in pre-pubertal bitches. The changes observed were particularly advanced in EII animals, which were administered a higher dose of ZEN.

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