Real­world performance and safety of vaginal ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and postmenopausal sexual dysfunction.

Decreasing estrogen levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse and decreased pelvic floor strength and control. Sexual dysfunction associated with vaginal dryness occurs in postmenopausal patients. The present study (trial no. NCT05654610) was designed as an observational, multicenter, real-world clinical investigation to evaluate the performance and safety of the medical device Halova® ovules in decreasing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova ovules, both in monotherapy and in combination with vaginal lubricants. The primary objective was to evaluate the tolerability of Halova ovules in the management of symptoms associated with perimenopause or genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia and endometrial thickness was defined a secondary objective. Halova ovules were rated with 'excellent' clinical performance by 92.74% of participants as a standalone treatment and 95.71% of the study participants when used in association with vaginal lubricants. Sexual dysfunction-associated parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm, 82% (monotherapy) and 80% (polytherapy) for vaginal dryness and 72% in monotherapy vs. 48% polytherapy reducing dyspareunia. No adverse reactions associated with treatment with Halova were reported. The medical device demonstrated anti-atrophic activity in the genitourinary tract, resulting in significantly improved symptoms associated with normal sexual functioning.

The dynamic changes in the pattern of liver function tests in pregnant obese women.

Obesity is an important problem in healthcare regarding gestating women. The objective of the present study was to highlight the impact that obesity has on the hepatic function in pregnant women by comparing the functional tests used in current practice. In addition, the aim was to identify possible predictors of liver damage by analyzing specific anthropometric data. The present study was descriptive, observational, retrospective, and based on the observation sheets found in the database of the Institute for the Health of the Mother and Child, the Obstetrics Gynecology Department of Polizu Hospital. Patients who presented for consultation in each trimester of pregnancy were included in the study. Demographic data taken into account included age, body mass index (BMI), provenance environment, anthropometric data: Abdominal circumference and the complete set of paraclinical data from which we extracted these specific liver tests: Aspartate aminotransferase (AST), alanine transferase (ALT), direct bilirubin (BD), serum albumin and gamma-glutamyl transferase (GGT). The present study included 157 patients divided into two groups, distributed as follows: Group A: 66 obese pregnant women (BMI >25 kg/m2) and group B: 91 patients with normal weight (BMI <25 kg/m2). Measurement of serum ALT and AST were the most useful tests for routine diagnosis of liver disease. The effects of pregnancy on serum levels of ALT and AST are controversial. In some studies, there was a slight increase in ALT and AST during the second and third trimesters, a fact confirmed by our study, albeit the result was not statistically significant Most published studies claim that serum ALT and AST levels do not change during pregnancy. In conclusion, obesity during pregnancy does not drastically influence liver function. However, patients with greater abdominal circumference are prone to developing minor hepatic cytolysis syndrome during the gestation period. The liver functional tests described in the aforementioned groups agree with the results provided by the specialized studies.

Obesity and pregnancy.

Introduction: Obesity is the most frequent metabolic disturbance that can target women of reproductive age, among other population groups, and when obese pregnant women become patients, it represents a serious risk factor for both mother and fetus. Aim: The aim of this study is to offer an overview of the effects exerted by this disturbance on pregnancy. Materials and methods: The study targets 157 pacients admitted to "Alessandrescu-Rusescu" National Institute for Mother and Child Health - Polizu (INSMC), Bucharest, Romania. In order to define the criterion for obesity, WHO classification (body mass index > 30 kg/m²) was used. Data was collected restrospectively after acceptance by the Ethics Committee. Also, we gathered anthropometric data (weight, body mass index and analysis regarding the metabolic profile, including total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, blood sugar, glycosylated haemoglobin) from all subjects. Each analysis was correlated with each patient's body mass index. Another correlation was made between metabolic profile, antenatal complications and onset of gestational diabetes and premature birth. Statistical analysis was conducted using GraphPad 8 and MedCalc 14.1. Results: Patients had an average body weight of 66.75 kg with a standard deviation of 12.99 kg and a median of 64 kg. Average body mass index was 25.05 kg/m², with a standard deviation of 5,03 kg/m² and a median of 24.2 kg/m². There is a directly proportional and statistically significative correlation between the values of blood sugar, glycosylated haemoglobin, LDL, TG, uric acid and BMI. Also, there is a inversely proportional and statistically significative correlation between the values of HDL and BMI. The CT/HDL ratio, low HDL level and elevated LDL level are the main risk factors for premature birth, while the CT/HDL ratio, low HDL level and elevated TG are the main risk factors for the onset of gestational diabetes. Conclusions: According to the results of this study, the onset of obesity in pregnant woman is rather dependent on each patient's metabolic profile than body weight.

A Patented Blend Consisting of a Combination of Vitex agnus-castus Extract, Lepidium meyenii (Maca) Extract and Active Folate, a Nutritional Supplement for Improving Fertility in Women.

Background:Statistics from recent years have shown that 40% of infertile couples have a female etiological factor, 40% a male etiology and the remaining 20% a combination of female and male factors. For fertile couples, the chance of getting pregnant is 57% in three months of attempts, 75% in six months, 90% in one year, and 95% in two years. One-third of infertile couples have more than one cause involved in their inability to conceive. In 10-20% of cases, the reason for infertility cannot be determined. Approximately 25% of infertile women have ovulatory dysfunction. Objectives:This research investigates improvements on the fertility of couples following treatment with a daily tablet of the patented blend consisting in a combination of Vitex agnus-castus (Vitex) extract, Lepidium meyenii (Maca) extract and active folate alone or with a gel capsule of vitamin, minerals, oligo-elements plus DHA and EPA Omega 3 fatty acids. Materials and methods:Multicenter prospective interventional study with a duration of 18 months, conducted between June 2016 and December 2017. A total of 189 women were enrolled in the study. Participants were assigned to two treatment groups: group A, consisting of 103 patients who received a daily tablet of the patented blend consisting in a combination of Vitex extract, Maca extract and active folate, and group B, consisting of 86 patients who were given a daily tablet of the patented blend also administered to Group A and a gel capsule of vitamins, minerals, oligo-elements plus DHA and EPA omega 3 fatty acids. Paraclinical tests were conducted upon inclusion in the study and six months after treatment initiation in case of non-pregnancy. Every patient received ovulation kits and ovulation tests were performed on day 14 of the menstrual cycle. Outcomes:Average age of the women was 31.18 years (SD 5.18 years). There was a successful pregnancy rate of 37%, with no difference between the two arms of the study. The number of new pregnancies was relatively constant through the study duration. The number of women with ovulation increased from 10% to 42.9% by the end of the study. During the six-month-period of the study, there were no side effects reported between patients of the two groups. Conclusions:The supplement may be used by women trying to conceive. The patented blend consisting of a combination of Vitex, Maca and active folate regulates the menstrual cycle, stimulates ovulation and increases the likelihood of getting pregnant.

Placenta changes in pregnancy with gestational diabetes.

Placental damage may be responsible for the fetal complications in pregnancies complicated by diabetes. We have analyzed the prevalence of gestational diabetes (GD) in a population of 109 pregnant women, the risk factors and the placental changes associated with gestational diabetes. Tests carried out were oral glucose tolerance test at 24-28 weeks of gestation, using the IADPSG (International Association of Diabetes and Pregnancy Study Groups) criteria for gestational diabetes, glycated hemoglobin, fasting insulin, total cholesterol, high density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol, triglycerides, two-dimensional (2D) ultrasound and, also, there were analyzed macro and microscopic placental fragments from pregnant women with÷without GD. It has been recorded the weight of placenta at birth and there were analyzed the possible pathological changes. The prevalence of GD was 11.9%. We have applied the direct logistic regression to determine the impact of some factors over the probability of association with gestational diabetes. The most powerful predictor was the placental maturity grade, the patients with decreased maturity grade having chances 52.6 times higher than those with an increased placental maturity grade to associate gestational diabetes. Sizes of placentas in patients with gestational diabetes mellitus were significantly increased than in patients without this diagnosis (p=0.012) from week 24-28. Pathological changes were discovered in six of the 13 placentas of women with gestational diabetes mellitus, independent of the level of glycated hemoglobin (p=0.72). The level of hyperglycemia is only partially associated with the presence of placental changes, which may be caused by other maternal factors.

The antitoxoplasma gondii antibodies incidence to the different ocular diseases patients cases of human ocular toxoplasmosis infections in Romania.

Toxoplasmosis is an anthropo-zoonosis widely spread around the earth, whose ocular complications are very frequent and are often a first sign of infestation. This is a retrospective statistic research based on the clinical survey and periodic control of a lot of 135 patients with toxoplasmosis, out of which 90 presented ocular toxoplasmosis.

Accelerated streptokinase in ST-elevation myocardial infarction--a Romanian (ASK-ROMANIA) multicenter registry.

BACKGROUND: The classical streptokinase regimen (1.5 M.U. over 60 min) may be too slow in patients with ST-elevation myocardial infarction (STEMI). OBJECTIVE: To compare the efficacy and safety of four streptokinase regimens in STEMI patients. METHODS: 1880 consecutive patients admitted within 6 h of STEMI onset were allocated one of the following four streptokinase regimens: 1.5 M.U. over 60 min (n=517); 1.5 M.U./30 min (n=355); 1.5 M.U./20 min (n=507); 0.75 M.U./10 min, repeated or not after 50 min if no electrocardiographic criteria of reperfusion (n=501). RESULTS: Rates of coronary reperfusion (non-invasively detected) for SK1.5/30 (72.39%), SK1.5/20 (75.34%) and SK0.75/10 (72.85%) were similar and higher than for SK1.5/60 (64.03%, p=0.019, p<0.0001, and p=0.006, respectively). In-hospital mortality was significantly lower for SK1.5/20 (7.10%) and SK0.75/10 (7.38%) and at the limit of significance for SK1.5/30 (7.60%) compared with SK1.5/60 (11.60%, p<0.0001, 0.006, and 0.053, respectively). Intracerebral haemorrhage and other major bleeding had similar incidence in the four groups. CONCLUSIONS: Compared to the classical 1.5 M.U. over 60 min streptokinase regimen, significantly higher rates of coronary reperfusion and lower in-hospital mortality can be obtained by infusing the same dose over only 20 min, or either one or two half doses over only 10 min, without risk increase.

Accelerated streptokinase and enoxaparin in ST-segment elevation acute myocardial infarction (the ASENOX study).

BACKGROUND: The streptokinase (SK) regimen (1.5 MU/60 min) has remained unchanged in the ST-segment elevation acute myocardial infarction (STEMI) for the last 20 years. AIM: To compare the efficacy of an accelerated SK (ASK) regimen combined with enoxaparin (Enox) or heparin (UFH) with the standard SK and UFH combination in STEMI. METHODS: 633 consecutive patients, aged 21-74 years, admitted within 6 hours after the onset of STEMI, were divided in three groups: (1) ASKEnox (n=165): Enox 40 mg. i.v. followed by SK 1.5 MU over 20 min, either as a full dose or a double infusion of 0.75 MU over 10 min. separated by 50 min. After SK infusion, Enox was administered 1 mg/kg s.c. every 12 hours for 5-7 days; (2) ASKUFH (n=264): the same ASK regimen plus UFH 1,000 IU/h for 48-72 hours, (3) SSKUFH (n=204): SK 1.5 MU/60 min. plus UFH 1,000 IU/h for 48-72 hours. All patients received aspirin. Three coronary reperfusion (CR) criteria were used: 1. rapid cessation of chest pain; 2. rapid reduction of ST-segment elevation by more than 50% of the initial value; 3. rapid increase in plasma CK and CK-MB with a peak in the first 12 hours. RESULTS: The rates of CR in the ASKEnox (77.6%) and the ASKUFH (73.5%) groups were similar but both were significantly higher than that observed in the SSKUFH group (62.2%) (p=0.002 and 0.013, respectively). The 30-day mortality rates were similar in the ASKEnox (6.06%) and the ASKUFH (6.81%) groups but both were significantly lower than in the SSKUFH group (12.74%) (p=0.048 and 0.044, respectively). SK-induced hypotension was more frequent in the ASKEnox (39.4%) and ASKUFH (38.3%) groups compared with the SSKUFH group (20.6%) (p<0.0001), but it was transient and well tolerated. Haemorrhagic stroke occurred in two patients from the SSKUFH and one patient from the ASKUFH groups. CONCLUSIONS: ASKEnox and ASKUFH regimens are safe and result in a significantly higher rate of CR and a lower in-hospital mortality compared with the traditional SSKUFH regimen.

Streptokinase-induced hypotension has no detrimental effect on patients with thrombolytic treatment for acute myocardial infarction. A substudy of the Romanian Study for Accelerated Streptokinase in Acute Myocardial Infarction (ASK-ROMANIA).

UNLABELLED: The Streptokinase (SK) regimen (1.5 MU/60 minutes) has remained unchanged for the past 20 years in patients with ST-segment elevation acute myocardial infarction (STEMI) due to fear of hypotension (a specific effect of this thrombolytic agent) and of hemorrhagic complications. OBJECTIVE: To evaluate the influence of the Streptokinase-induced hypotension (SK-hTA) on the rate of coronary reperfusion (CR), incidence of cardiogenic shock (CS), 30-day mortality and incidence of stroke in patients (pts.) with STEMI. The SK-hTA was defined as decrease of the systolic blood pressure with at least 20% within the first 20 min. after the start of the SK infusion. METHODS: A group of 837 pts. (age 20-90) with thrombolytic treatment, with three "accelerated" SK regimens within the first 6 hours after the onset of STEMI and enrolled in the Romanian open, prospective, non-randomised study for accelerated SK in STEMI (ASK-ROMANIA) have been included. The SK regimens consisted in infusing of the standard dose of 1.5 M.U. either in 30 min. (regimen SK1.5/30, 173 pts).) or in 20 min. (regimen SK1.5/20, 377 pts.) or of the half dose (0.75 M.U.) in 10 min. followed by a new infusion of 0.75 M.U. after 50 min. only if no bed-side signs of CR have been recorded (regimen SK 0.75/10, 287 pts.). The speed of the SK infusion was maintained in all pts. experiencing SK-hTA. All pts. received aspirin and heparin or enoxaparin if not contraindicated. Three noninvasive CR criteria have been used: 1. Rapid cessation of the chest pain. 2. Rapid decrease of the ST segment elevation by more than 50% of the initial value. 3. Rapid increase of the CK and CK-MB with a peak within the first 12 hrs. RESULTS: SK-hTA appeared in 372 pts. (44.55%) at 9+/-5 min after the start of the SK infusion. In this subgroup the rate of CR was 74.46%, non-significantly higher than the one of 68.81% registered in pts. without SK-hTA (p=0.071). SK-hTA disappeared in all patients after 16+/-6 minutes without a specific therapy. Fourteen pts. with SK-hTA (3.76%) and 16 pts. without SK-hTA (3.44%) developed CS after thrombolysis ( non-significant difference). The global in-hospital mortality was 10.21% in pts. with SK-hTA and 9.89% in pts. without this side effect (non-significant difference). The incidences of hemorrhagic and ischemic strokes were 0.26% (1 patient) respectively 0.52% (2 pts.) in the SK-hTA subgroup and 0.43% (2 pts.) respectively 0.64% (3 pts.) in the subgroup without SK-hTA. CONCLUSIONS: 1. Despite a very high incidence (44.55%) the SK-hTA has not a detrimental effect in pts. treated with accelerated SK regimens for STEMI. 2. Streptokinase can be rapidly administered without an increased risk.

Double bolus of 0.75 MU streptokinase plus enoxaparin versus front-loaded alteplase plus unfractionated heparin in ST-segment elevation myocardial infarction.

OBJECTIVE: To compare the efficacy and safety of an accelerated streptokinase regimen (double bolus of 0.75 MU in 10 min) in combination with enoxaparin (SK0.75Enox regimen) with the one of the front loaded alteplase (t-PA 100 mg/90 min) plus heparin (the t-PAHep regimen) in patients (pts.) with ST-segment elevation acute myocardial infarction (STAMI). METHODS: One hundred seventy three pts. (age 18-74) treated within the first 6 hrs. after the onset of STAMI with the above two mentioned thrombolytic regimens were included. 1. The group SK0.75Enox (102 pts.) received an i.v. bolus of 40 mg Enox followed by 0.75 MU SK in 10 min. A second bolus of 0.75 MU SK would be administrated only if no bed-side signs of coronary reperfusion (CR) were detected within the next 50 min. After thrombolysis Enox was administered 1 mg/kg bodyweight every 12 hrs. for 5-7 days. 2. The group t-PAHep (71 pts.) received 15 mg oft-PA in bolus followed by 50 mg in 30 min and 35 mg within the next 60 min; t-PA was followed by heparin 1000 u/hour for the next 48-72 hours. All the patients received aspirin. Three noninvasive CR criteria were used: 1. Rapid cesation of the chest pain. 2. Rapid decrease of the ST segment elevation by more than 50% from the initial value. 3. Rapid increase of the CK and CK-MB with a peak within the first 12 hrs. RESULTS: Two patients (2.85%) from the t-PAHep group had non-fatal stroke (one haemorrhagic, one ischemic). No other major haemoragical events were registered in both groups. During the thrombolytic infusion hypotension appeared more frequently in the SK0.75Enox group (31.4%) than in the t-PAHep one (8.5%) (p>0.0001) but without any consequence regarding the patients' outcome. The ratio of CR was 78.4% in the SK0.75Enox group and 70.4% in the t-PAHep one (p = 0.308). In-hospital reocclusion appeared in 4 pts. from the t-PAHep group (5.7%) but in none in the SK0.75Enox one. Six pts. (5.9%) from the SK0.75Enox group and 5 pts. from the t-PA one (7.04%) died within the first 30 days after the onset of STAMI (p = 0.993). CONCLUSIONS: The combination SK0.75Enox is at least as safe and efficacious as the t-PAHep one.

Efficacy and safety of a new streptokinase regimen with enoxaparin in acute myocardial infarction.

OBJECTIVE: To compare a new streptokinase regimen combined with either enoxaparin or unfractionated heparin (UFH) and the traditional streptokinase regimen combined with UFH in patients with acute myocardial infarction (AMI). METHODS: 412 patients (<75 years), hospitalized within 6 hours of the onset of chest pain, were allocated thrombolytic therapy by the treating physician: streptokinase 0.75 MU/10 minutes, repeated if no coronary reperfusion after one dose, plus enoxaparin 40 mg intravenously followed by 1 mg/kg bodyweight subcutaneously at 12-hour intervals for 5-7 days (n = 102); the same streptokinase regimen plus UFH 1000 IU/60 minutes intravenously for 48-72 hours ( n = 106); or streptokinase 1.5 MU/60 minutes plus the same UFH regimen (n = 204). All patients received 250-325 mg aspirin/day. Coronary reperfusion rates, 30-day mortality and hemorrhagic complications were recorded. RESULTS: Coronary reperfusion rates with 0.75 streptokinase + enoxaparin (78.4%) and 0.75 streptokinase + UFH (74.5%) were significantly higher than those with 1.5 streptokinase + UFH (62.2%), but there was no significant difference between the groups receiving the new regimen. Overall 30-day mortality (6.3%) was significantly lower than with 1.5 streptokinase + UFH (12.7%) ( p = 0.037). The incidence of major and minor hemorrhagic events was similar in all groups. CONCLUSIONS: The accelerated streptokinase regimen was well tolerated and resulted in a significantly higher coronary reperfusion rate and significantly lower mortality compared with the traditional regimen. The 0.75 streptokinase + enoxaparin combination was at least as efficacious as the 0.75 streptokinase + UFH combination and is preferred because of its ease of administration and predictable anticoagulant effect.