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ОRIGINAL ARTICLES

120
Abstract

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized, blinded, prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of a medicine at everyday practice in a nonselected population.

Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.

Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar as a pre-filled pen injector with a dose adjustment of 5 IU (Primapur®), aimed at investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART). The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists gonadotropin-releasing hormone (GnRH) antagonist and long protocols with GnRH agonists. The stimulation protocols analyzed where Primapur® was applied for at least 5 days.

Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved – 9.5 ± 7.2, mature (MII) – 6.8 ± 6.6, fertilized (2PN) – 6.1 ± 5.8, clinical pregnancy per ET (PR) – 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved – 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) – 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) – 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved – 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) – 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) – 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.

Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice.

40
Abstract

Aim: to identify the risk factors for gestational diabetes mellitus (GDМ) and predictors of perinatal lesions of central nervous system (CNS) in combination of GDМ and maternal obesity.

Materials and Methods. А retrospective observational case-control uncombined study was conducted to determine GDМ risk factors and their effect on perinatal pathology in 250  women divided into 2 groups. The main group included 150 pregnant women diagnosed with GDМ, the control group – 100 pregnant women without carbohydrate metabolism disorders. An assessment of hereditary, obstetric and gynecological history, somatic health was carried out. Patients of the main group were divided into smaller groups: 1А (n = 77) – mothers whose newborns postnatal had adverse perinatal outcomes associated with the influence of maternal hyperglycemia and 1В (n = 73) – mothers whose newborns were born healthy. CHAID method (Chi Squared Automatic Interaction Detection) was used to create an algorithm for predicting adverse perinatal outcomes in GDМ. Аt the second stage, a single-center prospective observational non-combined cohort study was conducted to assess the effect of maternal hyperglycemia on the formation of perinatal lesions of CNS. The concentration of neuron-specific enolase (NSE) was determined before the labor in the amniotic fluid of full-term fetuses in the group of pregnant women without carbohydrate metabolism disorders (n = 42) and in the group of pregnant women with GDM (n = 33).

Results. Obesity, late reproductive age, family history of diabetes mellitus type 2 (DM-2), abortions, early reproductive losses, large for gestational age fetuses in history are the main risk factors for GDM developing. An algorithm was developed that allowed the prediction of the risk of the newborn perinatal pathology in the mother with GDM. The concentration of NSE in the amniotic fluid of full-term fetuses before the onset of labor increases with a combination of GSD and obesity (5.56 [3.37–6.24] by 1.68 times compared to the concentration in pregnant women with normal weight without carbohydrate metabolism disorders (3.29 [1.49–4.89]) (p = 0,006). 

Conclusion. Pregnant women with obesity and a family history of DM-2 have the highest possibility of perinatal complications. Increasing the concentration of NSE in amniotic  fluid in patients with GDМ confirms damage to the fetal CNS in the antenatal  period. The maximum NSE level was determined in the combination of GSМ and obesity 

REVIEW ARTICLE

69
Abstract

Aim: to summarize results of up-to-date world researches on the current trends of symptomatic myoma treatment.

Materials and Мethods. A search of publications was carried out in the main international databases in Russian and English languages: PubMed/MEDLINE, The Cochrane Library, Embase, eLibrary. The analysis included studies published over the past 10 years examining the clinical efficacy and safety of various groups of pharmacological agents for the treatment of uterine myoma combined with heavy menstrual bleeding in women of reproductive age.

Results. Currently, the treatment of uterine fibroids is divided into three main methods: surgical, minimally invasive organ-preserving methods, and pharmacotherapy. Until now, surgical intervention remains the main method of treatment, and, unfortunately, is often carried out in the volume of hysterectomy. However, today it is important to have a personalized approach to the management of a patient with symptomatic uterine myoma, taking into account her desire to preserve reproductive function. The development of the possibilities of drug therapy made a great contribution to the optimization of managing such patients.

Conclusion. The global trend is to decrease the number of radical interventions, as well as the development and improvement of new methods of treating symptomatic uterine fibroids. Currently, pharmacotherapy of leiomyoma can significantly improve the quality of life of patients, reduce radical surgical interventions, optimize surgical treatment, and in certain situations, completely eliminate the need for surgery.

139
Abstract

Aim: to systematize data on rehabilitation methods and management tactics for women with external form of genital endometriosis.

Materials and Methods. We searched for publications in international scientific databases: scientific electronic library eLibrary, Scholar, ScienceDirect, Cochrane Library, PubMed/MEDLINE for the last 5 years. The data on the modern approach to the therapy and rehabilitation of women with external genital endometriosis are presented. Search terms in Russian and English were used: “endometriosis”, “rehabilitation”, “gynecology”, “quality of life”.

Results. Endometriosis is considered an independent risk factor for the development of malignant tumors not only of the reproductive system, but also of the large intestine, bladder, mammary glands. The review presents a current view of the treatment and rehabilitation of women with external genital endometriosis. Endometriosis is a polyetiological disease that can manifest itself as dysmenorrhea, dyspareunia, chronic pelvic pain, as well as dysuria and dyshesia when involving adjacent organs in the pathological process. Relapses, infertility, emotional and psychosexual disorders, problems with socialization are often detected in these patients.

Conclusion. It is necessary not only to conduct comprehensive treatment, but also to develop personalized rehabilitation programs that can improve the quality of life, as well as create comfortable conditions for social adaptation in society.



ISSN 2313-7347 (Print)
ISSN 2500-3194 (Online)