Predictive preventive personalized medicine Liver cancer is the fifth most common form of cancer worldwide [1], with an incidence rate almost equals the mortality rate and ranks 3 rd among causes of cancer related death [2]. The coexistence of two life threatening conditions, cancer and liver cirrhosis makes the staging challenging. However, there are some staging systems, e.g. the Barcelona staging system for Hepatocellular carcinoma (HCC) [3], that suggest treatment options and management. Whereas diagnosis in early stages gives hope for a curative outcome, the treatment regime for around 80 % [2] of the patients classified as severe stages only gears towards palliation [4]. An intra-arterial radiation approach, radioembolisation (RE) is ubiquitously applied as one of palliative approaches. Although, in general RE shows promising results in intermediate and advanced stage HCC [5], individual treatment outcomes are currently unpredictable. Corresponding stratification criteria are still unclear. We hypothesised that individual radioresistance/radiosensitivity may play a crucial role in treatment response towards RE strongly influencing individual outcomes. Further, HCC represents a highly heterogeneous group of patients which requires patient stratification according to clear criteria for treatment algorithms to be applied individually. Multilevel diagnostic approach (MLDA) is considered helpful to set-up optimal predictive and prognostic biomarker panel for individualised application of radioembolisation. Besides comprehensive medical imaging, our MLDA includes non-invasive multi-omics and sub-cellular imaging. Individual patient profiles are expected to give a clue to targeting shifted molecular pathways, individual RE susceptibility, treatment response. Hence, a dysregulation of the detoxification pathway (SOD2/Catalase) might indicate possible adverse effects of RE, and highly increased systemic activities of matrix metalloproteinases indicate an enhanced tumour aggressiveness and provide insights into molecular mechanisms/targets. Consequently, an optimal set-up of predictive and prognostic biomarker panels may lead to the changed treatment paradigm from untargeted "treat and wait" to the cost-effective predictive, preventive and personalised approach, improving the life quality and life expectancy of HCC patients. Keywords: Market access, Value, Strategy, Companion diagnostics, Cost-effectiveness, Reimbursement, Health technology assessment, Economic models, Predictive preventive personalized medicine Achieving and sustaining seamless "drug -companion diagnostic" market access requires a sound strategy throughout a product life cycle, which enables timely creation, substantiation and communication of value to key stakeholders [1, 2]. The study aims at understanding the root-cause of market access inefficiencies of companies by gazing at the "Rx-CDx" co-development process through the prism of "value", and developing a perfect co-development scenario based on the literature review and discussions with the ...
To determine the role and effectiveness of the proposed therapeutic and preventive complex in the correction of psychoemotional state in the dynamics of pregnancy in pregnant women after assisted reproductive technologies (ART) application in order to improve the tactics of antenatal observation and prevention of obstetric and perinatal complications. 299 pregnant women were comprehensively examined and a set of therapeutic and preventive measures was carried out: the main group included 249 women whose pregnancy occurred as a result of ART application. The control group consisted of 50 pregnant women with spontaneous pregnancy. The complex of measures for pregnant women after ART application included: micronized progesterone, magnesium oxide, folic acid, L-arginine aspartate, Omega-3 polyunsaturated fatty acids and long-term psychological correction – before ART program, at 8-10 weeks of pregnancy, at 16-18 weeks of pregnancy and at 28-30 weeks of pregnancy. Introduction of the proposed complex of psychoemotional correction contributed to the formation of reactive anxiety and personal anxiety levels at a moderate level in women of subgroups IA-44 (89.8%) and 43 (87.6%), IIA – 43 (89.6%) and 44 (91.7%) and IIIA – 30 (83.3%) and 26 (72.2%), which is considered to be an adaptive, physiological type during pregnancy. The positive effect of the proposed complex of psychoemotional correction demonstrates the improvement of processes of formation of type of component gestational dominant, its return to the optimal type in women of subgroup IA – 41 (83.6%), IIA – 39 (81.3%) and IIIA – 26 (72.2%) that is close to the physiological course of pregnancy and contributes to the reduction of perinatal and obstetric complications among pregnant women of these subgroups.
This article is devoted to the treatment of urodynamic disorders in women with the genitourinary syndrome by using a fractional CO2-laser. Nowdays, the development of genitourinary syndrome is an urgent problem among women of different ages. Genitourinary disorders are a complex of symptoms associated with the development of atrophic and dystrophic processes in the estrogenic tissues (the urethra, lower third of the uterus, pelvic floor ligaments and muscles). The objective: to determine the pathogenetic effectiveness of CO2 laser in the treatment of urodynamic disorders in premenopausal women with genitourinary syndrome.Materials and methods. The study covered 130 female patients with symptoms of the genitourinary syndrome. The patients were divided into two groups depending on their treatment. The main group consisted of 56 women using CO2 laser therapy. The comparison group consisted of 74 women who were treated with local application of hormone. To assess the efficacy of treatment and the functional status of the lower urinary tract, a comprehensive pre-treatment and post-treatment urodynamic examination were performed.Results. The average age of the patients in the examined groups was 47.2±2.5 years. After the treatment, the urodynamic examination showed an increase of the maximal intraurethral pressure from 16.8±17.9 to 26.7±21.2 mm Hg in the main group (p<0.01). The urethral closure pressure increased from 15.3±13.2 to 26.8±18.5 mm Hg (p<0.01). These changes were found upon examination of the functional length of the urethra, which increased from 2.0±0.3 to 3.0±0.4 cm, and thus reached normative values for healthy women. At the same time, the pre-treatment and post-treatment indicators did not statistically differ in comparison group.Conclusions. The results of the study show that the MonaLisaTouch method of laser fractional ablation of vaginal and vulva epithelium is highly effective compared with local hormonal therapy and can be recommended as a monotherapy for urogenital disorders and pelvic floor dysfunction.
Research objective: to determine the role and effectiveness of the proposed therapeutic and prophylactic complex in the correction of vaginal biocenosis disorders in the dynamics of pregnancy in pregnant women after assisted reproductive technologies (ART) to improve the tactics of antenatal observation and prevention of obstetric and perinatal complications.Materials and methods. 299 pregnant women were examined: the main group included 249 women with pregnancy after ART, the control group consisted of 50 pregnant women with spontaneous pregnancy.Therapeutic and prophylactic measures for pregnant women after ART included: micronized progesterone, magnesium oxide, folic acid, L-arginine aspartate, ω-3-polyunsaturated fatty acids, long-term psychological correction (on the eve of the ART program, at 8–10 weeks, 16–18 weeks and 28–30 weeks of pregnancy). The drug for antibiotic therapy for local sanitation of the genital tract was chosen taking into account the sensitivity to antibiotics of certain microbial associates and was prescribed for 7–10 days.At the second stage of sanitation of the genital tract probiotics were prescribed under the control of pH-metry to maintain the acidic environment of the vaginal contents, colonize the vagina and the vaginal part of the cervix with lactobacilli.Results. There was a significant decrease in the proportion of women with a large number of epithelial cells in the main groups, which are a sign of alterative inflammation, and this is coincides with a similar indicator in the control group. Women with moderate leukocyte count and mixed Gram-negative microflora prevailed in IB, IIB and IIIB subgroup, who received conventional therapy. There was no significant difference in IIIA and IIIB subgroups.In the vaginal biocenosis significantly increased the Lactobacillus spp. content against the background of probiotics with local and general action in ІА, ІІА and ІІІА subgroups. The average Lactobacillus spp. concentration was significantly different from the average indicators of subgroups receiving conventional therapy for vaginal sanitation, with a significant decrease in the biocenosis of aerobic and anaerobic microorganisms and Candida albicans, which indicates the effectiveness of the proposed two-stage treatment.Conclusions. The proposed improved two-stage sanitation of the genital tract with a selective probiotic against the background of long-term progesterone and magnesium support ensures the stabilization of the vaginal pH at the physiological level corresponding to the normocenosis, and contributes to a significant increase in Lactobacillus spp. within the physiological norm with a significant decrease of Candida albicans concentration in the biotope, as well as opportunistic pathogens of aerobic and anaerobic origin. This is provides conditions for the prolongation of pregnancy in women after ART treatment cycles.
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