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EN
Myomas are a common cause of infertility and miscarriages. Their pathogenesis is muftifactorial. It includes sex-hormones and their receptors, change of expression of cytokines and growth factors as well as epigenetics. Sex-hormones, mainly estrogens, play a key role in the development of myomas, which can be observed by their development in the fertility period and their regression during menopause. Other research has shown that myomas can be hereditary. The clinical symptoms of myomas vary depending on their localization and size. Submucosal myomas may cause massive menstrual bleeding and may be the cause of anemia. Enlarged myomas can be the source of pain and pressure symptoms within the pelvis; they may also be responsible for infertility and miscarriages. There are many options for the treatment of myomas – uterine artery embolization, operative myomectomy or pharmacological treatment (gonadoliberin analogues, anti-estrogens and antiprogestagens). With more treatment options available, clinical decisions are harder. A new drug – ulipristal acetate – has been registered for the preoperative treatment of uterine fibroids. It is already present in more than 30 countries, registered as Esmya, Inisia or Fibristal. The first reports of pregnancies after using this drug have been described. The article presents a case of a 30-year-old woman, gravida 0, para 0, who was admitted for myomectomy. A three-month Esmya treatment was administered followed by a successful myomectomy – we present the results of this treatment.
PL
Mięśniaki są jedną z najczęstszych przyczyn niepłodności i poronień. Z patogenezą tych łagodnych nowotworów wiąże się wiele czynników – przede wszystkim hormony płciowe i ich receptory, zmiany ekspresji pewnych cytokin i czynników wzrostu oraz czynniki genetyczne. Hormony płciowe, zwłaszcza estrogeny, odgrywają kluczową rolę w rozwoju mięśniaków, o czym świadczy ich rozwój w okresie rozrodczym kobiet i regresja w menopauzie. Inne badania wykazały, że mięśniaki mogą być dziedziczne. Objawy kliniczne są różne, zależą od lokalizacji i rozmiaru guza. Mięśniaki podśluzówkowe mogą powodować masywne krwawienia miesiączkowe i być przyczyną niedokrwistości, zaś powiększone mięśniaki bywają źródłem bólu i uczucia ucisku w obrębie miednicy. Istnieje wiele możliwości leczenia mięśniaków: embolizacja tętnic macicznych, zabieg miomektomii, leczenie farmakologiczne (analogi gonadoliberyny, antyestrogeny i antyprogestageny). Ze względu na rosnącą liczbę opcji terapeutycznych decyzje kliniczne dotyczące rodzaju leczenia stają się coraz trudniejsze. Octan uliprystalu został zarejestrowany w leczeniu przedoperacyjnym mięśniaków macicy. Jest już dostępny w ponad 30 krajach, występuje pod nazwami Esmya, Inisia czy Fibristal. Opublikowano pierwsze doniesienia o porodach po leczeniu tą nową substancją. W artykule przedstawiono przypadek 30-letniej nieródki, u której po trzymiesięcznym leczeniu octanem uliprystalu udało się wykonać całkowitą miomektomię.
EN
The aim of the project, carried out within the Polish Society for Pharmacoeconomics (PTFE), was to estimate the potential costs of treatment of the side effects which (theoretically) may occur as a result of treatments for the selected diseases. This paper deals solely with dermatology related events. Herein, several Drug Programs financed by the National Health Fund in Poland, in 2012, were analyzed. The adverse events were selected based on the Summary of Product Characteristics of the chosen products. We focused the project on those potential adverse events which were defined in SPC as frequent and very frequent. The results are presented according to their therapeutic areas, and in this paper, the focus is upon that which is related to dermatology. The events described as ‘very common’ had an incidence of ≥ 1/10, and that which is ‘common’ - ≥ 1/100, <1 /10. In order to identify the resources used, we, with the engagement of clinical experts, performed a survey. In our work, we employed only the total direct costs incurred by the public payer, based on valid individual cost data in February 2014. Moreover, we calculated the total spending from the public payer’s perspective, as well as the patient’s perspective, and the percentage of each component of the total cost in detail. The paper, thus, informs the reader of the estimated costs of treatment of side effects related to the dermatologic symptoms and reactions. Based on our work, we can state that the treatment of skin adverse drug reactions generates a significant cost - one incurred by both the public payer and the patient.
EN
The project was performed within the Polish Society for Pharmacoeconomics (PTFE). The objective was to estimate the potential costs of treatment of side effects, which theoretically may occur as a result of treatment of selected diseases. We analyzed the Drug Programs financed by National Health Fund in Poland in 2012 and for the first analysis we selected those Programs where the same medicinal products were used. We based the adverse events selection on the Summary of Product Characteristics of the chosen products. We extracted all the potential adverse events defined as frequent and very frequent, grouping them according to therapeutic areas. This paper is related to the results in the pulmonology area. The events described as very common had an incidence of ≥ 1/10, and the common ones ≥ 1/100, <1/10. In order to identify the resources used, we performed a survey with the engagement of clinical experts. On the basis of the collected data we allocated direct costs incurred by the public payer. We used the costs valid in December 2013. The paper presents the estimated costs of treatment of side effects related to the pulmonology disease area. Taking into account the costs incurred by the NHF and the patient separately e calculated the total spending and the percentage of each component cost in detail. The treatment of adverse drug reactions generates a significant cost incurred by both the public payer and the patient.
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