Результаты исследований: Научные публикации в периодических изданиях › статья › Рецензирование
Changes in the clinical symptoms of fibrocystic mastopathy during monotherapy with transdermal micronized progesterone : Results of the breast-2 multicenter open prospective cohort study. / Protasova, A. E.
в: Akusherstvo i Ginekologiya (Russian Federation), Том 2020, № 8, 2020, стр. 159-168.Результаты исследований: Научные публикации в периодических изданиях › статья › Рецензирование
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TY - JOUR
T1 - Changes in the clinical symptoms of fibrocystic mastopathy during monotherapy with transdermal micronized progesterone
T2 - Results of the breast-2 multicenter open prospective cohort study
AU - Protasova, A. E.
N1 - Publisher Copyright: © Protasova A.E., 2020. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020
Y1 - 2020
N2 - Objective. To investigate the efficiency and safety of monotherapy with the transdermal micronized progesterone Progestogel for diffuse fibrocystic mastopathy. Materials and methods. The observational study enrolled 722 patients aged 37.1±0.3 years with preserved menstrual function and diagnosed diffuse fibrocystic mastopathy. The observation period consisted of a continuous medication usage period about 3 months (3 cycles), or, if necessary, a second course of as many as 6 months (6 cycles). The main criterion for the efficiency of the therapy was to estimate the number of masses, as evidenced by ultrasonography. During the study, the investigators made breast ultrasound and radiographic examinations, Breast Imaging-Reporting and Data System (BI-RADS) assessment, recorded pain intensity with a visual analogue scale (VAS), and assessed a patient’s health status according to the Clinical Global Impression Scale (CGI). Results. The clinical breast assessment throughout the investigation, by using the main efficiency criterion showed a decrease in the average number of masses in one patient during the treatment: 5.09±0.15 (before treatment), 2.97±0.13 (after 3-month therapy), and 2.29±0.16 (after 6-month therapy), (p < 0.001). There was a significant reduction in the signs of the disease, as assessed by ultrasonography of mass sizes (p <0.001). The changes in the breast detected by its clinical examination and mammography showed statistically significantly better BI-RADS scores (p < 0.001). Pain syndrome intensity assessment using the VAS demonstrated a significant decrease: 47.5±0.8 (before treatment), 13.5±0.6 (following 3 months), and 7.7 ± 0.8 (following 6 months) (p <0.001). Conclusion. The investigation provided evidence for the sufficient efficacy and safety profile of Progestogel monotherapy for fibrocystic mastopathy.
AB - Objective. To investigate the efficiency and safety of monotherapy with the transdermal micronized progesterone Progestogel for diffuse fibrocystic mastopathy. Materials and methods. The observational study enrolled 722 patients aged 37.1±0.3 years with preserved menstrual function and diagnosed diffuse fibrocystic mastopathy. The observation period consisted of a continuous medication usage period about 3 months (3 cycles), or, if necessary, a second course of as many as 6 months (6 cycles). The main criterion for the efficiency of the therapy was to estimate the number of masses, as evidenced by ultrasonography. During the study, the investigators made breast ultrasound and radiographic examinations, Breast Imaging-Reporting and Data System (BI-RADS) assessment, recorded pain intensity with a visual analogue scale (VAS), and assessed a patient’s health status according to the Clinical Global Impression Scale (CGI). Results. The clinical breast assessment throughout the investigation, by using the main efficiency criterion showed a decrease in the average number of masses in one patient during the treatment: 5.09±0.15 (before treatment), 2.97±0.13 (after 3-month therapy), and 2.29±0.16 (after 6-month therapy), (p < 0.001). There was a significant reduction in the signs of the disease, as assessed by ultrasonography of mass sizes (p <0.001). The changes in the breast detected by its clinical examination and mammography showed statistically significantly better BI-RADS scores (p < 0.001). Pain syndrome intensity assessment using the VAS demonstrated a significant decrease: 47.5±0.8 (before treatment), 13.5±0.6 (following 3 months), and 7.7 ± 0.8 (following 6 months) (p <0.001). Conclusion. The investigation provided evidence for the sufficient efficacy and safety profile of Progestogel monotherapy for fibrocystic mastopathy.
KW - Fibrocystic mastopathy
KW - Mastalgia
KW - Mastodynia
KW - Micronized progesterone
KW - Progestogel
UR - http://www.scopus.com/inward/record.url?scp=85094180569&partnerID=8YFLogxK
U2 - 10.18565/aig.2020.8.159-168
DO - 10.18565/aig.2020.8.159-168
M3 - Article
AN - SCOPUS:85094180569
VL - 2020
SP - 159
EP - 168
JO - АКУШЕРСТВО И ГИНЕКОЛОГИЯ
JF - АКУШЕРСТВО И ГИНЕКОЛОГИЯ
SN - 0300-9092
IS - 8
ER -
ID: 76490365