TY - JOUR
T1 - Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records
AU - Kubik, Paweł
AU - Gallo, Daniela
AU - Tanda, Maria Laura
AU - Jankau, Jerzy
AU - Rauso, Raffaele
AU - Gruszczyński, Wojciech
AU - Pawłowska, Aleksandra
AU - Chrapczyński, Paweł
AU - Malinowski, Maciej
AU - Grzanka, Dariusz
AU - Smolińska, Marta
AU - Antosik, Paulina
AU - Piesiaków, Maria Luiza
AU - Łukasik, Bartłomiej
AU - Pawłowska-Kubik, Agnieszka
AU - Stabile, Giorgio
AU - Guida, Stefania
AU - Kodłubański, Łukasz
AU - Decates, Tom
AU - Zerbinati, Nicola
N1 - Publisher Copyright: © 2023 by the authors.
PY - 2023/6
Y1 - 2023/6
N2 - The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto’s disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto’s disease.
AB - The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto’s disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto’s disease.
UR - http://www.scopus.com/inward/record.url?scp=85163776539&partnerID=8YFLogxK
U2 - 10.3390/gels9060440
DO - 10.3390/gels9060440
M3 - Article
C2 - 37367111
AN - SCOPUS:85163776539
SN - 2310-2861
VL - 9
JO - Gels
JF - Gels
IS - 6
M1 - 440
ER -