Kubik Paweł, Gallo Daniela, Tanda Maria Laura, Jankau Jerzy, Rauso Raffaele, Gruszczyński Wojciech, Pawłowska Aleksandra, Chrapczyński Paweł, Malinowski Maciej, Grzanka Dariusz, Smolińska Marta, Antosik Paulina, Piesiaków Maria-Luiza, Łukasik Bartłomiej, Pawłowska-Kubik Agnieszka, Stabile Giorgio, Guida Stefania, Kodłubański Łukasz, Decates Tom, Zerbinati Nicola
K-LAB Badania i Rozwój, 81-312 Gdynia, Poland.
Endocrine Unit, Department of Medicine and Surgery, University of Insubria, ASST dei Sette Laghi, 21100 Varese, Italy.
Gels. 2023 May 26;9(6):440. doi: 10.3390/gels9060440.
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.
本研究的目的是测试交联有聚乙二醇并含有微粉化羟基磷灰石部分（Neauvia Stimulate）的透明质酸对桥本氏病患者局部组织和全身影响的作用，从长期安全性角度来看，这些影响至关重要。这种最常见的自身免疫性疾病是使用基于透明质酸的填充剂以及基于羟基磷灰石的生物刺激剂时经常提到的禁忌证。分析了组织病理学的广谱方面，以确定术前以及术后5天、21天和150天炎症浸润的关键特征。结果表明，与术前状态相比，该治疗对组织中炎症浸润强度的降低有统计学显著效果，同时抗原识别（CD4）和细胞毒性（CD8）T淋巴细胞的发生率也有所降低。完全基于统计学确定性表明，用Neauvia Stimulate治疗对这些抗体的水平没有影响。所有这些都与风险分析相符，即在观察期间未出现警示症状。对于桥本氏病患者，选择交联有聚乙二醇的透明质酸填充剂应被认为是合理且安全的。
