Razavian Elnaz, Tehrani Setareh
Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran.
Department of Dermatology, Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran.
Galen Med J. 2019 Jan 1;8:e1148. doi: 10.31661/gmj.v8i0.1148. eCollection 2019.
The 33-mg/mL hyaluronic acid (HA) formulation is a highly concentrated, cross-linked, cohesive, smooth, and completely reversible volumizing filler approved by Conformité Européene. For the first time, we aimed to evaluate the long-term efficacy and safety of the 33- mg/mL HA filler for soft tissue augmentation in the treatment of facial wrinkles.
After optimal wrinkle correction was achieved in the patients undergoing treatment by injecting the 33-mg/mL HA filler at the injection site plus one touch-up at a 2-week interval, the safety and efficacy of the filler were assessed on the 5-point Facial Volume Loss Scale through the 1-year study period. Patients were evaluated daily for 14 days and after 6 and 12 months post-treatment.
A total of 86 subjects were treated. The mean wrinkle scores of the patients were 3.95+0.79 (range of 3-5) before treatment, 2.3+0.94 (range 1-5) six months after treatment, and 2.93+1.29 (range of 1-5) one year after treatment. Clinically significant mean wrinkle correction (P=0.001) was still evident at>12 months of treatment through 33-mg/ mL HA formulation. A clinically significant correction at>12 months after treatment was maintained by 79% of patients. Nodule formation and swelling were more frequent when the 33- mg/mL HA filler was used compared with the use of less concentrated HA fillers. One patient developed angioedema-like swelling and induration last few months.
The 33-mg/ mL HA filler can provide long-term correction lasting for one year or more. Adverse effects, especially swelling and nodule formation were more common in this filler compared with less concentrated HA fillers. The side effects were correlated with the volume of the injected filler. We recommend using this concentration with low volume or combining high volume with lower concentration.
33毫克/毫升透明质酸（HA）制剂是一种高浓度、交联、粘性、光滑且完全可逆的填充剂，已获得欧洲符合性认证。我们首次旨在评估33毫克/毫升HA填充剂用于软组织填充治疗面部皱纹的长期疗效和安全性。
通过在注射部位注射33毫克/毫升HA填充剂并每隔2周进行一次补打，对接受治疗的患者实现最佳皱纹矫正后，在为期1年的研究期间，通过5分面部容积丧失量表评估填充剂的安全性和疗效。患者在治疗后14天内每天接受评估，并在治疗后6个月和12个月进行评估。
共治疗86名受试者。患者治疗前的平均皱纹评分为3.95±0.79（范围为3 - 5），治疗后6个月为2.3±0.94（范围为1 - 5），治疗后1年为2.93±1.29（范围为1 - 5）。通过33毫克/毫升HA制剂治疗超过12个月时，仍有明显的临床显著平均皱纹矫正（P = 0.001）。79%的患者在治疗后超过12个月维持了临床显著矫正。与使用浓度较低的HA填充剂相比，使用33毫克/毫升HA填充剂时结节形成和肿胀更为频繁。1名患者在最后几个月出现血管性水肿样肿胀和硬结。
33毫克/毫升HA填充剂可提供持续一年或更长时间的长期矫正。与浓度较低的HA填充剂相比，这种填充剂的不良反应，尤其是肿胀和结节形成更为常见。副作用与注射填充剂的体积相关。我们建议使用低体积的这种浓度或高体积与低浓度相结合。
