Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.
Scar Laser and Plastic Surgery Center, Yonsei Cancer Hospital, Yonsei University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2022 Feb 7;37(5):e37. doi: 10.3346/jkms.2022.37.e37.
Human immunodeficiency virus (HIV)-associated facial lipoatrophy (FLA) is a stigmatizing side effect associated with the use of highly active antiretroviral therapy. We sought to evaluate the safety and efficacy of the hyaluronic acid filler mixed with micronized cross-linked acellular dermal matrix (HA/MADM) in HIV-associated FLA.
We conducted an open-label safety and efficacy study in patients with HIV-associated FLA. Fourteen patients received single injection of the HA/MADM, and 13 patients completed the 24-week follow-up evaluation. Treatment efficacy, safety, and patient and physician satisfaction were evaluated. Repeated measure analysis of variance with post-hoc analysis with the Wilcoxon signed rank test was performed to compare and incorporate parameters at each time point.
All 13 patients maintained a significant improvement of the Carruthers Lipoatrophy Severity Scale grade throughout the study period, along with improvement of the depressed volume due to lipoatrophy measured using a three-dimensional camera system. More than 80% of patients and physicians were satisfied with the treatment, and no treatment-related adverse events were reported, except for one case of transient subcutaneous nodule formation.
Our study findings suggest that injectable HA/MADM is a potentially effective and safe treatment option for treating HIV-positive patients with FLA.
人类免疫缺陷病毒（HIV）相关面部脂肪萎缩（FLA）是一种与使用高效抗逆转录病毒疗法相关的具有耻辱性的副作用。我们旨在评估透明质酸填充剂与微交联去细胞真皮基质（HA/MADM）混合制剂治疗 HIV 相关 FLA 的安全性和有效性。
我们开展了一项针对 HIV 相关 FLA 患者的开放性标签安全性和有效性研究。14 名患者接受了 HA/MADM 的单次注射，其中 13 名患者完成了 24 周的随访评估。评估了治疗的有效性、安全性以及患者和医生的满意度。采用重复测量方差分析和 Wilcoxon 符号秩检验的事后分析比较和纳入每个时间点的参数。
所有 13 名患者在整个研究期间均保持了 Caruthers 脂肪萎缩严重程度量表评分的显著改善，同时也改善了三维摄像系统测量的因脂肪萎缩而导致的凹陷容积。超过 80%的患者和医生对治疗表示满意，除了 1 例短暂性皮下结节形成外，没有报告与治疗相关的不良事件。
我们的研究结果表明，注射用 HA/MADM 是一种治疗 HIV 阳性 FLA 患者的潜在有效且安全的治疗选择。
