用于非手术鼻整形的实验性混合聚合物-透明质酸填充剂的短期疗效：一项非对照初步研究

文献信息

中文摘要

背景： 使用透明质酸填充剂的非手术鼻整形可对选定的鼻部轮廓不规则进行微创矫正。结合可生物降解聚合物微球的混合制剂已被开发用于提供即时容积矫正以及额外的结构支撑；然而，关于这些制剂的临床证据仍然有限。
目的： 评估一种含有交联透明质酸、聚己内酯和聚乳酸微球的实验性混合填充剂相关的短期安全性、耐受性、初步美学效果和患者满意度。
方法： 这项前瞻性、单中心、非对照初步研究纳入了150名接受非手术鼻整形的成年人。参与者在基线、第2天、第2周、第1个月和第3个月接受评估。结局包括治疗中出现的不良事件、整体美学改善量表评分、患者满意度、鼻尖突出度、鼻背高度和操作特征。
结果： 在第1个月时，86.7%的参与者观察到GAIS评分为改善或显著改善，第3个月时为83.3%。第1个月时90.0%的参与者报告满意度评分为4-5分，第3个月时为86.7%。70.0%的参与者鼻尖突出度增加超过1.5 mm，而63.3%的参与者鼻背高度增加超过2.0 mm。轻度事件包括一过性红斑3.3%、轻微瘀伤13.3%以及注射部位疼痛VAS评分大于5分10.0%。在三个月的随访期间，未观察到严重或需要治疗的不良事件、血管损害、皮肤坏死、视觉障碍、感染、肉芽肿、迟发性炎症反应或填充剂迁移。
结论： 该实验性制剂在非对照初步研究环境中表现出良好的短期耐受性和早期美学改善。这些发现并未确立比较有效性、长期持久性、组织整合或长期生物相容性。需要进行延长随访的对照研究。

英文摘要

BACKGROUND: Nonsurgical rhinoplasty using hyaluronic acid fillers provides minimally invasive correction of selected nasal contour irregularities. Hybrid formulations incorporating biodegradable polymeric microspheres have been developed to provide immediate volumetric correction together with additional structural support; however, clinical evidence regarding these formulations remains limited.
OBJECTIVE: To evaluate the short-term safety, tolerability, preliminary aesthetic effectiveness, and patient satisfaction associated with an investigational hybrid filler containing cross-linked hyaluronic acid, polycaprolactone, and polylactic acid microspheres.
METHODS: This prospective, single-center, uncontrolled pilot study included 150 adults undergoing nonsurgical rhinoplasty. Participants were assessed at baseline, Day 2, Week 2, Month 1, and Month 3. Outcomes included treatment-emergent adverse events, Global Aesthetic Improvement Scale ratings, patient satisfaction, nasal tip projection, dorsal height, and procedural characteristics.
RESULTS: Improved or Very Improved GAIS ratings were observed in 86.7% of participants at Month 1 and 83.3% at Month 3. Satisfaction scores of 4-5 were reported by 90.0% at Month 1 and 86.7% at Month 3. Tip projection increased by more than 1.5 mm in 70.0%, while dorsal height increased by more than 2.0 mm in 63.3%. Mild events included transient erythema in 3.3%, minor bruising in 13.3%, and injection-site pain with a VAS score greater than 5 in 10.0%. No serious or treatment-requiring adverse event, vascular compromise, skin necrosis, visual disturbance, infection, granuloma, delayed inflammatory reaction, or filler migration was observed during three months of follow-up.
CONCLUSION: The investigational formulation demonstrated favorable short-term tolerability and early aesthetic improvement in an uncontrolled pilot setting. These findings do not establish comparative effectiveness, long-term durability, tissue integration, or long-term biocompatibility. Controlled studies with extended follow-up are required.