Duranti F, Salti G, Bovani B, Calandra M, Rosati M L
Angio-Dermo-Surgery Center, University of Perugia School of Medicine, Italy.
Dermatol Surg. 1998 Dec;24(12):1317-25. doi: 10.1111/j.1524-4725.1998.tb00007.x.
Several biomaterials are available for the purpose of soft tissue augmentation, but none of them has all the properties of the ideal filler material. The recent development of hyaluronic acid gels for dermal implantation give the physician new possibilities of effective treatment in this field.
This study provides a clinical and histological evaluation of safety and efficacy of a cross-linked stabilized non-animal hyaluronic acid gel (Restylane, Q-Med, Uppsala, Sweden) to determine its characteristics, advantages, disadvantages, and side-effects.
158 patients were treated with facial intradermal implant of hyaluronic acid gel for augmentation therapy of wrinkles and folds, and for lip augmentation and/or recontouring. The results were evaluated in all patients by subjective judgement by the physician and the patient, and by photographic method at time 0 and after 1, 2, 4 and 8 months from the procedure. In addition, a smaller histological study was carried out in five volunteer patients for a term of 52 weeks to determine the interaction and duration of the material in human healthy skin.
Clinically, both the physicians' and patients' evaluations revealed very satisfactory results, with a global 78.5% and 73.4% respectively of moderate or marked improvement after eight months, independent of the treated area. The photographic evaluation revealed even better results with a 80.4% of moderate or marked improvement after 8 months. The safety evaluation showed a 12.5% of postoperative immediate adverse events, that were localized and transient. There was no evidence of major systemic side effects. Histologically, the product was shown to be long-lasting and well tolerated as judged by histological techniques.
Stabilized, non-animal, hyaluronic acid gel is well tolerated and effective in augmentation therapy of soft tissues of the face. This material presents several advantages in comparison to previously used injectable biomaterials and expands the arsenal of therapeutic tools in the field of soft tissue augmentation.
有几种生物材料可用于软组织填充，但它们都不完全具备理想填充材料的所有特性。用于真皮植入的透明质酸凝胶的最新进展为医生在该领域提供了新的有效治疗可能性。
本研究对一种交联稳定的非动物透明质酸凝胶（瑞蓝，Q-Med公司，瑞典乌普萨拉）的安全性和有效性进行临床和组织学评估，以确定其特性、优缺点及副作用。
158例患者接受了透明质酸凝胶面部皮内植入，用于皱纹和褶皱的填充治疗以及唇部填充和/或重塑。所有患者的结果通过医生和患者的主观判断以及在手术开始时、术后1、2、4和8个月时的摄影方法进行评估。此外，对5名志愿者患者进行了为期52周的较小规模组织学研究，以确定该材料在人类健康皮肤中的相互作用和持续时间。
临床上，医生和患者的评估均显示结果非常令人满意，8个月后分别有78.5%和73.4%的患者有中度或明显改善，与治疗部位无关。摄影评估显示结果更好，8个月后有80.4%的患者有中度或明显改善。安全性评估显示术后立即出现的不良事件发生率为12.5%，这些事件为局部且短暂性的。没有证据表明存在重大全身副作用。组织学上，根据组织学技术判断，该产品显示出持久且耐受性良好。
稳定的非动物透明质酸凝胶在面部软组织填充治疗中耐受性良好且有效。与先前使用的可注射生物材料相比，这种材料具有几个优点，并扩展了软组织填充领域的治疗工具库。
