Injectable hyaluronic acid gel for soft tissue augmentation - A clinical and histological study
Injectable hyaluronic acid gel for soft tissue augmentation - A clinical and histological study
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DOI：
10.1111/j.1524-4725.1998.tb00007.x
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发表时间：
1998-12-01
影响因子：
2.4
通讯作者：
Rosati, ML
中科院分区：
文献类型：
--
作者：
Duranti, F;Salti, G;Rosati, ML
背景有几种生物材料可用于软组织填充，但没有一种具有理想填充材料的所有特性。最近开发的透明质酸凝胶真皮植入给医生neu，可能性的有效治疗在这一领域。本研究提供了一种交联稳定的非动物透明质酸凝胶（Restylane，Q-Med，Uppsala，Sweden）的安全性和有效性的临床和组织学评价，以确定其特征、优点、缺点和副作用。对158例面部皱纹、丰唇、丰唇患者采用透明质酸凝胶皮内植入治疗。所有患者的结果由医生针对患者的主观判断进行评价，并在手术后0和1，2，4和8个月时通过摄影方法进行评价。此外，在5名志愿者患者中进行了为期52周的较小的组织学研究，以确定材料与人类健康皮肤的相互作用和持续时间。在临床上，医生和患者的评估均显示非常满意的结果，8个月后，无论治疗部位如何，总体上分别有78.5%和73.4%的患者中度或显著改善。摄影评估显示效果更好，8个月后中度或显着改善率为80.4%。安全性评价显示12.5%的术后即刻不良事件为局部和一过性。没有证据表明存在严重的全身正弦效应。组织学上，该产品被证明是持久和良好的耐受性，通过组织学技术判断。稳定的非动物透明质酸凝胶耐受性良好，可有效用于面部软组织的隆乳治疗。与以前使用的可注射生物材料相比，这种材料具有几个优点，并扩展了软组织增强领域的治疗工具库。(C)1998年由美国皮肤外科学会
BACKGROUND. 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 neu, possibilities of effective treatment in this field.OBJECTIVE. This study provides a clinical and histological evaluation of safety and efficacy of a cross-linked stabilized nonanimal hyaluronic acid gel (Restylane, Q-Med, Uppsala, Sweden) to determine its characteristics, advantages, disadvantages, and side-effects.METHODS. 158 patients were treated with facial intradermal implant of hyaluronic acid gel for augmentation therapy of wrinkles and folks, and for lip augmentation and/or recontouring. The results were evaluated in all patients by subjective judgement by the physician aim 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 ill human healthy skin.RESULTS. 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 sine effects. Histologically, the product was shown to be long-lasting and well tolerated as judged by histological techniques.CONCLUSIONS. 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. (C) 1998 by the American Society for Dermatologic Surgery Inc.