Dermal Fillers

真皮填料
  • 文章类型: Journal Article
    可注射的皮肤填充物为皮肤抗衰老和面部嫩肤提供了更广泛的选择。PLLA微球作为可降解和持久的填料越来越受欢迎。本研究仅关注PLLA对真皮胶原蛋白的影响。没有调查它对表皮的影响。在这项研究中,我们研究了PLLA微球对表皮干细胞(EpiSCs)的影响。
    通过体外培养不同浓度的PLLA微球对表皮干细胞(EpiSCs)的作用,原代大鼠EpiSCs的鉴定。CCK-8检测,凋亡染色,流式细胞术,Transwell分析,伤口愈合试验,q-PCR分析,免疫荧光染色检测PLLA对EpiSCs的影响。此外,我们观察到通过体内将PLLA注射到大鼠皮肤的真皮中对表皮的影响。
    PLLA微球促进细胞增殖和迁移,同时延缓细胞衰老并保持其干性。体外,大鼠背部皮肤皮内注射PLLA微球导致延缓衰老,随访2、4和12周皮肤的组织学和免疫组织化学染色证明了这一点。
    这项研究表明PLLA对大鼠表皮和EpiSCs的积极作用,同时为PLLA的抗衰老机制提供了新的见解。
    UNASSIGNED: Injectable skin fillers offer a wider range of options for cutaneous anti-aging and facial rejuvenation. PLLA microspheres are increasingly favored as degradable and long-lasting fillers. The present study focused solely on the effect of PLLA on dermal collagen, without investigating its impact on the epidermis. In this study, we investigated the effects of PLLA microspheres on epidermal stem cells (EpiSCs).
    UNASSIGNED: Different concentrations of PLLA microspheres on epidermal stem cells (EpiSCs) in vitro through culture, and identification of primary rat EpiSCs. CCK-8 detection, apoptosis staining, flow cytometry, Transwell assay, wound healing assay, q-PCR analysis, and immunofluorescence staining were used to detect the effects of PLLA on EpiSCs. Furthermore, we observed the effect on the epidermis by injecting PLLA into the dermis of the rat skin in vivo.
    UNASSIGNED: PLLA microspheres promote cell proliferation and migration while delaying cell senescence and maintaining its stemness. In vitro, Intradermal injection of PLLA microspheres in the rat back skin resulted in delayed aging, as evidenced by histological and immunohistochemical staining of the skin at 2, 4, and 12 weeks of follow-up.
    UNASSIGNED: This study showed the positive effects of PLLA on rat epidermis and EpiSCs, while providing novel insights into the anti-aging mechanism of PLLA.
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  • 文章类型: Journal Article
    棒状甲壳素纳米晶体(ChNC)的有希望的应用之一是用作颗粒乳化剂来开发Pickering乳液。我们报道了一种ChNC稳定的水包油乳液系统,并开发了Pickering乳液模板法制备聚乳酸(PLA)中空微球。结果表明,未改性的ChNCs和乙酰化的ChNCs均能很好地乳化聚乳酸在甘露醇水溶液中的二氯甲烷(DCM)溶液。形成非常稳定的乳液。在相同的油水比和ChNC负载下,乳液稳定性随着ChNCs乙酰化水平的增加而提高,伴随着液滴大小的减小。通过溶剂蒸发,PLA中空微球模板化成功,表面结构也强烈依赖于ChNC的乙酰化水平。在低水平的乙酰化下,形成的单孔或多孔表面结构,这归因于溶剂萃取和蒸发引起的DCM的外扩散。这些表面缺陷随着ChNC乙酰化水平的增加而减少。此外,所得PLA微球的水悬浮液显示出剪切稀化性质和良好的生物相容性,因此作为可注射填料具有很好的应用前景。这项工作可以通过调节ChNC的乙酰化水平来调节Pickering乳液模板化聚合物中空微球的表面结构,从而提供有用的信息。
    One of the promising applications of rod-like chitin nanocrystals (ChNCs) is the use as particle emulsifier to develop Pickering emulsions. We reported a ChNC-stabilized oil-in-water emulsion system, and developed a Pickering emulsion-templated method to prepare polylactide (PLA) hollow microspheres here. The results showed that both non-modified ChNCs and acetylated ChNCs could well emulsify the dichloromethane (DCM) solution of PLA-in-aqueous mannitol solution systems, forming very stable emulsions. At the same oil-to-water ratios and ChNC loadings, the emulsion stability was improved with increasing acetylation levels of ChNCs, accompanied by reduced size of droplets. Through the solvent evaporation, the PLA hollow microspheres were templated successfully, and the surface structure was also strongly dependent on the acetylation level of ChNCs. At a low level of acetylation, the single-hole or multi-hole surface structure formed, which was attributed to the out-diffusion of DCM caused by the solvent extraction and evaporation. These surface defects decreased with increased acetylation levels of ChNCs. Moreover, the aqueous suspension with as-obtained PLA microspheres revealed shear-thinning property and good biocompatibility, thereby had promising application as injectable fillers. This work can provide useful information around tuning surface structures of the Pickering emulsion-templated polymer hollow microspheres by regulating acetylation level of ChNCs.
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  • 文章类型: Journal Article
    背景:近年来,软组织材料已被用作前额填充物。在某些情况下,一些填充材料需要及时移除或重新填充;因此,重要的是开发一种方法来识别填充材料的位置和类型。本研究总结了不同充填材料在高频超声下的影像学表现,为临床治疗提供参考。
    方法:我们筛选了2015年4月至2023年7月在中国医学科学院整形外科医院进行的面部超声图像,并对额叶填充材料的类型及其成像结果进行了分类和总结。
    结果:本研究包括114例患者的超声成像结果,包括39个透明质酸(HA)填充,45用聚丙烯酰胺水凝胶(PAG)填充,14人接受自体脂肪移植,2人接受了假体植入,2名同时接受HA和PAG填充的人,和12个接受硅油填充的人。HA主要表现为超声检查的消声区,图像可分为四种类型。PAG主要表现为细小的点状回声,可分为五种类型。脂肪移植表现为低回声区,密度不均,可分为五种类型。最后,硅油填充材料在额头上出现云状高回声,可见于整个皮肤层,深部组织成像不清楚。
    结论:高频超声是评估额头填充材料类型和位置的一种安全可靠的方法,可以很容易地应用于临床实践。
    方法:本期刊要求作者为每篇文章分配一定程度的证据。对于这些循证医学评级的完整描述,请参阅目录或在线作者说明www。springer.com/00266.
    BACKGROUND: In recent years, soft tissue materials have been applied as forehead fillers. Some filling materials need to be removed or refilled in a timely manner in certain situations; therefore, it is important to develop a method to identify the location and type of filling materials. This study summarizes the imaging findings of different filling materials under high-frequency ultrasound, providing a reference for clinical treatment.
    METHODS: We screened facial ultrasound images performed at the Plastic Surgery Hospital of the Chinese Academy of Medical Sciences from April 2015 to July 2023 and classified and summarized the types of frontal filling materials and their imaging results.
    RESULTS: This study included ultrasound imaging results from 114 patients, including 39 with hyaluronic acid (HA) filling, 45 with polyacrylamide hydrogel (PAG) filling, 14 who received autologous fat transplantation, 2 who received prosthesis implantation, 2 who received both HA and PAG filling, and 12 who received silicone oil filling. HA mainly manifests as an anechoic zone on ultrasonography, with images divisible into four types. PAG primarily presents as fine punctate echoes, divisible into five types. Fat transplantation presents as a low-echo area with uneven density, divisible into five types. Finally, the silicone oil-filling material appears as a cloud-like high echo on the forehead, visible throughout the entire skin layer, and unclear imaging in deep tissues.
    CONCLUSIONS: High-frequency ultrasound is a safe and reliable method to evaluate the type and position of forehead filling materials, which can be easily applied in clinical practice.
    METHODS: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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  • 文章类型: Journal Article
    烟酰胺(或烟酰胺)是在哺乳动物细胞中具有基本代谢功能的小分子水溶性维生素。烟酰胺已成为各种护肤品和化妆品中的关键功能成分。这种维生素在NAD+合成中起着关键作用,特别有助于皮肤细胞的氧化还原反应和能量产生。通过多样化的生化机制,还已知烟酰胺影响人类DNA修复和细胞应激反应。基于几十年来在化妆品中的安全使用,烟酰胺最近作为一种活性成分获得了广泛的欢迎,它符合护肤品中的“Kligman标准”。从治疗的角度来看,烟酰胺的内在特性可用于治疗寻常痤疮,黄褐斑,牛皮癣。从药妆学的角度来看,烟酰胺已被广泛用作多用途抗衰老成分。其中,它被证明显著降低皮肤氧化应激,炎症,和色素沉着。总的来说,通过多式联运机制,烟酰胺可部分预防和/或逆转与皮肤老化相关的多种生物物理变化。本叙事综述提供了对烟酰胺治疗和美容功能机制的多因素见解。该成分在护肤品中不断发展的作用得到了严格评估,强烈关注起作用的生化机制。最后,我们前瞻性地探索了烟酰胺在皮肤填充剂和替代注射制剂中的新适应症和潜在应用。
    Niacinamide (or nicotinamide) is a small-molecule hydrosoluble vitamin with essential metabolic functions in mammalian cells. Niacinamide has become a key functional ingredient in diverse skincare products and cosmetics. This vitamin plays a pivotal role in NAD+ synthesis, notably contributing to redox reactions and energy production in cutaneous cells. Via diversified biochemical mechanisms, niacinamide is also known to influence human DNA repair and cellular stress responses. Based on decades of safe use in cosmetics, niacinamide recently gained widespread popularity as an active ingredient which aligns with the \"Kligman standards\" in skincare. From a therapeutic standpoint, the intrinsic properties of niacinamide may be applied to managing acne vulgaris, melasma, and psoriasis. From a cosmeceutical standpoint, niacinamide has been widely leveraged as a multipurpose antiaging ingredient. Therein, it was shown to significantly reduce cutaneous oxidative stress, inflammation, and pigmentation. Overall, through multimodal mechanisms, niacinamide may be considered to partially prevent and/or reverse several biophysical changes associated with skin aging. The present narrative review provides multifactorial insights into the mechanisms of niacinamide\'s therapeutic and cosmeceutical functions. The ingredient\'s evolving role in skincare was critically appraised, with a strong focus on the biochemical mechanisms at play. Finally, novel indications and potential applications of niacinamide in dermal fillers and alternative injectable formulations were prospectively explored.
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  • 文章类型: Journal Article
    真皮填充剂可注射性是医学美容专业人员采用商业产品和成功的临床施用的关键因素。我们先前已经报道了(体外和离体)基于交联透明质酸(HA)的真皮填充剂在手动和自动可注射性要求方面的基准。为了进一步增强面向功能的产品表征工作流程和真皮填充剂可注射性评估的临床相关性,本研究的目的是进行体内评估.因此,MaiLi®产品系列(OxiFree™技术)的几种变体在体外和体内的可注射性属性方面进行了表征,重点是水凝胶系统的均匀性和易于注射。首先,在SimSkin®皮肤等效物中进行标准化的体外测定,随着临床注射器的变化,注射部位,注射技术。然后,在质地分析装置中比较地进行了SimSkin®皮肤等效物中的自动注射,以获得细粒度注射力曲线结果.最后,招募了五名女性参与者参与研究的体内研究(病例报告),随着临床注射器的变化,注射部位,注射技术。一般来说,从平移的角度对获得的定量力值和注射力曲线进行了严格评估,基于围绕OxiFree™制造技术的讨论和使用中的专业临床医生反馈。总的来说,本研究概述了MaiLi®产品系列在可注射性属性方面的显著同质性,以及医疗美容临床医生一贯高度的管理。
    Dermal filler injectability is a critical factor for commercial product adoption by medical aesthetic professionals and for successful clinical administration. We have previously reported (in vitro and ex vivo) cross-linked hyaluronic acid (HA)-based dermal filler benchmarking in terms of manual and automated injectability requirements. To further enhance the function-oriented product characterization workflows and the clinical relevance of dermal filler injectability assessments, the aim of this study was to perform in vivo evaluations. Therefore, several variants of the MaiLi® product range (OxiFree™ technology) were characterized in vitro and in vivo in terms of injectability attributes, with a focus on hydrogel system homogeneity and ease of injection. Firstly, standardized in vitro assays were performed in SimSkin® cutaneous equivalents, with variations of the clinical injector, injection site, and injection technique. Then, automated injections in SimSkin® cutaneous equivalents were comparatively performed in a texture analysis setup to obtain fine-granulometry injection force profile results. Finally, five female participants were recruited for the in vivo arm of the study (case reports), with variations of the clinical injector, injection site, and injection technique. Generally, the obtained quantitative force values and injection force profiles were critically appraised from a translational viewpoint, based on discussions around the OxiFree™ manufacturing technology and on in-use specialized clinician feedback. Overall, the present study outlined a notable level of homogeneity across the MaiLi® product range in terms of injectability attributes, as well as consistently high ease of administration by medical aesthetic clinicians.
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  • 文章类型: Review
    肉芽肿形成是由皮肤填充剂的注射引起的罕见且持续的皮肤炎症状况。这种反应的确切原因尚不清楚,但它可能与刺激成分或免疫功能异常有关。治疗肉芽肿可能很困难。然而,最近的研究表明,Janus激酶(JAK)抑制剂有望成为难治性肉芽肿疾病的潜在治疗方法。
    目的是评估托法替尼治疗填充剂注射继发肉芽肿的疗效和安全性,并讨论和总结可能的机制。
    本研究的重点是3例接受填充剂注射后出现肉芽肿形成并随后接受托法替尼治疗的患者。使用诸如照片和监测任何不良反应的参数来评估治疗的有效性和安全性。此外,本研究进行了文献综述,以探讨托法替尼的潜在作用和潜在作用.
    所有三例病例均通过超标签使用口服托法替尼,从肿胀和结节中恢复,无副作用。现有的数据综述揭示了一些治疗皮肤肉芽肿性疾病的方法,如抑制巨噬细胞活化和下调JAK-STAT通路。
    本报告强调了JAK抑制剂在治疗由填充剂注射引起的肉芽肿中的有效性。在了解肉芽肿反应的潜在机制方面的最新进展为JAK抑制剂被视为有希望的治疗选择铺平了道路。然而,需要进一步的研究来全面评估托法替尼治疗肉芽肿的安全性和长期有效性.
    UNASSIGNED: Granuloma formation is an uncommon and persistent skin inflammatory condition caused by the injection of dermal fillers. The exact cause of this reaction is not well understood, but it may be associated with irritating components or abnormal immune function. Treating granulomas can be difficult. However, recent research has shown that Janus kinase (JAK) inhibitors hold promise as a potential therapy for refractory granulomatous diseases.
    UNASSIGNED: The aim was to evaluate the efficacy and safety of tofacitinib as a treatment for granulomas secondary to filler injection and the possible mechanisms were discussed and summarized.
    UNASSIGNED: This study focuses on three cases of patients who experienced granuloma formation after receiving filler injections and were subsequently treated with tofacitinib. The efficacy and safety of the treatment were evaluated using parameters such as photographs and monitoring for any adverse reactions. In addition, a literature review was conducted to explore the underlying mechanisms and potential effects of tofacitinib.
    UNASSIGNED: All three cases recovered from swelling and nodules without side effects through the off-label use of oral tofacitinib. Existing data review reveals some approaches for cutaneous granulomatous disorders like inhibiting macrophage activation and downregulation of the JAK-STAT pathway.
    UNASSIGNED: This report emphasizes the effectiveness of JAK inhibitors in treating granulomas caused by filler injections. Recent advancements in understanding the underlying mechanisms of granulomatous reactions have paved the way for JAK inhibitors to be regarded as a promising treatment choice. However, further research is necessary to fully assess the safety and long-term effectiveness of using tofacitinib for granuloma treatment.
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  • 文章类型: Journal Article
    背景:作为新一代胶原蛋白刺激器,聚己内酯(PCL)填充剂已广泛应用于面部真皮填充剂和其他医疗美学领域。然而,PCL的意外血管内注射可能导致并发症,如组织水肿,皮瓣坏死,甚至失明。迄今为止,对于PCL诱导的血管内栓塞尚无有效的治疗方法。
    目的:本研究的目的是确定血管内施用含PCL的填充剂导致的栓塞的可行解决方案。
    方法:进行了两种不同的动物实验:(1)PCL诱导的大鼠腹壁下动脉栓塞,接下来是粗略的观察,组织学评估,和血清细胞因子分析;(2)PCL诱导的兔耳动脉栓塞,立即用肝素和硝酸甘油治疗。然后通过粗略观察评估耳朵,激光散斑成像,体内成像系统(IVIS)成像,和组织学评估。盐水和透明质酸(HA)用作对照,透明质酸酶被用作阳性药物。
    结果:在大鼠腹壁下动脉栓塞模型中,血管内注射HA和PCL均导致皮瓣坏死,表明填充剂引起的血管内栓塞可导致严重的并发症。在兔耳动脉栓塞模型中,肝素和硝酸甘油的联合治疗在术后第7天导致PCL组缺血区域的相对血液再灌注恢复80%,这与用透明质酸酶处理的HA组相当。组织学分析表明,肝素和硝酸甘油的给药可显着减轻血管内血栓形成和炎症细胞聚集。
    结论:肝素和硝酸甘油联合使用可有效恢复PCL填充剂所致血管内栓塞的血流再灌注,减轻局部组织水肿和皮瓣坏死。这些发现为将来使用含PCL的填充剂注射进行血管内栓塞的临床管理提供了新方法。
    方法:本期刊要求作者为每个提交的证据分配一个级别,该级别的证据适用于循证医学排名。这不包括评论文章,书评,和有关基础科学的手稿,动物研究,尸体研究,和实验研究。对于这些循证医学评级的完整描述,请参阅目录或在线作者说明www。springer.com/00266.
    BACKGROUND: As a new-generation collagen stimulator, polycaprolactone (PCL) containing filler has been extensively applied in facial dermal fillers and other medical aesthetic fields. However, inadvertent intravascular injection of PCL may result in complications such as tissue edema, flap necrosis, and even blindness. To date, there is no effective treatment for PCL-induced intravascular embolism.
    OBJECTIVE: The aim of this study was to identify a viable resolution for the embolism resulting from intravascular administration of PCL-containing fillers.
    METHODS: Two different animal experiments were performed: (1) PCL-induced rat inferior epigastric arteries embolism, followed by gross observation, histological evaluation, and cytokines analysis from serum; and (2) PCL-induced rabbit auricular artery embolism, immediately treated with heparin and nitroglycerin. The ears were then evaluated by gross observation, Laser speckle imaging, in vivo imaging system (IVIS) imaging, and histological evaluation. Saline and hyaluronic acids (HA) were used as controls, hyaluronidase was used as a positive drug.
    RESULTS: In a rat model of inferior epigastric arteries embolism, both intravascular injection of HA and PCL resulted in flap necrosis, indicating that the filler-induced intravascular embolism can lead to serious complications. In a rabbit model of auricular artery embolism, the combination treatment of heparin and nitroglycerin resulted in a relative blood reperfusion recovery of 80% in the ischemic area of the PCL group on day 7 post-operation, which was comparable to that of the HA group treated with hyaluronidase. Histological analysis revealed that the administration of heparin and nitroglycerin significantly attenuated intravascular thrombosis formation and inflammatory cell aggregation.
    CONCLUSIONS: The combination of heparin and nitroglycerin effectively restores blood flow reperfusion in the intravascular embolization caused by PCL filler injection, alleviates local tissue edema and flap necrosis. These findings offer a novel approach for future clinical management of intravascular embolization with PCL-containing filler injection.
    METHODS: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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  • 文章类型: Letter
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  • 文章类型: Journal Article
    背景:眶下填充剂注射是一种常用的面部微创美容手术,会导致血管并发症.
    目的:在本研究中,我们旨在探索眶下血管的解剖结构,并建立准确的眶下填充剂注射方案.
    方法:使用计算机断层扫描对84例半面部标本进行了眶下区域的血管结构评估。考虑了四个部分(P1-P4)和五个部分(C1-C5)。我们记录了每个切片和每个位置的已识别动脉的数量以及深动脉的数量。此外,我们还测量了眶下动脉(IOA)的分布.
    结果:在P1-P4时,在P4段检测到的动脉数量最少,总动脉和深动脉识别的概率分别为317/1727(18.4%)和65/338(2.3%),分别。在五个指定位置(C1-C5)遇到已识别动脉的概率为277/1727(16%),318/1727(18.4%),410/1727(23.7%),397/1727(23%),和325/1727(18.8%),分别。在C2处鉴定IOA的概率为68/84(81%)。
    结论:我们描述了一种有效的眶下区域填充剂注射技术,以最大程度地减少相关风险。
    方法:本期刊要求作者为每篇文章分配一定程度的证据。对于这些循证医学评级的完整描述,请参阅目录或在线作者说明www。springer.com/00266.
    BACKGROUND:  Infraorbital filler injection is a commonly used minimally invasive cosmetic procedure on the face, which can cause vascular complications.
    OBJECTIVE:  In this study, we aimed to explore the anatomical structure of the infraorbital vasculature and to establish an accurate protocol for infraorbital filler injection.
    METHODS:  The vascular structure of the infraorbital region was evaluated in 84 hemifacial specimens using computed tomography. Four segments (P1-P4) and five sections (C1-C5) were considered. We recorded the number of identified arteries in each slice and at each location and the number of deep arteries. Furthermore, we also measured the infraorbital artery (IOA) distribution.
    RESULTS:  At P1-P4, the lowest number of arteries was detected in segment P4, with a 317/1727 (18.4%) and 65/338 (2.3%) probability of total and deep arterial identification, respectively. The probabilities of encountering an identified artery at the five designated locations (C1-C5) were 277/1727 (16%), 318/1727 (18.4%), 410/1727 (23.7%), 397/1727 (23%), and 325/1727 (18.8%), respectively. The probability of an IOA being identified at C2 was 68/84 (81%).
    CONCLUSIONS:  We described an effective filler injection technique in the infraorbital region to minimize the associated risks.
    METHODS: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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  • 文章类型: Journal Article
    背景:透明质酸(HA)填充剂治疗是手术的微创替代方法,可使脸颊丰满。HAVOL(Restylane®Volyme)是一种柔性HA填料,适用于使中表面轮廓化和体积化。
    方法:这是随机的,评估者致盲,无治疗对照研究评估了HAVOL在中国受试者中用于矫正中方体积不足和中方轮廓缺陷的有效性和安全性。总共111名受试者随机接受HAVOL,37名受试者不接受治疗(对照)。主要终点是反应,在盲评估者评估的Medicis中面体积量表(MMVS)上,治疗组最后一次注射后6个月和对照组随机化后6个月,其中反应定义为面部两侧均较基线改善≥1点。
    结果:在6个月时,HAVOL优于未治疗,达到主要目标:76%对8%的MMVS响应者,差异为68%(CI:55.7%-79.4%,p<0.0001)。在最后一次注射后12个月,这些效果持续了51%。大多数(≥96%)在第1个月时改善了面部中部丰满的美学外观(使用全球美学改善量表[GAIS]),在12个月内保持≥80%的效果。1个月后,3D摄影拍摄的体积变化增加至3.6mL(接近3.4mL的总注射体积),并在12个月内保持稳定。超过97%的人报告对HAVOL治疗后的结果满意。此外,HAVOL耐受性良好,无意外相关不良事件。
    结论:这项研究表明,在中国人群中,HAVOL治疗有效且耐受性良好。
    BACKGROUND: Hyaluronic acid (HA) filler treatment is a minimally-invasive alternative to surgery to volumize the cheeks. HAVOL (Restylane® Volyme) is a flexible HA filler suited to contouring and volumizing the midface.
    METHODS: This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HAVOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HAVOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face.
    RESULTS: HAVOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HAVOL. Additionally, HAVOL was well tolerated, with no unanticipated related adverse events.
    CONCLUSIONS: This study showed that HAVOL is effective and well tolerated for midface treatment in a Chinese population.
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