Artecoll：一种可持久注射的除皱填充材料：一项针对251名受试者的对照，随机，多中心临床试验的报告。,Plastic and Reconstructive Surgery

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Artecoll：一种可持久注射的除皱填充材料：一项针对251名受试者的对照，随机，多中心临床试验的报告。
Plastic and Reconstructive Surgery ( IF 3.2 ) Pub Date : 2004-10-07 , DOI: 10.1097/01.prs.0000133169.16467.5f
Steven R Cohen ₁ , Ralph E Holmes

Affiliation

Artecoll是一种由聚甲基丙烯酸甲酯微球和牛胶原蛋白组成的可注射皱纹填充剂，在美国以外广泛可用。为了确保国内供应，美国食品和药物管理局要求进行多中心研究性器械豁免研究。这项研究由八个中心的251名受试者组成，他们分别注射了Artecoll或当前批准的胶原蛋白真皮填充剂（对照组），治疗了1334处的唇部皱纹，鼻唇沟，radial骨上唇纹和口角纹。治疗是随机的，并在1、3和6个月时收集随访安全性，疗效，研究者成功评级和受试者满意度评级数据。两组的不良反应和免疫球蛋白G血清水平的安全性数据均较低且相似。功效数据蒙面观察者使用照相的面部褶皱评估量表进行的测量显示，与胶原相比，Artecoll在6个月时的综合改善显着（p <0.001）。在6个月时，Artecoll的四个注射部位中的每个部位的研究者成功等级和受试者满意度等级均优于（p <0.001）。在Artecoll组中，对111位受试者（86.7％）进行了为期12个月的随访，结果显示持续的明显增强。在整个12个月的安全性研究期间，Artecoll报告的不良事件少于6个月的对照组，尽管差异无统计学意义。001）。在6个月时，Artecoll的四个注射部位中的每个部位的研究者成功等级和受试者满意度等级均优于（p <0.001）。在Artecoll组中，对111位受试者（86.7％）进行了为期12个月的随访，结果显示持续的明显增强。在整个12个月的安全性研究期间，Artecoll报告的不良事件少于6个月的对照组，尽管差异无统计学意义。001）。在6个月时，Artecoll的四个注射部位中的每个部位的研究者成功等级和受试者满意度等级均优于（p <0.001）。在Artecoll组中，对111位受试者（86.7％）进行了为期12个月的随访，结果显示持续的明显增强。在整个12个月的安全性研究期间，Artecoll报告的不良事件少于6个月的对照组，尽管差异无统计学意义。

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Artecoll: a long-lasting injectable wrinkle filler material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects.

Artecoll, an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, is widely available outside the United States. For domestic availability, a multicenter Investigational Device Exemption study was required by the U.S. Food and Drug Administration. This study consisted of 251 subjects at eight centers who received injections of Artecoll or the currently approved collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial fold, radial upper lip lines, and corner-of-the-mouth lines. The treatments were randomized, and follow-up safety, efficacy, investigator success rating, and subject satisfaction rating data were collected at 1, 3, and 6 months. The safety data, measured as adverse events and immunoglobulin G serum levels, were low and similar for both groups. The efficacy data, measured by masked observers using a photographic facial fold assessment scale, demonstrated a combined significant improvement with Artecoll compared with collagen at 6 months (p < 0.001). At 6 months, the investigator success ratings and the subject satisfaction ratings for each of the four injections sites were superior for Artecoll (p < 0.001). In the Artecoll group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant augmentation. Artecoll had fewer adverse events reported throughout the 12-month safety study period than the control group did in 6 months, although the difference was not statistically significant.

更新日期：2019-11-01

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