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多中心、双盲、安慰剂对照自体成纤维细胞治疗鼻唇沟皱纹的临床试验。

A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles.

机构信息

Dermatology, Laser and Vein Specialists of the Carolinas, Charlotte, North Carolina, USA.

出版信息

Dermatol Surg. 2012 Jul;38(7 Pt 2):1234-43. doi: 10.1111/j.1524-4725.2012.02349.x. Epub 2012 Mar 12.

DOI:10.1111/j.1524-4725.2012.02349.x
PMID:22409385
Abstract

BACKGROUND

Changes associated with aging are partly due to loss of collagen and elastin. Treatment with autologous fibroblasts grown in culture (azficel-T) can help correct the appearance of aging by replacing lost dermal constituents.

OBJECTIVE

To demonstrate the safety and effectiveness of autologous fibroblasts in the treatment of nasolabial fold (NLF) wrinkles.

METHODS AND MATERIALS

Adults with moderate to very severe NLF wrinkles were randomized to receive three treatments with autologous fibroblasts or placebo at 5-week intervals. Blinded evaluators and subjects assessed efficacy using a validated wrinkle assessment scale.

RESULTS

Three hundred seventy-two subjects were enrolled and underwent treatment. Seventy-eight percent of subjects treated with autologous fibroblast therapy and 48% of subjects treated with placebo achieved at least a 1-point improvement on the subject assessment at 6 months (p < 0.001), and 64% of subjects treated with autologous fibroblast therapy and 36% of those treated with placebo showed at least a 1-point improvement evaluator's assessment (p < 0.001). Adverse events were generally mild, and the treatment was well tolerated.

CONCLUSION

Autologous fibroblast therapy is safe and effective for the treatment of NLF wrinkles. The availability of autologous cell therapy marks the beginning of a new phase in aesthetic therapy.

摘要

背景

与衰老相关的变化部分归因于胶原蛋白和弹性蛋白的流失。使用在培养中生长的自体成纤维细胞(azficel-T)进行治疗,可以通过替代丢失的真皮成分来帮助纠正衰老的外观。

目的

证明自体成纤维细胞治疗鼻唇沟(NLF)皱纹的安全性和有效性。

方法和材料

中度至重度 NLF 皱纹的成年人被随机分为三组,每 5 周接受一次自体成纤维细胞或安慰剂治疗。经过验证的皱纹评估量表,由盲法评估者和受试者评估疗效。

结果

372 名受试者入组并接受了治疗。接受自体成纤维细胞治疗的受试者中有 78%和接受安慰剂治疗的受试者中有 48%在 6 个月时(p < 0.001)在受试者评估中至少改善了 1 分,接受自体成纤维细胞治疗的受试者中有 64%和接受安慰剂治疗的受试者中有 36%(p < 0.001)在评估者评估中至少改善了 1 分。不良反应通常为轻度,且治疗耐受性良好。

结论

自体成纤维细胞治疗是治疗 NLF 皱纹的安全有效方法。自体细胞治疗的出现标志着美容治疗的新阶段的开始。

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