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一种新型单相、双交联透明质酸填充剂用于改善深层皱纹的疗效和耐受性。

Efficacy and tolerability of a new monophasic, double-crosslinked hyaluronic acid filler for correction of deep lines and wrinkles.

作者信息

Pavicic Tatjana

机构信息

Clinic and Polyclinic for Dermatology and Allergology, Ludwig-Maximilians-University, Munich, Germany.

出版信息

J Drugs Dermatol. 2011 Feb;10(2):134-9.

PMID:21283917
Abstract

BACKGROUND

A monophasic, highly crosslinked hyaluronic acid dermal filler offers further treatment options for deep lines.

OBJECTIVE

To investigate the efficacy and tolerability of Belotero.

METHODS AND MATERIALS

A total of 149 patients received injections. Efficacy was assessed on the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). Adverse events were recorded at each evaluation session.

RESULTS

Mean WSRS improved significantly (P<0.001) by 1.9 score points without any decline throughout the 12-week period. Improvement was found in 89.9 percent of patients on the (GAIS), 59.7 percent of whom were designated as very much/much improved. Investigator and patient satisfaction was stated in more than 90 percent of cases as excellent/good. Adverse events, exclusively localized to the injection area, occurred in 85.9 percent of patients immediately after injection and declined to 12.8 percent in week 2. None were serious.

CONCLUSION

The findings indicate the benefit of the highly cross-linked, monophasic hyaluronic acid dermal filler, especially in the treatment of patients with deep and extremely deep folds. Overall, the filler appears to be well tolerated. This evaluation raised no major safety concerns.

摘要

背景

单相、高度交联的透明质酸真皮填充剂为治疗深层皱纹提供了更多选择。

目的

研究贝莱德瑞(Belotero)的疗效和耐受性。

方法和材料

共149例患者接受注射。根据皱纹严重程度评分量表(WSRS)和整体美学改善量表(GAIS)评估疗效。在每次评估时记录不良事件。

结果

平均WSRS显著改善(P<0.001),提高了1.9分,且在整个12周期间无任何下降。89.9%的患者在GAIS量表上有改善,其中59.7%的患者被评定为改善非常明显/明显改善。超过90%的病例中,研究者和患者满意度被评为优秀/良好。不良事件仅局限于注射部位,85.9%的患者在注射后立即出现,在第2周降至12.8%。均不严重。

结论

研究结果表明,高度交联的单相透明质酸真皮填充剂有益,尤其是在治疗深层和极深层皱纹患者时。总体而言,该填充剂耐受性良好。本次评估未引发重大安全问题。

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