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一项比较小颗粒型与黏弹型聚己内酯交联透明质酸钠填充剂治疗口周皱纹的随机、盲法、前瞻性临床研究。

A Randomized, Blinded, Prospective Clinical Study Comparing Small-Particle Versus Cohesive Polydensified Matrix Hyaluronic Acid Fillers for the Treatment of Perioral Rhytids.

出版信息

Aesthet Surg J. 2021 May 18;41(6):NP493-NP499. doi: 10.1093/asj/sjaa161.

Abstract

BACKGROUND

Perioral rhytids are a bothersome sign of aging for many patients. Although multiple treatments exist, choosing an optimal modality may be difficult considering that rhytids in this region are fine and the anatomy dynamic.

OBJECTIVES

The authors sought to compare the efficacy and safety as well as patient satisfaction of a small-particle hyaluronic acid filler with 0.3% lidocaine (SP-HAL, Restylane Silk) and cohesive polydensified matrix hyaluronic acid filler (CPM-HA, Belotero Balance) in reducing superficial perioral rhytids.

METHODS

The study was double-blinded, and 48 patients with moderate to severe superficial perioral rhytids were enrolled. Patients were randomized to receive either CPM-HA in the left perioral region and SPHAL in the right or vice versa. Rhytid severity was measured by patients utilizing a linear analog scale, and by investigators utilizing a validated 5-point scale, for 180 days following treatment.

RESULTS

Both SP-HAL and CPM-HA achieved a reduction in rhytid severity, and neither treatment group returned to baseline after 180 days. Investigator-reported scores for rhytid severity were significantly better for SP-HAL than CPM-HA and remained so at 180 days (P < .05). SP-HAL also proved significantly better for reducing rhytids according to patient scores, although this difference occurred between 120 and 180 days only. Adverse events included rash and mild acne for CPM-HA, and SP-HAL was associated with 1 postinflammatory nodule and 2 occurrences of Tyndall effect.

CONCLUSIONS

Although both SP-HAL and CPM-HA are effective at reducing perioral rhytid severity and have similar safety profiles, SP-HAL possesses a longer duration of effect.

摘要

背景

口周皱纹是许多患者衰老的烦恼迹象。尽管有多种治疗方法,但由于该区域的皱纹细小且解剖结构动态,选择最佳治疗方法可能较为困难。

目的

作者旨在比较含有 0.3%利多卡因的小颗粒透明质酸填充剂(SP-HAL,瑞蓝·丝丽)与凝聚性多密度透明质酸填充剂(CPM-HA,贝洛特·平衡)治疗轻度口周皱纹的疗效、安全性和患者满意度。

方法

该研究为双盲研究,共纳入 48 例中重度口周皱纹患者。患者随机接受左侧口周 CPM-HA 治疗,右侧口周 SP-HAL 治疗,或反之。治疗后 180 天,患者和研究者均采用线性模拟评分量表评估皱纹严重程度,同时采用经过验证的 5 分制量表进行评估。

结果

SP-HAL 和 CPM-HA 均可减轻皱纹严重程度,且两组在 180 天后均未恢复至基线水平。研究者评估的皱纹严重程度评分 SP-HAL 组显著优于 CPM-HA 组,且在 180 天时仍保持这一优势(P < .05)。尽管 SP-HAL 组在 120 天至 180 天之间的疗效更优,但根据患者评分,SP-HAL 组在减轻皱纹方面也显著优于 CPM-HA 组。不良反应包括 CPM-HA 组的皮疹和轻度痤疮,以及 SP-HAL 组的 1 例炎症后结节和 2 例 Tyndall 效应。

结论

虽然 SP-HAL 和 CPM-HA 均能有效减轻口周皱纹严重程度,且安全性相似,但 SP-HAL 的作用持续时间更长。

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