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一项多中心随机试验,比较羟基磷灰石钙与两种透明质酸治疗鼻唇沟的效果。

A multicenter, randomized trial comparing calcium hydroxylapatite to two hyaluronic acids for treatment of nasolabial folds.

作者信息

Moers-Carpi Marion, Vogt Stephan, Santos Begonia Martinez, Planas Jorge, Vallve Sonia Rovira, Howell David J

机构信息

Private Clinic, Hautok, Munich, Germany.

出版信息

Dermatol Surg. 2007 Dec;33 Suppl 2:S144-51. doi: 10.1111/j.1524-4725.2007.33354.x.

Abstract

INTRODUCTION

In this study, we examined Radiesse (calcium hydroxylapatite; CaHA), Juvederm 24 (hyaluronic acid; HA-1A), Juvederm 24HV (HA-1B), and Perlane (HA-2) for patient satisfaction, likelihood to return, immediate efficacy, and duration of correction.

OBJECTIVE

This multicenter, blinded, randomized study compares patient satisfaction variables, efficacy, and durability of CaHA gel and HA for correction of nasolabial folds (NLFs) through 12 months after 4-month touch-up.

METHODOLOGY

A total of 205 randomized patients received either CaHA gel or HA for NLF treatment at initial visit and 4-month touch-up. Patients returned at 4, 8, and 12 months after the second injection for evaluation. Surveys measured patient satisfaction; effectiveness measures included the Global Aesthetic Improvement Scale (GAIS).

RESULTS

More CaHA gel patients were satisfied or extremely satisfied than each HA tested. At 8 months, significantly more CaHA gel-treated NLFs were improved on the GAIS than any HA. The volumes of CaHA gel and three HA materials injected through 4 months were 2.2, 2.9, 4.8, and 2.9 mL, respectively (p<.005). No serious adverse events were observed.

CONCLUSIONS

In this controlled study, CaHA gel ranked highest in patient satisfaction and likelihood to return. The material was more effective and longer lasting than each HA in maintaining NLF augmentation.

摘要

引言

在本研究中,我们对瑞蓝(羟基磷灰石钙;CaHA)、乔雅登24(透明质酸;HA - 1A)、乔雅登24HV(HA - 1B)和瑞蓝致美(HA - 2)进行了患者满意度、再次治疗可能性、即时疗效和矫正持续时间方面的研究。

目的

这项多中心、盲法、随机研究比较了CaHA凝胶和透明质酸在改善鼻唇沟(NLF)方面的患者满意度变量、疗效和持久性,随访期为4个月补充注射后12个月。

方法

共有205名随机分组的患者在初次就诊和4个月补充注射时接受了CaHA凝胶或透明质酸治疗NLF。患者在第二次注射后的4个月、8个月和12个月返回进行评估。通过调查衡量患者满意度;有效性指标包括整体美容改善量表(GAIS)。

结果

与每种测试的透明质酸相比,更多接受CaHA凝胶治疗的患者表示满意或极其满意。在8个月时,GAIS显示接受CaHA凝胶治疗的NLF改善情况明显优于任何一种透明质酸。4个月内注射的CaHA凝胶和三种透明质酸材料的量分别为2.2 mL、2.9 mL、4.8 mL和2.9 mL(p<0.005)。未观察到严重不良事件。

结论

在这项对照研究中,CaHA凝胶在患者满意度和再次治疗可能性方面排名最高。在维持NLF隆起方面,该材料比每种透明质酸更有效且持续时间更长。

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