Rzany Berthold, Bayerl Christiane, Bodokh Isaac, Boineau Dominique, Dirschka Thomas, Queille-Roussel Catherine, Sebastian Michael, Sommer Boris, Edwartz Carolina, Podda Maurizio
*RZANY & HUND, Privatpraxis, Berlin, Germany; †Department of Dermatology and Allergology, HSK Wiesbaden, Lehrkrankenhaus der Universität Mainz, Wiesbaden, Germany; ‡Department of Dermatology, Cannes Hospital, Cannes, France; §Centre dermato-chirurgical et médecine de la nutrition, Bordeaux, France; ‖Dermatologische Praxis, Wuppertal, Germany; ¶CPCAD, Hôpital l'Archet 2, Nice, France; #Gemeinschaftspraxis für Dermatologie, Mahlow, Germany; **Praxis Dr. med. Boris Sommer, Frankfurt, Germany; ††Galderma, Uppsala, Sweden; ‡‡Department of Dermatology, Klinikum Darmstadt, Darmstadt, Germany.
Dermatol Surg. 2017 Jan;43(1):58-65. doi: 10.1097/DSS.0000000000000923.
Hyaluronic acid (HA) filler injection is a popular nonsurgical aesthetic procedure.
To compare the effectiveness and safety of 2 hyaluronic acid fillers (HAEC and HARES) for treatment of moderate nasolabial folds (NLFs).
This was an evaluator- and subject-blinded split-face study. HAEC or HARES was randomly assigned to the left or right NLF at baseline. Retreatment was performed after 9 months; follow-up extended to 18 months after baseline (9 months after retreatment). Effectiveness assessments included the Wrinkle Severity Rating Scale (WSRS) and subject preference. Safety assessments included adverse events (AEs) and local tolerability symptoms recorded by subjects during 3 weeks after treatment.
HAEC was noninferior to HARES measured as mean change from baseline in WSRS score at 6 months. Mean WSRS score change from baseline was similar between products up to 18 months. A majority of subjects (>70%) were still responders at 18 months (after retreatment at 9 months). The volume required at retreatment was approximately two-thirds of that at baseline. There was no difference in subject preference between products. Both fillers were well tolerated and associated with few treatment-related AEs.
HAEC and HARES were effective and well tolerated for treatment of moderate NLFs.
透明质酸（HA）填充剂注射是一种流行的非手术美容方法。
比较两种透明质酸填充剂（HAEC和HARES）治疗中度鼻唇沟（NLFs）的有效性和安全性。
这是一项评估者和受试者双盲的半脸研究。在基线时，HAEC或HARES被随机分配到左侧或右侧鼻唇沟。9个月后进行再次治疗；随访延长至基线后18个月（再次治疗后9个月）。有效性评估包括皱纹严重程度评分量表（WSRS）和受试者偏好。安全性评估包括治疗后3周内受试者记录的不良事件（AE）和局部耐受性症状。
在6个月时，以WSRS评分相对于基线的平均变化衡量，HAEC不劣于HARES。在长达18个月的时间里，两种产品相对于基线的WSRS评分平均变化相似。大多数受试者（>70%）在18个月时（9个月再次治疗后）仍是有反应者。再次治疗所需的剂量约为基线时的三分之二。两种产品在受试者偏好方面没有差异。两种填充剂耐受性良好，且与很少的治疗相关不良事件相关。
HAEC和HARES治疗中度鼻唇沟有效且耐受性良好。
