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一种新型透明质酸填充剂的评估。Puragen与Captique治疗鼻唇沟的双盲、随机对照研究。

Assessment of a new hyaluronic acid filler. double-blind, randomized, comparative study between Puragen and Captique in the treatment of nasolabial folds.

作者信息

Onesti Mariagiuseppina, Toscani Marco, Curinga Giuseppe, Chiummariello Stefano, Scuderi Nicolò

机构信息

Department of Plastic and Reconstructive Surgery, University of Rome, La Sapienza, Rome, Italy.

出版信息

In Vivo. 2009 May-Jun;23(3):479-86.

Abstract

Fillers represent a field of aesthetic medicine under remarkable expansion. Over the past few years, in the USA, there has been a huge increase in the use of fillers, especially for hyaluronic acid (400% in 2004). The causes of this increase have been the greater tolerability of this reabsorbable filler with respect to the others, and its prolonged efficacy in time due to chemical modifications of its molecular structure. In our study, we report the results of a double-blind comparative study between Puragen (latest-generation hyaluronic acid with double cross-linking) and Captique (second generation hyaluronic acid with single cross-linking), in the treatment of nasolabial folds. Each patient received Puragen in one nasolabial fold and Captique in the contralateral fold, at random. Clinical efficacy was assessed independently by the investigator and the patient 2, 4 and 6 months after baseline or when the optimal cosmetic result was obtained. The tolerability assessment was made by the patient (using a daily diary to record any adverse events) for 2 weeks after each treatment, and by the operator 2, 4, and 6 months after baseline. Sixty-eight patients completed follow up at 6 months. From the results obtained in this study, Puragen remained stably in the treated tissues even after 6 months while less satisfactory results were obtained with Captique.

摘要

填充剂是美容医学中一个正在显著扩张的领域。在过去几年里,在美国,填充剂的使用量大幅增加,尤其是透明质酸(2004年增长了400%)。这种增长的原因在于,与其他填充剂相比,这种可吸收填充剂具有更高的耐受性,并且由于其分子结构的化学修饰,其效果能在更长时间内得以维持。在我们的研究中,我们报告了Puragen(新一代双交联透明质酸)和Captique(第二代单交联透明质酸)在治疗鼻唇沟方面的双盲对比研究结果。每位患者随机在一侧鼻唇沟使用Puragen,在对侧鼻唇沟使用Captique。在基线后的2个月、4个月和6个月或获得最佳美容效果时,由研究者和患者独立评估临床疗效。耐受性评估由患者(使用每日日记记录任何不良事件)在每次治疗后2周进行,由操作人员在基线后的2个月、4个月和6个月进行。68名患者完成了6个月的随访。从本研究获得的结果来看,即使在6个月后,Puragen仍稳定地存在于治疗组织中,而Captique的效果则不太令人满意。

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