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羟基磷酸钙与非动物源稳定透明质酸用于矫正鼻唇沟:一项为期12个月的多中心、前瞻性、随机、对照、半脸试验。

Calcium hydroxylapatite versus nonanimal stabilized hyaluronic acid for the correction of nasolabial folds: a 12-month, multicenter, prospective, randomized, controlled, split-face trial.

作者信息

Moers-Carpi Marion Michaela, Tufet Jaime Opi

机构信息

Private Clinic, Hautok, Munich, Germany.

出版信息

Dermatol Surg. 2008 Feb;34(2):210-5. doi: 10.1111/j.1524-4725.2007.34039.x. Epub 2007 Dec 17.

DOI:10.1111/j.1524-4725.2007.34039.x
PMID:18093199
Abstract

BACKGROUND

Fillers continue to proliferate in dermatology. Rigorous clinical trials can help determine the advantages and disadvantages of these products as they come to market.

OBJECTIVE

This randomized, split-face, controlled study compared the efficacy, safety, durability, and volumes of calcium hydroxylapatite (CaHA) versus nonanimal-stabilized hyaluronic acid (NASHA) in nasolabial folds.

METHODS AND MATERIALS

Sixty patients were enrolled at two medical clinics in Europe (Summer 2005). Patients received two injections 3 months apart. Patients returned at 6, 9, and 12 months for a blinded evaluation, using accepted aesthetic rating scales. Adverse events were recorded throughout the study.

RESULTS

At all time points, CaHA was found to be more effective than NASHA. At 12 months, 79% of CaHA folds were still improved or better versus 43% of NASHA folds (p<.0001). In addition, 30% less total CaHA volume was required compared to NASHA. Evaluators assessed CaHA as superior in 47% of patients and inferior in only 5% (p<.0001). Blinded evaluators and patients preferred CaHA two to one (p<.05). Both products were safe and well tolerated.

CONCLUSION

CaHA was found to be significantly more effective than NASHA. At all time points, CaHA demonstrated longer lasting results and greater improvement than NASHA.

摘要

背景

填充剂在皮肤科领域持续增多。严格的临床试验有助于确定这些产品上市时的优缺点。

目的

这项随机、半脸、对照研究比较了羟基磷灰石(CaHA)与非动物稳定透明质酸(NASHA)在鼻唇沟治疗中的疗效、安全性、持久性和填充量。

方法和材料

2005年夏季,在欧洲的两家医疗诊所招募了60名患者。患者每隔3个月接受两次注射。患者在6、9和12个月时返回进行盲法评估,使用公认的美学评分量表。在整个研究过程中记录不良事件。

结果

在所有时间点,发现CaHA比NASHA更有效。在12个月时,79%接受CaHA治疗的鼻唇沟仍有改善或更佳,而接受NASHA治疗的为43%(p<0.0001)。此外,与NASHA相比,所需的CaHA总体积少30%。评估者认为47%的患者使用CaHA效果更佳,只有5%的患者效果较差(p<0.0001)。盲法评估者和患者对CaHA与NASHA的偏好比例为二比一(p<0.05)。两种产品均安全且耐受性良好。

结论

发现CaHA比NASHA显著更有效。在所有时间点,CaHA都比NASHA显示出更持久的效果和更大的改善。

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