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皮内注射阿柏西普肉毒素A与生理盐水用于面部提升的比较:一项半脸随机对照试验。

The comparison between intradermal injection of abobotulinumtoxinA and normal saline for face-lifting: a split-face randomized controlled trial.

作者信息

Wanitphakdeedecha Rungsima, Ungaksornpairote Chanida, Kaewkes Arisa, Rojanavanich Viboon, Phothong Weeranut, Manuskiatti Woraphong

机构信息

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Bangkok Christian Hospital, Bangkok, Thailand.

出版信息

J Cosmet Dermatol. 2016 Dec;15(4):452-457. doi: 10.1111/jocd.12289. Epub 2016 Sep 19.

Abstract

BACKGROUND

Botulinum toxin type A (BTA) has been approved for the treatment of strabismus, blepharospasm, muscle spasm, cervical dystonia, pain syndrome, glabella wrinkles, and severe primary axillary hyperhidrosis. Intradermal injection of BTA has been used off-label by many clinicians for the purpose of face-lifting effect. Few studies on onabotulinumtoxinA (ONA) demonstrated no clinical efficacy on face-lifting effect when comparing to normal saline solution (NSS). So far, there is no split-face comparison study on face-lifting effect of abobotulinumtoxinA (ABO).

OBJECTIVE

To determine the face-lifting effect of ABO intradermal injection and NSS.

METHODS

Twenty-two subjects with symmetrical faces on both facial expression and expressionless were randomly injected with ABO at 1:7 cc dilution (500 unit or one vial in 7 cc of NSS) on one side and NSS on the other side using intradermal injection technique. Standardized photographic documentation was obtained at baseline, and at 2 weeks after treatment. The face-lifting effect was graded by two blinded dermatologists using photographic comparison and rated by the patients. Side effects were also recorded at the end of the study.

RESULTS

Face-lifting effect was demonstrated in 40.9% and 4.5% of patients with ABO and NSS, respectively. There was a statistically significant difference in face-lifting effect when comparing between ABO and NSS (P = 0.021). The face-lifting was reported in 50.0% of patients receiving ABO injection. The patients with oval-face shape tended to respond better with ABO (P = 0.046). The odd of face-lifting effect for patients aged younger than 32 was higher than patients aged older than 32 with the odds ratio of 7.9 and 95% confidence interval of 1.1-56.1. Facial asymmetry was found in 22.7% of subjects.

CONCLUSIONS

This study demonstrated the face-lifting effect of ABO intradermal injection. Patients with oval-face shape and aged younger than 32 tended to respond better. Therefore, patient selection should be emphasized to improve efficacy of this technique.

摘要

背景

A型肉毒杆菌毒素(BTA)已被批准用于治疗斜视、眼睑痉挛、肌肉痉挛、颈部肌张力障碍、疼痛综合征、眉间皱纹和严重的原发性腋窝多汗症。许多临床医生将BTA皮内注射用于提升面部效果这一未获批准的用途。关于A型肉毒毒素(ONA)的少数研究表明,与生理盐水溶液(NSS)相比,其在提升面部效果方面无临床疗效。迄今为止,尚无关于阿柏西普肉毒毒素A(ABO)提升面部效果的半脸对照研究。

目的

确定ABO皮内注射和NSS的面部提升效果。

方法

22名面部表情和无表情时均对称的受试者,采用皮内注射技术,一侧随机注射1:7 cc稀释度的ABO(500单位或1瓶ABO溶于7 cc NSS中),另一侧注射NSS。在基线和治疗后2周获取标准化照片记录。由两名不知情的皮肤科医生通过照片对比对面部提升效果进行分级,并由患者进行评分。研究结束时还记录了副作用。

结果

接受ABO和NSS治疗的患者中,面部提升效果分别为40.9%和4.5%。ABO和NSS之间在面部提升效果上存在统计学显著差异(P = 0.021)。接受ABO注射的患者中有50.0%报告有面部提升效果。椭圆形脸的患者对ABO的反应往往更好(P = 0.046)。32岁以下患者面部提升效果的几率高于32岁以上患者,优势比为7.9,95%置信区间为1.1 - 56.1。22.7%的受试者存在面部不对称。

结论

本研究证明了ABO皮内注射的面部提升效果。椭圆形脸且年龄小于32岁的患者反应往往更好。因此,应强调患者选择以提高该技术的疗效。

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