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一项关于透明质酸用于矫正口周纹时产生瘀斑和疼痛的双盲、随机、半脸对照试验性研究,分别使用无利多卡因、仅利多卡因以及利多卡因和肾上腺素的情况。

A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine.

作者信息

Moradi Amir, Shirazi Azadeh, Moradi-Poehler Jeanette, Turner Jessica, Howell David J

机构信息

Dr Moradi is a facial plastic surgeon, Ms Moradi-Poehler is a certified clinical research coordinator, and Ms Turner is a nurse in private practice in Vista, California. Dr Shirazi is a Clinical Dermatologist at Scripps Green Hospital, La Jolla, California. Dr Howell is a medical communications specialist in San Francisco, California.

出版信息

Aesthet Surg J. 2015 May;35(4):443-55. doi: 10.1093/asj/sjv043.

DOI:10.1093/asj/sjv043
PMID:25908703
Abstract

BACKGROUND

Hyaluronic acid (HA) fillers are sometimes mixed with lidocaine to mitigate pain. Whether the addition of epinephrine to lidocaine provides greater benefits in bruising and pain has not been fully reported.

OBJECTIVES

The investigators explored the severity of bruising and pain in patients treated with the cohesive polydensified matrix HA (CPMHA) in 3 different preparations: CPMHA (Belotero Balance [BEL]), CPMHA with lidocaine (BEL-L), and CPMHA with lidocaine and epinephrine (BEL-LE).

METHODS

In a blinded, split-face, 14-day study, 30 patients were divided into groups of 10. One group received 1.0 mL BEL in the perioral lines on 1 side and 1.0 mL of BEL-LE on the other side. A second group received 1.0 mL of BEL on 1 side and 1.0 mL of BEL-L on the other side. The third group received 1.0 mL of BEL-L on 1 side and 1.0 mL of BEL-LE on the other side. Over 3 visits, the treating investigator, the patients, and a blinded investigator rated the bruising.

RESULTS

Bruising occurred in each treatment group by day 1 but resolved for half of the patients by day 7 and for all patients by day 14. Split-face comparison did not reveal a significant difference in pain and bruising scores among the 3 preparations.

CONCLUSIONS

No significant difference was found in bruising or pain in patients treated with BEL, BEL-L, and BEL-LE. Studies with a considerably larger sample size are warranted to determine statistically significant and clinically meaningful differences between and among the various formulations.

摘要

背景

透明质酸(HA)填充剂有时会与利多卡因混合以减轻疼痛。利多卡因中添加肾上腺素是否在减轻瘀伤和疼痛方面具有更大益处尚未得到充分报道。

目的

研究人员探讨了在3种不同制剂中使用凝聚性多密度基质HA(CPMHA)治疗的患者的瘀伤和疼痛严重程度:CPMHA(贝洛特罗平衡[BEL])、含利多卡因的CPMHA(BEL-L)和含利多卡因及肾上腺素的CPMHA(BEL-LE)。

方法

在一项为期14天的双盲、半脸研究中,30名患者被分成10人一组。一组在一侧口周纹中注射1.0 mL BEL,另一侧注射1.0 mL BEL-LE。第二组在一侧注射1.0 mL BEL,另一侧注射1.0 mL BEL-L。第三组在一侧注射1.0 mL BEL-L,另一侧注射1.0 mL BEL-LE。在3次就诊过程中,主治研究人员、患者和一名盲法研究人员对瘀伤情况进行评分。

结果

各治疗组在第1天均出现瘀伤,但一半患者在第7天瘀伤消退,所有患者在第14天瘀伤消退。半脸比较未发现3种制剂在疼痛和瘀伤评分上有显著差异。

结论

使用BEL、BEL-L和BEL-LE治疗的患者在瘀伤或疼痛方面未发现显著差异。需要进行样本量更大的研究,以确定不同制剂之间具有统计学显著性和临床意义的差异。

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