Wilson Monique Vanaman, Fabi Sabrina Guillen, Greene Ryan
Cosmetic Laser Dermatology, San Diego, California.
Greene.MD Plastic Surgery & Laser Center, Weston, Florida.
JAMA Facial Plast Surg. 2017 Mar 1;19(2):88-93. doi: 10.1001/jamafacial.2016.1274.
The pivotal approval trial for a smooth, highly cohesive, viscous, 20-mg/mL hyaluronic acid filler demonstrated sustained aesthetic improvement, with a mean injection volume of 6.65 mL. In daily practice, however, it is not often practical or necessary to use large injection volumes to achieve the desired cosmetic outcome.
To assess the efficacy, longevity, and patient satisfaction associated with correction of age-related midface volume loss using the low volumes of hyaluronic acid filler more commonly used in day-to-day practice.
DESIGN, SETTING, AND PARTICIPANTS: A 2-center, retrospective cohort study examined medical records of 61 healthy patients who underwent treatment for facial volume loss with hyaluronic acid filler from November 1, 2013, through April 31, 2014. Follow-up visits were conducted at 1, 3, 6, and 12 months after the procedure. Data were pooled from a private facial plastic surgery practice in Weston, Florida, and a private cosmetic dermatology practice in San Diego, California.
Patients were treated with hyaluronic acid filler according to the investigator's usual practices.
The main outcome measure was patient-graded Global Aesthetic Improvement Scale scores at 1, 3, 6, and 12 months after treatment. Scores range from 1 to 5; 1 indicates very much improved and 5, worse.
A total of 61 consecutive, healthy adult patients (mean [SD] age, 57.4 [12.8] years) with mild to severe facial volume loss were enrolled in the study. A total of 46 patients (75%) were white, 3 (5%) were black/African American, 9 (15%) were Hispanic/Latino, 1 (2%) was Asian/Pacific Islander, and 2 (3%) were other. Three patients (5%) were male, and 58 (95%) were female. Mean initial treatment volume was 1.6 mL. At follow-up, 29 patients (48%) elected to have a touch-up treatment; mean total touch-up volume was 1.4 mL. The patient-graded Global Aesthetic Improvement Scale scores at 1, 3, 6, and 12 months after treatment demonstrated that 73% (41 of 56) to 89% (24 of 27) of the study patients reported being very much or moderately improved. Most patients were rated by investigators on the Global Aesthetic Improvement Scale as very much or moderately improved at the 12-month follow-up. At 12 months after the procedure, 43 of 51 patients (84%) reported satisfaction with their outcome. At all time points, most patients would elect to undergo the procedure again (range, 17 [68%] to 61 [100%]). Adverse events were mild, and all resolved spontaneously within 14 days. At the 2-year follow-up, there were no reports of delayed adverse events.
Midface volumization using the low volumes of hyaluronic acid filler more commonly used in daily clinical practice is effective and well tolerated.
一项针对一种质地光滑、高度黏附、黏稠的20毫克/毫升透明质酸填充剂的关键批准试验表明，其美学改善效果具有持续性，平均注射量为6.65毫升。然而，在日常实践中，为达到理想的美容效果而使用大量注射量通常既不实际也无必要。
评估使用日常实践中更常用的低剂量透明质酸填充剂来矫正与年龄相关的中面部容量缺失时的疗效、持久性及患者满意度。
设计、地点和参与者：一项双中心回顾性队列研究，对2013年11月1日至2014年4月31日期间接受透明质酸填充剂治疗面部容量缺失的61例健康患者的病历进行了检查。术后1、3、6和12个月进行随访。数据来自佛罗里达州韦斯顿一家私人面部整形手术诊所和加利福尼亚州圣地亚哥一家私人美容皮肤科诊所。
根据研究者的常规做法，使用透明质酸填充剂对患者进行治疗。
主要结局指标为治疗后1、3、6和12个月患者分级的全球美学改善量表评分。评分范围为1至5分；1分表示改善非常明显，5分表示变差。
共有61例连续的健康成年患者（平均[标准差]年龄为57.4[12.8]岁）纳入研究，这些患者存在轻度至重度面部容量缺失。其中46例患者（75%）为白人，3例（5%）为黑人/非裔美国人，9例（15%）为西班牙裔/拉丁裔，1例（2%）为亚裔/太平洋岛民，2例（3%）为其他种族。3例患者（5%）为男性，58例（95%）为女性。平均初始治疗量为1.6毫升。随访时，29例患者（48%）选择进行补打治疗；平均总补打量为1.4毫升。治疗后1、3、6和12个月患者分级的全球美学改善量表评分显示，73%（56例中的41例）至89%（27例中的24例）的研究患者报告改善非常明显或中等。在12个月随访时，大多数患者经研究者根据全球美学改善量表评定为改善非常明显或中等。术后12个月，51例患者中的43例（84%）报告对治疗结果满意。在所有时间点，大多数患者会选择再次接受该治疗（范围为17例[68%]至61例[100%]）。不良事件轻微，所有不良事件均在14天内自发缓解。在2年随访时，未报告延迟性不良事件。
在日常临床实践中，使用更常用的低剂量透明质酸填充剂进行中面部容积填充是有效的，且耐受性良好。
3级。
