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患者对至少 5 年美学用肉毒毒素 A 的满意度和安全性:4402 例眉间区治疗的回顾性横断面分析。

Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: a retrospective cross-sectional analysis of 4,402 glabellar treatments.

机构信息

*Hospital Do Servidor Publico Municipal, Sao Paulo, Brazil; †Carruthers Clinical Research, Vancouver, British Columbia, Canada; ‡Aesthetic Solutions, Chapel Hill, North Carolina; §Goldman, Butterwick, Fitzpatrick, Groff and Fabi: Cosmetic Laser Dermatology, San Diego, California; ‖Allergan, Inc., Irvine, California.

出版信息

Dermatol Surg. 2015 Jan;41 Suppl 1:S19-28. doi: 10.1097/DSS.0000000000000275.

Abstract

BACKGROUND

Despite extensive clinical experience with onabotulinumtoxinA, few data exist on patient satisfaction or safety with continuous treatment.

OBJECTIVE

This international multicenter study evaluated patient satisfaction and safety with long-term continuous facial aesthetic treatment with onabotulinumtoxinA.

METHODS

Retrospective chart review with a cross-sectional design was used to assess onabotulinumtoxinA treatment, including dosing, concomitant facial aesthetic medications and procedures, and adverse events (AEs). Validated Facial Line Satisfaction Questionnaire, Self-Perception of Age measure, and Facial Line Outcomes questionnaire instruments, and a de novo questionnaire were used to determine patient satisfaction.

RESULTS

A total of 207 patients consisted of the intent-to-treat population, with 194 in the per protocol analyses. Patients received a total of 4,402 glabellar treatments over a mean of 9.1 years, with a mean dose of 21.6 U per treatment. Overall, 92.3% of patients were mostly or very satisfied. Among the 89.7% of patients who reported looking younger, the mean perceived age was 6.9 years younger. Documented AEs were infrequent, mostly mild in severity, and declined in frequency over time.

LIMITATIONS

This population was self-selecting as they chose to continue treatment for 5 or more years to be eligible.

CONCLUSION

Continuous treatment with onabotulinumtoxinA for a mean of 9.1 years was associated with very high patient satisfaction.

摘要

背景

尽管已广泛应用肉毒毒素 A 进行临床治疗,但关于患者对连续治疗的满意度和安全性的数据却很少。

目的

本国际性多中心研究评估了肉毒毒素 A 对长期连续面部美学治疗的患者满意度和安全性。

方法

采用回顾性图表审查和横断面设计,评估肉毒毒素 A 治疗情况,包括剂量、同时使用的面部美学药物和程序以及不良反应(AE)。采用经验证的面部线满意度问卷、自我年龄感知量表和面部线结局问卷以及新开发的问卷来确定患者满意度。

结果

共有 207 例患者被纳入意向治疗人群,194 例患者被纳入方案人群。患者接受了总计 4402 次眉间区治疗,平均治疗时间为 9.1 年,每次治疗的平均剂量为 21.6U。总体而言,92.3%的患者表示非常满意或满意。在 89.7%的报告自己看起来更年轻的患者中,平均感知年龄年轻了 6.9 岁。记录到的不良事件频率较低,大多为轻度,且随时间推移而减少。

局限性

本研究人群为自我选择,他们选择继续治疗 5 年或以上才有资格入组。

结论

连续 9.1 年使用肉毒毒素 A 治疗与患者非常高的满意度相关。

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