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一项关于高效局部用皮质类固醇在下肢网状和毛细血管扩张性静脉硬化治疗后效果的随机、双盲、安慰剂对照研究。

A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of a High-Potency Topical Corticosteroid After Sclerotherapy for Reticular and Telangiectatic Veins of the Lower Extremities.

作者信息

Friedmann Daniel P, Liolios Ana M, Wu Douglas C, Goldman Mitchel P, Eimpunth Sasima

机构信息

*Westlake Dermatology Clinical Research Center, Westlake Dermatology & Cosmetic Surgery, Austin, Texas; †Cosmetic Laser Dermatology, San Diego, California; ‡Department of Dermatology, University of California, San Diego, San Diego, California; §Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Dermatol Surg. 2015 Oct;41(10):1158-63. doi: 10.1097/DSS.0000000000000467.

Abstract

BACKGROUND

Although typically mild, transient, and expected, most adverse events (AEs) postsclerotherapy are inflammatory in nature.

OBJECTIVE

To evaluate the effects of a high-potency topical corticosteroid (TC) applied immediately postsclerotherapy.

MATERIALS AND METHODS

Subjects undergoing bilateral lower extremity sclerotherapy with polidocanol had extremities randomized to a single application of betamethasone dipropionate and placebo saline solutions immediately post-treatment in a double-blind manner. Adverse events were assessed for each extremity by subjects at t = 0 (preapplication) and t = 15 (15 minutes postapplication) and by an investigator at t = 0 and t = 15, and at Days 14 and 60. Subjects and investigator evaluated efficacy with a quartile improvement scale.

RESULTS

Sixteen female subjects completed the study. Subjects reported no statistically significant differences in AEs between TC and placebo at either t = 0 or t = 15. Investigator scores for erythema and swelling/urtication were not significantly different between groups at the same time points. Although most subjects demonstrated 26% to 75% improvement at Day 60, results were not significantly different between extremities on subject and investigator evaluation.

CONCLUSION

High-potency TC application immediately postsclerotherapy produced no statistically significant differences in subject- and investigator-assessed AEs and clearance rates compared with placebo. Foam sclerotherapy with polidocanol is safe and effective for the treatment of lower extremity reticular veins.

摘要

背景

尽管硬化治疗后的大多数不良事件(AE)通常症状轻微、短暂且在意料之中,但其本质上是炎症性的。

目的

评估在硬化治疗后立即应用高效局部皮质类固醇(TC)的效果。

材料与方法

接受聚多卡醇双侧下肢硬化治疗的受试者,其双下肢以双盲方式在治疗后立即随机接受一次丙酸倍他米松和安慰剂生理盐水溶液的涂抹。受试者在t = 0(涂抹前)和t = 15(涂抹后15分钟)对每个下肢的不良事件进行评估,研究者在t = 0、t = 15、第14天和第60天进行评估。受试者和研究者使用四分位数改善量表评估疗效。

结果

16名女性受试者完成了研究。受试者报告在t = 0或t = 15时,TC组和安慰剂组在不良事件方面无统计学显著差异。在相同时间点,两组之间研究者对红斑和肿胀/荨麻疹的评分无显著差异。尽管大多数受试者在第60天显示改善26%至75%,但在受试者和研究者评估中,双下肢的结果无显著差异。

结论

与安慰剂相比,硬化治疗后立即应用高效TC在受试者和研究者评估的不良事件及清除率方面无统计学显著差异。聚多卡醇泡沫硬化疗法治疗下肢网状静脉安全有效。

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