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二极管激光脱毛的固定低辐射暴露与递增辐射暴露方法:一项随机、双侧腋窝、比较性单盲试验。

Fixed, low radiant exposure vs. incremental radiant exposure approach for diode laser hair reduction: a randomized, split axilla, comparative single-blinded trial.

作者信息

Pavlović M D, Adamič M, Nenadić D

机构信息

Dermatology Center Parmova, Ljubljana, Slovenia.

Department of Gynecology, Military Medical Academy, Belgrade, Serbia.

出版信息

J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2377-81. doi: 10.1111/jdv.13239. Epub 2015 Aug 24.

Abstract

BACKGROUND

Diode lasers are the most commonly used treatment modalities for unwanted hair reduction. Only a few controlled clinical trials but not a single randomized controlled trial (RCT) compared the impact of various laser parameters, especially radiant exposure, onto efficacy, tolerability and safety of laser hair reduction.

OBJECTIVE

To compare the safety, tolerability and mid-term efficacy of fixed, low and incremental radiant exposures of diode lasers (800 nm) for axillary hair removal, we conducted an intrapatient, left-to-right, patient- and assessor-blinded and controlled trial.

METHODS

Diode laser (800 nm) treatments were evaluated in 39 study participants (skin type II-III) with unwanted axillary hairs. Randomization and allocation to split axilla treatments were carried out by a web-based randomization tool. Six treatments were performed at 4- to 6-week intervals with study subjects blinded to the type of treatment. Final assessment of hair reduction was conducted 6 months after the last treatment by means of blinded 4-point clinical scale using photographs. The primary endpoint was reduction in hair growth, and secondary endpoints were patient-rated tolerability and satisfaction with the treatment, treatment-related pain and adverse effects.

RESULTS

Excellent reduction in axillary hairs (≥ 76%) at 6-month follow-up visit after receiving fixed, low and incremental radiant exposure diode laser treatments was obtained in 59% and 67% of study participants respectively (Z value: 1.342, P = 0.180). Patients reported lower visual analogue scale (VAS) pain score on the fixed (4.26) than on the incremental radiant exposure side (5.64) (P < 0.0003). The only side-effect was mild and transient erythema. Subjects better tolerated the fixed, low radiant exposure protocol (P = 0.03). The majority of the study participants were satisfied with both treatments.

CONCLUSION

Both low and incremental radiant exposures produced similar hair reduction and high and comparable patient satisfaction. However, low radiant exposure diode laser treatments were less painful and better tolerated.

摘要

背景

二极管激光是最常用于减少多余毛发的治疗方式。仅有少数对照临床试验,但没有一项随机对照试验(RCT)比较过各种激光参数,尤其是辐射剂量,对激光脱毛疗效、耐受性和安全性的影响。

目的

为比较二极管激光(800纳米)固定、低和递增辐射剂量用于腋下脱毛的安全性、耐受性和中期疗效,我们进行了一项患者自身对照、从左至右、患者和评估者双盲的对照试验。

方法

对39名有多余腋毛的研究参与者(皮肤类型为II - III型)进行二极管激光(800纳米)治疗评估。通过基于网络的随机工具进行随机分组并分配至双侧腋下不同治疗方式。每隔4至6周进行6次治疗,研究对象对治疗类型不知情。最后一次治疗6个月后,通过使用照片的双盲4分临床量表对毛发减少情况进行最终评估。主要终点是毛发生长减少,次要终点是患者评定的耐受性、对治疗的满意度、治疗相关疼痛和不良反应。

结果

接受固定、低和递增辐射剂量二极管激光治疗后,在6个月随访时,分别有59%和67%的研究参与者实现了腋下毛发的显著减少(≥76%)(Z值:1.342,P = 0.180)。患者报告固定辐射剂量侧的视觉模拟评分(VAS)疼痛评分(4.26)低于递增辐射剂量侧(5.64)(P < 0.0003)。唯一的副作用是轻度和短暂的红斑。受试者对固定、低辐射剂量方案的耐受性更好(P = 0.03)。大多数研究参与者对两种治疗都满意。

结论

低和递增辐射剂量均产生了相似的毛发减少效果,且患者满意度高且相当。然而,低辐射剂量二极管激光治疗疼痛较轻且耐受性更好。

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