Kreuter Alexander, Hyun Julia, Stücker Markus, Sommer Anna, Altmeyer Peter, Gambichler Thilo
Department of Dermatology and Allergology, Ruhr-University Bochum, Bochum, Germany.
J Am Acad Dermatol. 2006 Mar;54(3):440-7. doi: 10.1016/j.jaad.2005.11.1063. Epub 2006 Jan 30.
In previous trials, UV therapy has been demonstrated to be effective in the treatment of localized scleroderma (LS). To date, a randomized comparison study to evaluate the efficacy and safety of different, commonly used phototherapeutic modalities in LS is still outstanding.
The aim of this study was to compare the safety and efficacy of low-dose (LD) UVA1, medium-dose (MD) UVA1, and narrowband (NB) UVB phototherapy in the treatment of LS.
Sixty four patients with LS were consecutively included in a prospective, open, randomized controlled 3-arm study. Severity of LS was determined by means of a clinical score, and clinical improvement was also monitored by histopathologic analysis and 20-MHz ultrasound.
A total of 27 patients were treated with LD UVA1 (20 J/cm2), 18 patients received MD UVA1 (50 J/cm2), and 19 patients were treated with NB UVB dependent on their skin type. Phototherapy was performed 5 times weekly for 8 weeks. Two of the 64 patients included in this trial discontinued therapy. Skin status significantly improved in all patients who finished the treatment protocol, resulting in a reduction of the clinical score in all groups (LD UVA1, 7.6-5.0 [P < .001, 95% confidence interval 1.6-3.4]; MD UVA1, 11.1-6.6 [P < .001, 95% confidence interval 2.5-6.2]; NB UVB, 7.3-4.9 [P < .001, 95% confidence interval 1.6-3.2]). The reduction of the score was accompanied by an improvement of the visual analog scale for itching and tightness, histologic score, and 20-MHz ultrasound. MD UVA1 was significantly more effective than NB UVB (P < .05). There were no significant differences between LD UVA1 and NB UVB and the former and MD UVA1 (P > .05).
We had a relatively small study sample and nonblinded assessment of primary outcome.
Phototherapy, as previously reported in several noncontrolled trials, is an effective therapeutic option in LS, with a favorable risk/benefit ratio. UVA1 phototherapy should be considered among the first approaches in the management of LS.
在既往试验中,紫外线疗法已被证明对局限性硬皮病(LS)的治疗有效。迄今为止,一项评估不同常用光疗方式在LS中的疗效和安全性的随机对照研究仍未完成。
本研究旨在比较低剂量(LD)UVA1、中剂量(MD)UVA1和窄谱(NB)UVB光疗在治疗LS中的安全性和疗效。
64例LS患者连续纳入一项前瞻性、开放性、随机对照的三臂研究。通过临床评分确定LS的严重程度,并通过组织病理学分析和20兆赫超声监测临床改善情况。
根据皮肤类型,27例患者接受LD UVA1(20 J/cm²)治疗,18例患者接受MD UVA1(50 J/cm²)治疗,19例患者接受NB UVB治疗。光疗每周进行5次,共8周。本试验纳入的64例患者中有2例中断治疗。所有完成治疗方案的患者皮肤状况均显著改善,所有组的临床评分均降低(LD UVA1组,7.6 - 5.0[P < 0.001,95%置信区间1.6 - 3.4];MD UVA1组,11.1 - 6.6[P < 0.001,95%置信区间2.5 - 6.2];NB UVB组,7.3 - 4.9[P < 0.001,95%置信区间1.6 - 3.2])。评分降低伴随着瘙痒和紧绷视觉模拟量表、组织学评分及20兆赫超声的改善。MD UVA1比NB UVB显著更有效(P < 0.05)。LD UVA1与NB UVB之间以及前者与MD UVA1之间无显著差异(P > 0.05)。
我们的研究样本相对较小,且对主要结局的评估未设盲。
如先前在多项非对照试验中所报道,光疗是LS的一种有效治疗选择,风险/效益比良好。UVA1光疗应被视为LS治疗的首选方法之一。