Department of Dermatology, University of Regensburg, Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
J Eur Acad Dermatol Venereol. 2011 Jul;25(7):765-73. doi: 10.1111/j.1468-3083.2010.03857.x. Epub 2010 Oct 3.
Data from an uncontrolled trial suggest synchronous balneophototherapy (sBPT), which simulates treatment conditions at the Dead Sea, to be effective in the management of atopic dermatitis (AD).
The purpose of this prospective randomized controlled study was to compare the efficacy and safety of sBPT with narrow-band (NB) UVB monotherapy (PT) for AD.
In this phase III multicentre trial, 180 patients with moderate-to-severe AD were allocated to two groups in a 1:1 ratio; group 1 received sBPT consisting of NB UVB treatment and synchronous bathing in 10% Dead Sea salt solution, group 2 monotherapy with UVB 311 nm. The confirmatory study design consisted of up to 35 treatment sessions. Primary endpoint, analysed on an intention-to-treat-basis (n=169), was the relative improvement of the severity SCORing of the Atopic Dermatitis Index (SCORAD) from baseline to the end of treatment (35 sessions or early cure). Sample-size calculation aimed at establishing at least 15% superiority.
SCORing of the Atopic Dermatitis Index at baseline was comparable between sBPT (61.8±14.1) and PT (61.5±12.4) group. At the end of therapy, a clinically relevant and statistically significant difference of 26.2% could be shown (P<0.001). Exploratory testing showed statistically significant superiority of sBPT after 6 months. Mild adverse events more frequently occurred in the sBPT group (n=46, PT: n=31), whereas more patients withdrew early because of adverse events in the PT group (n=6, sBPT: n=2).
A clear advantage of sBPT in comparison to PT was proven. Tolerability was comparable; both treatments showed to be safe.
一项非对照试验的数据表明，模拟死海治疗条件的同步浴光疗法（sBPT）对特应性皮炎（AD）的治疗有效。
本前瞻性随机对照研究的目的是比较 sBPT 与窄谱（NB）UVB 单一疗法（PT）治疗 AD 的疗效和安全性。
在这项 III 期多中心试验中，180 名中重度 AD 患者按 1:1 的比例分为两组；组 1 接受包括 NB-UVB 治疗和 10%死海盐水同步沐浴的 sBPT，组 2 接受 UVB 311nm 单一疗法。确证性研究设计包括最多 35 次治疗。主要终点为从基线到治疗结束（35 次或早期治愈）时，根据意向治疗人群（n=169）计算的严重程度 SCORing 的特应性皮炎指数（SCORAD）相对改善。样本量计算旨在确定至少 15%的优势。
sBPT（61.8±14.1）和 PT（61.5±12.4）组的基线 SCORing 的特应性皮炎指数相当。治疗结束时，可显示出 26.2%的临床相关且具有统计学意义的差异（P<0.001）。探索性测试表明，sBPT 在 6 个月后具有统计学上的显著优势。sBPT 组更频繁地出现轻度不良反应（n=46，PT：n=31），而 PT 组因不良反应而提前退出的患者更多（n=6，sBPT：n=2）。
与 PT 相比，sBPT 的优势明显。耐受性相当，两种治疗均安全。
