Department of Dermatology and Venereology, Peking University First Hospital, Beijing, China.
Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, Beijing, China.
J Evid Based Med. 2024 Jun;17(2):390-398. doi: 10.1111/jebm.12623. Epub 2024 Jun 19.
Narrowband ultraviolet B (NB-UVB) has been recommended as first-line therapy for early-stage mycosis fungoides (MF) in international guidelines. NB-UVB can be used as monotherapy or part of a multimodality treatment regimen. There is limited evidence on the effectiveness and optimal patients of NB-UVB in combination with systemic therapies in MF. We aimed to assess the effectiveness of the combination versus NB-UVB monotherapy in early-stage MF and if plaque lesion status was related to these effects.
This observational cohort study included 247 early-stage MF patients who had received NB-UVB combined with systemic therapies vs. NB-UVB monotherapy from 2009 to 2021. The primary outcome was partial or complete response. Overall response rate and median time to response were calculated. Hazard ratios (HRs) were estimated using the Cox model.
In 139 plaque-stage patients, the response rate for combination therapy group was higher than that of monotherapy group (79.0% vs. 54.3%, p = 0.006). The adjusted HR for combination therapy compared with NB-UVB monotherapy was 3.11 (95% CI 1.72-5.63). The combination therapy group also showed shorter time to response (4 vs. 6 months, p = 0.002). In 108 patch-stage patients, the response rate and time to response in two treatment groups showed no significant difference. There was therefore an observed interaction with patients' plaque lesion status for the effect size of NB-UVB combination therapy. No serious adverse events were observed.
Adding systemic treatments to NB-UVB did not improve the treatment outcome of patch-stage patients, but it surpassed NB-UVB monotherapy for early-stage patients with plaques.
窄谱中波紫外线(NB-UVB)已被国际指南推荐为早期蕈样真菌病(MF)的一线治疗方法。NB-UVB 可单独使用或作为多模式治疗方案的一部分。关于 NB-UVB 联合全身治疗 MF 的有效性和最佳患者人群的证据有限。我们旨在评估联合治疗与 NB-UVB 单药治疗在早期 MF 中的疗效,以及斑块病变状态是否与这些疗效相关。
这项观察性队列研究纳入了 2009 年至 2021 年期间接受 NB-UVB 联合全身治疗与 NB-UVB 单药治疗的 247 例早期 MF 患者。主要结局是部分或完全缓解。计算总缓解率和中位缓解时间。使用 Cox 模型估计风险比(HR)。
在 139 例斑块期患者中,联合治疗组的缓解率高于单药治疗组(79.0% 比 54.3%,p=0.006)。与 NB-UVB 单药治疗相比,联合治疗的调整 HR 为 3.11(95%CI 1.72-5.63)。联合治疗组的缓解时间也更短(4 个月比 6 个月,p=0.002)。在 108 例斑片期患者中,两组的缓解率和缓解时间无显著差异。因此,NB-UVB 联合治疗的疗效在患者斑块病变状态上存在观察到的交互作用。未观察到严重不良事件。
在 NB-UVB 基础上添加全身治疗并未改善斑片期患者的治疗结局,但对早期有斑块的患者,NB-UVB 联合治疗优于 NB-UVB 单药治疗。