Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：窄波段紫外线（NB-UVB）已被国际指南推荐为早期真菌病（MF）的一线治疗。NB-UVB可以用作单一疗法或多模态治疗方案的一部分。关于NB-UVB与MF的全身治疗组合的有效性和最佳患者的证据有限。我们旨在评估联合治疗与NB-UVB单药治疗早期MF的有效性，以及斑块病变状态是否与这些影响相关。
方法：这项观察性队列研究包括247例早期MF患者，这些患者接受了NB-UVB联合全身疗法与2009年至2021年NB-UVB单药治疗。主要结果是部分或完全反应。计算总反应率和中位反应时间。使用Cox模型估计危险比（HR）。
结果：在139例斑块期患者中，联合治疗组的反应率高于单药治疗组（79.0％vs.54.3%,p=0.006)。与NB-UVB单药治疗相比，联合治疗的校正HR为3.11（95％CI1.72-5.63）。联合治疗组的反应时间也较短（4vs.6个月,p=0.002)。在108个贴片期患者中，两个治疗组的缓解率和缓解时间无显著差异。因此，对于NB-UVB联合治疗的效应大小，观察到与患者斑块病变状态的相互作用。未观察到严重不良事件。
结论：在NB-UVB基础上增加全身治疗并不能改善斑块期患者的治疗结果，但它超过了NB-UVB单药治疗早期斑块患者。
方法：这项观察性队列研究包括247例早期MF患者，这些患者接受了NB-UVB联合全身疗法与2009年至2021年NB-UVB单药治疗。主要结果是部分或完全反应。计算总反应率和中位反应时间。使用Cox模型估计危险比（HR）。
结果：在139例斑块期患者中，联合治疗组的反应率高于单药治疗组（79.0％vs.54.3%,p=0.006)。与NB-UVB单药治疗相比，联合治疗的校正HR为3.11（95％CI1.72-5.63）。联合治疗组的反应时间也较短（4vs.6个月,p=0.002)。在108个贴片期患者中，两个治疗组的缓解率和缓解时间无显著差异。因此，对于NB-UVB联合治疗的效应大小，观察到与患者斑块病变状态的相互作用。未观察到严重不良事件。
结论：在NB-UVB基础上增加全身治疗并不能改善斑块期患者的治疗结果，但它超过了NB-UVB单药治疗早期斑块患者。
