■不同形式的光疗,是白癜风管理的支柱。结合治疗方式,如局部卡泊三醇(为了更快,更强烈的色素沉着),低剂量硫唑嘌呤与PUVA已被证明是有益的管理白癜风由于不同的色素沉着机制和它们的协同作用。局部应用bFGF相关的十肽(bFGFrP),然后进行阳光照射/UVA光疗,产生有效的再色素沉着。bFGFrP已显示出有助于较小病变的靶向光疗,并且其与其他治疗方式的组合非常有希望。然而,关于联合治疗的研究很少;特别是口服PUVA和bFGFrP。这项研究旨在评估bFGFrP与口服PUVA联合治疗白癜风(较大的体表面积20%或更多)的安全性和有效性。
■第四阶段,随机化,多中心研究(N=120)在6个月治疗期的成年稳定白癜风患者中,每月随访一次。补骨脂素(选项卡。Melanocyl)剂量0.6mg/kg,在暴露于UVA光疗前2小时口服。口服PUVA治疗,最初,在4J/cm2的照射剂量(PUVA组),如果耐受每周两次,则每四次增加0.5J/cm2。主要终点是靶病变的色素沉着(EOR)程度改善(最大尺寸至少2cm×2cm,没有白细胞增多),而次要终点是bFGFrP+口服PUVA联合治疗组和口服PUVA单药治疗组治疗期结束6个月时患者总体评估(PGA)和安全性的改善。
■6个月结束,61.8%(34例患者,n=55),而30.2%(16例患者,n=53)来自口服PUVA单一疗法组(n=53)。关于色素沉着(GOR)的等级,完全色素沉着为5.5%(3例,n=55)在联合治疗组,而单药治疗组(p≤0.05)没有患者表现出完全的色素沉着,联合组的PGA显示出显着的总体改善(p≤0.05);联合组的6例患者(10.9%)与1例(1.9%)显示出完全改善。治疗期间,没有报告不良事件.
■与口服PUVA单药治疗相比,口服PUVA治疗中添加bFGFrP导致强烈且更快地诱导色素沉着,具有良好的安全性。
UNASSIGNED: Phototherapy in its different forms, is mainstay of vitiligo management. Combining treatment modalities like topical calcipotriol (for quicker, more intense repigmentation), Low dose azathioprine with
PUVA have proven to be beneficial in management of vitiligo due to different mechanisms of repigmentation and their synergistic effects. Topical bFGF-related decapeptide (bFGFrP) application followed by sun exposure/ UVA phototherapy yields effective repigmentation. bFGFrP has shown to aid the targeted phototherapy in smaller lesions and its combinations with other treatment modalities have been very promising. However, there is paucity of studies on combination treatments; especially oral
PUVA along with bFGFrP. This study was aimed at evaluating safety and efficacy of combination of bFGFrP with Oral PUVA in vitiligo (larger body surface area 20% or more).
UNASSIGNED: Phase IV, randomized, multicentre study (N = 120) in adult patients with stable vitiligo of 6 months treatment period with monthly follow up visits. Psoralen (Tab. Melanocyl) dosage 0.6 mg/kg orally 2 h before exposure to UVA phototherapy. Oral
PUVA therapy, initially, at an irradiation dose 4 J/cm2 (
PUVA group), followed by increments 0.5 J/cm2 every four sittings if tolerated for twice weekly. Primary end point was improvement in extent of repigmentation (EOR) in target lesion (at least 2 cm × 2 cm in greatest dimension, without leukotrichia), while secondary endpoints were improvement in patient global assessment (PGA) and safety at end of 6 months of treatment period in bFGFrP + oral PUVA combination group and Oral
PUVA monotherapy group.
UNASSIGNED: End of 6 months, significantly greater EOR >50%) was achieved in 61.8% (34 patients, n = 55) from combination group while 30.2% (16 patients, n = 53) from the oral PUVA monotherapy group (n = 53). Regarding Grade of repigmentation (GOR), complete repigmentation was observed 5.5% (3 patients, n = 55) in combination group whereas no patient showed complete repigmentation in monotherapy group (p ≤ 0.05), PGA showed significant overall improvement in combination group (p ≤ 0.05); 6 patients (10.9%) from combination group Vs one (1.9%) showed complete improvement. During treatment period, there were no reported adverse events.
UNASSIGNED: Addition of bFGFrP to oral PUVA therapy resulted in intense and faster induction of repigmentation than oral
PUVA monotherapy with favorable safety profile.