準分子雷射加上tacrolimus軟膏對UV有抵抗性的白斑有效


  Sept. 21, 2004 - 根據一項發表於9月號皮膚學學誌上的比較性、前瞻性、隨機分派、個體間早期試驗結果顯示,結合0.1%局部tacrolimus軟膏與308-nm準分子雷射在治療對紫外線(UV)治療無效的白斑病灶上比單獨雷射治療更有效。
  
  法國尼斯I'Archet醫院皮膚科Thierry Passeron醫師指出,窄頻(NB)-UV-B被認為是治療廣泛性白斑最佳的治療;根據研究人員表示,UV-B療法被認為透過對黑色素細胞與角質細胞分泌的細胞激素的直接作用,而刺激黑色素細胞轉移,以及從髮囊凹處增殖。
  
  研究人員指出,最近對於白斑自體免疫來源的實驗,也強調了UV療法的免疫抑制作用對於白斑再色素化可能的應用;Tacrolimus,一種新的局部免疫抑制藥物,被開發用於治療異位性皮膚炎,已經被兩項前瞻性試驗受矚目的結果證實可以治療白斑。
  
  為了確定結合雷射治療與免疫抑制方式的效果,研究人員徵集14位受試者,年齡從12到63歲,患有Fitzpatrick皮膚類型II到VI的、而且有白斑至少3個月以上的患者;總共有43個白斑病灶被隨機分派接受每週兩次的308-nm準分子雷射治療持續六週,或是雷射治療加上0.1%局部tacrolimus軟膏每天塗抹兩次(雙重治療組);治療後的病灶再與受試者另外一邊未接受治療的病灶相比較。
  
  起初的雷射劑量是12 mcal/cm2(50 mJ/cm2),低於使用於白斑皮膚最低的引起紅腫的劑量,而且每個接受隔次治療時將劑量加到12 mcal/cm2。試驗主要終點是治療效果,定義為再色素化超過75%。
  
  6週後的結果顯示這兩種治療相較於控制組,對於再色素化有顯著的效果(P<.001);所有病灶(100%)以雙重治療(共23位)的結果顯示再色素化,相較於單獨雷射治療(共20位)的85%,雙重治療組相較於單獨雷射治療再色素化地比較快(10次治療相較於12次治療)。
  
  雙重治療組達到75%以上再色素化的病灶比例比雷射單獨治療多(70%相較於20%,P<.001)。
  
  雙重治療組對於UV治療無效的區域(例如骨質為主的部位)相較於單獨治療組(60%相較於0%,P<.002)有更高的治療成功率,但是在兩組治療對UV敏感的位置,例如臉部、軀幹、與四肢沒有明顯的差異(77%相較於57%,P=.61)。
  
  治療反應被發現與病灶位置有關:對UV敏感的病灶相較於對UV沒有敏感性的病灶產生反應的程度更高(P=.004);對於治療反應與年齡(P=.73)、性別(P=.39)、皮膚種類(P=.17)或是最低引起紅腫的劑量(P=.72)之間沒有關係。
  
  此外,研究也發現,對治療的耐受性是很好的;不良反應包括中度至嚴重的紅腫,每位病患至少發生一次,以及罕見的大泡性病灶(每組有兩個病灶),36%的病患因為tacrolimus軟膏發生中度的刺痛。
  
  研究人員指出,結合0.1%的tacrolimus軟膏每天2次,以及308-nm的準分子雷射療法每週2次對於UV敏感的或是不敏感的區域有絕佳的效果;研究人員也指出,需要監視試驗(有控制組的)以及更大的樣本數目來確認這些早期試驗結果。

Excimer Laser Plus Tacrolimus<

By Yael Waknine
Medscape Medical News

Sept. 21, 2004 — Combination therapy with topical 0.1% tacrolimus ointment and the 308-nm excimer laser is significantly more effective than laser monotherapy in the repigmentation of ultraviolet (UV)-resistant vitiliginous lesions, according to the results of a comparative, prospective, randomized, intra-individual preliminary study published in the September issue of the Archives of Dermatology.

"Narrowband (NB)-UV-B therapy is considered the best treatment for extensive vitiligo vulgaris," write Thierry Passeron, MD, from the Department of Dermatology at the Hôpital de l'Archet in Nice, France, and colleagues. According to the authors, UV-B therapy is thought to stimulate melanocytic migration and proliferation from the niches located in hair follicles through direct action on melanocytes and the actions of cytokines secreted by keratinocytes.

"Recent studies on the autoimmune origin of vitiligo also emphasize the probable implication of the immunosuppressive action of UV therapy in the repigmentation of vitiliginous plaques," the authors note. "[T]acrolimus, a new topical immunosuppressive drug developed for the treatment of atopic dermatitis, has shown some interesting results in treating vitiligo in 2 prospective studies."

To determine the effectiveness of combining laser therapy with an immunosuppressive approach, the investigators recruited 14 subjects, aged 12 to 63 years, with Fitzpatrick skin types II to IV and having had vitiligo for a minimum of three months. A total of 43 vitiliginous lesions were randomized to receive either 308-nm excimer laser monotherapy twice weekly for six weeks or the laser sessions plus topical 0.1% tacrolimus ointment applied twice daily (dual therapy group). Treated lesions were matched with untreated lesions (controls) on the subjects' opposite side.

Initial laser dose was 12 mcal/cm2 (50 mJ/cm2) less than the minimal erythemal dose in vitiliginous skin, and fluences were increased by 12 mcal/cm2 at every second session. The primary outcome was treatment efficacy as defined by lesion repigmentation of 75% or greater.

Results at six weeks showed both treatments to have had a significant effect on repigmentation compared with controls (P < .001 for each). All lesions (100%) treated with dual therapy (n = 23) showed repigmentation compared with 85% of those treated with laser monotherapy (n = 20). Lesions in the dual therapy group had a quicker onset of repigmentation compared with the monotherapy group (10 sessions vs. 12 sessions).

The percentage of lesions achieving repigmentation of 75% or greater was significantly higher in the dual therapy group compared with the monotherapy group (70% vs. 20%; P < .001).

The dual therapy group also showed a significantly higher rate of treatment efficacy for lesions in UV-resistant areas (eg, bony prominences) compared with the monotherapy group (60% vs. 0%; P < .002), but no statistical difference was found between the two treatments in UV-sensitive areas such as the face, neck, trunk, and limbs (77% vs. 57%; P = .61).

Treatment response was found to be related to lesion locale: UV-sensitive lesions responded to a significantly greater degree than did UV-resistant lesions (P = .004). No association was found between response to treatment and age (P = .73), sex (P = .39), skin type (P = .17), or minimal erythemal dose (P = .72).

Treatment was well tolerated. Adverse events included moderate to severe erythema occurring at least once in each patient and rare bullous eruptions (two lesions in each group). Moderate stinging due to tacrolimus ointment application occurred in 36% of patients.

"The combination of 0.1% tacrolimus ointment applied twice daily and 308-nm excimer laser therapy performed twice a week gives excellent results on UV-sensitive and UV-resistant areas," the authors write. "A monitored study (with controls) on a larger population would be in order to confirm these encouraging preliminary results."

The authors report no pertinent financial disclosures.

Arch Dermatol. 2004;140:1065-1069

Reviewed by Gary D. Vogin, MD

    
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