de Quatrebarbes Julie, Estève Eric, Bagot Martine, Bernard Philippe, Beylot-Barry Marie, Delaunay Michele, D'Incan Michel, Souteyrand Pierre, Vaillant Loïc, Cordel Nadège, Courville Philippe, Joly Pascal
Department of Dermatology and Pathology, University of Rouen, Rouen, France.
Arch Dermatol. 2005 Sep;141(9):1117-20. doi: 10.1001/archderm.141.9.1117.
To determine if a therapeutic regimen of twice-weekly applications of mechlorethamine hydrochloride and betamethasone dipropionate cream is effective in the treatment of early-stage mycosis fungoides while increasing cutaneous tolerance.
Prospective nonrandomized study conducted from November 1999 to November 2002.
Eleven university or hospital dermatology departments in France.
Sixty-four consecutive patients with newly diagnosed early-stage mycosis fungoides (stage IA, n = 33; stage IB, n = 26; stage IIA, n = 5).
Patients were treated with twice-weekly applications of a 0.02% aqueous solution of mechlorethamine followed by an application of betamethasone cream during a 6-month period.
The primary end point was the rate of complete response during the treatment. Secondary end points were mean delay to achieve complete response, rate of severe cutaneous reactions of intolerance, and rate of relapse after achieving complete response.
Thirty-seven patients (58%) had a complete response after a mean +/- SD treatment duration of 3.6 +/- 2.5 months: 20 (61%) of 33 patients with stage IA disease, 15 (58%) of 26 patients with stage IB disease, and 2 (40%) of 5 patients with stage IIA disease. Eighteen patients (28%) developed severe cutaneous reactions of intolerance that necessitated treatment discontinuation. Relapse was observed in 17 patients (46%) after a mean +/- SD time of 7.7 +/- 6.5 months.
A regimen of twice-weekly applications of mechlorethamine and betamethasone cream is an effective treatment for early-stage mycosis fungoides. The decreased frequency of applications provides an advantage to the patient by being easy to use with limited adverse effects.
确定每周两次应用盐酸氮芥和丙酸倍氯米松乳膏的治疗方案在治疗早期蕈样肉芽肿时是否有效,同时提高皮肤耐受性。
1999年11月至2002年11月进行的前瞻性非随机研究。
法国11个大学或医院皮肤科。
64例新诊断的早期蕈样肉芽肿患者(IA期,n = 33;IB期,n = 26;IIA期,n = 5)。
患者在6个月期间每周两次应用0.02%氮芥水溶液,随后涂抹倍他米松乳膏。
主要终点是治疗期间的完全缓解率。次要终点是达到完全缓解的平均延迟时间、严重皮肤不耐受反应率以及达到完全缓解后的复发率。
37例患者(58%)在平均±标准差治疗持续时间3.6±2.5个月后达到完全缓解:33例IA期疾病患者中的20例(61%),26例IB期疾病患者中的15例(58%),5例IIA期疾病患者中的2例(40%)。18例患者(28%)出现严重皮肤不耐受反应,需要停药。17例患者(46%)在平均±标准差时间7.7±6.5个月后复发。
每周两次应用氮芥和倍他米松乳膏的方案是早期蕈样肉芽肿的有效治疗方法。应用频率降低对患者有利,因为使用方便且不良反应有限。