Richard M-A
Université de la Méditerranée Aix-Marseille II, Assistance Publique-Hôpitaux de Marseille, Service de Dermatologie, Hôpital de la Timone, 264 rue Saint-Pierre, 13005 Marseille, France.
Ann Dermatol Venereol. 2010 Nov;137 Suppl 3:S111-23. doi: 10.1016/S0151-9638(10)70038-7.
After an open preliminary study, two double-blind placebo-controlled randomized studies have confirmed the value of per os alitretinoin in the management of severe chronic hand eczema (CHE). The first showed dose-dependent efficacy and a response defined as "clear" or "almost clear" by 53% of the patients receiving 10-40 mg of alitretinoin per day for 12 weeks. In the second multicenter study (the Bach study), comparing the efficacy of a 12-week alitretinoin treatment (10 mg, 30 mg) to placebo for CHE, a "clear or almost clear" result was observed in 17% (placebo group), 28% (group alitretinoin 10 mg), and 48% (group alitretinoin 30 mg). The onset of action was also significantly shorter in the group treated with 30 mg of alitretinoin compared to the group treated with 10 mg. In a study of randomized retreatment versus placebo, 80% of the patients who were initially responders to alitretinoin and whose CHE had relapsed found "clear" or "almost clear" with alitretinoin 30 mg administered for 12-24 weeks compared to 48% with alitretinoin 10 mg. In all the studies, clinical tolerance was comparable and satisfactory, with the most frequent negative side effects being headache, flushing, and mucocutaneous signs identical to those compared with other retinoids. An increase in cholesterol and/or triglycerides was the most frequent biological side effect. Central hypothyroidism, with no clinical expression, was observed more rarely. These studies confirm that alitretinoin treatment can be envisaged as second-line therapy in adults with CHE that does not respond to well-observed treatment with class potent or very potent dermocorticoids.
经过一项开放性初步研究后,两项双盲安慰剂对照随机研究证实了口服阿利维A酸在重度慢性手部湿疹(CHE)治疗中的价值。第一项研究显示了剂量依赖性疗效,接受每日10 - 40毫克阿利维A酸治疗12周的患者中,53%的患者反应定义为“清除”或“几乎清除”。在第二项多中心研究(巴赫研究)中,比较了阿利维A酸12周治疗(10毫克、30毫克)与安慰剂治疗CHE的疗效,安慰剂组“清除或几乎清除”的比例为17%,阿利维A酸10毫克组为28%,阿利维A酸30毫克组为48%。与10毫克阿利维A酸治疗组相比,30毫克阿利维A酸治疗组的起效时间也显著更短。在一项随机再治疗与安慰剂对照研究中,最初对阿利维A酸有反应但CHE复发的患者,接受12 - 24周30毫克阿利维A酸治疗后,80%的患者“清除”或“几乎清除”,而接受10毫克阿利维A酸治疗的患者这一比例为48%。在所有研究中,临床耐受性相当且令人满意,最常见的负面副作用是头痛、潮红以及与其他维甲酸类药物相比相同的皮肤黏膜症状。胆固醇和/或甘油三酯升高是最常见的生物学副作用。未观察到有临床症状的中枢性甲状腺功能减退,但其出现更为罕见。这些研究证实,对于对强效或超强效外用糖皮质激素规范治疗无反应的成年CHE患者,阿利维A酸治疗可被视为二线治疗方案。