Innovaderm Research Inc., 1851 Rue Sherbrooke E., Suite 502, Montreal, QC H2K 4L5, Canada.
Br J Dermatol. 2010 Feb 1;162(2):420-6. doi: 10.1111/j.1365-2133.2009.09572.x. Epub 2009 Nov 10.
Patients with severe chronic hand eczema (CHE) often respond to therapy with oral alitretinoin (9-cis retinoic acid). However, the efficacy of alitretinoin after disease relapse has not been demonstrated.
To assess the efficacy and safety of a second course of oral alitretinoin in patients with severe CHE who relapsed after achieving 'clear' or 'almost clear' hands following a previous course of alitretinoin.
The double-blind study included 117 patients with CHE who had responded to therapy in an earlier clinical trial and subsequently relapsed. Patients were randomized to receive their previous treatment or placebo. Treatment was alitretinoin 30 mg or 10 mg or placebo given once daily for 12-24 weeks. Response was defined as an overall Physician's Global Assessment rating of 'clear' or 'almost clear' hands at the end of therapy.
Response rates were 80% in patients retreated with 30 mg alitretinoin compared with 8% for placebo (P < 0.001). In patients retreated with 10 mg alitretinoin response rates were 48%, compared with 10% in the placebo group. Alitretinoin was well tolerated. Adverse reactions comprised typical retinoid class effects, and no late-arising side-effects were observed during this second course of treatment.
The majority of patients with CHE who previously achieved 'clear' or 'almost clear' hands following treatment with alitretinoin 30 mg per day also responded to a second course of treatment. Retreatment was well tolerated. Intermittent treatment with alitretinoin is suitable for the long-term management of CHE.
患有严重慢性手部湿疹(CHE)的患者通常对口服阿利维 A(9-顺式维甲酸)治疗有反应。然而,阿利维 A 在疾病复发后的疗效尚未得到证实。
评估在先前接受阿利维 A 治疗后手部达到“清晰”或“几乎清晰”,随后复发的严重 CHE 患者中,再次接受口服阿利维 A 治疗的疗效和安全性。
这项双盲研究纳入了 117 例在早期临床试验中对治疗有反应但随后复发的 CHE 患者。患者被随机分配接受之前的治疗或安慰剂。治疗方案为阿利维 A 30 mg 或 10 mg 或安慰剂,每天一次,治疗 12-24 周。治疗结束时,整体医生全球评估(PGA)手部“清晰”或“几乎清晰”定义为缓解。
用 30 mg 阿利维 A 治疗的患者缓解率为 80%,而安慰剂组为 8%(P<0.001)。用 10 mg 阿利维 A 治疗的患者缓解率为 48%,而安慰剂组为 10%。阿利维 A 耐受性良好。不良反应包括典型的类视黄醇类效应,在这第二疗程中未观察到迟发性副作用。
先前接受 30 mg/天阿利维 A 治疗手部达到“清晰”或“几乎清晰”的 CHE 患者,多数也对第二疗程治疗有反应。再次治疗耐受良好。阿利维 A 的间歇性治疗适用于 CHE 的长期管理。