Faergemann Jan, Gupta A K, Al Mofadi A, Abanami A, Shareaah A Abu, Marynissen Greet
Department of Dermatology, Sahlgrenska University Hospital, S-413 45 Gothenburg, Sweden.
Arch Dermatol. 2002 Jan;138(1):69-73. doi: 10.1001/archderm.138.1.69.
Pityriasis (tinea) versicolor has a high tendency to recur after being treated successfully. Prophylactic treatment to reduce recurrence is needed.
To determine whether recurrence of pityriasis versicolor could be prevented by prophylactic itraconazole treatment.
Open treatment followed by a randomized, double-blind, placebo-controlled phase.
Multinational outpatient centers.
A total of 239 consecutive patients were included; 238 started open treatment. A total of 209 patients started prophylactic treatment: 106 in the itraconazole group and 103 in the placebo group.
Open treatment: itraconazole, 200 mg once daily for 7 days. Prophylactic treatment: itraconazole, 200 mg, or placebo twice daily 1 day per month for 6 consecutive months.
Mycological cure rates at the end of open treatment and at the end of prophylactic treatment.
Mycological cure at the end of open treatment was 92% (205/223). At the prophylactic treatment end point (6 months), mycological cure was 88% (90/102) in the itraconazole group and 57% (56/99) in the placebo group (P<.001). In open treatment, 11 patients were not able to be evaluated for efficacy. In prophylactic treatment, 4 patients in the itraconazole group and 4 in the placebo group were not able to be evaluated. Adverse events were reported during open treatment by 26 patients (11%) and during prophylactic treatment by 17 (16%) in the itraconazole group and 14 (14%) in the placebo group. No patients experienced any serious adverse events.
Prophylactic itraconazole treatment is efficacious for pityriasis versicolor after 6 months, as is itraconazole in the treatment of pityriasis versicolor.
花斑糠疹(花斑癣)在成功治疗后极易复发,因此需要进行预防性治疗以降低复发率。
确定预防性伊曲康唑治疗能否预防花斑糠疹复发。
开放治疗后进入随机、双盲、安慰剂对照阶段。
跨国门诊中心。
共纳入239例连续病例;238例开始开放治疗。共有209例患者开始预防性治疗:伊曲康唑组106例,安慰剂组103例。
开放治疗:伊曲康唑,每日1次,每次200mg,共7天。预防性治疗:伊曲康唑200mg或安慰剂,每月1天,每日2次,连续6个月。
开放治疗结束时及预防性治疗结束时的真菌学治愈率。
开放治疗结束时真菌学治愈率为92%(205/223)。在预防性治疗终点(6个月)时,伊曲康唑组真菌学治愈率为88%(90/102),安慰剂组为57%(56/99)(P<0.001)。开放治疗中,11例患者无法评估疗效。预防性治疗中,伊曲康唑组和安慰剂组各有4例患者无法评估。开放治疗期间,伊曲康唑组26例患者(11%)报告了不良事件,预防性治疗期间,伊曲康唑组17例(16%)、安慰剂组14例(14%)报告了不良事件。无患者发生任何严重不良事件。
预防性伊曲康唑治疗6个月后对花斑糠疹有效,伊曲康唑治疗花斑糠疹同样有效。