Gupta A K, Hofstader S L, Summerbell R C, Solomon R, Adam P, Alexis M, Raboobee N, De Doncker P
Department of Medicine, Sunnybrook Health Science Center and the University of Toronto, Ontario, Canada.
J Am Acad Dermatol. 1998 Aug;39(2 Pt 1):216-9. doi: 10.1016/s0190-9622(98)70078-7.
The number of newly diagnosed cases of tinea capitis in children appears to be on the rise, particularly in urban centers.
The purpose of this study was to assess the effectiveness, safety, and compliance of itraconazole pulse therapy for tinea capitis.
Fifty subjects (48 children [less than 18 years of age] and 2 adults) with tinea capitis were treated with pulse itraconazole in a multicenter evaluation. Each pulse lasted 1 week, with 2 weeks between the first two pulses and 3 weeks between the second and third pulses. The decision to administer a second or third pulse was determined by the response of the subject at the time that the next pulse was due. During the 1-week pulse of active therapy, itraconazole (5 mg/kg/day) was dosed as follows: more than 40 kg, 200 mg per day (two capsules per day); 20 to 40 kg, 100 mg per day (one capsule per day); and 10 to 19 kg, 50 mg per day (one half of a capsule per day). The duration of the study was 12 weeks with mycologic evaluation at this time. Subjects who were classified as treatment failures at 12 weeks after the start of therapy were given the option of receiving an additional 1-week pulse of active therapy, with 3 weeks between successive pulses.
The causative organisms were Trichophyton tonsurans (41 subjects), T violaceum (7), T. soudanense (1), and T rubrum (1). Thirteen subjects were lost to follow-up, with 37 subjects (35 children and 2 adults) available for evaluation 12 weeks after the start of therapy. At this time, cure (clinical and mycologic) was observed in 30 (81%) of 37 subjects. When the tinea capitis was mild, cure was obtained after one pulse in two subjects and after two pulses in five subjects. With tinea capitis of moderate extent, complete cure was obtained after one pulse in one subject, two pulses in eight subjects, and after three pulses in seven subjects. When tinea capitis was severe, two and three pulses produced complete cure in one and six subjects, respectively. Of the seven subjects whose conditions failed to respond (three subjects with moderate disease and four subjects with severe disease), five subjects chose to receive extra itraconazole. Clinical and mycologic cure was observed after four pulses in four subjects and after five pulses in one subject. There were no associated clinical adverse effects with itraconazole therapy.
With tinea capitis, itraconazole pulse therapy is effective and safe and is associated with high compliance. The pulse regimen enables the duration of treatment to be individualized, according to the extent of disease and its rate of resolution.
儿童头癣新诊断病例数似乎在上升,尤其是在城市中心。
本研究旨在评估伊曲康唑脉冲疗法对头癣的有效性、安全性和依从性。
50名头癣患者(48名儿童[小于18岁]和2名成人)在多中心评估中接受伊曲康唑脉冲治疗。每个脉冲持续1周,前两个脉冲之间间隔2周,第二个和第三个脉冲之间间隔3周。是否给予第二个或第三个脉冲取决于下一个脉冲应给予时受试者的反应。在1周的积极治疗脉冲期间,伊曲康唑(5mg/kg/天)的给药如下:体重超过40kg,每天200mg(每天两粒胶囊);20至40kg,每天100mg(每天一粒胶囊);10至19kg,每天50mg(每天半粒胶囊)。研究持续时间为12周,此时进行真菌学评估。在治疗开始12周后被分类为治疗失败的受试者可选择接受额外1周的积极治疗脉冲,连续脉冲之间间隔3周。
致病生物体为断发毛癣菌(41名受试者)、紫色毛癣菌(7名)、苏丹毛癣菌(1名)和红色毛癣菌(1名)。13名受试者失访,37名受试者(35名儿童和2名成人)在治疗开始12周后可供评估。此时,37名受试者中有30名(81%)观察到治愈(临床和真菌学)。当头癣为轻度时,2名受试者在一个脉冲后治愈,5名受试者在两个脉冲后治愈。对于中度头癣,1名受试者在一个脉冲后完全治愈,8名受试者在两个脉冲后完全治愈,7名受试者在三个脉冲后完全治愈。当头癣严重时,两个和三个脉冲分别使1名和6名受试者完全治愈。在7名病情无反应的受试者中(3名中度疾病受试者和4名重度疾病受试者),5名受试者选择接受额外的伊曲康唑治疗。4名受试者在四个脉冲后观察到临床和真菌学治愈,1名受试者在五个脉冲后观察到临床和真菌学治愈。伊曲康唑治疗未出现相关临床不良反应。
对于头癣,伊曲康唑脉冲疗法有效且安全,依从性高。脉冲方案可根据疾病程度及其消退速度使治疗持续时间个体化。