不同方案国产特比萘芬治疗头癣随机双盲比较研究

A randomized double-blind comparative study of domestic terbinafine in the treatment of tinea capitis

目的：评价国产特比萘芬治疗头癣的疗效及安全性，探索最佳给药方案。方法：头癣患者随机分成三组，A组连服2周，B组连服4周，C组连服1周后间隔2周再连服1周，4周治疗中不口服特比萘芬时给安慰剂，按体重给药，于第8周末评价疗效及安全性。结果：76例可评价患者分离的病原菌主要包括犬小孢子菌48株（62．3％）、须癣毛癣菌24株（31．2％）。于8周末评价时，治愈率分别为64％、889％和83．3％。只见轻微副作用。结论：口服国产特比萘芬治疗头癣疗效高、安全性好、患者耐受性好，连续服药1周后间隔2周再连续服药1周，为我们的推荐方案。

Objectives: To assess the efficacy and safety of domestic terbinafine with different regimens for the treatment of tinea capitis. Methods: Tinea capitis patients were diagnosed clinically, microscopically and by culture, and were enrolled in a randomized 3 groups for clinical trial. The regimens used were: domestic terbinafine for 2 weeks and followed by 2 weeks of placebo(group A); terbinafine for 4 weeks(group B); terbinafine for 1 week followed by 2 weeks of placebo and another 1 week of terbinafine (group C). The dosage of drug was given according to patients body weight. The therapeutic response and adverse events were evaluated at 8 week. Results: At 8 weeks 76 patients (25 cases in group A,27cases in group B and 24 cases in group C)received final evaluation. The cure rates of 3 study groups were observed to be 64%, 88.9% and 83.3%, respectively with mild adverse effects. Conclusions: Oral domestic terbinafine is very effective and safe for the treatment of tinea capitis. The authors recommend the third regimen as the first choice in terms of its efficacy and safety.