抗皮肤真菌药联苯苄唑溶液的Ⅱ期临床试验

PHASE Ⅱ CLINICAL TRIAL OF 1% BIFONAZOLE SOLUTION IN THE TREATMENT OF DERMATOMYCOSES

联苯苄唑是一种新的咪唑类广谱抗真菌药，本项临床研究以1％克霉唑溶液作对照，采用多中心随机双盲对照试验和开放试验，评价1％联苯等唑溶液治疗皮肤真菌病的疗效和安全性。在随机双盲对照试验中，共治疗患者257例，其中联苯苄唑组132例，克霉唑组125例。两组的治愈率分别是78．8％和73．6％，有效率分别是90．2％和87．2％，真菌阴转率分别是89．4％和81．8％，不良反应发生率分别是5．3％和4．8％。经统计学处理，两组间均无显著性差异（P＞0．05）。联苯苄唑溶液组的起效时间平均4．3±2．4d，而克霉唑溶液组平均5．4±2．7d，联苯苄唑溶液的起效时间较克霉唯溶液快（P＜0．01）。

Bifonazole is a new broad - spectrum imidazolyl antimycotic. This study conducted double blind randomized controlled and open multi - center clinical trials, to evaluate the efficacy and safty of 1 % bi f0nazole sol in the treatment of dermatomycoses. 1% Coltrimazole sol was chosen as the control.In the double blind randomized controlled trial, total 257 patients entered the study, 132 in bifonazole group and 125 in clotrimazole group. The cure rates of bifonazole sol and clotrimazole solwere 78. 8% and 73. 6%, the efficacy rates were 90. 2% and 87. 2% respectively. The mycotic clearance rate was 89. 4% of bifonazole sol vs, 81. 8% of clotrimazole sol. The adverse effects of bifonazole sol and clotrimazole sol were 5. 3% and 4. 8% respectively. There was no statistical significant difference between the two groups (P >0. 05).The average time of initial effect of 1% bifonazole sol was 4. 3 ± 2. 4 (d) vs, 5. 4 ± 2. 7(d) of 1% clotrimazole sol. The average time of initial effect of 1% bifonazole sol was shorter than that of 1% clotrimazole sol (P < 0. 01 ).