Clin Ther. 1985;7(5):574-83.
Two randomized, double-blind, parallel-group studies, each conducted at five medical centers, assessed the efficacy and safety of a new antifungal agent, ciclopirox olamine cream 1%, in patients with tinea versicolor. In one study, the antifungal agent was compared with its cream vehicle; in the other, it was compared with another antifungal compound, 1% clotrimazole cream. In both studies, treatments were applied twice daily for 14 days. Results with ciclopirox olamine cream were significantly better (P less than 0.05) than those with the vehicle alone after one and two weeks of therapy and at one and two weeks posttherapy. After two weeks of treatment, 49% of the 73 patients treated with the antifungal cream were clinically and mycologically cured, whereas only 24% of the 72 patients using the vehicle were similarly cured (P less than 0.001). The clinical cure rate with ciclopirox olamine cream also was significantly better (P less than 0.05) than that with clotrimazole cream. After two weeks of treatment, 77% of the patients treated with ciclopirox olamine, compared with 45% of those treated with clotrimazole, had both clinical and mycological cures (P less than or equal to 0.001). Fourteen days posttreatment, the proportion of patients with a combined response was still greater in the ciclopirox olamine group (86%) than in the clotrimazole group (73%). No side effects were observed in any treatment group.
两项随机、双盲、平行组研究，每项研究在五个医学中心进行，评估了一种新型抗真菌药物1%环吡酮胺乳膏治疗花斑癣患者的疗效和安全性。在一项研究中，将该抗真菌药物与其乳膏基质进行比较；在另一项研究中，将其与另一种抗真菌化合物1%克霉唑乳膏进行比较。在两项研究中，治疗均为每日两次，持续14天。治疗1周和2周后以及治疗后1周和2周时，环吡酮胺乳膏的治疗效果显著优于单独使用基质（P小于0.05）。治疗两周后，73例接受抗真菌乳膏治疗的患者中有49%在临床和真菌学上治愈，而72例使用基质的患者中只有24%同样治愈（P小于0.001）。环吡酮胺乳膏的临床治愈率也显著优于克霉唑乳膏（P小于0.05）。治疗两周后，接受环吡酮胺治疗的患者中有77%实现了临床和真菌学治愈，而接受克霉唑治疗的患者中这一比例为45%（P小于或等于0.001）。治疗后14天，环吡酮胺组联合反应患者的比例（86%）仍高于克霉唑组（73%）。任何治疗组均未观察到副作用。
