Evans E G, Dodman B, Williamson D M, Brown G J, Bowen R G
Department of Microbiology, University of Leeds and General Infirmary.
BMJ. 1993 Sep 11;307(6905):645-7. doi: 10.1136/bmj.307.6905.645.
To compare the efficacy and safety of terbinafine 1% cream and clotrimazole 1% cream in the treatment of tinea pedis.
Multicentre, double blind parallel group study.
32 general practices and one hospital.
256 patients with mycologically confirmed tinea pedis. Of the 211 patients evaluable, 107 were randomised to terbinafine (75 male, 32 female; mean (range) age 40 (12-81) years) and 104 to clotrimazole (79 male, 25 female; mean (range) age 36 (12-71) years).
Terbinafine 1% cream applied twice daily for one week and inert cream applied twice daily for the next three weeks. Clotrimazole 1% cream applied twice daily for four weeks.
Mycological cure (negative results on microscopy and culture) and effective treatment (mycological cure plus no or minimal signs and symptoms) measured at weeks 1, 2, 3, 4, and 6.
At week four rates of mycological cure were 93.5% for terbinafine and 73.1% for clotrimazole (p = 0.0001); and at week six 97.2% for terbinafine and 83.7% for clotrimazole (p = 0.001). Rates of effective treatment at week 4 were 89.7% for terbinafine and 58.7% for clotrimazole (p = 0.0001); and 89.7% for terbinafine and 73.1% for clotrimazole (p = 0.002) at week 6.
These results indicate that a one week course of terbinafine 1% cream is more effective in the treatment of tinea pedis than a four week course of clotrimazole 1% cream, both in terms of mycological cure and effective treatment.
比较1%特比萘芬乳膏和1%克霉唑乳膏治疗足癣的疗效和安全性。
多中心、双盲平行组研究。
32家普通诊所和1家医院。
256例经真菌学确诊的足癣患者。在211例可评估患者中,107例被随机分配至特比萘芬组(男75例,女32例;平均(范围)年龄40(12 - 81)岁),104例被随机分配至克霉唑组(男79例,女25例;平均(范围)年龄36(12 - 71)岁)。
1%特比萘芬乳膏每日涂抹两次,连用一周,接下来三周每日涂抹惰性乳膏。1%克霉唑乳膏每日涂抹两次,连用四周。
在第1、2、3、4和6周时评估真菌学治愈(显微镜检查和培养结果为阴性)和有效治疗(真菌学治愈加无或仅有轻微体征和症状)情况。
在第4周时,特比萘芬组的真菌学治愈率为93.5%,克霉唑组为73.1%(p = 0.0001);在第6周时,特比萘芬组为97.2%,克霉唑组为83.7%(p = 0.001)。在第4周时,特比萘芬组的有效治疗率为89.7%,克霉唑组为58.7%(p = 0.0001);在第6周时,特比萘芬组为89.7%,克霉唑组为73.1%(p = 0.002)。
这些结果表明,就真菌学治愈和有效治疗而言,1%特比萘芬乳膏一周疗程治疗足癣比1%克霉唑乳膏四周疗程更有效。