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目的评价1%硝酸异康唑乳膏治疗足癣和体股癣的疗效及安全性,并与2%硝酸咪康唑霜对照。方法采用多中心随机双盲对照试验。试验组及对照组分别外用1%硝酸异康唑乳膏和2%硝酸咪康唑霜,2次/d,疗程足癣4周,体股癣2周。结果足癣试验组71例,对照组72例;体股癣试验组73例,对照组73例。足癣患者在4周时临床有效率试验组87.3%,对照组87.5%,在6周时分别为88.7%和91.7%;在4周时真菌学清除率试验组83.1%,对照组94.4%(P=0.0363),在6周时分别为84.5%和90.3%;在4周时总有效率试验组77.5%,对照组86.1%;在6周时分别为78.9%和86.1%。体股癣患者在2周时临床有效率试验组87.7%,对照组93.2%,在4周时分别为91.8%和94.5%;在2周时真菌学清除率试验组82.2%,对照组89.0%;在4周时分别为89.0%和93.2%;在2周时总有效率试验组78.1%,对照组86.3%,在4周时分别为87.7%和93.2%。与药物相关的不良反应发生率试验组为2.1%,对照组为1.4%,表现为用药局部刺激、瘙痒、灼痛感或红斑。结果显示1%硝酸异康唑乳膏治疗足癣和体股癣的疗效及安全性与2%硝酸咪康唑霜相似(P>0.05)。结论1%硝酸异康唑乳膏治疗足癣和体股癣有效、安全。
Objective To evaluate the efficacy and safety of 1% isoconazole nitrate cream in the treatment of tinea pedis and tinea corporis and compare with 2% miconazole nitrate cream. Methods A multicenter randomized double-blind controlled trial was used. The experimental group and the control group were topically treated with 1% isoconazole nitrate cream and 2% miconazole nitrate cream twice a day for 4 weeks and tinea pedis for 2 weeks. Results Tinea pedis test group 71 cases, control group 72 cases; body tinea cruris test group 73 cases, control group 73 cases. Tinea pedis was 87.3% in the clinically effective trial group and 87.5% in the control group at 4 weeks, 88.7% and 91.7% at 6 weeks, 83.1% in the 4 weeks and 94.4% in the control group P = 0.0363), 84.5% and 90.3% at 6 weeks, respectively. At 4 weeks, the total effective rate was 77.5% in the trial group and 86.1% in the control group; 78.9% and 86.1% at 6 weeks, respectively. Tinea of patients with tinea corporis was 87.7% in the clinical trial group and 93.2% in the control group at 2 weeks, 91.8% and 94.5% at 4 weeks, 82.2% in the 2nd week, 89.2% in the control group, ; 89.0% and 93.2% at 4 weeks, respectively. At 2 weeks, the total effective rate was 78.1% in the trial group and 86.3% in the control group, reaching 87.7% and 93.2% at 4 weeks respectively. The incidence of drug-related adverse events in the trial group was 2.1% in the control group and 1.4% in the control group, indicating local irritation, itching, burning sensation or erythema. The results showed that the efficacy and safety of 1% isoconazole nitrate cream in the treatment of tinea pedis and tinea corporis was similar to that of 2% miconazole nitrate cream (P> 0.05). Conclusion 1% isoconazole nitrate cream for the treatment of tinea pedis and tinea corporis effective and safe.