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目的观察不同疗程1%国产卢立康唑乳膏对念珠菌性包皮龟头炎的治疗效果及安全性。方法采用随机方法将90例患者平均分成A、B、C 3组,分别给予卢立康唑1周治疗,2周治疗以及酮康唑乳膏2周对照治疗,用药后1、2、4周评价临床疗效、真菌学清除率以及不良反应。结果 90例入组患者中有86例患者进行疗效评价,治疗后1周时3组的有效率分别为69.0%、64.3%、65.5%(P>0.05),3组的真菌清除率分别为82.8%、82.1%、82.8%(P>0.05);治疗后2周时3组的有效率分别为72.4%、78.6%、75.9%(P>0.05),3组的真菌清除率分别为82.8%、85.7%、86.2%(P>0.05);治疗后4周时3组的有效率分别为75.9%、85.7%和82.8%(P>0.05),3组真菌清除率分别为86.2%、85.7%和89.7%(P>0.05),治疗后第1、2、4周3组之间疗效和真菌清除率均无显著性差异(P>0.05)。不良事件发生率低(2.3%),仅为局部不良反应。结论 1%卢立康唑乳膏治疗念珠菌性包皮龟头炎安全有效,1周疗程与2周疗程疗效相当。
Objective To observe the curative effect and safety of 1% domestic Luliconazole cream on Candida balanitis with different course of treatment. Methods A total of 90 patients were randomly divided into A, B and C groups. The patients were treated with luliconazole for 1 week, 2 weeks and ketoconazole cream for 2 weeks respectively. The clinical evaluation was performed at 1, 2 and 4 weeks after treatment Efficacy, mycological clearance and adverse reactions. Results The efficacy of 90 patients was evaluated in 86 patients. The effective rates of the three groups were 69.0%, 64.3% and 65.5% respectively at 1 week after treatment (P> 0.05). The fungal clearance rates of the three groups were 82.8 %, 82.1%, 82.8% (P> 0.05). The effective rates of the three groups were 72.4%, 78.6% and 75.9% respectively at 2 weeks after treatment (P> 0.05) 85.7% and 86.2% (P> 0.05). After 4 weeks of treatment, the effective rates of the three groups were 75.9%, 85.7% and 82.8%, respectively. The fungal clearance rates of the three groups were 86.2% and 85.7% 89.7% (P> 0.05). There was no significant difference in curative effect and fungal clearance between the first, second and fourth week after treatment (P> 0.05). The incidence of adverse events was low (2.3%) and was only a local adverse event. Conclusion Luriconazole cream is safe and effective in the treatment of candidal foreskin balanitis. The 1-week course of treatment is equivalent to that of 2-week course.