尿素乳膏治疗手足皲裂症临床研究

A clinical trial of urea acid compound ointment for the treatment of rhagadia manus et pedis

目的评价本院自制制剂尿素乳膏治疗手足皲裂症的疗效和安全性。方法采用随机双盲、安慰剂对照研究,试验组和对照组均为局部用药,2次/d,疗程4周。结果手足皲裂患者26例,包括试验组和对照组各13例。治疗4周后,试验组的总有效率为100%,而对照组的总有效率为61.6%。两组之间的有效率比较,具有统计学意义(P<0.01)。试验组有1例发生不良事件。结论尿素乳膏治疗手足皲裂症具有很高的疗效,且安全性和耐受性良好,使用方便。

Objective To evaluate the efficacy and safety of urea acid compound ointment for the treatment of rhagadia manus et pedis. Methods The trail was performed in randomized double-blind and placebo control method. All the subjects were administratd with drugs twice a day for four weeks. Results The total number of all the subjects was 26; including 13 subjects in trial group and 13 subjects in control group. The total improved rates were 100% in trail group after four-week therapy; while in control group; were 61.6%. The improved rates between two groups had statistic differences （ P 〈 0. 01 ）. One case of adverse event occured in trail group. Conclusion The urea acid compound ointment has good efficacy; safety and tolerability in treatment of rhagadia manus et pedis ; and can be used conveniently.