复方乳酸软膏治疗手足皲裂症临床研究

A double-blind placebo-controlled clinical trial of lactic acid compound ointment in the treatment of rhagadia manus et pedis

目的:评价复方乳酸软膏治疗手足皲裂症的疗效。方法:采用多中心、随机双盲、安慰剂对照研究,试验组和对照组均为每日局部用药2次,疗程4周。结果:共入选手足皲裂患者125例,包括试验组63例,对照组62例。治疗4周后,试验组的总有效率为100%,而对照组为57.4%。两组有效率间比较,具有统计学意义(P=0.000)。试验组和对照组各有1例发生不良反应,发生率1.6%。结论:复方乳酸软膏治疗手足皲裂症具有满意的疗效,且耐受性良好,使用方便。

Objective: To evaluate the efficacy and safety of lactic acid compound ointment in the treatment of rhagadia manus et pedis.Methods: The trail was performed in multiple-center randomized double-blind placebo-controlled method. All the subjects were applied with the ointment twice a day for four weeks. Results: Total 125 subjects were recruited into the trial, including 63 subjects in the test group and 62 subjects in control group. The total response rate were 100% in the test group after four-week therapy, while in control group, the rate was 57.4%. The difference in response rates between the two groups was statistically significant (P=0.000). One case of side-effect occurred each in test group and control group respectively, accounting for 1.6%. Conclusion: The lactic acid compound ointment showed a good efficacy, high safety and tolerability in the treatment of rhagadia manus et pedis.