倍他米松新霉素软膏治疗湿疹的随机、双盲、平行对照临床研究

Betamethasone/neomycin ointment in treatment of eczema:a randomized,double-blind,and controlled clinical trial

目的：评价倍他米松新霉素软膏治疗湿疹的疗效和安全性。方法：采用随机、双盲、平行对照临床试验方法,将湿疹病人分为2组。A组每日早晚用倍他米松新霉素软膏,B组每日早晚用新氢松软膏,疗程均2 wk。疗程结束后评价靶部位总积分的变化及不良反应。结果：共入选58例,A组和B组各29例。治疗后,A组总积分由9．3±s1．3(用药前)下降至1．4±2．6(用药后d 7)和0．4±1．6(用药后d 14),B组总积分由9．4±1．6(用药前)下降至2．3±2．3(用药后d 7)和0．3±0．8(用药后d 7),2组各时间点,差异均无显著意义(P＞0．05)。治疗d 7,A组有效率83%,B组72%,2组疗效差异显著(P＜0．05)；治疗d 14,A组有效率90%,B组97%,2组疗效无显著差异(P＞0．05)。2组均无局部和系统不良反应。结论：倍他米松新霉素软膏治疗湿疹是安全、有效的。

AIM： To evaluate the efficacy and safety of betamethasone/neomycin ointment in the treatment of eczema. METHODS： A randomized, double-blind, and controlled clinical trial was employed. The patients with eczema were divided into group A and group B. Betamethasone/neomycin ointment and hydrocortisone/ neomycin ointment were applied respectively to all sub-acute eczema in group A and B, twice daily for 2 wk. The change of total scores and adverse reactions were evaluated for all patients in the two groups. RESULTS： Fiftyeight patients were involved in this study, including 29 patients in group A and other 29 patients for the group B. There were no statistically significant difference in the total scores of target lesion changes in group A （9.3 ± 1.3 （before treatment） to 1.4 ± 2.6 （d 7 after treatment）, 0.4 ± 1.6 （d 14 after treatment）） and group B （9.4 ± 1.6 （before treatment） to 2.3± 2.3 （d 7 after treatment）, 0.3 ± 0.8 （d 14 after treatment））. After 7-d treatment, the effective rates of group A and B were 83 % and 72 % respectively, with significant difference in clinical efficacy between the two groups （P 〈 0.05） while there was no significant difference after 14-d treatment （P 〉 0.05） and the effective rate of group A and B was 90 % and 97 % respectively. There were no adverse reactions in all patients during the trial. CONCLUSION： Betamethasone/neomycin ointment is effective and safe for treatment of patients with eczema.