倍他米松新霉素软膏治疗限局性亚急性湿疹的临床研究

Clinical study of betamethasone neomycin ointment in treatment of patients with subacute eczema

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 :选择限局性亚急性湿疹患者进行随机双盲、平行组对照临床试验研究 ,选择新氢松软膏进行对照。结果 :共入选病例 4 5例 ,其中试验组 2 3例 ,对照组 2 2例。试验组用药后总积分由用药前 12 .3± 2 .4下降至 5 .6± 2 .2 (第 1wk)和 2 .8± 2 .1(第 2wk) ,明显优于对照组 [13.2± 2 .3(用药前 ) ,9.2± 3.7(第 1wk) ,6 .8± 3.5 (第 2wk) ],经秩和检验有显著性差异P <0 .0 1) ;试验组总有效率86 .96 % (2 0 2 3例 ) ,高于对照组 31.82 % (7 2 2例 )(P <0 .0 1)。两组均无药物相关性局部及全身不良反应。结论 :倍他米松新霉素软膏外用治疗亚急性湿疹 ,与新氢松软膏对照组比较 ,总体疗效试验组明显优于对照组 。

AIM: To evaluate the efficacy and the safety of betamethasone neomycin ointment in treatment of patients with subacute eczema. METHODS: The clinical trial was performed on patients with limited, subacute eczema by a randomized double blind method. Hydrocortisone neomycin ointment was chosen as controls. RESULTS: There were 45 patients involved in this study, including 23 patients in betamethasone neomycin ointment group and 22 patients in hydrocortisone neomycin ointment group. The total integra decrease of betamethasone neomycin ointment group [ 12.26 ± 2.42 to 5.61 ± 2.23 ( d 7 ), 2.83 ± 2.06 ( d 14 )] was better than that of hydrocortisone neomycin ointment group [ 13.18 ± 2.28 to 9.18 ± 3.72 ( d 7 ), 6.82 ± 3.46 ( d 14 )] on the 7th and 14th day after the treatment (P< 0.01 ). The total effective rate of betamethasone neomycin ointment group ( 86.96 %) was higher than that of hydrocortisone neomycin ointment group ( 31.82 %, P< 0.01 ). Nether located nor systemic side effects were found in both groups. CONCLUSION: Betamethasone neomycin ointment is an effective and easily tolerated agent for treatment of subacute eczema compared with hydrocortisone neomycin ointment.