复方山莨菪碱软膏与冻疮膏治疗冻疮疗效比较

A COMPARISON OF ANISODAMINE COMPOUND OINTMENT AND DONG CHUANG OINTMENT FOR THE TREATMENT OF CHILBLAIN

为研究复方山莨菪碱软膏治疗冻疮的疗效和安全性，以冻疮膏作阳性对照，进行随机，双盲，多中心，对照，平行Ⅱ期临床试验。两药分别用于手、足部位，每日３次，连续用药１５ｄ。结果表明，复方山莨菪碱软膏治疗冻疮治愈率４２．８％，有效率８３．５％，而冻疮膏的治愈率为２０％，有效率５７．７％。统计学上有明显差异，（Ｐ＜０．００１）。两药均各有２例发生局部刺激，药物不良反应的发生率均为１．５％。结果提示复方山莨菪碱软膏治疗冻疮具有用药方便，安全，有效且无明显药物不良反应之优点。

To study the efficacy and safety of anisodmine compound ointment in the treatment of dong chuang ,a randomized,double-blind,multi center ,effective controlled clinical trial was performed.137 patients were given anisodamine compound ointment and another 130 patients were given dong chuang ointment.Both drugs were used on the surface of suffered skin 3 times a day for 2 weeks. The result showed that the curative rates and effective rates were 38.7%, 86.9%and 20%, 57.7% in the two groups respectively. The effective rates between the two groups was significant difference (P<0.01). No systemic effects were found in both treatment and local. The adverse effects of both drugs were slight and the rates were only 1.5% respectively. These results suggested that anisodamine compound ointment has the advantage of safety, high effective rates and has on evidently averse reaction for the treatment of chilblain.