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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 compound anisodamine ointment in the treatment of chilblain, a randomized, double-blind, multicenter, controlled and parallel phase II clinical trial was conducted with chilblain as a positive control. Two drugs were used in the hands and feet, 3 times a day, continuous medication 15d. The results showed that the cure rate of compound anisodamine ointment was 42.8% and the effective rate was 83.5%. The cure rate of frostbite paste was 20% and the effective rate was 57.7%. There was a statistically significant difference (P <0.001). Two drugs each have local irritation in two cases, the incidence of adverse drug reactions were 1.5%. The results suggest that compound anisodamine ointment for the treatment of frostbite has the advantages of convenient, safe, effective and no adverse drug reactions.