Abstract:

Objective To evaluate the clinical efficacy and safety of Compound Flumetasone Ointment for the patients with neurodermatitis. Methods A multi-center, randomized, open and parallel controlled clinical trial was performed in the present study. 240 patients with neurodermatitis from five centers were divided randomly into 2 groups: the experimental group with Compound Flumetasone Ointment and the control group with Sicorten Plus. The treatment course for both was 3 weeks. The efficacy was evaluated by the total symptom scores (TSS) before and at the end of the treatment. The side reactions were also recorded. Results At the end of the treatment, the difference of effective analysis between these two groups had no statistical significance (P=0.2626). The cure rate in the experimental and control group was 44.25% and 39.29%, respectively (P=0.4371). The total effective rate in the experimental and control group was 88.5% and 84.8%, respectively (P=0.4202). Cost-benefit analysis showed the average cost per unit of effectiveness of Compound Flumetasone Ointment was higher than that of Sicorten Plus, with statistical significance（P<0.0001）. 2 cases (1.77%) of side-effect were seen in the experimental group, both complaining of the local itching at the applying site. Conclusions Compound Flumetasone Ointment is effective and safe for the treatment of neurodermatitis, with higer cost performance ratio compared with Sicorten Plus.