他扎罗汀凝胶与钙泊三醇软膏随机对照治疗寻常性斑块型银屑病多中心临床试验

A Randomized Controlled Multicenter Clinical Trial on Tazarotene Gel Versus Calcipotriol Ointment in the Treatment of Plaque Psoriasis Vulgaris

目的：评价国产０．０５％他扎罗汀凝胶治疗寻常性斑块型银屑病的疗效及安全性。方法：采用多中心、随机开放、有效药物对照、平行试验方法，０．０５％他扎罗汀凝胶局部外用每日１次，０．００５％钙泊三醇软膏每日２次外用，疗程１２周。入选病例共２０８ 例，其中入选他扎罗汀凝胶组１０５例，临床疗效评价９８例，安全性评价１０３例，入选钙泊三醇软膏组１０３例，临床疗效评价１０１例，安全性评价１０１例。结果：他扎罗汀凝胶组总有效率为 ７６．５％，钙泊三醇软膏组总有效率为７７．２％，他扎罗汀凝胶治疗斑块型银屑病总的疗效与钙泊三醇软膏相似（Ｐ＞０．０５），两组均未发现系统药物不良反应，局部刺激反应发生率分别为１２．６％和９．９％。结论：他扎罗汀凝胶治疗寻常性斑块型银屑病女全有效。

OBJECTIVE: To evaluate the efficacy and safety of 0.05% tazarotene gel in the treatment of patients with plaque psoriasis vulgaris. METHODS: A randomized open labeled controlled multicenter clinical trial was conducted. Total 208 patients with plaque psoriasis were enrolled in present clinical study. Among them, 105 patients were topically treated with 0.05%tazarotene gel once daily. 103 patients were assessable for safety and 98 patients were assessable for efficacy. 103 patients patients were topically treated with 0.005% calcipotriol ointment twice daily, 101 patients were assessable for safety and efficacy. The duration of treatment was 12 weeks for both groups. RESULTS: The results showed that Total effective rate was 76.5% for tazarotene gel group, 77.2% for calcipotriol ointment group (P>0.05). Local skin irritation was found in 12.6% in tazarotene gel group and 9.9% in calcipotriol ointment group (P>0.05)respectively, no systemic adverse event was found in either groups. CONCLUSION: The present study suggest that 0.05% tazarotene gels were safe and effective in the treatment of plaque psoriasis vulgaris.