双盲双模拟活性药物随机Ⅲ期研究和伊曲康唑胶囊相比,咪康唑贴片局部治疗口腔念珠菌病患者的有效性和安全性
[Translation] Efficacy and safety of miconazole patch compared with itraconazole capsules in the topical treatment of patients with oral candidiasis: a double-blind, double-dummy, randomized phase III study of active drugs
主要目的:比较斯皮仁诺 100 毫克和LORAMYC 50 毫克在治疗结束(V4,第14-15 天)时的临床治愈率。
次要目的:比较两种治疗在V4的临床有效率;比较两种治疗在V4的部分改善率;真菌学疗效评价;比较两种治疗在28-30天的复发率;评价治疗无效或治疗结束后随访阶段复发受试者念珠菌属的药物敏感性;评价药物安全性等
[Translation] Primary objective: To compare the clinical cure rates of Sporanox 100 mg and LORAMYC 50 mg at the end of treatment (V4, 14-15 days).
Secondary objectives: To compare the clinical efficacy of the two treatments at V4; To compare the partial improvement rates of the two treatments at V4; To evaluate the mycological efficacy; To compare the relapse rates of the two treatments at 28-30 days; To evaluate the drug sensitivity of Candida species in subjects who were ineffective or relapsed in the follow-up period after treatment; To evaluate the safety of the drugs, etc.
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