维药新药治疗寻常型银屑病临床研究指导原则(草案)

Guideline of Clinical Research of New Drugs of Traditional Uygur Medicine for Treatment of Psoriasis Vulgaris (Draft)

针对寻常型银屑病维医诊疗方案进行多中心临床病历回顾性调查研究,收集人口学、诊断学、治疗学、疗效评价、护理学资料等信息,进行整理研究。归纳分析其主症和次症表现,将寻常型银屑病分为异常血液质型、异常胆液质型、异常咸性黏液质型、异常黑胆液质型共4型,建立寻常型银屑病维医辨证分型标准。根据银屑病皮损面积和皮损严重程度评分,结合维医主症和次症变化,建立该病的病症结合疗效评定标准。在此基础上,按照国家新药审评的技术要求和程序,研究制订了维药新药治疗寻常型银屑病的临床研究指导原则。

The multi-central clinical records retrospective survey for psoriasis vulgans was carried out by collecting related information such as demographic, diagnostics, therapeutics, efficacy evaluation, nursing data, and so on. The Uygur medical differentiation classification standard about psoriasis vulgaris was established and it was divided into four types： abnormal Khan Hilit type, abnormal Sapra Hilit type, abnormal saltness Balgham Hilit type, and abnormal Sawda Hilit type, according to main symptom and secondary symptom feature. The disease efficacy evaluation standard was established based on score of surface area and severity of skin injury combining with the changes of main symptom and secondary symptoms. On the basis, guidelines for clinical research of new drugs of Uygur medicine used in the treatment of psoriasis vulgaris were formulated in accordance with the technical requirements and procedure of national center for drug evaluation.